Clinical Symptoms and Adverse Effects Associated With Energy Drink Consumption in Adolescents.

PubMed

Bashir, Dalia; Reed-Schrader, Essie; Olympia, Robert P; Brady, Jodi; Rivera, Ruby; Serra, Theresa; Weber, Christopher

2016-11-01

The aims of the study were to determine the prevalence of energy drink consumption by adolescents, to identify associated clinical symptoms and adverse effects, and to gain an understanding to the motivation behind its consumption. A prospective, questionnaire-based study was conducted at 2 emergency departments from June 2011 to June 2013. The questionnaire was distributed to a convenience sample of adolescents aged 12 to 18 years. Stratification was performed on the basis of frequency of consumption: frequent consumption (at least once a month) and infrequent consumption (less frequent than once a month). Data analysis was performed on 612 completed questionnaires. Two hundred two responders (33%) were considered frequent energy drink consumers. Frequent consumers were more likely to be involved in high-risk behaviors and more likely to consume other caffeinated drinks. In the previous 6 months, frequent energy drink consumers were more likely to report headache (76%), anger (47%), and increased urination (24%) and were more likely to require medical evaluation for headache (41%) and difficulty breathing (22%). Frequent energy drink consumers were more likely to believe that energy drinks "help me do better in school" (12%), "help me do better in sports" (35%), "are just for fun" (46%), "help me stay up at night" (67%), and "make me concentrate/focus better" (34%). Clarifying common misconceptions associated with energy drink consumption, especially in high-risk adolescents and frequent energy drink consumers, may decrease the frequency of symptoms experienced by adolescents, such as headache and difficulty breathing, requiring medical evaluation.

Yellow fever vaccine used in a psoriatic arthritis patient treated with methotrexate: a case report.

PubMed

Stuhec, Matej

2014-01-01

The yellow fever vaccines on the market are contraindicated for immunocompromised and elderly patients. A case of yellow fever vaccine used in a 27-year-old Slovenian male with psoriatic arthritis during treatment with methotrexate is described. We demonstrate a positive case, since there were no adverse effects in concurrent administration of yellow fever vaccine and methotrexate. This patient did not show severe adverse reactions and did not contract yellow fever despite potential exposure. More research is needed on possible adverse effects of concurrent administration of yellow fever vaccine and methotrexate to determine the potential of this method for more frequent use.

Marijuana for Glaucoma: A Recipe for Disaster or Treatment?

PubMed Central

Sun, Xiaoshen; Xu, Chaoying S.; Chadha, Nisha; Chen, Allshine; Liu, Ji

2015-01-01

Marijuana has been shown to lower intraocular pressure (IOP) but with limited duration of action and numerous adverse effects. Use of marijuana to lower IOP as a means of glaucoma treatment would require frequent use throughout the day, leading to significant adverse effects, possible progression toward Cannabis Use Disorder (CUD), and/or withdrawal symptoms. The treatment of glaucoma based on the cannabis plant or drugs based on the cannabinoid molecule should be considered carefully before being prescribed. Considerations should include the adverse physical and psychological adverse effects, including substance abuse. Currently, the deleterious effects of marijuana outweigh the benefits of its IOP-lowering capacity in most glaucoma patients. Under extremely rare circumstances, a few categories of glaucoma patients may be potential candidates for treatment with medical marijuana. Further studies on alternate routes and more focused means of cannabinoid molecule delivery to the eye for glaucoma treatment are needed. PMID:26339209

Marijuana for Glaucoma: A Recipe for Disaster or Treatment?

PubMed

Sun, Xiaoshen; Xu, Chaoying S; Chadha, Nisha; Chen, Allshine; Liu, Ji

2015-09-01

Marijuana has been shown to lower intraocular pressure (IOP) but with limited duration of action and numerous adverse effects. Use of marijuana to lower IOP as a means of glaucoma treatment would require frequent use throughout the day, leading to significant adverse effects, possible progression toward Cannabis Use Disorder (CUD), and/or withdrawal symptoms. The treatment of glaucoma based on the cannabis plant or drugs based on the cannabinoid molecule should be considered carefully before being prescribed. Considerations should include the adverse physical and psychological adverse effects, including substance abuse. Currently, the deleterious effects of marijuana outweigh the benefits of its IOP-lowering capacity in most glaucoma patients. Under extremely rare circumstances, a few categories of glaucoma patients may be potential candidates for treatment with medical marijuana. Further studies on alternate routes and more focused means of cannabinoid molecule delivery to the eye for glaucoma treatment are needed.

Opportunities for Web-based Drug Repositioning: Searching for Potential Antihypertensive Agents with Hypotension Adverse Events.

PubMed

Wang, Kejian; Wan, Mei; Wang, Rui-Sheng; Weng, Zuquan

2016-04-01

Drug repositioning refers to the process of developing new indications for existing drugs. As a phenotypic indicator of drug response in humans, clinical side effects may provide straightforward signals and unique opportunities for drug repositioning. We aimed to identify drugs frequently associated with hypotension adverse reactions (ie, the opposite condition of hypertension), which could be potential candidates as antihypertensive agents. We systematically searched the electronic records of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) through the openFDA platform to assess the association between hypotension incidence and antihypertensive therapeutic effect regarding a list of 683 drugs. Statistical analysis of FAERS data demonstrated that those drugs frequently co-occurring with hypotension events were more likely to have antihypertensive activity. Ranked by the statistical significance of frequent hypotension reporting, the well-known antihypertensive drugs were effectively distinguished from others (with an area under the receiver operating characteristic curve > 0.80 and a normalized discounted cumulative gain of 0.77). In addition, we found a series of antihypertensive agents (particularly drugs originally developed for treating nervous system diseases) among the drugs with top significant reporting, suggesting the good potential of Web-based and data-driven drug repositioning. We found several candidate agents among the hypotension-related drugs on our list that may be redirected for lowering blood pressure. More important, we showed that a pharmacovigilance system could alternatively be used to identify antihypertensive agents and sustainably create opportunities for drug repositioning.

[Serious systemic adverse events associated with allergen-specific immunotherapy in children with asthma].

PubMed

Dai, Li; Huang, Ying; Wang, Ying; Han, Huan-Li; Li, Qu-Bei; Jiang, Yong-Hui

2014-01-01

To retrospectively assess serious systemic adverse effects of standardized dust-mite vaccine in children with asthma. Medical records of 704 children (5-17 years in age) with asthma between January, 2005 and December, 2011 were reviewed. Serious systemic adverse events following treatment with a standardized dust-mite vaccine in these children were analyzed. A total of 336 systemic adverse reactions were observed in 17.0% (120/704) of the patients analyzed of these adverse reactions, 18 (5.4%) were serious (level 3), 318 (94.6%) were not serious (below level 3), and no single case of anaphylactic shock (level 4) was recorded. Systemic adverse events occurred most frequently in the 5 to 11-year age group and in the summer season (from June to August). In the 18 severe cases, the peak expiratory flow (PEF) dropped by 20% immediately after the vaccine injection, and other major clinical symptoms included cough, wheezing and urticaria. All children with serious systemic adverse effects were given inhaled hormone and atomized short-acting beta agonists, oral antihistamines, intravenous dexamethasone and/or intramuscular adrenaline. After these treatments, the clinical symptoms were significantly relieved. The rate of serious systemic adverse events following allergen-specific immunotherapy is relatively low in children with allergic asthma. Conventional medications are effective in managing these immunotherapy-associated adverse events.

Energy drink usage among university students in a Caribbean country: Patterns of use and adverse effects.

PubMed

Reid, Sandra D; Ramsarran, Jonathan; Brathwaite, Rachel; Lyman, Sarika; Baker, Ariane; Cornish, D'Andra C; Ganga, Stefan; Mohammed, Zahrid; Sookdeo, Avinash T; Thapelo, Cathrine K

2015-06-01

There has been little inquiry addressing whether or not concerns about adverse effects of energy drink usage are relevant in the Caribbean. This survey investigated energy drink usage and adverse consequences among tertiary level students in Trinidad and Tobago. A cross-sectional survey of 1994 students from eight institutions was conducted using a de novo questionnaire based on findings from a focus group of students. Chi-squared analyses and logistic regression were used to assess relationships between energy drink usage, adverse effects and other factors affecting energy drink use, and to verify predictors of energy drink use. Prevalence of use was 86%; 38% were current users. Males were more likely to use, used more frequently and at an earlier age. Energy drinks were used most commonly to increase energy (50%), combat sleepiness (45%) and enhance academic performance (40%), and occurred during sports (23%) and mixed with alcohol (22.2%). The majority (79.6%) consumed one energy drink per sitting; 62.2% experienced adverse effects, most commonly restlessness (22%), jolt and crash (17.1%) and tachycardia (16.6%). Awareness of adverse effects was associated with no use (p=0.004), but adverse effects were not a deterrent to continued use. Energy drink usage is prevalent among students. The use is not excessive, but associated with high rates of adverse effects and occurs in potentially dangerous situations like during exercise and with alcohol. There is a need to educate students about the potential adverse effects of energy drinks. Copyright © 2014 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

Detecting and Managing Adverse Effects of Antipsychotic Medications: Current State of Play.

PubMed

Ames, Donna; Carr-Lopez, Sian M; Gutierrez, Mary A; Pierre, Joseph M; Rosen, Jennifer A; Shakib, Susan; Yudofsky, Lynn M

2016-06-01

Antipsychotics are some of the most frequently prescribed medications not only for psychotic disorders and symptoms but also for a wide range of on-label and off-label indications. Because second-generation antipsychotics have largely replaced first-generation antipsychotics as first-line options due to their substantially decreased risk of extrapyramidal side effects, attention has shifted to other clinically concerning adverse events associated with antipsychotic therapy. The focus of this article is to update the nonextrapyramidal side effects associated with second-generation antipsychotics. Issues surrounding diagnosis and monitoring as well as clinical management are addressed. Published by Elsevier Inc.

[Pharmacovigilance in Portugal: Activity of the Central Pharmacovigilance Unit].

PubMed

Batel-Marques, Francisco; Mendes, Diogo; Alves, Carlos; Penedones, Ana; Dias, Patricia; Martins, Angelina; Santiago, Luiz Miguel; Fontes-Ribeiro, Carlos; Caramona, Margarida; Macedo, Tice

2015-01-01

The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit. Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported. The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were anti-infectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable. The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs. In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.

Epilepsy in the School Aged Child: Cognitive-Behavioral Characteristics and Effects on Academic Performance.

ERIC Educational Resources Information Center

Black, Kathryn C.; Hynd, George W.

1995-01-01

Children with epilepsy frequently display cognitive sequelae that are overlooked or misunderstood by educational personnel, yet may adversely impact academic performance. Reviews common cognitive-behavioral characteristics of children with epilepsy, typical effects of anticonvulsant medications, and various periictal phenomena and their relative…

Effects of triclosan in breast milk on the infant fecal microbiome

USDA-ARS?s Scientific Manuscript database

Triclosan is frequently used for its antimicrobial properties and has been detected in human serum, urine, and breast milk. Animal and molecular studies have shown that triclosan exerts a wide range of adverse health effects at both high (ppm) and low (ppb) concentrations. Since triclosan is of grow...

Cinnamon: A systematic review of adverse events.

PubMed

Hajimonfarednejad, Mahdie; Ostovar, Mohadeseh; Raee, Mohammad Javad; Hashempur, Mohammad Hashem; Mayer, Johannes Gottfried; Heydari, Mojtaba

2018-04-05

Cinnamon, from the genus Cinnamomum and Lauraceae family, has been used as a popular spice for thousands of years around the world. Many studies have shown therapeutic effects of cinnamon including its antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. Due to popular use of cinnamon and several human reports on adverse events associated with short or long term use of cinnamon, we aimed to systematically review its human reports of adverse event. Databases including Medline, Scopus, Science Direct, Embase, PubMed Central and Google scholar were searched using the key words "cinnamon" or "cinnamomum" for clinical trials, case reports and case series. Also spontaneous reports about adverse effects of cinnamon were collected from five national and international spontaneous reporting schemes. Thirty eight clinical trials were found, five of them reported adverse events. Twenty case reports and seven case series, as well as, spontaneous reports including 160 adverse events were also included. The most frequent adverse events were gastrointestinal disorders and allergic reactions which were self-limiting in the majority of cases. The available data suggests that despite the safety of cinnamon use as a spice and/or flavoring agent, its use may be associated with significant adverse effects in medicinal uses with larger doses or longer duration of use and should be clinically monitored. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

[Nearby nature as a moderator of stress during childhood].

PubMed

Corraliza, José Antonio; Collado, Silvia

2011-04-01

The aim of this investigation is to study the relation between the amount of nature existing in children's daily environments and the way children deal with stressful events. Every day, children are exposed to situations that cause stress. Taking into account previous studies, it is thought that the greener the place where children spend their time, the better they cope with adversities. Thus, when comparing the stress level of children who are exposed to the same amount of adverse situations, the children who have more frequent daily contact with nature will show less stress than those who do not spend time in nature. This effect from nearby nature is called a buffering effect. The present study provides empirical evidence of the buffering effect caused by the existence of Nature in the residential and the school environment. Therefore, our results show that children who have more access to nature increase their resilience, showing a lower stress level than children whose contact with nature is less frequent.

Efficacy and tolerability of anti-epileptic drugs-an internet study.

PubMed

Wieshmann, U C; Baker, G

2017-05-01

To ascertain efficacy and tolerability of carbamazepine (CBZ), sodium valproate (VPA), lamotrigine (LTG) and levetiracetam (LEV) using the UKAED register (www.ukaed.info). Patients on CBZ (n=91), VPA (n=61), LTG (n=105), LEV (n=72) and healthy control subjects (CTR) on no medication (n=51) were extracted. All patients had anonymously provided information on seizure type and frequency and completed the Liverpool Adverse Event Profile (LAEP). The number of seizure-free patients in the last 4 weeks was overall CBZ/VPA/LTG/LEV=60%/79%/67%/67%, for generalized epilepsy was CBZ/VPA/LTG/LEV=67%/89%/65%/94%, and for localization-related epilepsy was CBZ/VPA/LTG/LEV=59%/71%/67%/57%. Mean LAEP scores were CBZ/VPA/LTG/LEV/CTR=42.21/39.66/39.86/43.01/29.69. The mean LAEP was significantly higher in patients reporting depression and in patients with active epilepsy than in patients without depression and remission. Central nervous system (CNS) adverse effects including memory problems, difficulty concentrating, depression, unsteadiness, restlessness, feelings of anger, shaky hands and dizziness were significantly more frequent in CBZ, VPA, LTG and LEV than in CTR. The feeling of anger was significantly more frequent in LEV, and depression was significantly more frequent in CBZ compared to the other drugs. In this Internet-based register of self-reported efficacy and tolerability, CBZ, VPA, LTG and LEV were similar. Self-reported CNS adverse effects were significantly more frequent than in controls. In addition, anger was associated with LEV and depression with CBZ. Confounding factors were depression and uncontrolled epilepsy. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Neurological Adverse Effects in Patients of Advanced Colorectal Carcinoma Treated with Different Schedules of FOLFOX

PubMed Central

Najam, Rahila; Mateen, Ahmed

2013-01-01

The study is designed to assess the frequency and severity of few dose limiting neurological adverse effects of four different schedules of FOLFOX. Patients with histologically confirmed advanced colorectal carcinoma (CRC) were included in the study. Toxicity was graded according to CTC v 2.0. The frequency of grade 3 and 4 adverse effects was comparatively assessed in each treatment arm. The difference in the pattern of toxicity between the treatment schedule was evaluated. The most frequent adverse symptom of neurological adverse effect was grade 1 paresthesia in the patients treated with FOLFOX4 schedule. Grade 4 peripheral neuropathy was reported in few patients of FOLFOX7 treatment arm. Frequency and onset of neurological adverse effects like paresthesia, dizziness, and hypoesthesia were significantly different (P < 0.05), whereas frequency and onset of peripheral neuropathy were highly significant (P < 0.01) in each treatment arm of FOLFOX. Peripheral neuropathy was associated with electrolyte imbalance and diabetes in few patients. Frequency of symptoms, for example, paresthesia, is associated with increased number of recurrent exposure to oxaliplatin (increased number of cycles) even at low doses (85 mg/m2), whereas severity of symptoms, for example, peripheral neuropathy, is associated with higher dose (130 mg/m2) after few treatment cycles. PMID:24187619

Side Effects of CV Medications Following Hospitalization for ACS Are Associated With More Frequent Health-Care Contacts.

PubMed

Le, Rachel J; Cullen, Michael W; Lahr, Brian D; Wright, R Scott; Kopecky, Stephen L

2017-05-01

Patients hospitalized for first acute coronary syndrome (ACS) are frequently discharged on multiple new medications. The short-term tolerability of these medications is unknown. This single-center cohort study assessed 30-day health-care utilization and how it may be impacted by medication prescribing trends. We included Olmsted County patients presenting with ACS and previously undiagnosed coronary artery disease in 2008 to 2009. All health-care contacts were reviewed 30 days after index hospital discharge for potential adverse medication effects including documented hypotension or bradycardia, or symptoms likely attributed to the medications. The study included 86 patients; their mean age was 63 (standard deviation: 15.5 years). Antianginal or antihypertensive cardiovascular (CV) medications were prescribed to 98% of patients at discharge; 76% were prescribed 2 or more. There were 233 health-care contacts in 30 days; 90 (39%) of these contacts were unscheduled. More CV medications tended to be prescribed to patients with unscheduled contacts, both pre-ACS ( P = .045) and upon hospital discharge ( P = .051). Hypotension and/or bradycardia at follow-up occurred in 52 patients (60%). Surprisingly, there was no association between hypotension and/or bradycardia at follow-up and increased health-care utilization ( P = .12). Potential adverse drug effects were reported in 34 (40%) patients. These patients had significantly more total health-care contacts ( P < .001) and unscheduled health-care contacts (median 0 vs 1.5; P < .001). Symptoms of adverse drug effects were associated with more frequent health-care utilization after ACS. Clinicians need to consider this while striving to increase patient compliance with post-ACS medications and optimize care transitions.

Nutritional and sports supplement use among deployed U.S. Army soldiers in a remote, austere combat outpost in eastern Afghanistan.

PubMed

Paisley, Robert D

2015-04-01

Nutritional and sports supplements are commonly used by soldiers, with uncertain implications for health and mission readiness. An anonymous survey was conducted of a company of U.S. Army paratroopers deployed to eastern Afghanistan between December 2011 and October 2012. Survey questions covered supplements used, duration of use, adverse effects, and medication interactions. Exercise habits, goals for exercise and supplement use, and information and acquisition sources were also queried. Out of 112 surveys distributed, 100 completed surveys were returned. 77 respondents reported using at least one supplement during deployment. On average, 2.5 supplements were used per individual surveyed. Nine respondents reported adverse effects of supplement use. No respondents reported serious complications of supplement use, drug interactions, or seeking medical care for supplement adverse effects. The Internet was the most frequently reported source of information on supplement use. Most frequently, supplements were acquired by Internet mail order. Supplement use occurs during deployment among paratroopers at a higher rate than reported in garrison, despite their remote and austere deployed location. These findings have profound implications for military health care providers and policy makers considering the health of deployed combat soldiers. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Tanning accelerators: prevalence, predictors of use, and adverse effects.

PubMed

Herrmann, Jennifer L; Cunningham, Rachel; Cantor, Alan; Elewski, Boni E; Elmets, Craig A

2015-01-01

Tanning accelerators are topical products used by indoor tanners to augment and hasten the tanning process. These products contain tyrosine, psoralens, and/or other chemicals. We sought to better define the population using accelerators, identify predictors of their use, and describe any related adverse effects. This cross-sectional study surveyed 200 indoor tanners about their tanning practices and accelerator use. Primary analysis compared accelerator users with nonusers with respect to questionnaire variables. Descriptive statistics and χ(2) contingency tables were applied to identify statistically significant variables. Of respondents, 53% used accelerators; 97% were female and 3% were male with a median age of 22 years (range: 19-67). Users were more likely to spray tan, tan frequently, and be addicted to tanning. Acne and rashes were more common in accelerator users. Adverse reactions to accelerators prevented their further use 31% of the time. A limited adult population was evaluated; exact accelerator ingredients were not examined. Tanning accelerator users are high-risk indoor tanners who tan more frequently and who are more likely addicted to tanning. Acne and rashes are more common with these products and act as only mild deterrents to continued use. Additional research should investigate accelerators' longer-term health effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Treatment of Functional Abdominal Pain With Antidepressants: Benefits, Adverse Effects, and the Gastroenterologist's Role.

PubMed

Zar-Kessler, Claire A M; Belkind-Gerson, Jaime; Bender, Suzanne; Kuo, Braden M

2017-07-01

Pediatric functional abdominal pain is often treated with tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). The aim is investigating antidepressant use for treatment efficacy, correlation of response to psychiatric factors, and impact of adverse effects in regard to physicians' prescribing patterns. Retrospective review (2005-2013) children (5-21 years old) with functional abdominal pain treated with SSRI or TCA. Of the 531 cases with functional abdominal pain, 192 initiated SSRIs or TCAs while followed by gastroenterology. Charts reviewed for symptoms, adverse effects, and response: decreased pain or increased daily functioning. Sixty-three of 84 (75%) SSRI patients improved, 56 of 92 (61%) TCA patients improved (P = 0.03). Logistic regression controlling for psychiatric factors: SSRI remained significant over TCA (P = 0.04). Thirty-two of 67 (48%) patients with constipation received TCAs and 26 of 45 (58%) patients with diarrhea received SSRIs (P = 0.64). Three SSRI patients reported gastrointestinal effects, all diarrheal-type symptoms, and 2 TCA patients reported gastrointestinal effects, both constipation, in all it led to discontinuation. Thirteen (29%) of diarrheal-type patients reported adverse effects causing discontinuation as compared to 7 (8%) in the constipation group (P = .01). Twenty-one (25%) SSRI patients reported adverse effects with 5 (6%) mood disturbances. Twenty (22%) TCA patients reported adverse effects, 13 (14%) with mood disturbances (P = .07). Overall, 12 (14%) SSRI patients discontinued medication due to adverse effects, whereas 16 (17%) TCA patients (P = 0.24) did. Patients had significantly greater response to SSRIs than TCAs, remaining significant after controlling for psychiatric factors. Little significance is given to patient's associated gastrointestinal symptoms, frequently resulting in adverse effects and termination of medication.

Surveillance of adverse effects during a vaccination campaign against meningitis C.

PubMed

Laribière, Anne; Miremont-Salamé, Ghada; Reyre, Hadrien; Abouelfath, Abdelilah; Liège, Ludovic; Moore, Nicholas; Haramburu, Françoise

2005-12-01

To describe adverse events occurring after mass vaccination with conjugate and nonconjugate vaccines and to assess the incidence of serious adverse effects. A mass immunisation campaign against meningococcal C disease was conducted in two French administrative areas, Landes and Pyrénées atlantiques, for 2 months (from October to December 2002). Adverse events were reported by families and physicians by means of a specific reporting form returned to the pharmacovigilance centre 15 days after vaccination. The target population was 260,630 individuals aged between 2 months and 24 years. About 179,000 children and young adults were vaccinated. A total of 92,711 report forms were received by the pharmacovigilance centre, and 12,695 subjects presented at least one adverse event. The most frequently involved systems/disorders were application site disorders (48.4%), whole-body general disorders (21.8%), central and peripheral nervous system disorders (14.6%), and gastrointestinal system disorders (4.7%). Most of these adverse events were transient and not serious. There were 13 serious adverse events: one each of syncope, fever, headache with fever, neuralgia, serum sickness, arthritis, purpura, facial paralysis, multiple sclerosis, lipoma, and meningism, and two cases of bronchospasm. No significant difference was found in rates of adverse event reports between both vaccines. The estimated incidence of serious adverse effect reports was 7 per 100,000. This campaign was the second immunisation campaign undertaken in France involving both physicians and families as reporters. Although unlabeled adverse effects were identified during this campaign, they were mostly nonserious and have been known to occur with other vaccines.

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Stub, Trine; Musial, Frauke; Kristoffersen, Agnete A; Alræk, Terje; Liu, Jianping

2016-06-01

Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine. Copyright © 2016 Elsevier Ltd. All rights reserved.

Radioactive Iodine Administration Is Associated with Persistent Related Symptoms in Patients with Differentiated Thyroid Cancer

PubMed Central

Droppelmann, Nicolás

2016-01-01

Context. Radioiodine (RAI) administration has adverse effects in patients treated for thyroid cancer (DTC), but there is scarce information regarding their intensity and duration. Objective. To evaluate frequency and intensity of early and late RAI-related symptoms in patients with DTC. Design. Observational prospective study. Patients. DTC patients who underwent thyroidectomy, with or without RAI. Measurements. Patients answered 2 surveys: (1) from 0 to 6 months and (2) between 6 and 18 months after initial treatment. Results. 110 patients answered the first survey and 61 both. Nearly 80 percent received RAI. Among early symptoms, periorbital edema, excessive tearing, salivary gland disturbances, dry mouth, taste disorders, and nausea were more frequent and intense among RAI patients. Regarding late symptoms, periorbital edema, salivary gland pain and swelling, and dry mouth were more frequent and intense in RAI patients. Frequency and intensity of adverse effects were not different between low and high RAI doses (50 versus ≥100 mCi). Conclusion. RAI-related symptoms are frequent and usually persist after 6 months of administration, even when low doses are given. This finding must be considered when deciding RAI administration, especially in low risk patients, among whom RAI benefit is controversial. PMID:27867395

Radioactive Iodine Administration Is Associated with Persistent Related Symptoms in Patients with Differentiated Thyroid Cancer.

PubMed

Florenzano, Pablo; Guarda, Francisco J; Jaimovich, Rodrigo; Droppelmann, Nicolás; González, Hernán; Domínguez, José M

2016-01-01

Context . Radioiodine (RAI) administration has adverse effects in patients treated for thyroid cancer (DTC), but there is scarce information regarding their intensity and duration. Objective . To evaluate frequency and intensity of early and late RAI-related symptoms in patients with DTC. Design . Observational prospective study. Patients . DTC patients who underwent thyroidectomy, with or without RAI. Measurements . Patients answered 2 surveys: (1) from 0 to 6 months and (2) between 6 and 18 months after initial treatment. Results . 110 patients answered the first survey and 61 both. Nearly 80 percent received RAI. Among early symptoms, periorbital edema, excessive tearing, salivary gland disturbances, dry mouth, taste disorders, and nausea were more frequent and intense among RAI patients. Regarding late symptoms, periorbital edema, salivary gland pain and swelling, and dry mouth were more frequent and intense in RAI patients. Frequency and intensity of adverse effects were not different between low and high RAI doses (50 versus ≥100 mCi). Conclusion . RAI-related symptoms are frequent and usually persist after 6 months of administration, even when low doses are given. This finding must be considered when deciding RAI administration, especially in low risk patients, among whom RAI benefit is controversial.

Phentolamine mesylate to reverse oral soft-tissue local anesthesia: A systematic review and meta-analysis.

PubMed

Prados-Frutos, Juan Carlos; Rojo, Rosa; González-Serrano, José; González-Serrano, Carlos; Sammartino, Gilberto; Martínez-González, José María; Sánchez-Monescillo, Andrés

2015-10-01

Knowing that patients desire reduced duration of local anesthesia, the authors performed a meta-analysis to evaluate the efficacy of phentolamine mesylate (PM) in reducing anesthesia duration and the occurrence of adverse effects. The authors searched studies in 4 electronic databases up to December 18, 2014. For each study, the methodological quality was assessed according to the Cochrane Collaboration's tool for assessing risk of bias. Randomized controlled trials (RCTs) that used PM met the inclusion criteria. Six RCTs met the inclusion criteria and were used to carry out a meta-analysis of the effectiveness of PM and a qualitative analysis of its adverse effects. The use of PM was more effective in reversing the anesthetic effect on the lower lip and tongue than was applying a placebo. Adverse effects reported in the studies were not statistically significant, the most frequent being headache, pain during injection, and postprocedure pain. Based on limited evidence, PM is effective in reducing the persistence of anesthesia duration on the lower lip and tongue, with infrequent adverse effects of little clinical significance. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

NEW APPROACHES AND TOOLS FOR THE CONDUCT OF COMMUNITY-BASED CUMULATIVE RISK ASSESSMENTS

EPA Science Inventory

Individuals have differential exposures and potential risk of adverse health effects, regardless of whether chemical exposure occurs singly or as mixtures of several chemicals. Elevated exposures can result from frequent contact with environmental contaminants and depends on the...

Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.

PubMed

Masip, Montserrat; Tuneu, Laura; Pagès, Neus; Torras, Xavier; Gallego, Adolfo; Guardiola, Josep Maria; Faus, María José; Mangues, Maria Antònia

2015-12-01

Current treatment combinations for chronic hepatitis C virus infection still include pegylated interferon and ribavirin despite the new therapeutic options available. Interferon-based treatments are associated with a high incidence of adverse effects. Central nervous system events are among the most frequent adverse drug reactions and their influence on treatment adherence and effectiveness is controversial. The aim of the study was to evaluate neuropsychiatric adverse effects of interferon-based treatment for chronic hepatitis C in standard multidisciplinary clinical practice. Risk factors for these adverse effects and their impact on adherence and sustained viral response were also evaluated. Setting Ambulatory care pharmacy in coordination with the liver unit and the infectious diseases unit at a 650-bed tertiary university hospital. We included all consecutive patients with chronic hepatitis C who completed treatment with pegylated interferon and ribavirin between 2005 and 2013. All patients underwent a multidisciplinary follow-up during treatment. Neuropsychiatric adverse effects were evaluated in relation to severity, management and outcome. The presence of anxiety and depression was evaluated by means of specific tests. A total of 717 treatments in 679 patients were included. During treatment, we detected 1679 neuropsychiatric adverse effects in 618 patients (86.2 %), generating 1737 clinical interventions. Fifty-seven (3.3 %) neuropsychiatric adverse effects were severe and 2 (0.1 %) were life-threatening (suicidal attempts). Most neuropsychiatric adverse effects (1555 events, 92.6 %) resolved without sequelae. Psychiatric medication was required in 289 patients (40.3 %). Sustained viral response was achieved in 400 cases (55.8 %) and was associated with adherence (OR = 1.942, 95 % CI = 1.235-3.052, p = 0.004). A multivariate analysis did not show any relationship between neuropsychiatric adverse effects and treatment adherence or sustained viral response. A psychiatric history was a strong risk factor for depression, anxiety and other psychiatric disorders during treatment. Neuropsychiatric adverse effects during interferon-based treatments in patients with chronic hepatitis C were common but mostly mild or moderate. Early detection and accurate multidisciplinary management avoided treatment discontinuation, ensuring adherence and attaining sustained viral response. The identified risk factors could be used to determine patients eligible for interferon-free combinations, thus optimizing health system economics.

The Effect of Sexual Abuse and Prenatal Substance Use on Successful Breastfeeding.

PubMed

Jansson, Lauren M; Velez, Martha L; Butz, Arlene M

Barriers to breastfeeding in women with substance use disorders (SUDs) often exist. Neonatal abstinence syndrome-related feeding difficulties, maternal SUD-related maladaptive behaviors, and psychological comorbidities can adversely affect breastfeeding. A neglected barrier that frequently occurs in women with SUDs is a history of sexual abuse. It is important that nurses and providers understand each maternal and/or infant factor that can affect the breastfeeding course to assist effectively with lactation support for these frequently misunderstood dyads. Copyright © 2017 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

Cutaneous Side-effects of Immunomodulators in MS.

PubMed

Lebrun, C; Bertagna, M; Cohen, M

2011-09-01

Local skin reactions to subcutaneous injections of interferon beta (IFNB) or glatiramer acetate (GA) in multiple sclerosis (MS) are frequent, while severe cutaneous toxicity is rare. Both IFNB and GA are immunomodulatory drugs that have excellent safety profiles and are currently used for treatment of MS. They are administered by SC injection every other day for IFNB-1b, three times a week for IFNB-1a or daily for 20 mg for GA. The most common adverse effects, which occur in approximately 20-60% of patients, include pain, inflammation and induration at the injection sites. Another adverse effect is frank panniculitis followed by localized lipoatrophy at the injection sites, which has been described in half of the patients receiving GA injections but is also described with Subcutaneous IFNB-1b. No guidelines have yet been established for the treatment of skin reactions, which is a frequent point for discussion between neurologists and dermatologists. In addition, no treatment has been found for established lipoatrophy. The prevention and management of cutaneous side-effects include patient education, regular examination and manual palpation of all injection sites. Non-steroid antiinflammatory gels, local corticosteroids or endermology can help patients to resolve side-effects and to continue immunomodulatory treatment.

Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries

PubMed Central

Restani, Patrizia; Di Lorenzo, Chiara; Garcia-Alvarez, Alicia; Badea, Mihaela; Ceschi, Alessandro; Egan, Bernadette; Dima, Lorena; Lüde, Saskia; Maggi, Franco M.; Marculescu, Angela; Milà-Villarroel, Raimon; Raats, Monique M.; Ribas-Barba, Lourdes; Uusitalo, Liisa; Serra-Majem, Lluís

2016-01-01

Background The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described. Objectives To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey. Subjects/Setting From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS. Results Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems. Conclusions Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals. PMID:26928206

A TOXICITY IDENTIFICATION EVALUATION OF SILTY MARINE HARBOR SEDIMENTS TO CHARACTERIZE PERSISTENT AND NON-PERSISTENT CONSTITUENTS

EPA Science Inventory

Sediment toxicity in silty marine harbor sediments is frequently dominated by ammonia or sulfide, leaving the adverse effects of persistent toxic substances unnoticed. To investigate the latter, we subjected interstitial water from three contaminated silty sediments to toxicity i...

The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.

PubMed

Carnovale, Carla; Brusadelli, Tatiana; Zuccotti, GianVincenzo; Beretta, Silvia; Sullo, Maria Giuseppa; Capuano, Annalisa; Rossi, Francesco; Moschini, Martina; Mugelli, Alessandro; Vannacci, Alfredo; Laterza, Marcella; Clementi, Emilio; Radice, Sonia

2014-09-01

To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use. We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization. The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.

Assessing the interrelatedness of multiple types of adverse childhood experiences and odds for poor health in South Carolina adults.

PubMed

Crouch, Elizabeth; Strompolis, Melissa; Bennett, Kevin J; Morse, Melanie; Radcliff, Elizabeth

2017-03-01

Adverse childhood experiences (ACEs) have been linked to negative health outcomes in adulthood, but little research has been done on the effect of ACEs on the health and well-being of adults in South Carolina (SC). This study analyzed a sample of 9744 respondents who participated in the 2014 South Carolina Behavioral Risk Factor Surveillance System (BRFSS) to examine the relationship among childhood experiences of physical, sexual, and emotional abuse, as well as witnessing household violence, on mental and physical health outcomes in adulthood among SC residents. Twenty-two percent of survey respondents reported poor general health (22.1%), and a smaller proportion reported high frequent mental distress in the past month (13.1%). Each category of childhood experiences was associated with an increase in the risk of poor general health. Individuals reporting three or more types of experiences were more likely to report poor health (aOR 2.89; 95% CI 2.86-2.92) than adults without such experiences. Respondents reporting three or more types of childhood adverse experiences were more likely to report frequent mental distress (aOR 3.29; 95% CI 3.26-3.33) compared to adults who did not report three or more types of adversity. Findings from the SC BRFSS highlight a connection between ACEs and negative health outcomes later in life. Given that results of this study also demonstrated that increased exposure to ACEs was associated with greater odds of negative health in adulthood, preventing adverse events such as experiencing abuse or witnessing domestic violence in childhood will have significant effects on later adult health. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Adverse reactions to mosquito bites in scholars from Monterrey, Nuevo Leon, Mexico].

PubMed

Manrique López, María Amelia; González Díaz, Sandra N; Arias Cruz, Alfredo; Sedó Mejía, Giovanni A; Canseco Villarreal, José Ignacio; Gómez Retamoza, Ernesto Antonio; Padrón López, Olga Magdalena; Cruz Moreno, Miguel Angel; Cisneros Salazar, Guillermo Daniel

2010-01-01

Allergic reactions to insect bites are a global problem, the true incidence and prevalence of morbidity from adverse reactions to mosquito bites are unknown. To describe the adverse reactions to mosquito bites in school-age children of Monterrey, Nuevo Leon. A cross-sectional descriptive study was made via a randomized application of questionnaires to children from public elementary schools in the metropolitan area of Monterrey, Nuevo Leon. A total of 11 public schools randomly selected were included in the study. One thousand questionnaires were submitted, of which 506 fulfilled the inclusion criteria; 55% were females. Seventy-six percent referred adverse reactions to mosquito bites, itching (75%) and rash (72%) being the most frequent ones, in the last 12 months. Adverse reactions to mosquito bites occur frequently. Early detection is important to establish a prompt treatment.

[Safety profile of zolpidem: two studies of 3805 patients by Swiss practitioners].

PubMed

Ganzoni, E; Gugger, M

1999-06-24

Evaluation and treatment of insomnia are frequent procedures in the physician's everyday practice, since many patients seek medical treatment for this condition. Knowledge of pharmacological therapeutical alternatives is therefore decisive, in order to identify the most efficaceous and safe therapy for the patient among the available hypnotics. The short-acting hypnotic zolpidem has been investigated in Switzerland in two multicenter safety studies in ambulatory practice. In the first study 8.9% (n = 125 of 1,972 treated patients), and in the second 7.2% of the patients (n = 175 of 1,833 treated patients) reported an adverse event. The most frequent events were related to the central nervous system (CNS) (somnolence, headache, confusion, vertigo); gastrointestinal and cutaneous symptoms were the most frequent non CNS-dependent effects. New, unknown or serious adverse events were not found and no specific risk factor or population at risk was identified. The safety profile of zolpidem is consistent with its known pharmacological properties, the results of previous clinical trials and the international experience obtained in large patients groups.

[Thyroid and treatment with amiodarone diagnosis, therapy and clinical management].

PubMed

Mikosch, Peter

2008-01-01

Amiodarone is a frequently used antiarrhythmic drug with a high antiarrhythmic potency. However, beside its antiarrhythmic effects Amiodarone also reveals a variety of adverse effects and drug-related complications. The affected organs include the eyes, skin, lungs, nervous system, liver, gastrointestinal tract and the thyroid. The thyroid is one of the most frequently affected organs by Amiodarone. An altered hormone equilibrium always occurs and has to be distinguished from Amiodarone induced hyperthyroidism and hypothyroidism. The differentiation of these states frequently causes problems and may even be a diagnostic and therapeutic challenge in certain cases. The article gives an overview on the interactions between Amiodarone and the thyroid, the diagnostic and therapeutic options and management strategies of patient on Amiodarone therapy in the view of thyroid function.

Evidence for Adverse Phonatory Change Following an Inhaled Combination Treatment

ERIC Educational Resources Information Center

Erickson, Elizabeth; Sivasankar, Mahalakshmi

2010-01-01

Purpose: Voice problems are reported as a frequent side effect of inhaled combination (IC) treatments. The purpose of this experimental study was to investigate whether IC treatments are detrimental to phonation. We hypothesized that IC treatment would significantly increase phonation threshold pressure (PTP) and perceived phonatory effort (PPE),…

Using Propensity Scores in Educational Research: General Principles and Practical Applications

ERIC Educational Resources Information Center

Graham, Suzanne E.; Kurlaender, Michal

2011-01-01

Educational researchers frequently study the impact of treatments or interventions on educational outcomes. However, when observational or quasiexperimental data are used for such investigations, selection bias can adversely impact researchers' abilities to make causal inferences about treatment effects. One way to deal with selection bias is to…

[Tolerability of iron preparation Actiferol Fe® in children treated for iron deficiency anemia].

PubMed

Jackowska, Teresa; Sapała-Smoczyńska, Alicja; Kamińska, Ewa

2015-01-01

Iron de„ciency anemia is the most frequently occurring anemia during the childhood period. Supplementation with adequate doses of iron remains a basic method of prevention and treatment. The various available products containing iron are characterized by a different degree of patient tolerability. Actiferol Fe® is a micronized, dispersible ferric pyrophosphate which improves its water solubility, and therefore it has better absorption and bioavailability. The assessment of tolerability of Actiferol Fe® in children who were administered this product to treat or prevent of iron de„ciency anemia. The methods of administration and the incidence of adverse effects were analyzed. Eighty children (64 boys and 16 girls) aged from one month to 6 years who met the criteria of an indication to be treated with iron were included into the study. The assessment of selected parameters was based on the questionnaire which included questions about tolerability, method of administration, convenience of usage and adverse e#ects. The questionnaire was „lled in by parents (usually by the mother). The study indicated that Actiferol Fe® has very good or good tolerability in 87.5% (70/80) of patients - 46.3% (37/80) and 41.2% (33/80), respectively. The most frequent method of administration was in liquid form after dissolving: in water - 31,3% (25/80), in orange juice - 18.8% (15/80) or in milk formulas - in 17.5% (14/80) of patients. The method of administration was assessed as convenient or very convenient by 84% (67/80) of participants. Out of the adverse effects reported, the most frequent were change in the stool consistency into harder, abdominal pain and constipation - in 20% (16/80), 11.25% (9/80), 10% (8/80) cases, respectively. Diarrhea, pain during defecation occurred occasionally. A dark color of the stool was reported by 55% (44/80) of patients. In only one case (1.25%) the parents resigned from the product administration and replaced it with another iron product (no connection with tolerability of the formulation). Actiferol Fe® is a product characterized by good tolerability, convenient usage and mild adverse effects.

Use of Nonopioid Analgesics and the Impact on Patient Outcomes.

PubMed

Sanzone, Anthony G

2016-05-01

Although opioids are widely used for the management of pain in patients with hip fracture, these medications are known to have a wide range of adverse effects that can result in suboptimal outcomes or serious life-threatening complications. Common opioid-related adverse events include gastrointestinal effects, central nervous system effects, and respiratory depression. Hip fractures occur most frequently among the elderly-the very population that is most susceptible to the adverse effects of opioids and the risks of serious physiological complications. There has been much interest during recent years in identifying alternative analgesic approaches that are less opioid-dependent. There is good evidence to show that nerve blocks can be effective in managing the acute pain associated with hip fracture. However, sciatic and femoral nerve blocks seem to increase the risk of several clinically significant adverse events. A retrospective cohort study that examined the effectiveness of scheduled intravenous acetaminophen as part of the pain management protocol for hip fracture patients revealed significant improvement in pain scores, narcotic use, length of stay, and missed physical therapy sessions. Limited data exist in patients with hip fracture on the effects of infiltration of the surgical site with the local anesthetic agent, bupivacaine. However, extensive use of bupivacaine in hip arthroplasty surgery suggests that it may be highly beneficial in the patient with hip fracture.

Adverse weather conditions for European wheat production will become more frequent with climate change

NASA Astrophysics Data System (ADS)

Trnka, Miroslav; Rötter, Reimund P.; Ruiz-Ramos, Margarita; Kersebaum, Kurt Christian; Olesen, Jørgen E.; Žalud, Zdeněk; Semenov, Mikhail A.

2014-07-01

Europe is the largest producer of wheat, the second most widely grown cereal crop after rice. The increased occurrence and magnitude of adverse and extreme agroclimatic events are considered a major threat for wheat production. We present an analysis that accounts for a range of adverse weather events that might significantly affect wheat yield in Europe. For this purpose we analysed changes in the frequency of the occurrence of 11 adverse weather events. Using climate scenarios based on the most recent ensemble of climate models and greenhouse gases emission estimates, we assessed the probability of single and multiple adverse events occurring within one season. We showed that the occurrence of adverse conditions for 14 sites representing the main European wheat-growing areas might substantially increase by 2060 compared to the present (1981-2010). This is likely to result in more frequent crop failure across Europe. This study provides essential information for developing adaptation strategies.

Notes from the Field: Increase in Reported Adverse Health Effects Related to Synthetic Cannabinoid Use - United States, January-May 2015.

PubMed

Law, Royal; Schier, Josh; Martin, Colleen; Chang, Arthur; Wolkin, Amy

2015-06-12

On April 6, 2015, CDC received notification of an increase in telephone calls to U.S. poison centers related to synthetic cannabinoid use. Monthly calls to all poison centers are tracked by the National Poison Data System, which reported that adverse health effects or concerns about possible adverse health effects related to synthetic cannabinoid use increased 330% from 349 in January 2015 to 1,501 in April 2015. Synthetic cannabinoids include various psychoactive chemicals or a mixture of such chemicals that are sprayed onto plant material, which is then often smoked or ingested to achieve a "high." These products are sold under a variety of names (e.g., synthetic marijuana, spice, K2, black mamba, and crazy clown) and can be sold in retail outlets as herbal products. Law enforcement agencies have regulated a number of these substances; however, manufacturers of synthetic cannabinoids frequently change the formulation to avoid detection and regulation. After the initial notification, CDC analyzed information from the National Poison Data System on reported adverse health effects related to synthetic cannabinoid use for the period January-May 2015.

Adverse event reporting in patients treated with levothyroxine: results of the pharmacovigilance task force survey of the american thyroid association, american association of clinical endocrinologists, and the endocrine society.

PubMed

Hennessey, James V; Malabanan, Alan O; Haugen, Bryan R; Levy, Elliot G

2010-01-01

To survey physicians to determine whether potency and consistency issues with levothyroxine sodium (LT4) have been resolved and to assess current experience regarding safety of substituting LT4 products. Members of the American Association of Clinical Endocrinologists, American Thyroid Association, and The Endocrine Society collaborated to create a survey instrument that would effectively sample the clinical experience of their society members and frequent prescribers of LT4. More than 18,000 e-mailed requests for information were generated, and the Web sites of each society provided links to the data collection form. The survey provided an opportunity to collect clinical observations of adverse events or product availability problems from physicians caring for patients with thyroid disease who required use of contemporary LT4 preparations. After adjustment for known reasons for unstable results from thyroid function tests, 199 reports of adverse events associated with changes in thyrotropin values were further analyzed. One hundred seventy-seven reports (88.9%) were associated with a change in the source of LT4; no change was noted in 21 (10.6%). Details regarding the circumstances of the change were provided in 167 of the 177 reports (94.4%), The reporting physicians themselves or their office staff had changed the LT4 preparation in only 1 of the 167 cases (0.6%). The remainder of changes had been made by the patient's pharmacy, either with the physician's knowledge (in 13 of 167 cases [7.8%]) or without his/her knowledge (in 153 of 167 cases [91.6%]). Fifty-four of 199 cases (27.1%) described serious adverse events; 52 of these (96.3%) were associated with a substitution of one LT4 preparation for another. The clinical use of contemporary LT4 products continues to be associated with some adverse outcomes. A small number of reports were associated with continued use of the same LT4 products. The most frequently reported adverse outcomes were associated with the approved generic substitution of LT4 products, frequently without the prescribing physician's knowledge.

Seven Steps to the Diagnosis of NSAIDs Hypersensitivity: How to Apply a New Classification in Real Practice?

PubMed Central

Makowska, Joanna S.

2015-01-01

Frequent use of non-steroidal anti-inflammatory drugs (NSAIDs) has been paralleled by increasing occurrence of adverse reactions, which vary from mild local skin rashes or gastric irritation to severe, generalized symptoms and even life-threatening anaphylaxis. NSAID-induced hypersensitivity reactions may involve both immunological and non-immunological mechanisms and should be differentiated from type A adverse reactions. Clinical diagnosis and effective management of a hypersensitive patient cannot be achieved without identifying the underlying mechanism. In this review, we discuss the current classification of NSAID-induced adverse reactions and propose a practical diagnostic algorithm that involves 7 steps leading to the determination of the type of NSAID-induced hypersensitivity and allows for proper patient management. PMID:25749768

Herbal remedies and their adverse effects in Tem tribe traditional medicine in Togo.

PubMed

Tchacondo, Tchadjobo; Karou, Simplice D; Batawila, Komlan; Agban, Amegninou; Ouro-Bang'na, Kawiwou; Anani, Kokou T; Gbeassor, Mensavi; de Souza, Comlan

2011-01-01

In Africa, up to 80% of the population relies on herbal concoctions for their primarily health care. In Togo, western Africa, Tem tribe is a population with old knowledge of medicinal plants, however, still very little is known about their medical practices. The present study was conducted to access for the apprehension of adverse effects of traditional remedies by Tem traditional healers (TH). Enquiry was performed by interviews with healers from August to October 2007 in Tchaoudjo prefecture (Togo). The study allowed us to interview 54 TH including 41(75.93%) males and 13(24.07%) females, who cited 102 recipes assumed to have adverse effects. The recipes were used alone to cure several diseases including haemorrhoids (22.55%), female sexual disorders and infertility (21.57%), gastrointestinal disorders (18.63%), and malaria (6.86%). A total of 34 plants belonging to 21 families were cited to be components of the recipes. Euphorbiaceae and Mimosaceae families were the most represented, however, Nauclea latifolia, Khaya senegalensis, Pseudocedrela kotschyi and Xeroderris stuhlmannii were the main components of recipes linked to adverse effects. A total of 20 adverse effects were linked to the administration of theses drugs, and among them; diarrhoea, abdominal pains, polyuria, general weakness and vomiting were the most frequently encountered. These findings were in accordance with several reports of the literature concerning medicinal plants, although they were based on empirical observations. Laboratory screenings are needed to access for the effectiveness as well as the possible toxic effects of the recipes.

Tolerability of mefloquine intermittent preventive treatment for malaria in HIV-infected pregnant women in Benin.

PubMed

Denoeud-Ndam, Lise; Clément, Marie-Caroline; Briand, Valérie; Akakpo, Jocelyn; Agossou, Videhouenou K; Atadokpédé, Félix; Dossou-Gbété, Lucien; Komongui, Didier G; Afangnihoun, Aldric; Girard, Pierre-Marie; Zannou, Djimon-Marcel; Cot, Michel

2012-09-01

To investigate the tolerability of mefloquine intermittent preventive treatment (MQ IPTp) for malaria in HIV-infected pregnant women compared with HIV-negative women. Prospective cohort study comparing samples of HIV-negative and HIV-infected pregnant women from 2 clinical trials conducted in Benin. One hundred and three HIV-infected women from the ongoing PACOME trial were compared with 421 HIV-negative women from a former trial, both trials aiming to evaluate the efficacy and tolerability of MQ IPTp, administered at the dose of 15 mg/kg. Descriptive analysis compared the proportion of women reporting at least 1 adverse reaction, according to HIV status. Multilevel logistic regression identified factors associated with the probability of reporting an adverse reaction for each MQ intake. Dizziness and vomiting were the most frequent adverse reactions. Adverse reactions were less frequent in HIV-infected women (65% versus 78%, P = 0.009). In multilevel analysis, HIV infection [odds ratio (OR) = 0.23, 95% confidence interval (CI) = 0.08 to 0.61] decreased the risk for adverse reactions, whereas detectable viral load (OR = 2.46, 95% CI = 1.07 to 5.66), first intake (versus further intakes, OR = 5.26, 95% CI = 3.70 to 7.14), older age (OR = 1.62, 95% CI = 1.13 to 2.32), and higher education level (OR = 1.71, 95% CI = 1.12 to 2.61) increased the risk. Moderate and severe adverse reactions were more frequent when antiretrovirals were started concomitantly with a MQ intake. This study provides reassuring data on the use of MQ IPTp in HIV-infected pregnant women. However frequent, adverse reactions remained moderate and did not impair adherence to MQ IPTp. In this high-risk group, MQ might be an acceptable alternative in case sulfadoxine-pyrimethamine loses its efficacy for intermittent preventive treatment.

Wind Turbine Infra and Low-Frequency Sound: Warning Signs that Were Not Heard

ERIC Educational Resources Information Center

James, Richard R.

2012-01-01

Industrial wind turbines are frequently thought of as benign. However, the literature is reporting adverse health effects associated with the implementation of industrial-scale wind developments. This article explores the historical evidence about what was known regarding infra and low-frequency sound from wind turbines and other noise sources…

Fate of Hexazinone and Picloram in Southern United States Forest Watersheds

Treesearch

D.G. Neary; P.B. Bush; J.L. Michael

1986-01-01

Herbicides are being used more frequently in the intensively managed forest ecosystems of the southeastern United States. Host of this increased use occurs during site preparation prior to replanting cutover or converted stands. Herbicides provide a cost effective tool for controlling herbaceous and woody weed competition which adversely affects pine establishment and...

Overcoming the Barriers Experienced in Conducting a Medication Trial in Adults with Aggressive Challenging Behaviour and Intellectual Disabilities

ERIC Educational Resources Information Center

Oliver-Africano, P.; Dickens, S.; Ahmed, Z.; Bouras, N.; Cooray, S.; Deb, S.; Knapp, M.; Hare, M.; Meade, M.; Reece, B.; Bhaumik, S.; Harley, D.; Piachaud, J.; Regan, A.; Ade Thomas, D.; Karatela, S.; Rao, B.; Dzendrowskyj, T.; Lenotre, L.; Watson, J.; Tyrer, P.

2010-01-01

Background: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. Method: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs…

Fate of Hexazinone and Picloram in Southern Forest Watersheds

Treesearch

Daniel G. Neary; Parshall B. Bush; Jerry L. Michael

1987-01-01

Herbicides are being used more frequently in the intensively managed forest ecosystems of the southeastern United States. Most of this increased use occurs during site preparation prior to replanting cutover or converted stands. Herbicides provide a cost-effective tool for controlling herbaceous and weed cunpetition which adversely affects pine establishnent and early...

Therapeutic use of traditional Chinese herbal medications for chronic kidney diseases

PubMed Central

Zhong, Yifei; Deng, Yueyi; Chen, Yiping; Chuang, Peter Y; He, John Cijiang

2013-01-01

Traditional Chinese herbal medications (TCHM) are frequently used in conjunction with western pharmacotherapy for treatment of chronic kidney diseases (CKD) in China and many other Asian countries. The practice of traditional Chinese medicine is guided by cumulative empiric experience. Recent in vitro and animal studies have confirmed the biological activity and therapeutic effects of several TCHM in CKD. However, the level of evidence supporting TCHM is limited to small, non-randomized trials. Due to variations in the prescription pattern of TCHM and the need for frequent dosage adjustment, which are inherent to the practice of traditional Chinese medicine, it has been challenging to design and implement large randomized clinical trials of TCHM. Several TCHM are associated with significant adverse effects, including nephrotoxicity. However, reporting of adverse effects associated with TCHM has been inadequate. To fully realize the therapeutic use of TCHM in CKD we need molecular studies to identify active ingredients of TCHM and their mechanism of action, rigorous pharmacologic studies to determine the safety and meet regulatory standards required for clinical therapeutic agents, and well-designed clinical trials to provide evidence-based support of their safety and efficacy. PMID:23868014

[Vaccination against yellow fever among patients on immunosuppressors with diagnoses of rheumatic diseases].

PubMed

Mota, Licia Maria Henrique da; Oliveira, Ana Cristina Vanderley; Lima, Rodrigo Aires Corrêa; Santos-Neto, Leopoldo Luiz dos; Tauil, Pedro Luiz

2009-01-01

Yellow fever is endemic in some countries. The anti-yellow fever vaccine is the only effective means of protection but is contraindicated for immunocompromised patients. The aim of this paper was to report on a case series of rheumatological patients who were using immunosuppressors and were vaccinated against this disease. This was a retrospective study by means of a questionnaire applied to these patients, who were vaccinated 60 days before the investigation. Seventy patients of mean age 46 years were evaluated. Most of them were female (90%). There were cases of rheumatoid arthritis (54), systemic lupus erythematosus (11), spondyloarthropathy (5) and systemic sclerosis (2). The therapeutic schemes included methotrexate (42), corticosteroids (22), sulfasalazine (26), leflunomide (18), cyclophosphamide (3) and immunobiological agents (9). Sixteen patients (22.5%) reported some minor adverse effect. Among the eight patients using immunobiological agents, only one presented a mild adverse effect. Among these patients using immunosuppressors, adverse reactions were no more frequent than among immunocompetent individuals. This is the first study on this topic.

Treatments for iron-deficiency anaemia in pregnancy.

PubMed

Reveiz, Ludovic; Gyte, Gillian Ml; Cuervo, Luis Gabriel; Casasbuenas, Alexandra

2011-10-05

Iron deficiency, the most common cause of anaemia in pregnancy worldwide, can be mild, moderate or severe. Severe anaemia can have very serious consequences for mothers and babies, but there is controversy about whether treating mild or moderate anaemia provides more benefit than harm. To assess the effects of different treatments for anaemia in pregnancy attributed to iron deficiency (defined as haemoglobin less than 11 g/dL or other equivalent parameters) on maternal and neonatal morbidity and mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 June 2011), CENTRAL (2011, Issue 5), PubMed (1966 to June 2011), the International Clinical Trials Registry Platform (ICTRP) (2 May 2011), Health Technology Assessment Program (HTA) (2 May 2011) and LATINREC (Colombia) (2 May 2011). Randomised controlled trials comparing treatments for anaemia in pregnancy attributed to iron deficiency. We identified 23 trials, involving 3.198 women. We assessed their risk of bias. Three further studies identified are awaiting classification. Many of the trials were from low-income countries; they were generally small and frequently methodologically poor. They covered a very wide range of differing drugs, doses and routes of administration, making it difficult to pool data. Oral iron in pregnancy showed a reduction in the incidence of anaemia (risk ratio 0.38, 95% confidence interval 0.26 to 0.55, one trial, 125 women) and better haematological indices than placebo (two trials). It was not possible to assess the effects of treatment by severity of anaemia. A trend was found between dose and reported adverse effects. Most trials reported no clinically relevant outcomes nor adverse effects. Although the intramuscular and intravenous routes produced better haematological indices in women than the oral route, no clinical outcomes were assessed and there were insufficient data on adverse effects, for example, on venous thrombosis and severe allergic reactions. Daily low-dose iron supplements may be effective at treating anaemia in pregnancy with less gastrointestinal side effects compared with higher doses. Despite the high incidence and burden of disease associated with this condition, there is a paucity of good quality trials assessing clinical maternal and neonatal effects of iron administration in women with anaemia. Daily oral iron treatment improves haematological indices but causes frequent gastrointestinal adverse effects. Parenteral (intramuscular and intravenous) iron enhances haematological response, compared with oral iron, but there are concerns about possible important adverse effects (for intravenous treatment venous thrombosis and allergic reactions and for intramuscular treatment important pain, discolouration and allergic reactions). Large, good quality trials, assessing clinical outcomes (including adverse effects) as well as the effects of treatment by severity of anaemia are required.

The role of Mycoplasma and Ureaplasma in adverse pregnancy outcomes.

PubMed

Murtha, Amy P; Edwards, James M

2014-12-01

Genital mycoplasmas are frequently found in the vaginal flora across socioeconomic and ethnic groups and have been demonstrated to be involved in adverse perinatal outcomes. Both Mycoplasma and Ureaplasma spp cause inflammation potentially leading to spontaneous preterm birth and PPROM as well as postdelivery infectious complications and neonatal infections. Herein we have provided an overview of the existing literature and supportive evidence for genital mycoplasma's role in perinatal complications. Future research will need to focus on clearly delineating the species, allowing for discrimination of their effects. Copyright © 2014 Elsevier Inc. All rights reserved.

Adverse reactions to two intravenous antibiotics (Augmentin and Zinacef) used for surgical prophylaxis in dogs.

PubMed

Gosling, Mark James; Martínez-Taboada, Fernando

2018-01-20

Antibiotic prophylaxis in dogs undergoing surgical procedures frequently involves the administration of a product without a veterinary licence. Two drugs commonly used for this purpose are the clavulanate amoxicillin Augmentin and the cefuroxime Zinacef. This prospective observational study aims to compare the incidence of adverse events associated with these two antibiotics in a clinical setting. The authors hypothesised that a higher incidence of adverse effects would be observed with Augmentin. Sixty-five dogs were included in the study and adverse events were recorded using a modified scoring system. A significantly higher incidence of adverse events to Augmentin (8/22; 36 per cent) was observed compared with Zinacef (1/43; 2 per cent) (P=0.0003). The majority of these adverse events involved cutaneous signs and/or hypotension. These findings might be taken into consideration when selecting one of these intravenous antibiotics for prophylaxis in anaesthetised dogs undergoing surgery. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Adverse events attributed to traditional Korean medical practices: 1999–2010

PubMed Central

Shin, Hyeun-Kyoo; Jeong, Soo-Jin; Ernst, Edzard

2013-01-01

Abstract Objective To investigate adverse events attributed to traditional medical treatments in the Republic of Korea. Methods Adverse events recorded in the Republic of Korea between 1999 and 2010 – by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine – were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers’ complaints, were investigated. Findings Overall, 9624 records of adverse events attributed to traditional medical practices – including 522 linked to herbal treatments – were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 – mostly infections, cases of pneumothorax and burns – were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104). Conclusion In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system. PMID:23940404

PD-1 checkpoint inhibition: Toxicities and management.

PubMed

Hahn, Andrew W; Gill, David M; Agarwal, Neeraj; Maughan, Benjamin L

2017-12-01

With the recent approval of 5 PD-1/PD-L1 inhibitors for a number of malignancies, PD-1 axis inhibition is drastically changing the treatment landscape of immunotherapy in cancer. As PD-1/PD-L1 are involved in peripheral immune tolerance, inhibition of this immune checkpoint has led to novel immune-related adverse events including colitis, hepatitis, pneumonitis, rash, and endocrinopathies among many others. In this seminar, we will analyze the incidence of immune-related adverse events for nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab. Then, we will discuss the specific management of the most common immune-mediated adverse events including colitis, hepatitis, pneumonitis, rash, endocrinopathies, nephritis, and neurologic toxicities. Immune-related adverse events are frequently treated with immunosuppressive medication such as steroids and mycofenolate mofetil. There are specific immune-related adverse events which are frequently seen by the treating oncologist from checkpoint inhibitors. It is essential to understand the recommended treatment options to minimize toxicity and mortality from this important class of anti-neoplastic therapies. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy and safety of oral ketamine for the relief of intractable chronic pain: A retrospective 5-year study of 51 patients.

PubMed

Marchetti, F; Coutaux, A; Bellanger, A; Magneux, C; Bourgeois, P; Mion, G

2015-08-01

This work summarizes the efficiency, failures and adverse effects of oral administration of ketamine at home for intractable pain. This 5-year retrospective study involved testing ketamine by intravenous in-hospital administration, then a conversion to an oral route, or oral treatment directly administered at home. The daily intravenous dose was increased by steps of 0.5 mg/kg to attain an effective daily dose of 1.5-3.0 mg/kg. Pain was evaluated on a numeric scale from 0 to 10, and evidence of adverse effects was collected every day. The effective daily dose was delivered orally (three to four intakes). If effective, ketamine was continued for 3 months. Short infusions or direct oral treatment began with a 0.5-mg/kg dose, then the daily ketamine dose was increased in 15- to 20-mg increments. Among 55 cases (51 patients, neuropathic pain 60%), the mean effective oral dose was 2 mg/kg. Ketamine was effective in 24 patients (44%, mean pain reduction 67 ± 17%), partially effective in 20% (mean pain reduction 30 ± 11%), with a mean opioid sparing of 63 ± 32%, and failure in 22%. Half of the patients experienced adverse effects, but only eight had to stop treatment. For patients with opioid therapy, failure of ketamine was less frequent (7% vs. 36%; p < 0.02), with fewer adverse effects (33% vs. 68%; p < 0.01). Pain was reduced or abolished in two-thirds of patients under ketamine therapy; ketamine was effective for patients taking opioids and resulted in few adverse effects. © 2014 European Pain Federation - EFIC®

SSRI adverse events: how to monitor and manage.

PubMed

Murphy, Tanya K; Segarra, Ana; Storch, Eric A; Goodman, Wayne K

2008-04-01

Antidepressants are efficacious for pediatric major depressive disorder, obsessive compulsive disorder (OCD), and non-OCD anxiety disorders. Antidepressants should be used in an evidence-based fashion, with frequent monitoring for side effects, especially when initiating treatment and adjusting dosage. With diligence to appropriate prescribing and monitoring, the benefits of therapy outweigh the potential of treatment related risk.

[Perception of clinical practice derived risks compared to adverse effects detected in an internal medicine service].

PubMed

Jiménez Muñoz, A B; Muiño Miguez, A; Quintás Viqueira, A; Pinilla Llorente, B; Durán García, M E; Rodríguez Pérez, M P

2008-01-01

To know how the health care workers perceive the risks derived from the care practice. To estimate the most frequent adverse effects (AE) and establish differences and similarities between the perception of risks and the AE produced. A self-administered questionnaire was applied to all the workers of an Internal Medicine Department of a General University Hospital on perception of risks and safety of the patient. After, and by using the screening guide of the IDEA project, edition 1, the clinical histories of the patients selected were analyzed by medical residents of preventive Medicine and Internal Medicine. Questionnaire. Fifty questionnaires we sent with a 42% response rate. Risks prioritized by obtaining a lower mean score: there is not action plan against catastrophes (2.79/10) and lack of spaces to report (3/10); those having greater percentage of open questions: long maintenance of urinary probes (47.61%) and inadequate prescription of antibiotics (33.33%). Study of AE. Incidence of patients with AE: 25% (95% CI 11.06-38.9). Incidence of AE: 26.6% (95% CI 12.6-40.6). 41.6% of AE was related to medication, 25% to nosocomial infection, 16.66% to technical problems in procedures and 16.66% were related to nursing cares. The perception of the health care workers on health care practice derived risks is different from the adverse events that really appear. The professionals are concerned about the information to patients than about scientific and technical quality. The most frequent adverse events produced are those related with medication. The only common point is concern for nosocomial infection.

Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland.

PubMed

Kuchari, Ernest; Han, Stanisław; Karłowicz-Bodalska, Katarzyna; Miśkiewicz, Katarzyna; Kutycka, Elzbieta

2014-01-01

Ibuprofen is a popular over-the-counter, non-steroidal anti-inflammatory medication, frequently used for the relief of fever, headaches, menstrual and other minor pains as well as a major active ingredient in numerous cold preparations. We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of IBUM soft capsules, IBUM Forte soft capsules, and IBUM oral suspension 100 mg/5 mL collected by the manufacturer (PPF HASCO-LEK S.A. Wroclaw, Poland) and National Monitoring Center in Warszawa in the period between October 2002 and June 2012. A total of 19,644,797 units of IBUM soft capsules 200 mg, 5,678,164 units of IBUM Forte soft capsules 400 mg and 4,333,325 units of IBUM oral suspension 100 mg/5 mL (29,656,286 units altogether) produced by PPF HASCO-LEK S.A. Wrodcaw, P'oland were marketed during the period analyzed. There were 5 spontaneous reports regarding these medications registered in Poland in the period analyzed. Forms of oral ibuprofen are very safe medication rarely causing adverse effects; nevertheless, the existing spontaneous monitoring system of adverse effects in Poland is not sensitive enough to detect all adverse effects and needs improvement.

Otorhinolaryngological Toxicities of New Drugs in Oncology.

PubMed

Hartl, Dana M; Morel, Daphné; Saavedra, Erika; Massard, Christophe; Rinaldo, Alessandra; Saba, Nabil F; Ferlito, Alfio; Soria, Jean-Charles

2017-04-01

Many new or relatively new cancer drugs-personalized anticancer agents-have been approved for use in various clinical settings in oncology or are still under evaluation in clinical trials. Targeted therapies as well as new immune checkpoint blockers have toxicity profiles that differ from conventional cytotoxic chemotherapy, and many can cause adverse effects that affect the mouth and pharynx, the nasal cavities, and the larynx. This review aims to provide an overview of current knowledge concerning these side effects and contemporary management. Adverse effects of the mouth/pharynx, nasal cavities, larynx, and cochlear-vestibular system are generally low grade (according to the Common Terminology Criteria for Adverse Events) and generally present non-life-threatening symptoms. However, the impact on patients' quality of life could be important. The incidence and severity vary according to the drug, its target(s), and dose, but there are currently no known predictive factors, and each patient has an individual toxicity profile. Management guidelines are based on expert opinion. These ear, nose, and throat adverse effects are not frequently mentioned in the literature because of the often non-specific nature of the symptoms and their mildness, but also the absence of specific treatment. These symptoms can contribute to decreased quality of life and lead to drug compliance issues if not diagnosed and managed appropriately.

Vaccines for preventing herpes zoster in older adults.

PubMed

Gagliardi, Anna M Z; Gomes Silva, Brenda Nazaré; Torloni, Maria R; Soares, Bernardo G O

2012-10-17

Herpes zoster or, as it is commonly called, 'shingles' is a neurocutaneous disease characterised by the reactivation of varicella zoster virus (VZV), the virus that causes chickenpox, which is latent in the dorsal spinal ganglia when immunity to VZV declines. It is an extremely painful condition which can often last for many weeks or months, impairing the patient's quality of life. The natural aging process is associated with a reduction of cellular immunity which predisposes to herpes zoster. Vaccination with an attenuated form of VZV activates specific T cell production, therefore avoiding viral reactivation. A herpes zoster vaccine with an active virus has been approved for clinical use among older adults by the Food and Drug Administration and has been tested in large populations. To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults. We searched the following sources for relevant studies: CENTRAL 2012, Issue 7, MEDLINE (1948 to July week 1, 2012), EMBASE (2010 to July 2012), LILACS (1982 to July 2012) and CINAHL (1981 to July 2012). We also reviewed reference lists of identified trials and reviews for additional studies. Randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent herpes zoster in older adults (mean age > 60 years). Two review authors independently collected and analysed data using a data extraction form. They also carried out an assessment of risk of bias. We identified eight RCTs with a total of 52,269 participants. Three studies were classified at low risk of bias. The main outcomes on effectiveness and safety were extracted from one clinical trial with a low risk of bias. Four studies compared zoster vaccine versus placebo; one study compared high-potency zoster vaccine versus low-potency zoster vaccine; one study compared refrigerated zoster vaccine versus frozen zoster vaccine; one study compared live zoster vaccine versus inactivated zoster vaccine and one study compared zoster vaccine versus pneumococcal polysaccharide vaccine (pneumo 23).Confirmed cases of herpes zoster were less frequent in patients who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49 (95% confidence interval (CI) 0.43 to 0.56), with a risk difference (RD) of 2%, and number needed to treat to benefit (NNTB) of 50. Analyses according to age groups indicated a greater benefit in participants aged 60 to 69 years, RR 0.36 (95% CI 0.30 to 0.45) and in participants aged 70 years and over, RR 0.63 (95% CI 0.53 to 0.75). Vaccine-related systemic adverse effects were more frequent in the vaccinated group (RR 1.29, 95% CI 1.05 to 1.57, number needed to treat to harm (NNTH) = 100). The pooled data risk ratio for adverse effects for participants with one or more inoculation site adverse effect was RR 4.51 (95% CI 2.35 to 8.68), and the NNTH was 2.8 (95% CI 2.3 to 3.4). Side effects were more frequent in younger (60 to 69 years) than in older (70 years and over) participants. Herpes zoster vaccine is effective in preventing herpes zoster disease. Although vaccine benefits are larger in the younger age group (60 to 69 years), this is also the age group with more adverse events. In general, zoster vaccine is well tolerated; it produces few systemic adverse events and injection site adverse effects of mild to moderate intensity.

[Sodium valproate as a cause of acute pancreatitis: a case report].

PubMed

Barreda, Luís; Rosas, Johana; Milian, William; Valdivia, Duilio; Targarona, Javier

2006-01-01

Valproic acid (VPA) is a commonly used medication approved by the U.S. FDA for the treatment of epilepsy, migraines and bipolar disorders. Adverse effects associated with VPA are typically benign, but there are more serious effects that are less frequent. These effects include hepatotoxicity, teratogenicity, possible polycystic ovaries with a potential sterile effect and acute pancreatitis. Even though acute pancreatitis is an adverse effect of very low frequency, it is very important due to the high mortality rate of patients with acute pancreatitis as a consequence of the use of valproic acid. In medical literature, by 2005, 80 cases of acute pancreatitis caused by valproic acid were reported, 33 of these cases were patients under the age of 18. This is a description of the clinical case of a 16 year old patient with necrotic pancreatitis caused by VPA, who was treated at the Acute Pancreatitis Unit of Edgardo Rebagliati Martins National Hospital.

Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety.

PubMed

Roth, Sanford H

2011-01-01

Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis.

Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety

PubMed Central

Roth, Sanford H

2011-01-01

Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis. PMID:21753867

Formulary decision-making about cephalosporins with similar therapeutic uses.

PubMed

Mabe, Don M

2003-05-15

The various costs and intangible factors that enter into formulary decisions in an era of increasingly frequent drug product shortages that can adversely affect patient care and increase treatment costs are described. Pharmacy administration at Carolinas HealthCare System analyzed the costs associated with making a formulary switch from the third-generation cephalosporin ceftriaxone to cefotaxime, which recently became available in generic form and has a similar spectrum of antimicrobial activity and therapeutic uses. Hard dollar costs for purchasing drugs and the supplies needed to administer them; soft dollar costs for staff time spent acquiring, preparing, and administering doses; and intangible factors were considered. A reliable supply of drug product from the manufacturer was an important intangible factor because of frequent drug shortages in the past few years and the adverse effect on patient care and the increased soft dollar costs associated with these shortages. Administrators at Carolinas HealthCare System decided not to make the proposed formulary change after weighing the many factors and costs.

Frequent premature atrial contractions impair left atrial contractile function and promote adverse left atrial remodeling.

PubMed

John, Anub G; Hirsch, Glenn A; Stoddard, Marcus F

2018-06-10

This study assessed if frequent premature atrial contractions (PACs) were associated with decreased left atrial (LA) strain and adverse remodeling. Left atrial dysfunction and enlargement increases risk of stroke. If frequent PACs cause LA dysfunction and remodeling, PAC suppressive therapy may be beneficial. Inclusion criteria were age ≥18 years and sinus rhythm. Exclusion criteria were atrial fibrillation or any etiology for LA enlargement. Hundred and thirty-two patients with frequent PACs (≥100/24 hours) by Holter were matched to controls. Speckle tracking strain of the left atrium was performed from the 4-chamber view. Strain measurements were LA peak contractile, reservoir and conduit strain and strain rates. In the frequent PAC vs control group, PACs were more frequent (1959 ± 3796 vs 28 ± 25/24 hours, P < .0001). LA peak contractile strain was reduced in the group with frequent PACs vs controls (-7.85 ± 4.12% vs -9.33 ± 4.45%, P = .006). LA peak late negative contractile strain rate was less negative in the frequent PAC vs control group (-0.63 ± 0.27 s -1 vs -0.69 ± 0.32 s -1 , P = .051). LA reservoir and conduit strain and strain rates did not differ. LA volume index (LAVI) was larger in the frequent PAC vs control group (26.6 ± 7.8 vs 24.6 ± 8.8 mL/m 2 , P < .05). Frequent PACs were an independent predictor of reduced LA peak contractile strain and reduced LA peak late negative contractile strain rate. Patients with frequent PACs have reduced LA peak contractile strain and strain rates and larger LAVI compared to controls. Frequent PACs are an independent predictor of reduced LA peak contractile strain and strain rate. These findings support the hypothesis that frequent PACs impair LA contractile function and promote adverse LA remodeling. © 2018 Wiley Periodicals, Inc.

Adverse childhood experiences and frequent insufficient sleep in 5 U.S. States, 2009: a retrospective cohort study.

PubMed

Chapman, Daniel P; Liu, Yong; Presley-Cantrell, Letitia R; Edwards, Valerie J; Wheaton, Anne G; Perry, Geraldine S; Croft, Janet B

2013-01-03

Although adverse childhood experiences (ACEs) have previously been demonstrated to be adversely associated with a variety of health outcomes in adulthood, their specific association with sleep among adults has not been examined. To better address this issue, this study examines the relationship between eight self-reported ACEs and frequent insufficient sleep among community-dwelling adults residing in 5 U.S. states in 2009. To assess whether ACEs were associated with frequent insufficient sleep (respondent did not get sufficient rest or sleep ≥ 14 days in past 30 days) in adulthood, we analyzed ACE data collected in the 2009 Behavioral Risk Factor Surveillance System, a random-digit-dialed telephone survey in Arkansas, Louisiana, New Mexico, Tennessee, and Washington. ACEs included physical abuse, sexual abuse, verbal abuse, household mental illness, incarcerated household members, household substance abuse, parental separation/divorce, and witnessing domestic violence before age 18. Smoking status and frequent mental distress (FMD) (≥ 14 days in past 30 days when self-perceived mental health was not good) were assessed as potential mediators in multivariate logistic regression analyses of frequent insufficient sleep by ACEs adjusted for race/ethnicity, gender, education, and body mass index. Overall, 28.8% of 25,810 respondents reported frequent insufficient sleep, 18.8% were current smokers, 10.8% reported frequent mental distress, 59.5% percent reported ≥ 1 ACE, and 8.7% reported ≥ 5 ACEs. Each ACE was associated with frequent insufficient sleep in multivariate analyses. Odds of frequent insufficient sleep were 2.5 (95% CI, 2.1-3.1) times higher in persons with ≥ 5 ACEs compared to those with no ACEs. Most relationships were modestly attenuated by smoking and FMD, but remained significant. Childhood exposures to eight indicators of child maltreatment and household dysfunction were significantly associated with frequent insufficient sleep during adulthood in this population. ACEs could be potential indicators promoting further investigation of sleep insufficiency, along with consideration of FMD and smoking.

Contents of Japanese pro- and anti-HPV vaccination websites: A text mining analysis.

PubMed

Okuhara, Tsuyoshi; Ishikawa, Hirono; Okada, Masahumi; Kato, Mio; Kiuchi, Takahiro

2018-03-01

In Japan, the human papillomavirus (HPV) vaccination rate has sharply fallen to nearly 0% due to sensational media reports of adverse events. Online anti-HPV-vaccination activists often warn readers of the vaccine's dangers. Here, we aimed to examine frequently appearing contents on pro- and anti-HPV vaccination websites. We conducted online searches via two major search engines (Google Japan and Yahoo! Japan). Targeted websites were classified as "pro," "anti," or "neutral" according to their claims, with the author(s) classified as "health professionals," "mass media," or "laypersons." We then conducted a text mining analysis. Of the 270 sites analyzed, 16 contents were identified. The most frequently appearing contents on pro websites were vaccine side effects, preventable effect of vaccination, and cause of cervical cancer. The most frequently appearing contents on anti websites were vaccine side effects, vaccine toxicity, and girls who suffer from vaccine side effects. Main disseminators of each content according to the author's expertise were also revealed. Pro-HPV vaccination websites should supplement deficient contents and respond to frequent contents on anti-HPV websites. Effective tactics are needed to better communicate susceptibility to cervical cancer, frequency of side effects, and responses to vaccine toxicity and conspiracy theories. Copyright © 2017 Elsevier B.V. All rights reserved.

Important exposure controls for protection against antineoplastic agents: Highlights for oncology health care workers.

PubMed

Alehashem, Maryam; Baniasadi, Shadi

2018-01-01

A great number of antineoplastic drugs (ANPDs) are used globally in cancer treatment. Due to their adverse health effects, occupational exposure to ANPDs is considered a potential health risk to health care workers. The current study aimed to evaluate safe-handling practices of ANPDs, exposure controls, and adverse health implications for health care providers exposed to ANDPs. Prevention measures, including engineering, administrative, and work practice controls, as well as personal protective equipment (PPE), were recorded daily through a questionnaire for six weeks. Acute adverse health effects experienced by health care workers were also documented. The implemented exposure controls for preparation, administration, cleaning, and waste disposal were not in accordance with the safe handling guidelines. Central nervous system disorders (26.33%) were the most frequent acute adverse effects reported by health care workers. A significant correlation was found between the number of experienced adverse effects and handling characteristics, including the number of preparations (r = 0.38, p < 0.05), dose, and the number of prepared drugs (r = 0.46, p < 0.01 and 0.39, p < 0.05), and working hours in different locations of oncology setting for six weeks (preparation room: r = 0.38, P < 0.05, treatment room: r = 0.46, P < 0.01, patient room: r = 0.63, P < 0.01, and station: r = 0.68, P < 0.01). Due to inadequate control measures, oncology health care workers were in danger of exposure to ANPDs and experienced acute adverse health effects. Implementation of appropriate exposure controls is required to prevent occupational exposure to ANPDs.

An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery.

PubMed

Symons, Nicholas R A; Almoudaris, Alex M; Nagpal, Kamal; Vincent, Charles A; Moorthy, Krishna

2013-01-01

To investigate the nature of process failures in postoperative care, to assess their frequency and preventability, and to explore their relationship to adverse events. Adverse events are common and are frequently caused by failures in the process of care. These processes are often evaluated independently using clinical audit. There is little understanding of process failures in terms of their overall frequency, relative risk, and cumulative effect on the surgical patient. Patients were observed daily from the first postoperative day until discharge by an independent surgeon. Field notes on the circumstances surrounding any nonroutine or atypical event were recorded. Field notes were assessed by 2 surgeons to identify failures in the process of care. Preventability, the degree of harm caused to the patient, and the underlying etiology of process failures were evaluated by 2 independent surgeons. Fifty patients undergoing major elective general surgery were observed for a total of 659 days of postoperative care. A total of 256 process failures were identified, of which 85% were preventable and 51% directly led to patient harm. Process failures occurred in all aspects of care, the most frequent being medication prescribing and administration, management of lines, tubes, and drains, and pain control interventions. Process failures accounted for 57% of all preventable adverse events. Communication failures and delays were the main etiologies, leading to 54% of process failures. Process failures are common in postoperative care, are highly preventable, and frequently cause harm to patients. Interventions to prevent process failures will improve the reliability of surgical postoperative care and have the potential to reduce hospital stay.

Intravenous maintenance fluid therapy in children.

PubMed

McNab, Sarah

2016-02-01

Intravenous fluids are frequently used in paediatrics but have been associated with significant adverse outcomes. Understanding the composition of fluid prescribed and administering an appropriate rate is essential for safe fluid administration, along with regular monitoring. Recent evidence has shown that using an isotonic fluid with a sodium concentration similar to plasma can decrease the risk of hyponatraemia without an increase in adverse effects. This should lead to a change in guidelines: isotonic fluid should now be used as the primary maintenance intravenous fluid given to the majority of children. © 2016 The Author Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Blonanserin treatment in patients with methamphetamine-induced psychosis comorbid with intellectual disabilities

PubMed Central

Okazaki, Kosuke; Makinodan, Manabu; Yamamuro, Kazuhiko; Takata, Tomoyo; Kishimoto, Toshifumi

2016-01-01

Objective Methamphetamine (MA) use has recently been associated with high levels of psychiatric hospitalization and serious social dysfunction. MA use causes frequent psychotic symptoms, which can be treated with antipsychotics. However, people with intellectual disabilities (ID) are vulnerable to adverse effects resulting from treatment with antipsychotic medications. Method We report two cases of MA-induced psychosis (MAP) in patients with ID who were treated with the antipsychotic blonanserin. Results In both the cases presented, symptoms of psychosis were improved by switching medications from other antipsychotic drugs to blonanserin. Despite the presence of ID in these patients, no significant adverse effects, such as sedation, were detected after treatment with blonanserin. Conclusion Blonanserin may be an effective and well-tolerated pharmacotherapeutical treatment for patients with MAP comorbid with ID. However, further work is necessary to validate this claim. PMID:28008256

Blonanserin treatment in patients with methamphetamine-induced psychosis comorbid with intellectual disabilities.

PubMed

Okazaki, Kosuke; Makinodan, Manabu; Yamamuro, Kazuhiko; Takata, Tomoyo; Kishimoto, Toshifumi

2016-01-01

Methamphetamine (MA) use has recently been associated with high levels of psychiatric hospitalization and serious social dysfunction. MA use causes frequent psychotic symptoms, which can be treated with antipsychotics. However, people with intellectual disabilities (ID) are vulnerable to adverse effects resulting from treatment with antipsychotic medications. We report two cases of MA-induced psychosis (MAP) in patients with ID who were treated with the antipsychotic blonanserin. In both the cases presented, symptoms of psychosis were improved by switching medications from other antipsychotic drugs to blonanserin. Despite the presence of ID in these patients, no significant adverse effects, such as sedation, were detected after treatment with blonanserin. Blonanserin may be an effective and well-tolerated pharmacotherapeutical treatment for patients with MAP comorbid with ID. However, further work is necessary to validate this claim.

Beyond the art of governmentality: unmasking the distributional consequences of health policies.

PubMed

Coyte, Peter C; Holmes, Dave

2006-06-01

The aim of this article is to critique health policy discourses that are taken for granted. This perspective will allow for the identification of 'exclusionary' health policies, which we define as policies that are thought to offer universal benefit, despite yielding adverse effects for significant groups of people in society. As such, policies that are said to be designed 'for all' frequently benefit only a subset of the population. Our intent is to highlight the distributional consequences of certain health policies that are largely institutionalized in contemporary society. We believe that these distributional effects are explicit representations of power in society and that institutions may provide individual 'choice' and 'freedom' that, in turn, yields separation as an outcome, a separating equilibrium. Specifically, if those who benefit from policies of partition are numerous and are to obtain significant advantage or incur limited costs, or if those who are adversely affected are scarce (or hidden), or the size of these adverse effects are small (or perceived to be minor), then partition becomes more likely as a 'legitimate', but exclusionary, instrument of public policy.

Contrast media use in the operating room.

PubMed

Bickham, Peggy; Golembiewski, Julie

2010-04-01

Iodinated contrast media is frequently used in the OR, but often is not well understood by health care providers who are administering it. Although used for diagnosis rather than treatment, contrast media is classified as a drug by the FDA, and has indications, contraindications, adverse effects, drug interactions, disease interactions, and laboratory interference issues related to its use. Iodinated contrast media is classified according to osmolarity and ionicity, and these characteristics contribute to potential for adverse effects and choice of agent. Financial and safety concerns are factors to be considered when selecting an appropriate agent. Adverse effects can range from mild and self-limited to severe and life threatening; potentially the most serious of these are anaphylactoid reactions and contrast-induced acute renal failure. Knowledge of risk factors and preventive strategies is vital, as are issues related to substitution of gadolinium-based contrast, an off-label use. It is important for the perianesthesia nurse to become familiar with these commonly used imaging medications. Copyright 2010 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Safety of Adrenaline Use in Anaphylaxis: A Multicentre Register.

PubMed

Cardona, Victòria; Ferré-Ybarz, Laia; Guilarte, Mar; Moreno-Pérez, Nuria; Gómez-Galán, Catalina; Alcoceba-Borràs, Eva; Delavalle, Maria Belén; Garriga-Baraut, Teresa

2017-01-01

The use of intramuscular adrenaline to treat anaphylaxis is suboptimal, despite being the first-line treatment recommended by national and international anaphylaxis guidelines. Fear of potentially severe side effects may be one of the underlying factors. The aim of this study was to assess the incidence and severity of adverse side effects after the use of adrenaline in anaphylaxis, as well as potential risk factors. Observational study based on a multicenter online registry of cases of adrenaline administration for suspected anaphylaxis. 277 registered valid cases were included: 138 (51.49%) female, median age 29 years (12-47), and 6 children under 2 years with a median age of 9 months (1-21). Side effects occurred in 58 cases (21.64%), with tremors, palpitations, and anxiety being the most frequent. There was a significant association of developing side effects with older age, higher dose of adrenaline, or use of the intravenous route. Potentially severe adverse effects (high blood pressure, chest discomfort, or ECG alterations) occurred only in 8 cases (2.99%); in these cases, no differences were found according to age or adrenaline dose, but again, intravenous administration was associated with more severe adverse events. This study shows that side effects affect less than 1 in 5 patients who receive adrenaline for an anaphylactic reaction, and are usually mild and transient. Therefore, in an emergency situation such as anaphylaxis, restricting adrenaline administration due to potential adverse effects would, in general, not be justified. © 2017 S. Karger AG, Basel.

Trends in anti-D immune globulin for childhood immune thrombocytopenia: Usage, response rates, and adverse effects

PubMed Central

Long, Michelle; Kalish, Leslie A.; Neufeld, Ellis J.; Grace, Rachael F.

2013-01-01

In 2010, the Food and Drug Administration (FDA) added a black box warning to anti-D immune globulin (Rho(D) immune globulin, anti-D) for immune thrombocytopenia (ITP) to warn of the complications related to severe hemolysis. The objective of this retrospective medical record review was to examine recent trends in anti-D use to treat ITP and rates of adverse events in a single large pediatric hematology program. Over a 7-year period, 176 (35%) of 502 ITP patients at our center received anti-D. Anti-D was the second most commonly prescribed drug for ITP from 2003 to 2010 overall and was given first most frequently (41%). Sixty-four percent of patients responded to anti-D, but 36% had adverse effects, including five patients requiring hospitalization. From 2003 to 2010, the use of anti-D as an initial therapy for ITP significantly decreased (P < 0.001). This trend preceded the 2010 FDA black box warning. In our experience, anti-D was associated with a significant number of adverse effects when used as a treatment for ITP, although none were life-threatening. Despite recent guidelines suggesting anti-D therapy for initial treatment for ITP, anti-D therapy for ITP has significantly decreased over the past 7 years. PMID:22190130

Factors influencing adverse events reporting within the health care system: the case of artemisinin-based combination treatments in northern Ghana.

PubMed

Chatio, Samuel; Aborigo, Raymond; Adongo, Philip Baba; Anyorigiya, Thomas; Dalinjong, Philip Ayizem; Akweongo, Patricia; Oduro, Abraham

2016-02-27

The use of artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria was a policy recommended by World Health Organization. In 2004, Ghana changed her first-line anti-malarial drug policy to use ACT. This study examined factors affecting adverse events reporting in northern Ghana after the introduction of ACT. This was a qualitative study based on sixty in-depth interviews with health workers, chemical shop owners and patients with malaria who were given ACT at the health facilities. Purposive sampling method was used to select study participants. The interviews were transcribed, coded into themes using Nvivo 9 software. The thematic analysis framework was used to analyse the data. Study respondents reported body weakness and dizziness as the most frequent side effects they had experienced from the used of ACT. Other side effects they reported were swollen testes, abdominal pain and shivering. These side effects were mostly associated with the use of artesunate-amodiaquine compared to other artemisinin-based combinations. Patients were not provided information about the side effects of the drugs and so did not report when they experienced them. Also long queues at health facilities and unfriendly health worker attitude were the main factors affecting adverse events reporting. Other factors such as wrong use of ACT at home, farming and commercial activities also affected effective adverse events reporting in the study area. Patients' lack of knowledge and health sector drawbacks affected side effect reporting on ACT. Intensive health education on likely side effects of ACT should be provided to patients by health workers. Also, improving health worker attitude toward clients will encourage patients to visit the health facilities when they react negatively to ACT and, subsequently, will improve on adverse events reporting.

Hepatotoxicity of nucleoside reverse transcriptase inhibitors.

PubMed

Montessori, Valentina; Harris, Marianne; Montaner, Julio S G

2003-05-01

Hepatotoxicity is an adverse effect of all available classes of antiretrovirals, including nucleoside reverse transcriptase inhibitors (NRTI). A syndrome of hepatic steatosis and lactic acidosis has been recognized as a rare, potentially fatal complication since the advent of NRTI monotherapy in the early 1990s. Today, NRTI remain the backbone of antiretroviral combination regimens, and, with the success of current treatment strategies, exposure to two or more of these agents may occur over a number of years. Hepatic steatosis and lactic acidosis are accordingly being observed more frequently, along with a more recently recognized syndrome of chronic hyperlactatemia. These as well as other adverse effects of NRTI are mediated by inhibition of human DNA polymerase gamma, resulting in mitochondrial dysfunction in the liver and other tissues. Early recognition and intervention are essential to avert serious outcomes.

Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients.

PubMed

Ann, Heawon; Kim, Ki Hyon; Choi, Hyun Young; Chang, Hyun Ha; Han, Sang Hoon; Kim, Kye Hyung; Lee, Jin Soo; Kim, Yeon Sook; Park, Kyung Hwa; Kim, Young Keun; Sohn, Jang Wook; Yun, Na Ra; Lee, Chang Seop; Choi, Young Wha; Lee, Yil Seob; Kim, Shin Woo

2017-09-01

Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea. Copyright © 2017 by The Korean Society of Infectious Diseases and Korean Society for Chemotherapy

Considerations for safe glucocorticoid therapy

PubMed

2018-06-01

Synthetic glucocorticoids have innumerable therapeutic applications and are frequently used in medical practice. Changes in the wide variety of synthetic molecules and the different routes of administration cause differences in anti-inflammatory action, therapeutic action and mineralocorticoid effects. Endocrinologists are generally consulted to evaluate the gradual decline in treatment, rather than to indicate it. We present general information and practical advice to the pediatrician to minimize the adverse effects and considerations to be taken into account for the suspension of treatment.

Clobazam and Aggression-Related Adverse Events in Pediatric Patients With Lennox-Gastaut Syndrome.

PubMed

Paolicchi, Juliann M; Ross, Gail; Lee, Deborah; Drummond, Rebecca; Isojarvi, Jouko

2015-10-01

Lennox-Gastaut syndrome is an intractable epileptic encephalopathy marked by frequent drop seizures. Most patients develop moderate intellectual disability and behavioral problems, including hyperactivity, aggressiveness, insecurity, and autistic features. Treatment with benzodiazepines, including clobazam, may increase aggression/behavioral problems in patients with Lennox-Gastaut syndrome. Post hoc analyses of data from the OV-1012 trial assessed the potential for behavioral effects with clobazam treatment in pediatric (2 to 18 years) patients with Lennox-Gastaut syndrome. OV-1012 was a phase 3, randomized, double-blind, parallel-group trial comprising a 4-week baseline period, 3-week titration period, and a 12-week maintenance period. Data from 194 patients were analyzed for a history of aggression/behavioral problems, occurrence of aggression-related adverse events, and by assessment of potential drug-related effects on four behavior domains of the Child Behavior Checklist. Twenty-nine aggression-related adverse events were reported for 27 (13.9%) patients. Similar percentages of clobazam-treated patients with and without a history of aggressive behavior experienced an aggression-related adverse event (16.7% versus 15.5%, respectively). In the medium- and high-dosage clobazam groups, onset of aggression-related adverse effects occurred within the 3-week titration period with 63.2% resolving by the end of the study. Aggression-related adverse event onset and resolution were similar for the low-dosage clobazam and placebo groups. Analysis of baseline to postbaseline T scores for the behavior domains of the Child Behavior Checklist indicated no significant differences between clobazam and placebo. Post hoc analyses indicate that the overall rate of aggression with clobazam treatment was low and dosage dependent. Clobazam treatment was effective in reducing drop seizures regardless of aggression experience. Copyright © 2015 Elsevier Inc. All rights reserved.

Sexual Dysfunction in Males: Significance of Adverse Childhood Experiences.

ERIC Educational Resources Information Center

Kinzl, Johann F.; And Others

1996-01-01

A survey of 301 male college students found that occasional sexual dysfunction was frequent in young male adults, and long-lasting adverse familial relationships to attachment figures were more influential in later sexual dysfunction than were childhood sexual abuse experiences. (Author/DB)

Alcohol, drugs, caffeine, tobacco, and environmental contaminant exposure: reproductive health consequences and clinical implications.

PubMed

Sadeu, J C; Hughes, Claude L; Agarwal, Sanjay; Foster, Warren G

2010-08-01

Reproductive function and fertility are thought to be compromised by behaviors such as cigarette smoking, substance abuse, and alcohol consumption; however, the strength of these associations are uncertain. Furthermore, the reproductive system is thought to be under attack from exposure to environmental contaminants, particularly those chemicals shown to affect endocrine homeostasis. The relationship between exposure to environmental contaminants and adverse effects on human reproductive health are frequently debated in the scientific literature and these controversies have spread into the lay press drawing increased public and regulatory attention. Therefore, the objective of the present review was to critically evaluate the literature concerning the relationship between lifestyle exposures and adverse effects on fertility as well as examining the evidence for a role of environmental contaminants in the purported decline of semen quality and the pathophysiology of subfertility, polycystic ovarian syndrome, and endometriosis. The authors conclude that whereas cigarette smoking is strongly associated with adverse reproductive outcomes, high-level exposures to other lifestyle factors are only weakly linked with negative fertility impacts. Finally, there is no compelling evidence that environmental contaminants, at concentrations representative of the levels measured in contemporary biomonitoring studies, have any effect, positive or negative, on reproductive health in the general population. Further research using prospective study designs with robust sample sizes are needed to evaluate testable hypotheses that address the relationship between exposure and adverse reproductive health effects.

Safety profiles of old and new antimicrobials for the treatment of MRSA infections.

PubMed

Bassetti, Matteo; Righi, Elda

2016-01-01

Methicillin-resistant Staphylococcus aureus (MRSA) is a frequent cause of severe nosocomial and community-acquired infections. Various adverse effects have been associated with compounds that are commonly used in the treatment of MRSA. Prolonged use of high-dose vancomycin has been linked with nephrotoxicity. Linezolid use has been associated with lactic acidosis in regimens longer than 14 days and occurrence of thrombocytopenia in patients with renal impairment. Daptomycin use correlates with reversible and often asymptomatic myopathy. Among new compounds, telavancin has shown increased toxicity compared to vancomycin, especially in patients with severe renal impairment, while a low rate of adverse effects was reported others glycolipopeptides such as dalbavancin and oritavancin and for new cephalosporins. Recently studied oxazolidinones (tedizolid and radezolid) also showed mild adverse effects in Phase 2 and 3 clinical trials. Due to the constant increase in antimicrobial resistance, the use of higher doses and prolonged regimens of antibiotics employed in the treatment of Gram-positive infections has become more common and linked to increased toxicity. Furthermore, new compounds with MRSA activity have been recently approved and will be regularly employed in clinical practice. The knowledge of the adverse effects and risk factors for the development of toxicity associated with anti-MRSA antimicrobials is paramount for the correct use of old and new compounds, especially in the treatment of severe infections.

Are cannabinoids an alternative for cachexia-anorexia syndrome in patients with advanced cancer?

PubMed

Cabeza, Claudia; Corsi, Oscar; Pérez-Cruz, Pedro

2017-12-29

Cachexia and anorexia are among the most frequent symptoms in patients with cancer. Cannabinoids have been used in patients with advanced cancer; however, their role is still controversial. To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, and generated a summary of findings table using the GRADE approach. We identified ten systematic reviews including three studies overall, of which two were randomized trials. We concluded it is not clear whether cannabinoids have any positive effect on increasing weight because the certainty of the evidence is very low. They might not have any effect on appetite, and are probably associated to frequent adverse effects.

Direct-to-consumer advertising in oncology: a content analysis of print media.

PubMed

Abel, Gregory A; Lee, Stephanie J; Weeks, Jane C

2007-04-01

Content analysis of cancer-related direct-to-consumer advertising (DTCA), with a focus on how benefit and risk/adverse effect information is presented, is essential to understanding its potential impact on oncology outcomes. We reviewed all oncology DTCA appearing in three patient-focused cancer magazines and a sample of selected popular magazines from January 2003 to June 2006. We determined the Flesch reading ease score (FRES) for the text in each advertisement (a score > or = 65 is readable for the average person). We also assessed the proportion, type size, and placement of benefits and risks/adverse effects, as well as the nature and content of advertising appeals. Of 284 advertisements identified, 49 were unique. Oncology-related DTCA was rare in the popular magazines, and appeared mostly in those aimed at female readership. About equal amounts of text were devoted to benefits and risks/adverse effects, and all text was difficult to read. The mean FRES for benefit text was 39.71; for risk/adverse effect text, it was 38.22, a difference of 1.49 (95% CI, -4.02 to 7.00). The largest font size for benefits was 4.60 mm on average; for risks/adverse effects, it was 2.38 mm, a difference of 2.22 mm (95% CI, 1.35 to 3.09). Appeals to medication effectiveness were frequent (95%) and often made with clinical trial data (61%). Oncology print DTCA is prevalent in cancer-related, patient-directed magazines, and infrequent in the popular press. The information presented is considerably difficult to read, raising important questions about the appropriateness of direct-to-consumer marketing for oncologic medications.

Sexual dysfunction, depression, and the impact of antidepressants.

PubMed

Kennedy, Sidney H; Rizvi, Sakina

2009-04-01

Sexual dysfunction is a common symptom of depression. Although decreased libido is most often reported, difficulties with arousal, resulting in vaginal dryness in women and erectile dysfunction in men, and absent or delayed orgasm are also prevalent. Sexual dysfunction is also a frequent adverse effect of treatment with most antidepressants and is one of the predominant reasons for premature drug discontinuation. Selective serotonin reuptake inhibitors are the most widely prescribed antidepressants and have significant effects on arousal and orgasm compared with antidepressants that target norepinephrine, dopamine, and melatonin systems. The availability of an antidepressant that does not cause or exacerbate sexual dysfunction represents an advance in pharmacotherapy for mood disorders and should reduce treatment noncompliance and decrease the need for switching antidepressants or adding antidotes. The purpose of this review was to provide an update on the prevalence, psychobiology, and relative adverse effect burden of sexual dysfunction associated with different antidepressants.

Antipsychotic use in the elderly: what doctors say they do, and what they do.

PubMed

Tiller, John; Ames, David; Brodaty, Henry; Byrne, Gerard; Chawla, Sudarshan; Halliday, Graeme; Snowdon, John; Hepworth, Graham; McArdle, Peter; Schweitzer, Isaac

2008-09-01

To review psychiatrists' attitudes and actual practice on the use of typical and atypical antipsychotics in the elderly. Audit data were collected from 18-old-age psychiatry units across Australia. The attitudes of old age psychiatrists and their perceptions of the efficacy, tolerability and clinical usefulness of antipsychotics were examined. The medications used for 321 patients were audited, and the attitudes of the 57 prescribing doctors were assessed. All available atypicals were prescribed and reported as more efficacious and clinically useful than typicals. Adverse events perceived by doctors as an obstacle to prescribing were more frequent than reported adverse event rates in product information. All diagnostic groups improved. Off-label use comprised almost 22% in this sample. Adverse events are impediments to prescribing, more so with typical than atypical antipsychotics. All available atypicals were used and appeared effective in this elderly population.

[Vaccinovigilance: Reports of adverse reactions in the year 2016].

PubMed

Albrecht, N; Ottiger, H

2017-08-01

In the year 2016, 107 reports of adverse reactions following the application of various authorized vaccines were received and evaluated by the IVI (Institute of Virology and Immunology). The notifications were submitted primarily by marketing authorization holders (81) or veterinarians and private persons (26). The aim of the Vigilance System is the identification of rare events to assess the individual risks of the vaccine application. During the last year, the correlation between reaction and vaccination was considered probable in 34% of the cases. As in previous years, companion animals were involved in most of the adverse effects (48% dogs, 21% cats), followed by cattle (13%). In dogs, approximately half of the reports concern the combination vaccines against distemper, hepatitis, parvovirus, parainfluenza and leptospirosis. The reported symptoms, such as itching, facial edema, acute vomiting and diarrhea, usually indicated forms of hypersensitivity. In cats, apathy was most frequently observed regardless of the vaccination.

Associations of early childhood adversities with mental disorders, psychological functioning, and suitability for psychotherapy in adulthood.

PubMed

Heinonen, Erkki; Knekt, Paul; Härkänen, Tommi; Virtala, Esa; Lindfors, Olavi

2018-06-01

Childhood adversities frequently precede adulthood depression and anxiety. Yet, how they impact needed treatment duration, type or focus in these common disorders, is unclear. For developing more individualized and precise interventions, we investigated whether specific early adversities associate with patients' distinct psychiatric problems, psychological vulnerabilities, and suitability for psychotherapy. A total of 221 depressed and anxious adult outpatients (excluding psychotic, severe personality, bipolar, and substance abuse disorders) referred from community, student, occupational, and private healthcare services filled the Childhood Family Atmosphere Questionnaire (CFAQ). They also filled self-reports on interpersonal behavior and problems, perceived competence, dispositional optimism, sense of coherence, defenses, and psychiatric history. Clinicians assessed the patients' symptomatology, personality, object relations, cognitive performance, and psychotherapy suitability. Regression analyses were conducted. Childhood adversities predicted both worse current psychological functioning (e.g., interpersonal problems), and better clinician-rated capacities for benefiting from psychotherapy (e.g. self-reflection, capacity for interaction). Parental problems had the most numerous negative associations to psychological functioning. Best capacities for psychotherapy were predicted by recollected family unhappiness. Associations with psychiatric criteria were, however, largely non-significant. In conclusion, for psychosocial treatment planning, patients' early adversities may indicate both vulnerability and resources. As childhood adversities are frequent among treatment-seekers, further studies examining how early adversities predict psychotherapy outcome are needed. Copyright © 2018. Published by Elsevier B.V.

Different drinking motives, different adverse consequences? Evidence among adolescents from 10 European countries.

PubMed

Wicki, Matthias; Kuntsche, Emmanuel; Eichenberger, Yvonne; Aasvee, Katrin; Bendtsen, Pernille; Dankulincová Veselská, Zuzana; Demetrovics, Zsolt; Dzielska, Anna; Farkas, Judit; de Matos, Margarida Gaspar; Roberts, Chris; Tynjälä, Jorma; Välimaa, Raili; Vieno, Alessio

2017-11-01

This study, which builds on previous research demonstrating that drinking motives are associated with adverse consequences, investigates the associations between drinking motives and non-alcohol-attributed adverse consequences and disentangles alcohol-related and direct effects. On the basis of a sample of 22 841 alcohol-using 13- to 16-year-olds (50.6% female) from Belgium, Denmark, Estonia, Finland, Ireland, Portugal, Scotland, Slovakia, Switzerland and Wales, structural equation models were used to estimate direct and indirect effects. Additionally, differences across countries were tested in a multigroup analysis. The indirect effect (via alcohol use) was greater for injuries and academic problems than for more general outcomes such as life dissatisfaction and negative body image. For social, enhancement and coping motives, we found positive indirect effects (via alcohol use) on injuries and academic problems; the association was negative for conformity motives. The direct effect, that is, the effect above and beyond alcohol use, indicated more negative consequences among those who tended to drink more frequently for coping motives. More negative consequences, such as injuries and negative body image, were also found among those who drink for conformity motives. The pattern of association was largely comparable across countries. While the actual mean level of drinking motives, alcohol use and adverse consequence varied across countries, the consistency of association patterns implies that drinking motive-inspired health promotion efforts are likely to be beneficial across Europe. This is particularly important for coping drinkers because they are especially prone to adverse consequences over and above their alcohol use. [Wicki M, Kuntsche E, Eichenberger Y, Aasvee K, Bendtsen P, Dankulincová Veselská Z, Demetrovics Z, Dzielska A, Farkas J, de Matos MG, Roberts C, Tynjälä J, Välimaa R, Vieno A. Different drinking motives, different adverse consequences? Evidence among adolescents from 10 European countries. © 2017 Australasian Professional Society on Alcohol and other Drugs.

[Acute renal insufficiency caused by phenyl-indane-dione. Apropos of 1 case].

PubMed

Horellou, M F; Feiss, P; Voultoury, J C; Gay, R

1978-01-01

One case of Phenindione (PID) adverse reaction is reported. The patient showed a typical picture of immunological reaction to the drug. In spite of severe bacteremia, she recovered. Only 33 cases of PID intolerance are reported in the literature. In all these patients, renal failure occurred. Superinfection is the most frequent cause of death. PID adverse reaction should be evoqued in the presence of signs such a fever, asthenia, anorexia and cutaneous reaction. The PID should be stopped immediatly but renal failure yet develops. During a PID treatment, frequent evaluation of blood azotemia, creatinine and proteinuria should be performed.

Vismodegib (ERIVEDGE°) In basal cell carcinoma: too many unknowns.

PubMed

2015-01-01

Basal cell carcinomas are the most common skin cancers. They are usually localised and carry a good prognosis. There is no standard treatment for the rare patients with metastatic basal cell carcinoma or very extensive basal cell carcinoma for whom surgery or radiotherapy is inappropriate. Vismodegib, a cytotoxic drug, is claimed to prevent tumour growth by inhibiting a pathway involved in tissue repair and embryogenesis. It has been authorised in the European Union for patients with metastatic or locally advanced and extensive basal cell carcinoma. Clinical evaluation of vismodegib is based on a non-comparative clinical trial involving 104 patients, providing only weak evidence. Twenty-one months after the start of the trial, 7 patients with metastases (21%) and 6 patients with advanced basal cell carcinoma (10%) had died. Given the lack of a placebo group, there is no way of knowing whether vismodegib had any effect, positive or negative, on survival. There were no complete responses among patients with metastases, but about one-third of them had partial responses. Among the 63 patients with locally advanced basal cell carcinoma, there were 14 complete responses and 16 partial responses. The recurrence rate in patients with complete responses was not reported. Similar results were reported in two other uncontrolled trials available in mid-2014. Vismodegib has frequent and sometimes serious adverse effects, including muscle spasms, fatigue and severe hyponatraemia. Cases of severe weight loss, alopecia, ocular disorders, other cancers (including squamous cell carcinoma) and anaemia have also been reported. More data are needed on possible hepatic and cardiovascular adverse effects. A potent teratogenic effect was seen in experimental animals. As vismodegib enters semen, contraception is mandatory for both men (condoms) and women. In practice, vismodegib has frequent and varied adverse effects, some of which are serious, while its benefits are poorly documented. Vismodegib should only be proposed to patients in whom basal cell cancer markedly undermines quality of life, and only in the context of clinical research.

Impact of caffeine and coffee on our health.

PubMed

Gonzalez de Mejia, Elvira; Ramirez-Mares, Marco Vinicio

2014-10-01

Coffee is the most frequently consumed caffeine-containing beverage. The caffeine in coffee is a bioactive compound with stimulatory effects on the central nervous system and a positive effect on long-term memory. Although coffee consumption has been historically linked to adverse health effects, new research indicates that coffee consumption may be beneficial. Here we discuss the impact of coffee and caffeine on health and bring attention to the changing caffeine landscape that includes new caffeine-containing energy drinks and supplements, often targeting children and adolescents. Copyright © 2014 Elsevier Ltd. All rights reserved.

Adverse Event Rates Associated with Transforaminal and Interlaminar Epidural Steroid Injections: A Multi-Institutional Study.

PubMed

El-Yahchouchi, Christine A; Plastaras, Christopher T; Maus, Timothy P; Carr, Carrie M; McCormick, Zachary L; Geske, Jennifer R; Smuck, Matthew; Pingree, Matthew J; Kennedy, David J

2016-02-01

Transforaminal epidural steroid injections (TFESI) have demonstrated efficacy and effectiveness in treatment of radicular pain. Despite little evidence of efficacy/effectiveness, interlaminar epidural steroid injections (ILESI) are advocated by some as primary therapy for radicular pain due to purported greater safety. To assess immediate and delayed adverse event rates of TFESI and ILESI injections at three academic medical centers utilizing International Spine Intervention Society practice guidelines. Quality assurance databases from a Radiology and two physical medicine and rehabilitation (PM&R) practices were interrogated. Medical records were reviewed, verifying immediate and delayed adverse events. There were no immediate major adverse events of neurologic injury or hemorrhage in 16,638 consecutive procedures in all spine segments (14,956 TFESI; 1,682 ILESI). Vasovagal reactions occurred in 1.2% of procedures, more frequently (P = 0.004) in TFESI (1.3%) than ILESI (0.5%). Dural punctures occurred in 0.06% of procedures, more commonly after ILESI (0.2% vs 0.04%, P = 0.006). Delayed follow up on PM&R patients (92.5% and 78.5, next business day) and radiology patients (63.1%, 2 weeks) identified no major adverse events of neurologic injury, hemorrhage, or infection. There were no significant differences in delayed minor adverse event rates. Central steroid response (sleeplessness, flushing, nonpositional headache) was seen in 2.6% of both TFESI and ILESI patients. 2.1% of TFESI and 1.8% of ILESI patients reported increased pain. No long-term sequelae were seen from any immediate or delayed minor adverse event. Both transforaminal and ILESI are safely performed with low immediate and delayed adverse event rates when informed by evidence-based procedural guidelines. By demonstrating comparable safety, this study suggests that the choice between ILESI and TFESIs can be based on documented efficacy and effectiveness and not driven by safety concerns.

Adverse effects of cannabis.

PubMed

2011-01-01

Cannabis, Cannabis sativa L., is used to produce a resin that contains high levels of cannabinoids, particularly delta9-tetrahydrocannabinol (THC), which are psychoactive substances. Although cannabis use is illegal in France and in many other countries, it is widely used for its relaxing or euphoric effects, especially by adolescents and young adults. What are the adverse effects of cannabis on health? During consumption? And in the long term? Does cannabis predispose users to the development of psychotic disorders? To answer these questions, we reviewed the available evidence using the standard Prescrire methodology. The long-term adverse effects of cannabis are difficult to evaluate. Since and associated substances, with or without the user's knowledge. Tobacco and alcohol consumption, and particular lifestyles and behaviours are often associated with cannabis use. Some traits predispose individuals to the use of psychoactive substances in general. The effects of cannabis are dosedependent.The most frequently report-ed adverse effects are mental slowness, impaired reaction times, and sometimes accentuation of anxiety. Serious psychological disorders have been reported with high levels of intoxication. The relationship between poor school performance and early, regular, and frequent cannabis use seems to be a vicious circle, in which each sustains the other. Many studies have focused on the long-term effects of cannabis on memory, but their results have been inconclusive. There do not * About fifteen longitudinal cohort studies that examined the influence of cannabis on depressive thoughts or suicidal ideation have yielded conflicting results and are inconclusive. Several longitudinal cohort studies have shown a statistical association between psychotic illness and self-reported cannabis use. However, the results are difficult to interpret due to methodological problems, particularly the unknown reliability of self-reported data. It has not been possible to establish a causal relationship in either direction, because of these methodological limitations. In Australia, the marked increase in cannabis use has not been accompanied by an increased incidence of schizophrenia. On the basis of the available data, we cannot reach firm conclusions on whether or not cannabis use causes psychosis. It seems prudent to inform apparently vulnerable individuals that cannabis may cause acute psychotic decompensation, especially at high doses. Users can feel dependent on cannabis, but this dependence is usually psychological. Withdrawal symptoms tend to occur within 48 hours following cessation of regular cannabis use, and include increased irritability, anxiety, nervousness, restlessness, sleep difficulties and aggression. Symptoms subside within 2 to 12 weeks. Driving under the influence of cannabis doubles the risk of causing a fatal road accident. Alcohol consumption plays an even greater role. A few studies and a number of isolated reports suggest that cannabis has a role in the occurrence of cardiovascular adverse effects, especially in patients with coronary heart disease. Numerous case-control studies have investigated the role of cannabis in the incidence of some types of cancer. Its role has not been ruled out, but it is not possible to determine whether the risk is distinct from that of the tobacco with which it is often smoked. Studies that have examined the influence of cannabis use on the clinical course of hepatitis C are inconclusive. Alcohol remains the main toxic agent that hepatitis C patients should avoid. In practice, the adverse effects of low-level, recreational cannabis use are generally minor, although they can apparently be serious in vulnerable individuals. The adverse effects of cannabis appear overall to be less serious than those of alcohol, in terms of neuropsychological and somatic effects, accidents and violence.

Adverse Health Consequences of Performance-Enhancing Drugs: An Endocrine Society Scientific Statement

PubMed Central

Pope, Harrison G.; Wood, Ruth I.; Rogol, Alan; Nyberg, Fred; Bowers, Larry

2014-01-01

Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated. This scientific statement synthesizes available information on the medical consequences of PED use, identifies gaps in knowledge, and aims to focus the attention of the medical community and policymakers on PED use as an important public health problem. PED users frequently consume highly supraphysiologic doses of PEDs, combine them with other PEDs and/or other classical drugs of abuse, and display additional associated risk factors. PED use has been linked to an increased risk of death and a wide variety of cardiovascular, psychiatric, metabolic, endocrine, neurologic, infectious, hepatic, renal, and musculoskeletal disorders. Because randomized trials cannot ethically duplicate the large doses of PEDs and the many factors associated with PED use, we need observational studies to collect valid outcome data on the health risks associated with PEDs. In addition, we need studies regarding the prevalence of PED use, the mechanisms by which PEDs exert their adverse health effects, and the interactive effects of PEDs with sports injuries and other high-risk behaviors. We also need randomized trials to assess therapeutic interventions for treating the adverse effects of PEDs, such as the anabolic-androgen steroid withdrawal syndrome. Finally, we need to raise public awareness of the serious health consequences of PEDs. PMID:24423981

Switching, Adverse Effects and Use of Over-the-Counter Analgesics among Users of Oral Anticoagulants: A Pharmacy-based Survey.

PubMed

Hellfritzsch, Maja; Hyllested, Lea Maria Rønneberg; Meegaard, Line; Wiberg-Hansen, Alexander; Grove, Erik Lerkevang; Pottegård, Anton

2017-07-01

Oral anticoagulants are widely used but information on important aspects in that respect is not available from medical registers or clinical databases. Therefore, we conducted a survey including patients filling a prescription for oral anticoagulants at two large Danish community pharmacies. We collected information concerning the patients' knowledge of their anticoagulant treatment including prior drug switching. Further, patients were asked about use of over-the-counter analgesics, adverse effects and how the treatment affected their everyday life. Among 335 eligible patients, 301 (90%) agreed to participate. Atrial fibrillation was the most common indication (65%), and most patients filled a prescription for a non-vitamin K antagonist oral anticoagulant (NOAC) (58%). Among the 12% (n = 35) of participants who had switched oral anticoagulant treatment, 69% had switched from a vitamin K antagonist (VKA) to a NOAC. Switching was most frequently caused by inconvenience (34%) and adverse effects (23%). Although half of all patients had recently bought over-the-counter analgesics, purchase of ibuprofen and aspirin was rare (6%). More VKA users than NOAC users felt limited in their everyday life because of anticoagulant treatment (18% versus 9%). Among non-incident NOAC users, 21% had experienced adverse effects during their current treatment. Based on first-hand information from a large sample of anticoagulant users, we conclude that the main drug-related issues leading to anticoagulant switching and perceived limitations in everyday life were inconvenience and adverse effects. This varied between drug groups. Further, use of NSAIDs obtained over the counter was rare. © 2017 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

Complications of local anaesthesia. An observational study.

PubMed

Brand, H S; Bekker, W; Baart, J A

2009-11-01

Local anaesthesia is increasingly used by dental hygienists. As little is known about the incidence of adverse effects during and after the administration of local anaesthetics, we evaluated side-effects associated with local anaesthesia. A prospective observational study was conducted using standard criteria among a group of 103 patients receiving mandibular block anaesthesia. Physical reactions like clenching fists (14.5%), moaning (12.6%) and turning pale (7.8%) were frequently observed. Patients (3.8%) showed a painful reaction because of needle contact with a nerve or the periosteum. Systemic complications were not observed. After the injection, 41.7% said they felt tense during the administration; 4.9% of the patients reported swallowing problems and 3.9% a tachycardia. These results suggest that administration of local anaesthesia has a small risk of adverse events. Complications, if they occur, seem minor and transient in nature.

Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study.

PubMed

Mason, S L; Grant, I A; Elliott, J; Cripps, P; Blackwood, L

2014-08-01

To assess the prevalence of gastrointestinal toxicity in dogs receiving chemotherapy with vincristine and cyclophosphamide and the efficacy of maropitant citrate (Cerenia™, Zoetis) in reducing these events. Dogs receiving chemotherapy with cyclophosphamide or vincristine were randomised to either receive maropitant or not in the period immediately after treatment and for 4 days afterwards. Owners completed a diary of adverse events following treatment. Adverse events occurred in 40/58 (69%) dogs in the vincristine group. Most of these adverse events were mild and included: lethargy (62%), appetite loss (43%), diarrhoea (34%) and vomiting (24%). Adverse events occurred in 34/42 (81%) dogs treated with cyclophosphamide. Most of these adverse events were mild and included: lethargy (62%), diarrhoea (36%), appetite loss (36%) and vomiting (21%). There was no difference in total clinical score, vomiting, diarrhoea, appetite loss or lethargy score between dogs treated with maropitant and non-treated dogs in either the vincristine or cyclophosphamide groups. Chemotherapy-related side effects are frequent but usually mild in dogs receiving vincristine or cyclophosphamide. Prophylactic administration of maropitant does not reduce the frequency of adverse events and maropitant should be administered only as required for individual cases. © 2014 British Small Animal Veterinary Association.

49 CFR 209.329 - Assessment considerations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... frequently repeated; (2) The adverse impact or the potentially adverse impact of the violation on the health... 49 Transportation 4 2010-10-01 2010-10-01 false Assessment considerations. 209.329 Section 209.329... Assessment considerations. (a) Proof of a respondent's willful violation of one of the requirements of parts...

49 CFR 209.329 - Assessment considerations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... frequently repeated; (2) The adverse impact or the potentially adverse impact of the violation on the health... 49 Transportation 4 2014-10-01 2014-10-01 false Assessment considerations. 209.329 Section 209.329... Assessment considerations. (a) Proof of a respondent's willful violation of one of the requirements of parts...

49 CFR 209.329 - Assessment considerations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... frequently repeated; (2) The adverse impact or the potentially adverse impact of the violation on the health... 49 Transportation 4 2013-10-01 2013-10-01 false Assessment considerations. 209.329 Section 209.329... Assessment considerations. (a) Proof of a respondent's willful violation of one of the requirements of parts...

49 CFR 209.329 - Assessment considerations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... frequently repeated; (2) The adverse impact or the potentially adverse impact of the violation on the health... 49 Transportation 4 2012-10-01 2012-10-01 false Assessment considerations. 209.329 Section 209.329... Assessment considerations. (a) Proof of a respondent's willful violation of one of the requirements of parts...

49 CFR 209.329 - Assessment considerations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... frequently repeated; (2) The adverse impact or the potentially adverse impact of the violation on the health... 49 Transportation 4 2011-10-01 2011-10-01 false Assessment considerations. 209.329 Section 209.329... Assessment considerations. (a) Proof of a respondent's willful violation of one of the requirements of parts...

Community Learning Projects: Transforming Post-Compulsory Education Provision in Rural Communities

ERIC Educational Resources Information Center

McLachlan, Kathryn; Arden, Catherine H.

2009-01-01

Rural communities such as Stanthorpe on Queensland's Southern Downs, in Australia, are familiar with turbulent environmental, social, technological and economic change and the adversity that frequently accompanies such changes. The capacity of individuals and communities to bounce back from adversity is referred to as resilience. Participation in…

Ultrasonographic evaluation of vincristine-induced gastric hypomotility and the prokinetic effect of mosapride in dogs.

PubMed

Tsukamoto, A; Ohno, K; Tsukagoshi, T; Maeda, S; Nakashima, K; Fukushima, K; Fujino, Y; Takeuchi, A; Tsujimoto, H

2011-01-01

Vincristine induces gastrointestinal motility disorders in humans. Adverse gastrointestinal events are commonly observed in dogs receiving vincristine. To evaluate gastric motility after vincristine administration in dogs and the prophylactic effect of a prokinetic agent, mosapride. Five healthy Beagle dogs. Five dogs received vincristine i.v. at a dosage of 0.75 mg/m(2). The motility index (MI) of the antral contraction was ultrasonographically evaluated 30 minutes postfeeding before administration of vincristine and for 6 days after vincristine treatment. After a 6-week washout period, the dogs received vincristine with mosapride (2 mg/kg p.o., q24h for 6 days), and the MI was re-evaluated. Adverse gastrointestinal events were evaluated according to the Veterinary Co-operative Group Common Terminology Criteria for Adverse Events (VCOG-CTCAE). After vincristine administration, a significant decrease (P < .05) in MI was observed on days 3 (6.64 ± 0.30) and 4 (8.02 ± 0.94), compared with pretreatment levels (10.00 ± 0.62). Gastrointestinal adverse events were observed in 4 dogs (grade 2 decreased appetite: 3 dogs; grade 1 vomiting: 2 dogs; and grade 1 diarrhea and grade 2 hematochezia: 1 dog). When mosapride citrate was administered with vincristine and for the next 5 days, no decrease in MI was observed. Furthermore, adverse gastrointestinal events occurred less frequently (grade 1 vomiting and grade 2 hematochezia in 1 dog each). Vincristine (0.75 mg/m(2)) induces gastric hypomotility in dogs. Preventive administration of mosapride citrate (2.0 mg/kg p.o., q24h) improves hypomotility and may decrease the adverse gastrointestinal effects of vincristine. Copyright © 2011 by the American College of Veterinary Internal Medicine.

Nonallergic Eyelid Edema After Botulinum Toxin Type A Injection

PubMed Central

Chang, Yin-Shuo; Chang, Chang-Cheng; Shen, Jen-Hsiang; Chen, Yu-Tsung; Chan, Karen Kar-Wun

2015-01-01

Abstract Periocular botulinum toxin type A (BoNTA) injections are generally safe. Ptosis is the most common adverse effect, whereas eyelid edema is rarely reported. There is no consensus on the latter's incidence, clinical course, or treatment strategy. Here we managed a 59-year-old woman who received BoNTA injections to her forehead, glabella, and eye corner. At 3-day follow-up, she presented with painless, nonpruritic, bilateral periorbital edema, and erythema. Preliminary diagnosis was a local allergic reaction, and topical corticosteroid was administered, but upon lack of improvement, edema secondary to venous and lymphatic congestion was hypothesized, and she was advised to apply hot pads over her eyes, blink frequently, and massage the area. Her eyelid edema resolved 2 weeks later. At 4-month follow-up, the patient requested and received another course of BoNTA at half the dose. Frequent blinking was instructed, and the patient reported a satisfactory outcome with no adverse effects. In our literature review, incidence of BoNTA-induced eyelid edema was 1.4% and showed Asian tendency. Although rare, BoNTA-induced periorbital edema is self-limiting, and normally resolves in 2 to 4 weeks without medical treatment. Patients at risk for edema, including Asian ethnicity, dermatochalasis, and poor periocular muscle tone, are advised to receive injections at half the dosage. Examination of the function and tone of the orbicularis oculi and levator palpebrae superioris muscles before treatment is recommended, and application of hot pads over the eyes, frequent blinking in the morning, and self-massage of the affected area to increase venous return have demonstrated to improve outcome. PMID:26402825

Towards Clinical Application of Neurotrophic Factors to the Auditory Nerve; Assessment of Safety and Efficacy by a Systematic Review of Neurotrophic Treatments in Humans.

PubMed

Bezdjian, Aren; Kraaijenga, Véronique J C; Ramekers, Dyan; Versnel, Huib; Thomeer, Hans G X M; Klis, Sjaak F L; Grolman, Wilko

2016-11-26

Animal studies have evidenced protection of the auditory nerve by exogenous neurotrophic factors. In order to assess clinical applicability of neurotrophic treatment of the auditory nerve, the safety and efficacy of neurotrophic therapies in various human disorders were systematically reviewed. Outcomes of our literature search included disorder, neurotrophic factor, administration route, therapeutic outcome, and adverse event. From 2103 articles retrieved, 20 randomized controlled trials including 3974 patients were selected. Amyotrophic lateral sclerosis (53%) was the most frequently reported indication for neurotrophic therapy followed by diabetic polyneuropathy (28%). Ciliary neurotrophic factor (50%), nerve growth factor (24%) and insulin-like growth factor (21%) were most often used. Injection site reaction was a frequently occurring adverse event (61%) followed by asthenia (24%) and gastrointestinal disturbances (20%). Eighteen out of 20 trials deemed neurotrophic therapy to be safe, and six out of 17 studies concluded the neurotrophic therapy to be effective. Positive outcomes were generally small or contradicted by other studies. Most non-neurodegenerative diseases treated by targeted deliveries of neurotrophic factors were considered safe and effective. Hence, since local delivery to the cochlea is feasible, translation from animal studies to human trials in treating auditory nerve degeneration seems promising.

Marijuana and Cannabinoids in ESRD and Earlier Stages of CKD.

PubMed

Rein, Joshua L; Wyatt, Christina M

2018-02-01

Marijuana is the most commonly used recreational drug in the United States, and legal recreational and medicinal use has gained public acceptance during the last decade. Twenty-nine US states have established medical marijuana programs, 8 of which have also legalized recreational marijuana, and Canada is expected to legalize recreational marijuana in 2018. Advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD) are chronic conditions with significant associated morbidity and mortality. Patients experience substantial symptom burden that is frequently undertreated due to adverse medication side effects. This article reviews the available evidence for the use of medical marijuana to manage chronic pain, nausea/vomiting, anorexia/cachexia, and pruritus, all of which are frequently reported by patients with advanced CKD or ESRD. Potential adverse health effects of medical and recreational marijuana use are also discussed. Regardless of personal, social, and political beliefs, marijuana use is becoming mainstream, and nephrologists should be aware of the potential impact on our patient population. Further research is warranted to investigate the renal endocannabinoid system, the impact of marijuana use on kidney disease outcomes, and the risks and benefits of medical marijuana use on symptoms of advanced CKD and ESRD. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Mefloquine adverse effects with atypical facial lesions in an overweight patient.

PubMed

Descloux, Elodie; De Monbrison, Frédérique; Basselin, Cécile; Vial, Thierry; Peyron, François

2010-09-01

The recommended dosage of mefloquine to treat Plasmodium falciparum infection is 25 mg/kg, with no recommendation for dosage exceeding 1500 mg. We describe an original case of adverse reaction to mefloquine in an overweight patient. Case report. A 32-year-old woman weighing 139 kg presented with uncomplicated P. falciparum infection after returning from Cameroon. She received 3250 mg of mefloquine (i.e. 23 mg/kg) administered in four doses. On day 2, she developed neuropsychiatric disorders and facial lesions. Nasal mucocutaneous vesicles and bullae, depressive mood, mild thrombocytopenia and hepatic cytolysis were evidenced. Parasitemia was negative. Recovery was complete on day 17. High mefloquine serum levels were measured (8.030 mg/L on day 3, 6.880 mg/L on day 8, and 3.370 mg/L on day 17). The causal relationship between mefloquine and the occurrence of these adverse effects is probable. However, as no viral or bacteriological investigations were performed, the drug responsibility remains uncertain. Mefloquine-induced bullous and facial lesions reversible upon drug withdrawal have already been described. The associated neuropsychiatric symptoms were strongly suggestive of mefloquine adverse effects, as such events are more frequently observed in cases of overdosage. Our case emphasizes the difficulties of dosage adaptation in overweight patients. Copyright © 2010 Elsevier Ltd. All rights reserved.

A randomised crossover study comparing bimatoprost and latanoprost in subjects with primary angle closure glaucoma.

PubMed

How, A C S; Kumar, R S; Chen, Y-M; Su, D H; Gao, H; Oen, F T; Ho, C-L; Seah, S K; Aung, T

2009-06-01

To compare the intraocular pressure (IOP) lowering efficacy and side effects of latanoprost 0.005% and bimatoprost 0.03% in subjects with chronic primary angle closure glaucoma (PACG). This was an observer-masked randomised crossover study of 60 PACG subjects who received either latanoprost or bimatoprost for 6 weeks, after which they were crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications was assessed by the reduction in IOP after 6 weeks of treatment compared with baseline. Fifty-four subjects (80 eyes) completed the study. Latanoprost reduced IOP (mean (SD)) by 8.4 (3.8) mm Hg and bimatoprost by 8.9 (3.9) mm Hg from a baseline of 25.2 (3.6) mm Hg and 25.2 (3.6) mm Hg respectively (p = 0.23). Adverse events were mild in both groups; however there were twice as many reports of an adverse event in the bimatoprost group (81%) compared with the latanoprost group (40%, p<0.01). Ocular irritation was the most frequently reported adverse event in both groups; 22 subjects (37.9%) treated with bimatoprost experienced ocular hyperaemia as compared with 13 subjects (22.4%) treated with latanoprost (p = 0.11). Bimatoprost once daily was similarly effective in reducing IOP compared with latanoprost once daily in subjects with chronic PACG. Both drugs were well tolerated with mild ocular adverse events.

Preliminary Experience with Transdermal Oxybutynin Patches for Hyperhidrosis.

PubMed

Bergón-Sendín, M; Pulido-Pérez, A; Sáez-Martín, L C; Suárez-Fernández, R

2016-12-01

Hyperhidrosis is very common and has a considerable impact on patients' quality of life. While oral oxybutynin is associated with good response rates, adverse effects are common and frequently cause patients to stop treatment. Following the recent launch of oxybutynin in a transdermal patch formulation in Spain, we undertook a preliminary study to assess treatment response and adverse effects in patients with hyperhidrosis. This prospective study of 25 patients treated twice weekly with transdermal oxybutynin patches over 10 weeks assessed treatment response on 2 subjective scales: the Hyperhidrosis Disease Severity Scale (HDSS) and a visual analog scale (VAS) for sweating. Sixty percent of patients showed an improvement in HDSS scores. VAS scores improved in all cases, and 68% of patients achieved a reduction of 3 points or more. Just 2 patients (8%) experienced treatment-related adverse effects (irritant dermatitis at the patch application site in both cases). Although our results are based on a small sample, they suggest that transdermal oxybutynin could be a useful option for the treatment of hyperhidrosis and that it has an excellent safety and tolerability profile. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

PubMed

Bondon-Guitton, Emmanuelle; Mourgues, Thibaut; Rousseau, Vanessa; Cousty, Sarah; Cottin, Judith; Drablier, Guillaume; Micallef, Joëlle; Montastruc, Jean-Louis

2017-09-01

Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database. Among 523,808 reports of adverse drug reactions, we identified 454 reports of gingival bleeding (0.09%). Most of them were "serious" (58.4%) and occurred in females (54.6%). The frequency of gingival bleeding increased with age. The most frequently "suspected" drugs were antithrombotics (67.8%), particularly fluindione. Other drugs frequently involved were furosemide followed by paracetamol, amiodarone, amoxicillin, paroxetine, ketoprofen, zolpidem, enalapril and ramipril. Thirty-nine reports involved a drug-drug interaction with antithrombotics, mainly with anti-infectives. Gingival bleeding can be an adverse drug reaction, often "serious" and rarely fatal. Patients older than 50 years and women are particularly at risk. Among drugs known to increase the risk of gingival bleeding, the most frequently involved were fluindione, furosemide, paracetamol, amiodarone, amoxicillin, paroxetine or ketoprofen. We also identified signal for drugs not usually known to be involved in bleeding, like zolpidem, enalapril or ramipril. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Transitions of cardiovascular risk from adolescence to young adulthood--the Bogalusa Heart Study: I. Effects of alterations in lifestyle.

PubMed

Croft, J B; Foster, T A; Parker, F C; Cresanta, J L; Hunter, S M; Webber, L S; Srinivasan, S R; Berenson, G S

1986-01-01

Adolescence and young adulthood represents a transition period for biologic and lifestyle characteristics. In a preliminary investigation of young adults (ages 18-20 years), the Bogalusa Heart Study documented patterns of alcohol, tobacco, and oral contraceptive use, as well as changes in education, occupational, marital and parenting status. Such behaviors accelerate the cardiovascular disease process and may differentially influence risk factor patterns of race and sex groups. Adverse levels of systolic blood pressure and alpha-lipoprotein cholesterol were more frequent in married vs single men; elevated triglyceride levels were more frequent in married vs single whites. However adverse levels of beta- and alpha-lipoprotein cholesterol were more frequent in nonparents than in parents. Cigarette smoking and oral contraceptive use were independently related to elevated beta-lipoprotein cholesterol and decreased alpha-lipoprotein cholesterol levels of young white women. Alcohol consumption was highest among white males, with 32% reporting daily consumption of the equivalent of two or more beers or one mixed drink. Alcohol consumption was negatively correlated with blood pressure in white males and positively correlated with alpha-lipoprotein cholesterol in black males. Since such lifestyle factors are related to physiologic risk factors that result in heart disease and adult cardiovascular morbidity and mortality in the older ages, early targeting during adolescence and young adulthood is important.

[Intestinal cleaning for colonoscopy in children: effectiveness, adherence and adverse effects of schemes differentiated by age].

PubMed

Miquel, Isabel; Arancibia, María Eugenia; Alliende, Francisco; Ríos, Gloria; Rodríguez, Lorena; Lucero, Yalda; Saelzer, Eric

2017-04-01

Adequate intestinal cleanliness is crucial to achieve optimal colonoscopy performance. Several bowel preparation (BP) schemes have been proposed, but there is still no consensus as regards which is the most suitable in paediatric patients. To describe the effectiveness, adherence, and adverse effects of BP protocols differentiated by age group in paediatric patients subjected to colonoscopy. Prospective, study that included patients < 18 years subjected to colonoscopy. BP protocols differentiated by age group were indicated as follows: < 6 m (glycerine suppository); 6 m-3y 11 m (poly-ethylene-glycol (PEG 3350 without electrolytes); 4y-9y 11 m (PEG 3350 without electrolytes + bisacodyl); 10 y-18 y (PEG 3350 with electrolytes). Demographic, clinical information, adherence and adverse effects were registered. Effectiveness was determined using a validated scale (Boston modified) during colonoscopy. A total of 159 patients were included, of which 87 (55%) were males, and with a median age of 4 years (range 1 m-17 years). Seventy eight percent of patients achieved successful BP. The higher effectiveness was observed in the groups of < 6 m (96%) and 10-18 y (91%). Constipation was significantly more frequent (29%) in the 4 yo-9 yo 11 m in which lower effectiveness was observed (69%). Good adherence was observed in 87% of patients. Adverse effects were observed in a third of patients, although they were mild and did not lead to the suspension of the BP. Satisfactory results were achieved with the BP schemes used, with a successful BP being obtained in 4 out of 5 patients. Results were different between groups, which is probably related to previous bowel transit and indicated medication.

Acute and long-term effects of cannabis use: a review.

PubMed

Karila, Laurent; Roux, Perrine; Rolland, Benjamin; Benyamina, Amine; Reynaud, Michel; Aubin, Henri-Jean; Lançon, Christophe

2014-01-01

Cannabis remains the most commonly used and trafficked illicit drug in the world. Its use is largely concentrated among young people (15- to 34-year-olds). There is a variety of cannabis use patterns, ranging from experimental use to dependent use. Men are more likely than women to report both early initiation and frequent use of cannabis. Due to the high prevalence of cannabis use, the impact of cannabis on public health may be significant. A range of acute and chronic health problems associated with cannabis use has been identified. Cannabis can frequently have negative effects in its users, which may be amplified by certain demographic and/or psychosocial factors. Acute adverse effects include hyperemesis syndrome, impaired coordination and performance, anxiety, suicidal ideations/tendencies, and psychotic symptoms. Acute cannabis consumption is also associated with an increased risk of motor vehicle crashes, especially fatal collisions. Evidence indicates that frequent and prolonged use of cannabis can be detrimental to both mental and physical health. Chronic effects of cannabis use include mood disorders, exacerbation of psychotic disorders in vulnerable people, cannabis use disorders, withdrawal syndrome, neurocognitive impairments, cardiovascular and respiratory and other diseases.

Dietary supplement adverse events: report of a one-year poison center surveillance project.

PubMed

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

Apheresis platelets are more frequently associated with adverse reactions than pooled platelets both in recipients and in donors: a study from French hemovigilance data.

PubMed

Daurat, Aurélien; Roger, Claire; Gris, JeanChristophe; Daurat, Gérald; Feissel, Michel; Le Manach, Yannick; Lefrant, JeanYves; Muller, Laurent

2016-06-01

Controversy exists regarding the safety of the different types of platelet (PLT) concentrates. This study was aimed at comparing the rate of adverse reactions associated with apheresis PLT concentrates (APCs) and pooled PLT concentrates (PPCs) both in donors and in recipients. From the French national hemovigilance system, types and numbers of recipient adverse reactions were compared over a period from 2009 to 2011. Donor adverse reactions were available for 2010 and 2011. This study involved 23 of 26 French regions. Main outcomes were the rates of adverse reaction in recipients and serious adverse reaction in donors. There were 790,854 PLT transfusions during the study period (477,747 [60%] with APCs, 313,107 [40%] with PPCs). APCs were associated with more adverse reactions (6244 vs. 2469 per 1,000,000, p < 0.001) and more severe and life-threatening reactions (respectively, 241 vs. 131 per 1,000,000, p < 0.001; and 182 vs. 121 per 1,000,000, p = 0.04). Mortality rates due to an adverse transfusion reaction were similar (15 vs. 6 per 1,000,000, p = 0.5). In donors, the number of whole blood (WB) donations was 4,722,685 whereas 266,095 apheresis procedures were performed. Serious adverse reactions were more frequent for apheresis procedures than for WB donations (5445 vs. 803 per 1,000,000, p < 0.001). Our findings suggest that apheresis PLTs may be more hazardous than pooled PLTs both in recipients and in donors. This study calls for randomized trials to confirm or refute these results. © 2016 AABB.

Adverse events in British hospitals: preliminary retrospective record review

PubMed Central

Vincent, Charles; Neale, Graham; Woloshynowych, Maria

2001-01-01

Objectives To examine the feasibility of detecting adverse events through record review in British hospitals and to make preliminary estimates of the incidence and costs of adverse events. Design Retrospective review of 1014 medical and nursing records. Setting Two acute hospitals in Greater London area. Main outcome measure Number of adverse events. Results 110 (10.8%) patients experienced an adverse event, with an overall rate of adverse events of 11.7% when multiple adverse events were included. About half of these events were judged preventable with ordinary standards of care. A third of adverse events led to moderate or greater disability or death. Conclusions These results suggest that adverse events are a serious source of harm to patients and a large drain on NHS resources. Some are major events; others are frequent, minor events that go unnoticed in routine clinical care but together have massive economic consequences. PMID:11230064

Frequency and risk factors for donor reactions in an anonymous blood donor survey.

PubMed

Goldman, Mindy; Osmond, Lori; Yi, Qi-Long; Cameron-Choi, Keltie; O'Brien, Sheila F

2013-09-01

Adverse donor reactions can result in injury and decrease the likelihood of donor return. Reaction reports captured in the blood center's database provide an incomplete picture of reaction rates and risk factors. We performed an anonymous survey, mailed to 40,000 donors in 2008, including questions about symptoms, height, weight, sex, and donation status. Reaction rates were compared to those recorded in our database. Possible risk factors were assessed for various reactions. The response rate was 45.5%. A total of 32% of first-time and 14% of repeat donors reported having any adverse symptom, most frequently bruising (84.9 per 1000 donors) or feeling faint or weak (66.2 per 1000). Faint reactions were two to eight times higher than reported in our database, although direct comparison was difficult. Younger age, female sex, and first-time donation status were risk factors for systemic and arm symptoms. In females, low estimated blood volume (EBV) was a risk factor for systemic symptoms. Only 51% of donors who consulted an outside physician also called Canadian Blood Services. A total of 10% of first-time donors with reactions found adverse effects information inadequate. This study allowed us to collect more information about adverse reactions, including minor symptoms and delayed reactions. Based on our findings of the risk factors and frequency of adverse reactions, we are implementing more stringent EBV criteria for younger donors and providing more detailed information to donors about possible adverse effects and their management. © 2012 American Association of Blood Banks.

Adverse adolescent relationship histories and young adult health: Cumulative effects of loneliness, low parental support, relationship instability, intimate partner violence and loss

PubMed Central

Adam, Emma K.; Chyu, Laura; Hoyt, Lindsay; Doane, Leah D.; Boisjoly, Johanne; Duncan, Greg; Chase-Lansdale, Lindsay; McDade, Thomas W.

2011-01-01

Purpose To examine the associations between adverse interpersonal relationship histories experienced during adolescence and health in young adulthood in a large, nationally representative sample. Methods Using data from Waves I, II and III of the National Longitudinal Study of Adolescent Health, multiple adverse relationship experiences are examined, including high loneliness, low perceived parental support, frequent transitions in romantic relationships (relationship instability), exposure to intimate partner violence, and loss by death of important relationship figures. These histories are assessed, both individually and in a relationship risk index, as predictors of self-reported general health and depressive symptoms at Wave III (ages 18 to 27), controlling for baseline (Wave I) health and for demographic and health behavior covariates. Results Net of baseline health and covariates, each type of relationship risk (experienced between Wave I and Wave III) was related to either depression or general health at Wave III, with the strongest effects seen for exposure to intimate partner violence. In addition, a cumulative relationship risk index examining the extent to which youth experienced high levels of multiple relationship risk factors revealed that each additional adverse relationship experience increased the odds of reporting poor mental and general health at Wave III, with increases occurring in an additive manner. Conclusions Multiple types of adverse relationship experiences predicted increases in poor general health and depressive symptoms from adolescence to early adulthood. Consistent with a cumulative risk hypothesis, the more types of adverse relationship experiences a youth experienced, the worse their young adult health outcomes. PMID:21856520

[H1N1 influenza vaccines in Tunisia: efficiency and safety].

PubMed

Chaabane, Amel; Aouam, Karim; Ben Fredj, Nadia; Toumi, Adnen; Braham, Dorra; A Boughattas, Naceur; Chakroun, Mohamed

2011-01-01

We carried out this study in order to evaluate the effectiveness and the safety of the two H1N1 vaccines available in Tunisia: Focetria(®) and Panenza(®). It's a prospective epidemiological study including 601 vaccinated subjects. The vaccine effectiveness was based on the occurrence of flu clinical symptoms after vaccination. The safety was based on the occurrence of unexpected events after vaccines administration. The vaccines imputability was established according to Begaud et al. method. The number of subjects vaccinated by Focetria(®) is more important than Panenza(®). The efficiency of vaccines would be 93.6%. Neither the medical statue nor the type of the vaccine used influence the occurrence of a flu episode after vaccination. We recorded 406 adverse effects (32.4%) with a high score of imputability (I3). Focetria(®) adverse effects were more frequent than Panenza(®) ones (p = 0.009). Almost all adverse events disappeared within few days. The two vaccines used in Tunisia remain enough efficient to face the influenza (H1N1) pandemia and are well tolerated independently of the demographic and pathological statue of the vaccinated person as well as nature of the vaccine used. © 2011 Société Française de Pharmacologie et de Thérapeutique.

[Not Available].

PubMed

Chaabane, Amel; Aouam, Karim; Fredj, Nadia Ben; Toumi, Adnen; Braham, Dorra; Boughattas, Naceur A; Chakroun, Mohamed

2011-01-01

We carried out this study in order to evaluate the effectiveness and the safety of the two H1N1 vaccines available in Tunisia: Focetria® and Panenza®. It's a prospective epidemiological study including 601 vaccinated subjects. The vaccine effectiveness was based on the occurrence of flu clinical symptoms after vaccination. The safety was based on the occurrence of unexpected events after vaccines administration. The vaccines imputability was established according to Begaud et al. The number of subjects vaccinated by Focetria® is more important than Panenza®. The efficiency of vaccines would be 93.6%. Neither the medical statue nor the type of the vaccine used influence the occurrence of a flu episode after vaccination. We recorded 406 adverse effects (32.4%) with a high score of imputability (I3). Focetria® adverse effects were more frequent than Panenza® ones (p=0.009). Almost all adverse events disappeared within few days. The two vaccines used in Tunisia remain enough efficient to face the influenza (H1N1) pandemia and are well tolerated independently of the demographic and pathological statue of the vaccinated person as well as nature of the vaccine used. Copyright © 2011 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.

Source Credibility and the Biasing Effect of Narrative Information on the Perception of Vaccination Risks.

PubMed

Haase, Niels; Betsch, Cornelia; Renkewitz, Frank

2015-08-01

Immunization rates are below the Global Immunization Vision and Strategy established by the World Health Organization. One reason for this are anti-vaccination activists, who use the Internet to disseminate their agenda, frequently by publishing narrative reports about alleged vaccine adverse events. In health communication, the use of narrative information has been shown to be effectively persuasive. Furthermore, persuasion research indicates that the credibility of an information source may serve as a cue to discount or augment the communicated message. Thus, the present study investigated the effect of source credibility on the biasing effect of narrative information regarding the perception of vaccination risks. 265 participants were provided with statistical information (20%) regarding the occurrence of vaccine adverse events after vaccination against a fictitious disease. This was followed by 20 personalized narratives from an online forum on vaccination experiences. The authors varied the relative frequency of narratives reporting vaccine adverse events (35% vs. 85%), narrative source credibility (anti-vaccination website vs. neutral health forum), and the credibility of the statistical information (reliable data vs. unreliable data vs. control) in a between-subjects design. Results showed a stable narrative bias on risk perception that was not affected by credibility cues. However, narratives from an anti-vaccination website generally led to lower perceptions of vaccination risks.

FACTORS IMPLICATED IN AMPHIBIAN POPULATION DECLINES IN THE US, AND AN EVALUATION OF THE CASE FOR INVASIVE SPECIES

EPA Science Inventory

Factors known or suspected to be adversely affecting native amphibian populations in the US were identified using information from 267 species accounts written in a standardized format by multiple authors in a forthcoming book. Land use was the most frequently implicated adverse ...

Nonsteroidal Anti-inflammatory Drugs for Sciatica: An Updated Cochrane Review.

PubMed

Rasmussen-Barr, Eva; Held, Ulrike; Grooten, Wilhelmus J A; Roelofs, Pepijn D D M; Koes, Bart W; van Tulder, Maurits W; Wertli, Maria M

2017-04-15

Systematic review and meta-analysis. To determine the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) on pain reduction, overall improvement, and reported adverse effects in people with sciatica. NSAIDs are one of the most frequently prescribed drugs for sciatica. We updated a 2008 Cochrane Review through June 2015. Randomized controlled trials that compared NSAIDs with placebo, with other NSAIDs, or with other medication were included. Outcomes included pain using mean difference (MD, 95% confidence intervals [95% CI]). For global improvement and adverse effects risk ratios (RR, 95% CI) were used. We assessed level of evidence using the Grades of Recommendation, Assessment, Development and Evaluation approach. Ten trials were included (N = 1651). Nine out of 10 trials were assessed at high risk of bias. For pain reduction (visual analog scale, 0 to 100) NSAIDs were no more effective than placebo (MD -4.56, 95% CI -11.11 to 1.99, quality of evidence: very low). For global improvement NSAIDs were more effective than placebo (RR 1.14 [95% CI 1.03 to 1.27], low quality of evidence). One trial reported the effect of NSAIDs on disability with very low-quality evidence that NSAIDs are no more effective than placebo. There was low-quality evidence that the risk for adverse effects is higher for NSAID than placebo (RR 1.40, 95% CI 1.02 to 1.93). Our findings show very low-quality evidence that the efficacy of NSAIDs for pain reduction is comparable with that of placebo, low-quality evidence that NSAIDs is better than placebo for global improvement and low-quality evidence for higher risk of adverse effects using NSAIDs compared with placebo. The findings must be interpreted with caution, due to small study samples, inconsistent results, and a high risk of bias in the included trials. 1.

Analysis of medication-related malpractice claims: causes, preventability, and costs.

PubMed

Rothschild, Jeffrey M; Federico, Frank A; Gandhi, Tejal K; Kaushal, Rainu; Williams, Deborah H; Bates, David W

2002-11-25

Adverse drug events (ADEs) may lead to serious injury and may result in malpractice claims. While ADEs resulting in claims are not representative of all ADEs, such data provide a useful resource for studying ADEs. Therefore, we conducted a review of medication-related malpractice claims to study their frequency, nature, and costs and to assess the human factor failures associated with preventable ADEs. We also assessed the potential benefits of proved effective ADE prevention strategies on ADE claims prevention. We conducted a retrospective analysis of a New England malpractice insurance company claims records from January 1, 1990, to December 31, 1999. Cases were electronically screened for possible ADEs and followed up by independent review of abstracts by 2 physician reviewers (T.K.G. and R.K.). Additional in-depth claims file reviews identified potential human factor failures associated with ADEs. Adverse drug events represented 6.3% (129/2040) of claims. Adverse drug events were judged preventable in 73% (n = 94) of the cases and were nearly evenly divided between outpatient and inpatient settings. The most frequently involved medication classes were antibiotics, antidepressants or antipsychotics, cardiovascular drugs, and anticoagulants. Among these ADEs, 46% were life threatening or fatal. System deficiencies and performance errors were the most frequent cause of preventable ADEs. The mean costs of defending malpractice claims due to ADEs were comparable for nonpreventable inpatient and outpatient ADEs and preventable outpatient ADEs (mean, $64,700-74,200), but costs were considerably greater for preventable inpatient ADEs (mean, $376,500). Adverse drug events associated with malpractice claims were often severe, costly, and preventable, and about half occurred in outpatients. Many interventions could potentially have prevented ADEs, with error proofing and process standardization covering the greatest proportion of events.

Childhood adversities predict strongly the use of psychotropic drugs in adulthood: a population-based cohort study of 24,284 Finns.

PubMed

Koskenvuo, Karoliina; Koskenvuo, Markku

2015-04-01

Exposure to adverse childhood experiences has been shown to be associated with negative health outcomes including mental health problems, but only a few studies with register-based data have used psychotropic drugs as an outcome variable. The purpose of this study is to examine whether adverse emotional childhood experiences, such as serious conflicts in the family and frequent fear of a family member, predict the use of psychotropic drugs in adulthood. In addition, the association of a child-parent relationship during childhood with the use of psychotropic drugs is studied. The participants of the population-based Health and Social Support Study (24,284 working aged Finns) were followed up for 9 years. The information on childhood experiences and child-parent relationships was obtained from the questionnaires in 1998 and 2003. The number of psychotropic purchases (antipsychotics, drugs for bipolar disorder, antidepressants, anxiolytics, hypnotics and sedatives) was obtained from the National-Drug-Prescription-Register. Logistic and multinomial regression models were used. A graded association between childhood adversities and the use of psychotropic drugs was found, even after adjustments for occupational training, work status, recent life events and health behaviour. Frequent fear of a family member showed the strongest association: the OR for multiple use of antidepressants was 3.08 (95% CI 2.72 to 3.49) and 2.69 (2.27 to 3.20) for multiple use of anxiolytics. Use of psychotropic drugs was clearly increased among those with poor child-parent relationship and multiple childhood adversities. The results highlight the effect of environmental factors during childhood on mental health and the need for early recognition of families at risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Epidemiology of Adverse Events and Medical Errors in the Care of Cardiology Patients.

PubMed

Ohta, Yoshinori; Miki, Izumi; Kimura, Takeshi; Abe, Mitsuru; Sakuma, Mio; Koike, Kaoru; Morimoto, Takeshi

2016-11-02

There have been epidemiological studies of adverse events (AEs) among general patients but those of patients cared by cardiologist are not well scrutinized. We investigated the occurrence of AEs and medical errors (MEs) among adult patients with cardiology in Japan. We conducted a cross-sectional study of adult outpatients at a Japanese teaching hospital from February through November 2006. We measured AE and ME incidents from patient report, which were verified by medical records, laboratory data, incident reports, and prescription queries. Two independent physicians reviewed the incidents to determine whether they were AEs or MEs and to assess severity and symptoms. We identified 144 AEs and 30 MEs (16.3 and 3.9 per 100 patients, respectively). Of the 144 AEs, 99 were solely adverse drug events (ADEs), 20 were solely non-ADEs, and the remaining 25 were both causes. The most frequent symptoms of ADEs were skin and allergic reactions due to medication. The most frequent symptoms of non-ADEs were bleeding due to therapeutic interventions. Among AEs, 12% was life threatening. Life-threatening AEs were 25% of non-ADEs and 5% of ADEs (P = 0.0003). Among the 30 MEs, 21MEs (70%) were associated with drugs. Adverse events were common among cardiology patients. Adverse drug events were the most frequent AEs, and non-ADEs were more critical than ADEs. Such data should be recognized among practicing physicians to improve the patients' outcomes.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

Safety of stable isotope use.

PubMed

Koletzko, B; Sauerwald, T; Demmelmair, H

1997-08-01

The increased employment of stable isotope tracers for diagnostic and research purposes frequently raises questions on potential risks associated with their use, which is of particular importance in the paediatric age group. Biological effects and the potential of adverse events has been evaluated in a large number of animal and, in part, also human studies. Possible differences in physical, chemical and biochemical behaviour resulting in kinetic and thermodynamic isotope effects between stable isotopes of the same element are related to the relative differences in atomic weight. Deuterium (2H), which differs markedly in mass from the predominant hydrogen isotope 1H, may induce serious side-effects at high concentrations in body fluids. The threshold dose for the occurrence of side-effects lies well above the usual tracer dosages for clinical use. In contrast to deuterium, heavier stable isotopes such as 13C, 15N or 18O that differ relatively little in mass from the predominant isotopes such as 12C, does not show any adverse biological effects even at highest enrichments. The doses of stable isotope tracer substances that are used for clinical diagnostic and research purposes appear safe and without any adverse effects. Stable isotope tracers should only be used in children if the trace is safe at the doses applied, and tracer is chemically pure and stable. In the case of intravenous application, the tracer preparation must also be sterile and pyrogen free.

Novel Associations between FAAH Genetic Variants and Postoperative Central Opioid related Adverse Effects

PubMed Central

Sadhasivam, Senthilkumar; Zhang, Xue; Chidambaran, Vidya; Mavi, Jagroop; Pilipenko, Valentina; Mersha, Tesfaye B.; Meller, Jaroslaw; Kaufman, Kenneth M.; Martin, Lisa J.; McAuliffe, John

2014-01-01

Opioid effects are potentiated by cannabinoid agonists including anandamide, an endocannabinoid. Inter-individual variability in responses to opioids is a major clinical problem. Multiple deaths and anoxic brain injuries occur every year in due to opioid induced respiratory depression in surgical patients and drug abusers of opioids and cannabinoids. This study aimed to determine specific associations between genetic variants of fatty acid amide hydrolase (FAAH) and postoperative central opioid adverse effects in children undergoing tonsillectomy. This is a prospective genotype blinded observational study 259 healthy children between 6 and 15 years that received standard perioperative care with a standard anesthetic and an intraoperative dose of morphine were enrolled. Associations between frequent polymorphisms of FAAH and central postoperative opioid adverse effects including, respiratory depression (RD), postoperative nausea and vomiting (PONV) and prolonged stay in Post Anesthesia Recovery Room (PACU) due to RD and PONV were analyzed. Five specific FAAH SNPs had significant associations with more than 2 fold increased risk for refractory PONV (adjusted p<0.0018), and nominal associations (p<0.05) with RD and prolonged PACU stay in white children undergoing tonsillectomy. FAAH SNP, rs324420 is a missense mutation with altered FAAH function and it is linked with other FAAH SNPs associated with PONV and RD in our cohort; association between PONV and rs324420 was confirmed in our extended cohort with additional 66 white children. Specific FAAH polymorphisms are associated with refractory PONV, opioid-related respiratory depression, and prolonged PACU stay due to opioid adverse effects in white children undergoing tonsillectomy. PMID:25558980

Evidence for the adverse effect of starvation on bone quality: a review of the literature.

PubMed

Kueper, Janina; Beyth, Shaul; Liebergall, Meir; Kaplan, Leon; Schroeder, Josh E

2015-01-01

Malnutrition and starvation's possible adverse impacts on bone health and bone quality first came into the spotlight after the horrors of the Holocaust and the ghettos of World War II. Famine and food restrictions led to a mean caloric intake of 200-800 calories a day in the ghettos and concentration camps, resulting in catabolysis and starvation of the inhabitants and prisoners. Severely increased risks of fracture, poor bone mineral density, and decreased cortical strength were noted in several case series and descriptive reports addressing the medical issues of these individuals. A severe effect of severely diminished food intake and frequently concomitant calcium- and Vitamin D deficiencies was subsequently proven in both animal models and the most common cause of starvation in developed countries is anorexia nervosa. This review attempts to summarize the literature available on the impact of the metabolic response to Starvation on overall bone health and bone quality.

Update in feline therapeutics: clinical use of 10 emerging therapies.

PubMed

Whitehouse, William; Viviano, Katrina

2015-03-01

The field of veterinary medicine is constantly evolving. New medications are being introduced into clinical practice, and novel uses for established medications are frequently being discovered as new information comes to light. Therapeutic options for our feline patients can be restricted based on inadequate clinical evidence, adverse effects and patient compliance concerns. Additionally, with the reduced availability of commonly used medications in some regions, clinicians are forced to utilize alternatives with which they may have limited experience. This review article is directed towards primary care veterinarians working with feline patients. The selection of medications discussed is based on many of the clinical challenges commonly encountered in practice. The evidence for use of some of these medications is limited due to their novelty. Known mechanisms of action, pharmacokinetic and pharmacodynamics data, adverse effects and clinical uses are reviewed where possible, with clinical recommendations made based on the evidence of data available. © ISFM and AAFP 2015.

Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015.

PubMed

Haber, Penina; Moro, Pedro L; Lewis, Paige; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

2016-05-11

Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013-5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months-17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months-17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18-64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barré syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3. In our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4. Published by Elsevier Ltd.

Increased prescribing of Valium, Librium, and other drugs--an example of the influence of economic and social factors on the practice of medicine.

PubMed

Waldron, I

1977-01-01

Drug prescriptions per capita in the United States have more than doubled since 1950 without a commensurate improvement in health. Drugs are often prescribed for clinical conditions in which therapeutic benefits do not outweigh the risk of adverse drug reactions. Deaths due to adverse drug reactions are roughly as frequent as deaths due to automobile accidents. Valium and Librium are the first and fourth most commonly prescribed drugs in the U.S., used by one ten adults each year. The rapid rise in use of these drugs has occurred during a period of rising social stress, as indicated by increases in alcohol consumption, suicide, and homicide, Valium and Librium are frequently prescribe for patients who go to doctors with social or other nonmedical problems, often in lieu of attempts to resolve these underlying problems. Overprescribing occurs because the decision to prescribe is influenced not only by consideration of therapeutic benefit, but also by nonmedical factors, for example the widespread expectation by both patient and doctor that the doctor will provide a drug or some other technological treatment. Prescribing decisions are also influenced by the profit-motivated activities of drug companies, including the expenditure of almost one-quarter of every sales dollar on drug promotion. The most widely used source of drug information for doctors is the industry-sponsored Physicians' Desk Reference, which overrates the therapeutic value of Valium and Librium as compared to disinterested medical sources. Drug companies also contribute to overprescribing by introducing numerous minor variants of existing drugs. The therapeutic benefits of such new drugs are often overestimated in the early years of use when adverse side effects are not well known and apparent efficacy is enhanced by placebo effects in uncontrolled observations.

Once-daily dosing vs. conventional dosing schedule of mesalamine and relapse of quiescent ulcerative colitis: systematic review and meta-analysis.

PubMed

Ford, Alexander C; Khan, Khurram J; Sandborn, William J; Kane, Sunanda V; Moayyedi, Paul

2011-12-01

Maintenance therapy with 5-aminosalicylates (5-ASAs) is recommended in patients with quiescent ulcerative colitis (UC), but compliance rates are low. Once-daily dosing may improve adherence, but impact on the relapse of disease activity is unclear as no previous meta-analysis has studied this issue. MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched (through April 2011). Eligible randomized controlled trials (RCTs) recruited adults with quiescent UC, and compared once-daily dosing of 5-ASAs with a more frequent dosing schedule of an identical total daily dose of the same 5-ASA drug. Minimum treatment duration was 6 months. Trials reported a dichotomous assessment of relapse of disease activity at last point of follow-up. Data concerning non-compliance and adverse events were extracted, where reported. Effect of once-daily vs. more frequent dosing schedule was reported as relative risk (RR) of relapse with a 95% confidence interval (CI). The search identified 3,061 citations, and seven RCTs containing 2,745 patients were eligible. All RCTs used mesalamine. Relapse rates were not significantly different between once-daily and conventional dosing schedules for mesalamine (RR of relapse=0.94; 95% CI: 0.82-1.08). Non-compliance (RR=0.87; 95% CI: 0.46-1.66) and adverse events were no more likely with once-daily dosing (RR=1.08; 95% CI: 0.97-1.20). Once-daily dosing with mesalamine is as effective as conventional dosing schedules for the prevention of relapse of quiescent UC, although there is no definitive evidence that compliance with once-daily dosing is better. Adverse events occur at a similar frequency.

Doping with anabolic androgenic steroids (AAS): Adverse effects on non-reproductive organs and functions.

PubMed

Nieschlag, Eberhard; Vorona, Elena

2015-09-01

Since the 1970s anabolic androgenic steroids (AAS) have been abused at ever increasing rates in competitive athletics, in recreational sports and in bodybuilding. Exceedingly high doses are often consumed over long periods, in particular by bodybuilders, causing acute or chronic adverse side effects frequently complicated by additional polypharmacy. This review summarizes side effects on non-reproductive organs and functions; effects on male and female reproduction have been recently reviewed in a parallel paper. Among the most striking AAS side effects are increases in haematocrit and coagulation causing thromboembolism, intracardiac thrombosis and stroke as well as other cardiac disturbances including arrhythmias, cardiomyopathies and possibly sudden death. 17α-alkylated AAS are liver toxic leading to cholestasis, peliosis, adenomas and carcinomas. Hyperbilirubinaemia can cause cholemic nephrosis and kidney failure. AAS abuse may induce exaggerated self-confidence, reckless behavior, aggressiveness and psychotic symptoms. AAS withdrawal may be accompanied by depression and suicidal intentions. Since AAS abuse is not or only reluctantly admitted physicians should be aware of the multitude of serious side effects when confronted with unclear symptoms.

Hypoglycaemia: an overview.

PubMed

Graveling, Alex J; Frier, Brian M

2009-08-01

Hypoglycaemia is a frequent side-effect of treatment with insulin and sulfonylureas for people with diabetes, threatening potentially serious morbidity and preventing optimal glycaemic control. Fear of hypoglycaemia and development of syndromes such as impaired awareness and counterregulatory deficiency provide additional hazards for intensification of treatment. Rapid lowering of HbA1c may be potentially dangerous in type 2 diabetes because of the adverse cardiovascular effects induced by hypoglycaemia. Hypoglycaemia can disrupt many everyday activities such as driving, work performance and recreational pursuits. Measures to reduce the risk of hypoglycaemia are labour-intensive and require substantial resources.

Effect of a quality program with adverse events identification on airway management during overtube-assisted enteroscopy.

PubMed

Lara, Luis F; Ukleja, Andrew; Pimentel, Ronnie; Charles, Roger J

2014-11-01

Adverse events associated with overtube-assisted enteroscopy are similar to those with routine endoscopy. Our endoscopy quality program identified a number of respiratory adverse events resulting in emergency resuscitation efforts. The aim is to report all adverse events identified by quality monitoring and outcomes of adverse events associated with overtube-assisted enteroscopy. A retrospective study used data prospectively obtained from consecutive patients undergoing overtube-assisted enteroscopy between December 2008 and July 2012. Patient characteristics, medical history, procedure indication, and procedure outcomes, including diagnosis, endoscopic therapy, and complications, were obtained. In 432 overtube-assisted enteroscopies, 15 adverse events (most frequently hypoxemia, 9 /15, 60 %) occurred in 14 patients (3.2 % of total cohort; 12 were outpatients) mostly during antegrade enteroscopy. Four patients required endotracheal intubation and 4 /12 outpatients required intensive care. The procedure was aborted in 13 /14 patients, and only 1 of 10 patients scheduled for repeat antegrade enteroscopy returned. There was no mortality. Based on the frequency of adverse events, and in consultation with anesthesia providers, from August 2012 all antegrade overtube-assisted enteroscopies at our institution were done with general anesthesia. From then till September 2013, 145 antegrade and 52 retrograde overtube-assisted enteroscopies have been done, with no adverse events. Monitoring of endoscopy practice identified adverse events associated with overtube-assisted enteroscopy. The peer-review prompted a change in practice: all patients undergoing antegrade overtube-assisted enteroscopy at our institution now have endotracheal intubation which has dramatically decreased the rate of respiratory adverse events. The impact of endoscopic quality measurements on practices, procedures, and outcomes will be of further interest. © Georg Thieme Verlag KG Stuttgart · New York.

Successful treatment of homozygous familial hypercholesterolemia using cascade filtration plasmapheresis.

PubMed

Kardaş, Fatih; Cetin, Aysun; Solmaz, Musa; Büyükoğlan, Rüksan; Kaynar, Leylagül; Kendirci, Mustafa; Eser, Bülent; Unal, Ali

2012-12-01

The aim of this study was to report the efficacy of low-density lipoprotein cholesterol (LDL-C) apheresisusing a cascade filtration system in pediatric patients with homozygous familial hypercholesterolemia (FH), and toclarify the associated adverse effects and difficulties. LDL-C apheresis using a cascade filtration system was performed in 3 pediatric patientswith homozygous FH; in total, 120 apheresis sessions were performed. Cascade filtration therapy significantly reduced the mean LDL-C values from 418 ± 62 mg/dL to 145 ± 43 mg/dL (p= 0.011). We observed an acute mean reduction in the plasma level of total cholesterol (57.9%), LDL-C (70.8%),and high-density lipoprotein cholesterol (HDL-C) (40.7%). Treatments were well tolerated. The most frequent clinicaladverse effects were hypotension in 3 sessions (2.5%), chills (1.7%) in 2 sessions, and nausea/vomiting in 3 sessions(2.5%). Our experience using the cascade filtration system with 3 patients included good clinical outcomes andlaboratory findings, safe usage, and minor adverse effects and technical problems. None declared.

A multicenter dose-escalation study of the analgesic and adverse effects of an oral cannabis extract (Cannador) for postoperative pain management.

PubMed

Holdcroft, Anita; Maze, Mervyn; Doré, Caroline; Tebbs, Susan; Thompson, Simon

2006-05-01

Cannabinoids have dose-related antinociceptive effects in animals. This clinical study aimed to investigate whether a single oral dose of cannabis plant extract (Cannador; Institute for Clinical Research, IKF, Berlin, Germany) could provide pain relief with minimal side effects for postoperative pain. Patients (aged 18-75 yr) were recruited and consented before surgery if patient-controlled analgesia was planned for provision of postoperative pain relief. Each patient received a single dose of 5, 10, or 15 mg Cannador if he or she had at least moderate pain after stopping patient-controlled analgesia. Starting with 5 mg, dose escalation was based on the number of patients requesting rescue analgesia and adverse effects. Pain relief, pain intensity, and side effects were recorded over 6 h and analyzed using tests for trend with dose. Rescue analgesia was requested by all 11 patients (100%) receiving 5 mg, 15 of 30 patient (50%) receiving 10 mg, and 6 of 24 patients (25%) receiving 15 mg Cannador (log rank test for trend in time to rescue analgesia with dose P < 0.001). There were also significant trends across the escalating dose groups for decreasing pain intensity at rest (P = 0.01), increasing sedation (P = 0.03), and more adverse events (P = 0.002). The number needed to treat to prevent one rescue analgesia request for the 10-mg and 15-mg doses, relative to 5 mg, were 2.0 (95% confidence interval, 1.5-3.1) and 1.3 (95% confidence interval, 1.1-1.7), respectively. The study was terminated because of a serious vasovagal adverse event in a patient receiving 15 mg. These significant dose-related improvements in rescue analgesia requirements in the 10 mg and 15 mg groups provide a number needed to treat that is equivalent to many routinely used analgesics without frequent adverse effects.

Nonallergic Eyelid Edema After Botulinum Toxin Type A Injection: Case Report and Review of Literature.

PubMed

Chang, Yin-Shuo; Chang, Chang-Cheng; Shen, Jen-Hsiang; Chen, Yu-Tsung; Chan, Karen Kar-Wun

2015-09-01

Periocular botulinum toxin type A (BoNTA) injections are generally safe. Ptosis is the most common adverse effect, whereas eyelid edema is rarely reported. There is no consensus on the latter's incidence, clinical course, or treatment strategy. Here we managed a 59-year-old woman who received BoNTA injections to her forehead, glabella, and eye corner. At 3-day follow-up, she presented with painless, nonpruritic, bilateral periorbital edema, and erythema. Preliminary diagnosis was a local allergic reaction, and topical corticosteroid was administered, but upon lack of improvement, edema secondary to venous and lymphatic congestion was hypothesized, and she was advised to apply hot pads over her eyes, blink frequently, and massage the area. Her eyelid edema resolved 2 weeks later. At 4-month follow-up, the patient requested and received another course of BoNTA at half the dose. Frequent blinking was instructed, and the patient reported a satisfactory outcome with no adverse effects. In our literature review, incidence of BoNTA-induced eyelid edema was 1.4% and showed Asian tendency. Although rare, BoNTA-induced periorbital edema is self-limiting, and normally resolves in 2 to 4 weeks without medical treatment. Patients at risk for edema, including Asian ethnicity, dermatochalasis, and poor periocular muscle tone, are advised to receive injections at half the dosage. Examination of the function and tone of the orbicularis oculi and levator palpebrae superioris muscles before treatment is recommended, and application of hot pads over the eyes, frequent blinking in the morning, and self-massage of the affected area to increase venous return have demonstrated to improve outcome.

Focal treatment of spasticity using botulinum toxin A in cerebral palsy cases of GMFCS level V: evaluation of adverse effects☆☆☆

PubMed Central

Tedesco, Ana Paula; Martins, Juliana Saccol; Nicolini-Panisson, Renata D’Agostini

2014-01-01

Objective To report on the experience of injections of botulinum toxin A (BTA) in a series of patients with cerebral palsy of Gross Motor Function Classification System (GMFCS) level V. Methods This was a retrospective case series study on 33 patients with cerebral palsy of GMFCS level V who received 89 sessions of BTA application (of which 84 were Botox® and five were other presentations), in which the basic aim was to look for adverse effects. Results The mean number of application sessions per patient was three, and the mean age at the time of each injection was 4 + 6 years (range: 1.6–13 years). The muscles that most frequently received injections were the gastrocnemius, hamstrings, hip adductors, biceps brachii and finger flexors. The mean total dose was 193 U and the mean dose per weight was 12.5 U/kg. Only one patient received anesthesia for the injections and no sedation was used in any case. No local or systemic adverse effects were observed within the minimum follow-up of one month. Conclusion The absence of adverse effects in our series was probably related to the use of low doses and absence of sedation or anesthesia. According to our data, BTA can be safely used for patients with cerebral palsy of GMFCS level V, using low doses and preferably without sedation or anesthesia. PMID:26229827

[Chonic diarrhea and malabsorption due to common variable immunodeficiency, gastrectomy and giardiasis infection: a difficult nutritional management].

PubMed

Domínguez-López, M E; González-molero, I; Ramírez-Plaza, C P; Soriguer, F; Olveira, G

2011-01-01

Gastric cancer is a frequent cause of cancer-related mortality in the world. Surgery is the only potentially curative therapy, although the adverse effects of surgery are common and considerable. Common variable immunodeficiency is in many cases cause of gastrointestinal system problems such as chronic diarrhea caused by infestation with giardia lamblia, nodular lymphoid hiperplasia ad loss of villi leading frequently to malapsortion and malnutrition. Nutritional deficiencies due to malapsorption (postgastrectomy and secondary to loss of villi, giardiasis and common variable inmunodeficiency) are common. We present the case of a patient with gastric cancer who underwent a gastrectomy with common variable hipogammaglobulinemia and chronic infestation by giardia lamblia, with serious diarrhea resistant to treatment and malabsorption.

Fetal gender and pregnancy outcomes in Libya: a retrospective study.

PubMed

Khalil, Mounir M; Alzahra, Esgair

2013-01-01

The relationship between pregnancy outcomes and fetal gender is well reported from different areas in the world, but not from Africa. In this study, we try to understand whether the recorded phenomenon of association of adverse pregnancy outcomes with a male fetus applies to our population. A total of 29,140 patient records from 2009 and 2010 were retrieved from Aljalaa Maternity Hospital, Tripoli, Libya. Analysis was carried out to find the correlation between fetal gender and different pregnancy outcomes. A male fetus was associated with an increased incidence of gestational diabetes mellitus (odds risk 1.4), preterm delivery (6.7% for males, 5.5% for females, odds risk 1.24), cesarean section (23.9% for males, 20% for females, odds risk 1.25), and instrumental vaginal delivery (4.4% for males, 3.1% for females, odds risk 1.48), p<0.005. Preeclampsia was more frequent among preterm females and postterm males, p<0.005. It was also more frequent in male-bearing primigravids, p<0.01. We confirm the existence of an adverse effect of a male fetus on pregnancy and labor in our population. We recommend further research to understand the mechanisms and clinical implications of this phenomenon.

Guidelines for antimicrobial prophylaxis.

PubMed

Nahata, M C

1996-08-01

Antimicrobials are frequently used to prevent infections. Principles of prophylaxis, and antimicrobial prophylaxis in surgery, tuberculosis, acquired immunodeficiency syndrome, influenza A, traveller's diarrhoea, malaria, recurrent otitis media, Haemophilus influenzae type b infection, pertussis, rheumatic fever, and urinary tract infection are described. Various strategies to improve the prophylactic use of antibiotics are discussed. Collaborative efforts among health care disciplines are needed to assure optimal antimicrobial prophylaxis. This should maximize efficacy and minimize adverse effects, the development of bacterial resistance and associated costs.

[Cross sectional study of comorbidities and concomitant medications in a cohort of human immunodeficiency virus-infected patients].

PubMed

García Gonzalo, Maria Asunción; Santamaría Mas, María Isabel; Pascual Tomé, Lidia; Ibarguren Pinilla, Maialen; Rodríguez-Arrondo, Francisco

2017-05-01

To assess the prevalence of comorbidities, concomitant therapies and adverse effects associated with the medication in a cohort of patients with HIV infection. Multicentre cross-sectional study. Infectious Diseases or Internal Medicine outpatient Clinics of 3 hospitals in the Basque Country. During a 3 month period, patients with the following inclusion criteria were randomly selected: HIV infection, age>18years, antiretroviral treatment (ART) for at least 6months, and no changes in ART in the previous 4weeks. A total of 224 patients (of the 225 expected) were included. Data were collected using a form, and include, epidemiological and anthropometric data, data related to HIV infection, comorbidities, current therapies, and adverse effects. Of the 224 patients, 95.5% had at least one comorbidity, the most common being HCV infection (51.3%), dyslipidaemia (37.9%), diabetes mellitus or impaired fasting glucose (21.9%), and hypertension (21.9%). A total of 155 patients (69.2%) were taking concomitant medication: anxiolytics (21.4%), antihypertensives (19.6%), proton pump inhibitors (17.9%), statins (17%), and antidepressants (16.5%). Adverse effects (AE) were observed in 62.9% of subjects, the most common being, changes in body fat distribution (32.6%) and gastrointestinal (24.1%). Patients with HIV infection are getting older, with more comorbidities, with very frequent use of concomitant treatments, and high number of adverse effects. This requires a multidisciplinary approach and a coordinated effort within the Primary Care setting. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

The Danish PEP Registry: Experience with the use of post-exposure prophylaxis following blood exposure to HIV from 1999-2012.

PubMed

Lunding, Suzanne; Katzenstein, Terese L; Kronborg, Gitte; Storgaard, Merete; Pedersen, Court; Mørn, Birgitte; Lindberg, Jens Å; Kronborg, Thit M; Jensen, Janne

2016-01-01

The risk of occupational exposures to blood cannot be eliminated completely and access to post-exposure prophylaxis (PEP) to prevent HIV transmission is important. However, PEP administration has been associated with frequent adverse effects, low compliance and difficulties to ensure a proper risk assessment. This nationwide study describes 14 years of experience with the use of PEP following blood exposure in Denmark. A descriptive study of all PEP cases following non-sexual exposure to HIV in Denmark from 1999-2012. A total of 411 cases of PEP were described. There was a mean of 29.4 cases/year, increasing from 23 cases in 1999 to 49 cases in 2005 and then decreasing to 16 cases in 2012. Overall 67.2% of source patients were known to be HIV-positive at the time of PEP initiation, with no significant change over time. The median time to initiation of PEP was 2.5 h (0.15-28.5) following occupational exposure. Adverse effects were reported by 50.9% with no significant difference according to PEP regimen. In 85.1% of cases with available data, either a full course of PEP was completed or PEP was stopped because the source was tested HIV-negative. Only 6.6% stopped PEP early due to adverse effects. PEP in Denmark is generally prescribed according to the guidelines and the annual number of cases has declined since 2005. Adverse effects were common regardless of PEP regimens used and new drug regimens should be considered.

Information for physicians and pharmacists about drugs that might cause dry mouth: a study of monographs and published literature.

PubMed

Nguyen, Caroline T; MacEntee, Michael I; Mintzes, Barbara; Perry, Thomas L

2014-01-01

Over three-quarters of the older population take medications that can potentially cause dry mouth. Physicians or pharmacists rarely inform patients about this adverse effect and its potentially severe damage to the teeth, mouth and general health. The objectives of this study were to (1) identify warnings in the literature about dry mouth associated with the most frequently prescribed pharmaceutical products in Canada; and (2) consider how this information might be obtained by physicians, pharmacists and patients. Monographs on the 72 most frequently prescribed medications during 2010 were retrieved from the Compendium of Pharmaceuticals and Specialties (CPS, a standard drug information reference for physicians and pharmacists), the National Library of Medicine's 'DailyMed' database, directly from the manufacturers, and from a systematic search of biomedical journals. The CPS provided monographs for 43% of the medications, and requests to manufacturers produced the remaining monographs. Mentions of dry mouth were identified in 61% of the products (43% amongst CPS monographs; an additional 43% amongst manufacturers' monographs; 7% in the DailyMed database and 7% from biomedical journals); five medications had contradictory reports in different monographs. Nearly two-thirds (61%) of the most commonly prescribed medications can cause dry mouth, yet warnings about this adverse effect and its potentially serious consequences are not readily available to physicians, pharmacists, dentists or patients.

Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: A multicentre, randomised, double-blind controlled trial.

PubMed

Beraha, Esther M; Salemink, Elske; Goudriaan, Anna E; Bakker, Abraham; de Jong, David; Smits, Natasha; Zwart, Jan Willem; Geest, Dick van; Bodewits, Pieter; Schiphof, Tom; Defourny, Harma; van Tricht, Mirjam; van den Brink, Wim; Wiers, Reinout W

2016-12-01

Previous randomised placebo-controlled trials with low-to-medium doses of baclofen (30-60mg) showed inconsistent results, but case studies suggested a dose-response effect and positive outcomes in patients on high doses of baclofen (up to 270mg). Its prescription was temporary permitted for the treatment of alcohol dependence (AD) in France, and baclofen is now widely prescribed. Recently, a small RCT found a strong effect of a mean dose of 180mg baclofen. In the present study the efficacy and safety of high doses of baclofen was examined in a multicentre, double-blind, placebo-controlled trial. 151 patients were randomly assigned to either six weeks titration and ten weeks high-dose baclofen (N=58; up to 150mg), low-dose baclofen (N=31; 30mg), or placebo (N=62). The primary outcome measure was time to first relapse. Nine of the 58 patients (15.5%) in the high-dose group reached 150mg and the mean baclofen dose in this group was 93.6mg (SD=40.3). No differences between the survival distributions for the three groups were found in the time to first relapse during the ten-weeks high-dose phase (χ 2 =0.41; p=0.813) or the 16-weeks complete medication period (χ 2 =0.04; p=0.982). There were frequent dose-related adverse events in terms of fatigue, sleepiness, and dry mouth. One medication related serious adverse event occurred in the high-dose baclofen group. Neither low nor high doses of baclofen were effective in the treatment of AD. Adverse events were frequent, although generally mild and transient. Therefore, large-scale prescription of baclofen for the treatment of AD seems premature and should be reconsidered. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

[Use of intravenous iron infusion in a gastroenterology day hospital: Indications, dosage and adverse effects].

PubMed

Dosal, Angelina; Calvet, Xavier; Moreno, Laura; López, María; Figuerola, Ariadna; Ruíz, Miquel Angel; Suárez, David; Gené, Emili; Miquel, Mireia; Villoria, Albert

2010-01-01

There are no data in the literature on the use of intravenous iron infusion in gastroenterology day hospitals. To determine the indications, dosage and tolerance of intravenous iron infusion in outpatients attending a gastroenterology day hospital. We retrospectively reviewed the medical records of patients who received intravenous iron infusion between August 2007 and July 2008. The indications, dosage, transfusion requirements, adverse effects and patients' clinical and laboratory data were recorded. During the study period, 111 patients (41% women, with a mean age of 63.8 ± 18 years) received intravenous iron infusions. The main causes of anemia indicating iron administration were portal hypertensive gastropathy (n=55), inflammatory bowel disease (n=22) and intestinal angiodysplasia (n=12). The patients received a total of 557 iron infusions with a mean dose of 1033 mg iron per patient. There were no adverse effects. Despite the treatment, 46 patients required transfusion. Iron and transfusion requirements and mortality were significantly higher in patients with liver cirrhosis than in the remainder of the study group. Intravenous iron therapy is frequently used in the gastroenterology day hospital. Most infusions were administered in patients with chronic iron loss. Patients with liver cirrhosis had the most severe anemia and underlying disease and the highest mortality.

Systemic steroids in the treatment of psoriasis: what is fact, what is fiction?

PubMed

Mrowietz, U; Domm, S

2013-08-01

The use of systemic steroids in the treatment of psoriasis is not recommended by dermatological textbooks and guidelines because of the risk of disease deterioration after dose reduction or withdrawal. In contrast to these recommendations, a recent analysis using data from a German nationwide healthcare insurance revealed that systemic steroids were the most frequently prescribed drugs for psoriasis by general practitioners, internal medicine physicians and dermatologists. As there is an obvious discrepancy between the use of systemic steroids for psoriasis and the reported adverse effects, a non-systematic literature search starting 1950 until today was performed to address beneficial and adverse effect of systemic steroids in psoriasis. Non-systematic literature search. Regarding the widespread use of systemic steroids in psoriasis and other medical conditions taking the high prevalence of psoriasis of 2-3% at least in Caucasians into consideration, there is a remarkable lack of literature addressing adverse effects such as rebound, pustular or erythrodermic flares or even new occurrence of psoriasis in patients with a negative disease history. A re-evaluation of the treatment of psoriasis and/or psoriatic arthritis with systemic steroids is necessary. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.

Sucroferric oxyhydroxide decreases serum phosphorus level and fibroblast growth factor 23 and improves renal anemia in hemodialysis patients.

PubMed

Shima, Hisato; Miya, Keiko; Okada, Kazuyoshi; Minakuchi, Jun; Kawashima, Shu

2018-06-08

Sucroferric oxyhydroxide, a novel iron-based phosphate-binder, has been shown to have beneficial effects in lowering serum phosphorus levels and improving renal anemia in clinical studies. Although an effect of this agent on fibroblast growth factor 23 (FGF23) has been reported in an animal study, there is little clinical data supporting this finding. This study aimed to evaluate the effect on chronic kidney disease-mineral and bone disorder, FGF23, renal anemia, iron-related parameters, adverse events of sucroferric oxyhydroxide in hemodialysis patients. Hemodialysis patients, receiving existing hyperphosphatemia drugs with insufficient benefit, were administered sucroferric oxyhydroxide with/without calcium carbonate for 16 weeks. Serum phosphorus level declined rapidly in Week 8 (p < 0.0001) and this decrease persisted until Week 16 (p < 0.0001). FGF23 decreased (p = 0.0412, Week 16), and hemoglobin increased (p < 0.0001, Week 16). Cumulative dose of erythropoiesis-stimulating agents (p = 0.0122, Week 16), and intravenous iron (p = 0.0233, Week 12) decreased. All adverse reactions were mild, and diarrhea was the most frequently observed adverse reaction (16.7%). Therefore, hyperphosphatemia treatment with sucroferric oxyhydroxide may safely improve serum phosphorus level, renal anemia, FGF23, and other factors that affect the prognosis of hemodialysis patients.

The bedding environment, sleep position, and frequent wheeze in childhood.

PubMed

Ponsonby, Anne-Louise; Dwyer, Terence; Trevillian, Leigh; Kemp, Andrew; Cochrane, Jennifer; Couper, David; Carmichael, Allan

2004-05-01

Synthetic quilt use has been associated with increased childhood wheeze in previous studies. Our aim was to examine whether the adverse effect of synthetic quilt use on frequent wheeze differed by usual sleep position. A population-based cross-sectional study of 6378 (92% of those eligible) 7-year-olds in Tasmania, Australia, was conducted in 1995. Exercise-challenge lung function was obtained on a subset of 414 children from randomly selected schools. Child bedding including pillow and overbedding composition and usual sleep position by parental questionnaire. Frequent wheeze (>12 wheeze episodes over the past year), using the International Study of Asthma and Allergies in Childhood parental questionnaire, and baseline and postexercise forced expiratory volume in 1 second lung-function measures. Frequent wheeze (n = 117) was positively associated with synthetic quilts, synthetic pillows, electric blankets, and sleeping in a bottom bunk bed but did not vary by sleep position. In a nested case-control analysis, the association between synthetic quilt use and frequent wheeze differed by sleep position. Among children who slept supine, synthetic (versus feather) quilt use was associated with frequent wheeze (adjusted odds ratio: 2.37 [1.08, 5.23]). However, among nonsupine sleepers, overlying synthetic quilt use was not associated with frequent wheeze (adjusted odds ratio: 1.06 [0.60, 1.88]). This difference in quilt effect by sleep position was highly significant. Similarly, synthetic quilt use was associated with lower postexercise forced expiratory volume in 1 second measures among supine but not nonsupine sleeping children. An increasing focus on the bedding environment immediately adjacent to the nose and mouth is required for respiratory disorders provoked by bedding, such as child asthma characterized by frequent wheeze.

Effect of perioperative oxygen supplementation on 30-day surgical site infection rate in abdominal, gynecologic, and breast surgery: the ISO2 randomized controlled trial.

PubMed

Thibon, Pascal; Borgey, France; Boutreux, Sébastien; Hanouz, Jean-Luc; Le Coutour, Xavier; Parienti, Jean-Jacques

2012-09-01

Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.

A comparison of the use, effectiveness and safety of bezafibrate, gemfibrozil and simvastatin in normal clinical practice using the New Zealand Intensive Medicines Monitoring Programme (IMMP)

PubMed Central

Beggs, Peter W; Clark, David WJ; Williams, Sheila M; Coulter, David M

1999-01-01

Aims Because of the importance of treating dyslipidaemia in the prevention of ischaemic heart disease and because patient selection criteria and outcomes in clinical trials do not necessarily reflect what happens in normal clinical practice, we compared outcomes from bezafibrate, gemfibrozil and simvastatin therapy under conditions of normal use. Methods A random sample of 200 patients was selected from the New Zealand Intensive Medicines Monitoring Programme’s (IMMP) patient cohorts for each drug. Questionnaires sent to prescribers requested information on indications, risk factors for ischaemic heart disease, lipid profiles with changes during treatment and reasons for stopping therapy. Results 80% of prescribers replied and 83% of these contained useful information. The three groups were similar for age, sex and geographical region, but significantly more patients on bezafibrate had diabetes and/or hypertension than those on gemfibrozil or simvastatin. After treatment and taking the initial measure into account, the changes in serum lipid values were consistent with those generally observed, but with gemfibrozil being significantly less effective than expected. More patients (15.8%) stopped gemfibrozil because of an inadequate response compared with bezafibrate (5.4%) and simvastatin (1.6%). Gemfibrozil treatment was also withdrawn significantly more frequently due to a possible adverse reaction compared with the other two drugs. Conclusions In normal clinical practice in New Zealand gemfibrozil appears less effective and more frequently causes adverse effects leading to withdrawal of treatment than either bezafibrate or simvastatin. PMID:10073746

Experimental introduction of a microsporidian into a wild population of Culex pipiens fatigans Wied

PubMed Central

Reynolds, D. G.

1972-01-01

Chemical control of C. p. fatigans frequently fails because the mosquito rapidly develops resistance to insecticides. A possible alternative or complementary method is biological control, including the introduction of pathogens. The microsporidian Plistophora culicis was known to infect readily and have an adverse effect on C. p. fatigans populations in the laboratory, so an attempt was made to introduce and establish this pathogen in a wild population of the mosquito on the Pacific island of Nauru. Two years after introduction the pathogen was still present in the wild population. However, the infection rate was similar to that found in naturally occurring infections in other mosquitos and is almost certainly not high enough to affect a natural population of C. p. fatigans adversely. PMID:4538542

Childhood adversity and the continued exposure to trauma and violence among adolescent gang members

PubMed Central

Quinn, Katherine; Pacella, Maria L.; Dickson-Gomez, Julia; Nydegger, Liesl A.

2017-01-01

This study examines experiences of childhood adversity, trauma, and violence among adolescent gang members prior to and during adolescent gang involvement to better understand the effects of violence and trauma on gang members. We conducted 58 qualitative semi-structured interviews with members of six adolescent gangs. Data was analyzed using thematic content analysis and the constant comparative method in MAXQDA. Findings revealed that frequent and ongoing exposure to neighborhood violence and personal and familial trauma led many youth to normalize experiences of violence. Furthermore, although they believed gangs would offer protection and social support, gang membership led to additional exposure to violence and trauma and bleak future expectations. Interventions for adolescent gang members should address the complex childhoods and cumulative traumatic experiences of these adolescents. PMID:28262961

[Analysis of after-vacination side-effects occurred in Teresina].

PubMed

de Araújo, Telma Maria Evangelista; de Carvalho, Patrícia Maria Gomes; Vieira, Raimunda Damasceno Ferreira

2007-01-01

This study focuses the profile of the adverse events after-vaccine occurrences in Teresina in 2006. The data had been collected by means of the form application with 73 participants in 18 Basic Units of Health. The results show that the vaccines that had more produced events adverse had been tetravalente, BCG and DPT The events most frequent had been: fever, hiporresponsivo hipotonic episode, moderate irritability and local manifestations. Amongst the behaviors adopted for the health professionals, 80% had been approximately adjusted. The year minors had been accomitted by the events. All the events had evolved for the cure. It was concluded that the action of vaccination still continues requiring constant qualification of the professionals of the area. It is suggested to deepen the knowledge with relation to the handling, diagnosis, inquiry and treatment.

Medical Error and Moral Luck.

PubMed

Hubbeling, Dieneke

2016-09-01

This paper addresses the concept of moral luck. Moral luck is discussed in the context of medical error, especially an error of omission that occurs frequently, but only rarely has adverse consequences. As an example, a failure to compare the label on a syringe with the drug chart results in the wrong medication being administered and the patient dies. However, this error may have previously occurred many times with no tragic consequences. Discussions on moral luck can highlight conflicting intuitions. Should perpetrators receive a harsher punishment because of an adverse outcome, or should they be dealt with in the same way as colleagues who have acted similarly, but with no adverse effects? An additional element to the discussion, specifically with medical errors, is that according to the evidence currently available, punishing individual practitioners does not seem to be effective in preventing future errors. The following discussion, using relevant philosophical and empirical evidence, posits a possible solution for the moral luck conundrum in the context of medical error: namely, making a distinction between the duty to make amends and assigning blame. Blame should be assigned on the basis of actual behavior, while the duty to make amends is dependent on the outcome.

Prevalence of Adverse Drug Reactions to Highly Active Antiretroviral Therapy (HAART) among HIV Positive Patients in Imam Khomeini Hospital of Tehran, Iran.

PubMed

Koochak, Hamid E; Babaii, Azita; Pourdast, Alia; Golrokhy, Raheleh; Rasoolinejad, Mehrnaz; Khodaei, Sepideh; Moghadam, Saeed R J; Taheri, Reza R; Seyed Alinaghi, Seyed Ahmad

2017-01-01

The present study assessed the prevalence of adverse drug reactions (ADRs) among HIV positive patients taking antiretroviral therapy referred to Imam Khomeini Hospital in Tehran, Iran. This is a cross sectional study regarding side effects of Highly Active Antiretroviral Therapy (HAART) in HIV positive patients referred to Voluntary Counseling and Testing (VCT) center in Imam Khomeini Hospital of Tehran, Iran during a period of the year 2009 to 2010. Two hundred patients under antiretroviral treatment evaluated for the side effects of drug based on available records, face to face interviews and written lab data. Data was collected from a sample of 200 HIV positive patients (72% male). Injection drug use was the most common route of HIV transmission. Co-Infections with Hepatitis C virus (HCV) found in the majority of patients (60.5%). Tuberculosis was the most prevalent opportunistic infection. One hundred eighty eight (94%) patients experienced at least one adverse drug reaction. The most frequent clinical and paraclinical findings were skin rash (28%) and abnormal liver function tests (36%). Given the high prevalence of adverse drug reactions among HIV positive patients taking antiretroviral therapy (ART) in this study, clinicians should be aware of ADRs at the initiation of ART as complications can affect patients' adherence to the therapy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety.

PubMed

Al-Mayouf, Sulaiman M; Alenazi, Abdullatif; AlJasser, Hind

2016-06-01

To report the indications and safety of biologic agents in childhood rheumatic diseases at a tertiary hospital. Children with rheumatic diseases treated with biologic agents at King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, from January 2001 to December 2011 were included. All patients were reviewed for: demographic characteristics, diagnosis, concomitant treatment and indications of using biologic agents, age at start of therapy and side effects during the treatment period. In all, 134 children (89 female) with various rheumatic diseases were treated with biologic agents. Mean age at starting biologic treatment was 9.3 (4.25-14) years and mean therapy duration was 14.7 (3-88) months. Juvenile idiopathic arthritis (JIA) was the most frequent diagnosis (70.1%) followed by systemic lupus erythematosus (12.7%) and vasculitis (4.5%). All patients received concomitant therapy (corticosteroids and disease-modifying antirheumatic drugs). In total, 273 treatments with biologic agents were used, (95 etanercept, 52 rituximab, 47 adalimumab, 37 infliximab, 23 anakinra, 10 tocilizumab and nine abatacept). Therapy was switched to another agent in 57 (42.5%) patients, mainly because of inefficacy (89.4%) or adverse event (10.6%). A total of 95 (34.8%) adverse events were notified; of these, the most frequent were infusion-related reactions (33.7%) followed by infections (24.2%) and autoantibody positivity (10.6%). One patient developed macrophage activation syndrome. Biologic agents were used in children with a range of rheumatic diseases. Of these, the most frequent was JIA. Off-label use of biologic agents in our cohort is common. These agents seem safe. However, they may associated with various adverse events. Sequential therapy seems well tolerated. However, this should be carefully balanced and considered on an individual basis. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Colchicine for primary prevention of atrial fibrillation after open-heart surgery: Systematic review and meta-analysis.

PubMed

Lennerz, Carsten; Barman, Manish; Tantawy, Mahmoud; Sopher, Mark; Whittaker, Peter

2017-12-15

Atrial fibrillation occurs frequently after open-heart surgery. It is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Prophylactic administration of colchicine may mitigate post-operative atrial fibrillation (POAF). We searched PubMed, ClinicalTrials.gov and CENTRAL databases to identify randomized controlled trials (RCTs) that; (1) compared prophylactic use of colchicine to placebo, or usual care, in patients with sinus rhythm who underwent elective open-heart surgery and (2) reported POAF-incidence. We excluded trials focused on incidence of atrial fibrillation after percutaneous interventions or colchicine treatment of diagnosed pericarditis or post-pericardiotomy-syndrome. A random-effects model was used to pool data for POAF-incidence as the primary outcome and for drug-related adverse effects, major adverse events (death and stroke), and hospital length-of-stay as secondary outcomes. We included five RCTs (1412 patients). Colchicine treatment reduced POAF-events by 30% versus placebo or usual care (18% vs. 27%, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.84, p=0.0002). Adverse drug-related effects, especially gastrointestinal intolerance, increased with colchicine; (21% vs. 8.2%, RR 2.52, 95% CI 1.62 to 3.93, p<0.0001). However, major adverse events were unchanged (3.2% vs. 3.2%, RR 0.96, 95% CI 0.48 to 1.95, p=0.92). Length-of-stay decreased by 1.2days with colchicine (95% CI -1.89 to -0.44, p=0.002). Colchicine demonstrated superior efficacy versus usual care for prevention of atrial fibrillation after cardiac surgery. Moreover, colchicine treatment was associated with shorter hospital stays. These benefits outweigh increased risk of adverse drug-related effects; although further work is needed to minimize gastrointestinal effects. Copyright © 2017 Elsevier B.V. All rights reserved.

Adverse-event profile of Crataegus spp.: a systematic review.

PubMed

Daniele, Claudia; Mazzanti, Gabriela; Pittler, Max H; Ernst, Edzard

2006-01-01

Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15), gastrointestinal complaints (n = 24), headache (n = 9), migraine (n = 8) and palpitation (n = 11). The WHO spontaneous reporting scheme received 18 case reports. In the identified trials, the most frequent adverse events were dizziness (n = 6), nausea (n = 5), fall (n = 2), gastrointestinal haemorrhage (n = 2), circulation failure (n = 2) and erythematous rash (n = 2). There were no reports of drug interactions. In conclusion, all data reviewed in this article seem to indicate that hawthorn is well tolerated even if some severe adverse events were reported; this suggests that further studies are needed to better assess the safety of hawthorn-containing preparations. Moreover, the unsupervised use of this drug can be associated with problems, especially if given with concomitant medications.

Expert panel evaluation of health information technology effects on adverse events.

PubMed

Abramson, Erika L; Kern, Lisa M; Brenner, Samantha; Hufstader, Meghan; Patel, Vaishali; Kaushal, Rainu

2014-08-01

Adverse events (AEs) among hospitalized patients occur frequently and result in significant sequelae. Federal policy is incentivizing health information technology (HIT) use, although research demonstrating safety benefits from HIT is mixed. Our objective was to evaluate the potential effects of HIT on reducing 21 different inpatient AEs. Identifying AEs most likely to be reduced by HIT can inform the design of future studies evaluating its effectiveness. We conducted a modified Delphi panel of national experts in HIT and safety. We conducted a focused literature review to inform the experts. Using a novel framework, experts rated each AE as 'definitely reduced by health IT,' 'possibly reduced by health IT' and 'not likely to be reduced by health IT'. From our panel discussion, experts identified six AEs as 'definitely reduced by health IT': (1) adverse drug events (ADEs) associated with digoxin; (2) ADE associated with IV heparin; (3) ADE associated with hypoglycaemic agents; (4) ADE associated with low molecular weight heparin and factor Xa inhibitor; (5) contrast nephropathy associated with catheter angiography; and (6) ADE hospital-acquired antibiotic-associated Clostridium difficile. Understanding the effects of HIT on patient outcomes will be essential to ensuring that the significant federal investment results in anticipated improvements. This study serves as an important early step in helping with the design of future work evaluating level of HIT infrastructure and rates of inpatient AEs. © 2014 John Wiley & Sons, Ltd.

The Safety of Acupuncture in Patients with Cancer Therapy–Related Thrombocytopenia

PubMed Central

Cybularz, Paul A.; Brothers, Karen; Singh, Gurneet M.; Feingold, Jennifer L.; Niesley, Michelle L.

2015-01-01

Abstract Background: Acceptance of acupuncture as an efficacious integrative modality for oncology-related side-effect management is rapidly expanding. It is imperative that guidelines regarding safe treatment supported by clinical experience are established. Oncology patients frequently experience thrombocytopenia as a side-effect of chemotherapy or radiation. However, safety data for acupuncture in adult patients with cancer who are thrombocytopenic is lacking. Materials and Methods: The medical records of 684 patients who received acupuncture treatments in an established acupuncture program at a private cancer treatment hospital were reviewed for adverse events occurring within the context of thrombocytopenia. Results: Of 2135 visits eligible for evaluation, 98 individual acupuncture visits occurred in patients with platelet counts <100,000/μL, including nine visits in which platelet counts were <50,000/μL. No adverse events of increased bruising or bleeding were noted. Medications and nutritional supplements or botanicals that may influence coagulation were also tabulated, with no apparent adverse events in this patient population. Conclusions: Discrepancies in the literature highlight the need to create cohesive safety guidelines backed by clinical research, specifically for groups at higher risk for adverse events. The preliminary evidence put forth in this study lays the foundation that supports the notion that acupuncture can be used safely with a high-need oncology population within an integrated model of care. In this descriptive retrospective case series of adult oncology patients with thrombocytopenia, no adverse events of increased bruising or bleeding were documented. Prospective trials are needed to confirm these initial observations. PMID:26401193

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction.

PubMed

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-05-15

Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

PubMed Central

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-01-01

Background/Aims Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. Methods A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. Results The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Conclusions Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs. PMID:28208003

Treatment of Vancomycin-Resistant Enterococcal Infections in the Immunocompromised Host: Quinupristin-Dalfopristin in Combination with Minocycline

PubMed Central

Raad, Issam; Hachem, Ray; Hanna, Hend; Girgawy, Essam; Rolston, Kenneth; Whimbey, Estella; Husni, Rola; Bodey, Gerald

2001-01-01

Between February 1994 and November 1998, 56 oncology patients infected with vancomycin-resistant enterococci (VRE) were treated with quinopristin-dalfopristin (Q-D) plus minocycline (MIN). Infections included bacteremia, urinary tract infection, pneumonia, and wound infection. The response rate was 68%, and the most frequent adverse event was arthralgia or myalgia (36%). Q-D–MIN is effective for VRE infection in cancer patients but is associated with a substantial frequency of arthralgia or myalgia. PMID:11600379

Dermatotoxicologic clinical solutions: hair dying in hair dye allergic patients?

PubMed

Edwards, Ashley; Coman, Garrett; Blickenstaff, Nicholas; Maibach, Howard

2015-03-01

This article describes how to identify allergic contact dermatitis resulting from hair dye, and outlines interventions and prevention principles for those who wish to continue dyeing their hair despite being allergic. Hair dye chemicals thought to be the most frequent sensitizers are discussed with instructions for health care providers on how to counsel patients about techniques to minimize exposure to allergenic substances. This framework should allow many patients to continue dyeing their hair without experiencing adverse side effects.

Zoledronic acid in pediatric metabolic bone disorders.

PubMed

Bowden, Sasigarn A; Mahan, John D

2017-10-01

Zoledronic acid (ZA), a highly potent intravenous bisphosphonate (BP), has been increasingly used in children with primary and secondary osteoporosis due to its convenience of shorter infusion time and less frequent dosing compared to pamidronate. Many studies have also demonstrated beneficial effects of ZA in other conditions such as hypercalcemia of malignancy, fibrous dysplasia (FD), chemotherapy-related osteonecrosis (ON) and metastatic bone disease. This review summarizes pharmacologic properties, mechanism of action, dosing regimen, and therapeutic outcomes of ZA in a variety of metabolic bone disorders in children. Several potential novel uses of ZA are also discussed. Safety concerns and adverse effects are also highlighted.

Localized intestinal perforations as a potential complication of brain hypothermic therapy for perinatal asphyxia.

PubMed

Nishizaki, Naoto; Maiguma, Atsuko; Obinata, Kaoru; Okazaki, Tadaharu; Shimizu, Toshiaki

2016-01-01

Brain hypothermic therapy (BHT) is becoming a frequently used standard of care for perinatal asphyxia. Although cardiovascular side effects, coagulation disorders, renal impairment, electrolyte abnormalities, impaired liver function, opportunistic infections, and skin lesions are well-known adverse effects of BHT in newborns, little information is available on the clinical features of intestinal perforation-related BHT. We herein report a case of therapeutic brain cooling for perinatal asphyxia complicated by localized intestinal perforation. In practice, the neonatologist should be aware that intestinal perforation in an infant with perinatal asphyxia is possible, particularly following BHT.

Adverse events and treatment interruption in tuberculosis patients with and without HIV co‐infection

PubMed Central

Breen, R A M; Miller, R F; Gorsuch, T; Smith, C J; Schwenk, A; Holmes, W; Ballinger, J; Swaden, L; Johnson, M A; Cropley, I; Lipman, M C I

2006-01-01

Background Serious treatment associated adverse events are thought to occur more frequently in individuals with tuberculosis (TB) who are co‐infected with HIV. A study was undertaken to assess the frequency of serious (grade III/IV) adverse events and interruption of anti‐TB treatment in the era of effective antiretroviral therapy. Methods The incidence of serious adverse events was retrospectively compared in 312 individuals treated for TB, 156 of whom were co‐infected with HIV. Results 111 HIV infected individuals (71%) received highly active antiretroviral therapy at the same time as anti‐TB treatment. Serious adverse events were recorded in 40% HIV infected and 26% HIV uninfected individuals (p = 0.008). Peripheral neuropathy and persistent vomiting were more common in co‐infected patients (p<0.001; p = 0.006), although all cause interruption of anti‐TB treatment occurred with similar frequency in the two groups (13% in HIV infected patients and 15% in HIV uninfected patients; p = 0.74). In 85% of HIV infected patients and 87% of HIV uninfected individuals this was due to hepatotoxicity, which typically presented within 2 months of starting treatment. The median delay in restarting treatment was 4 weeks, so most individuals required full TB re‐treatment. Conclusion Despite a greater rate of serious (grade III/IV) adverse events among HIV infected individuals, discontinuation of anti‐TB treatment occurred with a similar frequency in HIV infected and HIV uninfected individuals. PMID:16844730

Adverse reactions associated with acetylcysteine.

PubMed

Sandilands, E A; Bateman, D N

2009-02-01

Paracetamol (acetaminophen) is one of the most common agents deliberately ingested in self-poisoning episodes and a leading cause of acute liver failure in the western world. Acetylcysteine is widely acknowledged as the antidote of choice for paracetamol poisoning, but its use is not without risk. Adverse reactions, often leading to treatment delay, are frequently associated with both intravenous and oral acetylcysteine and are a common source of concern among treating physicians. A systematic literature review investigating the incidence, clinical features, and mechanisms of adverse effects associated with acetylcysteine. A variety of adverse reactions to acetylcysteine have been described ranging from nausea to death, most of the latter due to incorrect dosing. The pattern of reactions differs with oral and intravenous dosing, but reported frequency is at least as high with oral as intravenous. The reactions to the intravenous preparation result in similar clinical features to true anaphylaxis, including rash, pruritus, angioedema, bronchospasm, and rarely hypotension, but are caused by nonimmunological mechanisms. The precise nature of this reaction remains unclear. Histamine now seems to be an important mediator of the response, and there is evidence of variability in patient susceptibility, with females, and those with a history of asthma or atopy are particularly susceptible. Quantity of paracetamol ingestion, measured through serum paracetamol concentration, is also important as higher paracetamol concentrations protect patients against anaphylactoid effects. Most anaphylactoid reactions occur at the start of acetylcysteine treatment when concentrations are highest. Acetylcysteine also affects clotting factor activity, and this affects the interpretation of minor disturbances in the International Normalized Ratio in the context of paracetamol overdose. This review discusses the incidence, clinical features, underlying pathophysiological mechanisms, and treatment of adverse reactions to acetylcysteine and identifies particular "at-risk" patient groups. Given the commonality of adverse reactions associated with acetylcysteine, it is important to ensure that any adverse event does not preclude patients from receiving maximal hepatic protection, particularly in the context of significant paracetamol ingestion. Further work on mechanisms should allow specific therapies to be developed.

Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.

PubMed

Yang, Jaewon; Bahk, Won-Myong; Cho, Hyun-Sang; Jeon, Yang-Whan; Jon, Duk-In; Jung, Hee-Yeon; Kim, Chan-Hyung; Kim, Hee-Cheol; Kim, Yong-Ku; Kim, Young-Hoon; Kwon, Jun-Soo; Lee, Sang-Yeol; Lee, Seung-Hwan; Yi, Jung-Seo; Yoon, Bo-Hyun; Kim, Seung-Hyun

2010-07-01

The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 +/- 19.73 for the blonanserin group and -25.40 +/- 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.

[Alcohol's impact on children and families. A population survey].

PubMed

Florenzano, Ramón; Echeverría, Ángela; Sieverson, Catalina; Barr, Michelle; Fernández, Miguel Ángel

2016-01-01

Alcohol is widely used among young families, and leisure time is frequently family time. Heavy alcohol consumption can adversely affect children. The objective of this work is to measure the harm to others in Chile. This descriptive and probabilistic study forms part of a collaborative research funded by Thai Health and WHO. The survey was adapted by co-researchers and applied to a nationally representative sample of 1500 Chileans over 18years of age. A total of 408 respondents (27.2%) lived with children at home. Of this total, 10.5% felt that the use of alcohol by any member of the family had adversely affected a child. The most common adverse effects were verbal violence (29.7%), domestic violence (23.1%), unsupervised homes (18.7%), lack of money to provide basic needs of the child (14.3%), and physical violence (7.7%). Furthermore, in 6.6% of the cases child or family services agencies became involved. In almost half of the cases (46.3%), the drinker was the father, mother or step-parents. This was followed by other relatives (24.4%) and brothers (4.9%), or guardian of the child (2.4%). These data support the clinical observation that alcohol is common in Chilean homes. Its consumption not only damages the physical and mental health of the drinker but also those around him. Verbal violence and witnessing serious physical violence are frequent issues, as well as economic problems that end up with the inability to provide the child with its basic needs. Copyright © 2016. Publicado por Elsevier España, S.L.U.

A prospective study of frequency and characteristics of cough during ACE inhibitor treatment.

PubMed

Sato, Atsuhisa; Fukuda, Seiichi

2015-01-01

Angiotensin converting enzyme (ACE) inhibitors are reportedly effective, and positively indicated in patients with chronic heart failure with decreased contractility, after myocardial infarction, after cerebrovascular disorders, and in those with chronic kidney disease. However, the biggest challenge to continuous use of ACE inhibitors is the adverse reaction of cough. Accordingly, in the present study, we investigated the present state and characteristics of ACE inhibitor-induced cough in patients with essential hypertension currently being treated with an ACE inhibitor for an average of 18 months, who could be regularly checked for cough. Subjects in this study were 176 patients overall (mean age 67 ± 11 years old), 90 men and 86 women. The adverse reaction of cough was observed in 20% of patients, and more frequently in women than in men. However, in 26 of the patients with cough, the cough either resolved naturally or completely disappeared while the treatment continued, after which patients could continue taking the medication. Specifically, ACE inhibitor treatment was eventually discontinued due to cough in 5.1% of patients. Cough occurred less frequently with concomitant calcium antagonists or diuretics than with ACE inhibitor monotherapy. Cough as an adverse reaction occurred at a low frequency when medication was taken at bedtime. We considered a number of measures to counteract cough, then in addition to starting the ACE inhibitor treatment as early as possible, it is important to devise ways for the ACE inhibitor treatment to be continued for as long as possible, through the adept use of these measures.

Antibiotic Policies and Utilization in Oregon Hospice Programs.

PubMed

Novak, Rachel L; Noble, Brie N; Fromme, Erik K; Tice, Michael O; McGregor, Jessina C; Furuno, Jon P

2016-09-01

Antibiotics are frequently used in hospice care, despite limited data on safety and effectiveness in this patient population. We surveyed Oregon hospice programs on antibiotic policies and prescribing practices. Among 39 responding hospice programs, the median reported proportion of current census using antibiotics was 10% (interquartile range = 3.5%-20.0%). Approximately 31% of responding hospice programs had policies for antibiotic initiation, 17% of hospice programs had policies for antibiotic discontinuation, and 95% of hospice programs had policies for managing drug interactions. Diarrhea, nausea/vomiting, and yeast infections were the most frequently reported antibiotic-associated adverse events, occurring "sometimes" or "often" among 62%, 47%, and 62% of respondents, respectively. In conclusion, less than a third of participating hospice programs reported having a policy for antibiotic initiation and even less frequently a policy for discontinuation. More data are needed on the risks and benefits of antibiotic use in hospice care to inform these policies and optimize outcomes in this vulnerable patient population. © The Author(s) 2015.

Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008.

PubMed

Saokaew, Surasak; Suwankesawong, Wimon; Permsuwan, Unchalee; Chaiyakunapruk, Nathorn

2011-04-01

The use of herbal products continues to expand rapidly across the world and concerns regarding the safety of these products have been raised. In Thailand, Thai Vigibase, developed by the Health Product Vigilance Center (HPVC) under the Thai Food and Drug Administration, is the national database that collates reports from health product surveillance systems and programmes. Thai Vigibase can be used to identify signals of adverse events in patients receiving herbal products. The purpose of the study was to describe the characteristics of reported adverse events in patients receiving herbal products in Thailand. Thai Vigibase data from February 2000 to December 2008 involving adverse events reported in association with herbal products were used. This database includes case reports submitted through the spontaneous reporting system and intensive monitoring programmes. Under the spontaneous reporting system, adverse event reports are collected nationwide via a national network of 22 regional centres covering more than 800 public and private hospitals, and health service centres. An intensive monitoring programme was also conducted to monitor the five single herbal products listed in the Thai National List of Essential Medicines (NLEM), while another intensive monitoring programme was developed to monitor the four single herbal products that were under consideration for inclusion in the NLEM. The database contained patient demographics, adverse events associated with herbal products, and details on seriousness, causality and quality of reports. Descriptive statistics were used for data analyses. A total of 593 reports with 1868 adverse events involving 24 different products were made during the study period. The age range of individuals was 1-86 years (mean 47 years). Most case reports were obtained from the intensive monitoring programme. Of the reports, 72% involved females. The herbal products for which adverse events were frequently reported were products containing turmeric (44%), followed by andrographis (10%), veld grape (10%), pennywort (7%), plai (6%), jewel vine (6%), bitter melon (5%) and snake plant (5%). Gastrointestinal problems were the most common adverse effect reported. Serious adverse events included Stevens-Johnson syndrome, anaphylactic shock and exfoliative dermatitis. Adverse event reports on herbals products were diverse, with most of them being reported through intensive monitoring programmes. Thai Vigibase is a potentially effective data source for signal detection of adverse events associated with herbal products.

Radiological Insertion of Denver Peritoneovenous Shunts for Malignant Refractory Ascites: A Retrospective Multicenter Study (JIVROSG-0809)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sugawara, Shunsuke, E-mail: suga_shun@hotmail.com; Sone, Miyuki; Arai, Yasuaki

Purpose: Peritoneal venous shunts (PVSs) are widely used for palliating symptoms of refractory malignant ascites and are recognized as one of the practical methods. However, reliable clinical data are insufficient because most previous reports have been small studies from single centers. We conducted a retrospective, multicenter study to evaluate the safety and efficacy of radiologically placed PVSs in patients with malignant refractory ascites. Methods: A total of 133 patients with malignant ascites refractory to medical therapies were evaluated for patient characteristics, technical success, efficacy, survival times, adverse events, and changes in laboratory data. Results: PVSs were successfully placed in allmore » patients and were effective (i.e., improvement of ascites symptoms lasting 7 days or more) in 110 (82.7%). The median duration of symptom palliation was 26 days and median survival time was 41 days. The most frequent adverse event was PVS dysfunction, which occurred in 60 (45.1%) patients, among whom function was recovered with an additional minimally invasive procedure in 9. Abnormalities in coagulation (subclinical disseminated intravascular coagulation) occurred in 37 (27.8%) patients, although only 7 (5.3%) developed clinical disseminated intravascular coagulation. Other major adverse events were gastrointestinal bleeding (9.8%), sepsis (3.8%), and acute heart failure (3.0%). PVS was least effective in patients with elevated serum creatinine, bloody ascites, or gynecologic tumor. Conclusions: Radiological PVS is a technically feasible and effective method for palliating the symptoms from refractory malignant ascites, but preoperative evaluation and monitoring the postprocedural complications are mandatory to preclude severe adverse events after PVS.« less

Initial Experience with Balloon-Occluded Trans-catheter Arterial Chemoembolization (B-TACE) for Hepatocellular Carcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maruyama, Mitsunari, E-mail: mitunari@med-shimane.u.ac.jp; Yoshizako, Takeshi, E-mail: yosizako@med.shimane-u.ac.jp; Nakamura, Tomonori, E-mail: t-naka@med.shimane-u.ac.jp

2016-03-15

PurposeThis study was performed to evaluate the accumulation of lipiodol emulsion (LE) and adverse events during our initial experience of balloon-occluded trans-catheter arterial chemoembolization (B-TACE) for hepatocellular carcinoma (HCC) compared with conventional TACE (C-TACE).MethodsB-TACE group (50 cases) was compared with C-TACE group (50 cases). The ratio of the LE concentration in the tumor to that in the surrounding embolized liver parenchyma (LE ratio) was calculated after each treatment. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Effects (CTCAE) version 4.0.ResultsThe LE ratio at the level of subsegmental showed a statistically significant difference between the groups (tmore » test: P < 0.05). Only elevation of alanine aminotransferase was more frequent in the B-TACE group, showing a statistically significant difference (Mann–Whitney test: P < 0.05). While B-TACE caused severe adverse events (liver abscess and infarction) in patients with bile duct dilatation, there was no statistically significant difference in incidence between the groups. Multivariate logistic regression analysis suggested that the significant risk factor for liver abscess/infarction was bile duct dilatation (P < 0.05).ConclusionThe LE ratio at the level of subsegmental showed a statistically significant difference between the groups (t test: P < 0.05). B-TACE caused severe adverse events (liver abscess and infarction) in patients with bile duct dilatation.« less

Illnesses and deaths among persons attending an electronic dance-music festival - New York City, 2013.

PubMed

Ridpath, Alison; Driver, Cynthia R; Nolan, Michelle L; Karpati, Adam; Kass, Daniel; Paone, Denise; Jakubowski, Andrea; Hoffman, Robert S; Nelson, Lewis S; Kunins, Hillary V

2014-12-19

Outdoor electronic dance-music festivals (EDMFs) are typically summer events where attendees can dance for hours in hot temperatures. EDMFs have received increased media attention because of their growing popularity and reports of illness among attendees associated with recreational drug use. MDMA (3,4-methylenedioxymethamphetamine) is one of the drugs often used at EDMFs. MDMA causes euphoria and mental stimulation but also can cause serious adverse effects, including hyperthermia, seizures, hyponatremia, rhabdomyolysis, and multiorgan failure. In this report, MDMA and other synthetic drugs commonly used at dance festivals are referred to as "synthetic club drugs." On September 1, 2013, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) received reports of two deaths of attendees at an EDMF (festival A) held August 31-September 1 in NYC. DOHMH conducted an investigation to identify and characterize adverse events resulting in emergency department (ED) visits among festival A attendees and to determine what drugs were associated with these adverse events. The investigation identified 22 cases of adverse events; nine cases were severe, including two deaths. Twenty-one (95%) of the 22 patients had used drugs or alcohol. Of 17 patients with toxicology testing, MDMA and other compounds were identified, most frequently methylone, in 11 patients. Public health messages and strategies regarding adverse health events might reduce illnesses and deaths at EDMFs.

Modern malaria chemoprophylaxis.

PubMed

Shanks, G Dennis; Edstein, Michael D

2005-01-01

Currently available medications for malaria chemoprophylaxis are efficacious but the problems of patient compliance, the advance of parasite drug resistance, and real or perceived serious adverse effects mean that new chemical compounds are needed.Primaquine, which has been widely used to treat relapsing malaria since the 1950s, has been shown to prevent malaria when taken daily. Tafenoquine is a new 8-aminoquinoline with a much longer half-life than primaquine. Field trials to date indicate that tafenoquine is efficacious and can be taken weekly or perhaps even less frequently. Both primaquine and tafenoquine require exact knowledge of a person's glucose 6-phosphate dehydrogenase status in order to prevent drug-induced haemolysis. Other potential malaria chemoprophylactic drugs such as third-generation antifol compounds and Mannich bases have reached advanced preclinical testing. Mefloquine has been seen to cause serious neuropsychiatric adverse effects on rare occasions. Recent public controversy regarding reputedly common serious adverse effects has made many Western travellers unwilling to take mefloquine. Special risk groups exposed to malaria, such as long-term travellers, children, pregnant women, aircrew and those requiring unimpeded psychomotor reactions, migrants returning to visit malarious countries of origin and febrile persons who have returned from malaria endemic areas, all require a nuanced approach to the use of drugs to prevent malaria. The carrying of therapeutic courses of antimalarial drugs to be taken only if febrile illness develops is indicated in very few travellers despite its appeal to some who fear adverse effects more than they fear potentially lethal malaria infection. Travellers with a significant exposure to malaria require a comprehensive plan for prevention that includes anti-mosquito measures but which is still primarily be based on the regular use of efficacious antimalarial medications.

Recommendations for Optimizing Tuberculosis Treatment: Therapeutic Drug Monitoring, Pharmacogenetics, and Nutritional Status Considerations

PubMed Central

Choi, Rihwa; Jeong, Byeong-Ho

2017-01-01

Although tuberculosis is largely a curable disease, it remains a major cause of morbidity and mortality worldwide. Although the standard 6-month treatment regimen is highly effective for drug-susceptible tuberculosis, the use of multiple drugs over long periods of time can cause frequent adverse drug reactions. In addition, some patients with drug-susceptible tuberculosis do not respond adequately to treatment and develop treatment failure and drug resistance. Response to tuberculosis treatment could be affected by multiple factors associated with the host-pathogen interaction including genetic factors and the nutritional status of the host. These factors should be considered for effective tuberculosis control. Therefore, therapeutic drug monitoring (TDM), which is individualized drug dosing guided by serum drug concentrations during treatment, and pharmacogenetics-based personalized dosing guidelines of anti-tuberculosis drugs could reduce the incidence of adverse drug reactions and increase the likelihood of successful treatment outcomes. Moreover, assessment and management of comorbid conditions including nutritional status could improve anti-tuberculosis treatment response. PMID:28028995

The children of mentally ill parents.

PubMed

Mattejat, Fritz; Remschmidt, Helmut

2008-06-01

The children of mentally ill parents have a higher risk of developing mental illnesses themselves over the course of their lives. This known risk must be taken into account in the practical provision of health care. Selective literature review. The increased psychiatric risk for children of mentally ill parents is due partly to genetic influences and partly to an impairment of the parent-child interaction because of the parent's illness. Furthermore, adverse factors are more frequent in these families, as well as a higher risk for child abuse. Genetic and psychosocial factors interact with one another. For example, genetic factors moderate environmental effects; that is, the effect of adverse environmental factors depends on the genetic substrate. Preventive measures for children of mentally ill parents urgently need improvement. In this article, positively evaluated programs of preventive measures are discussed. Essential prerequisites for success include appropriate, specialized treatment of the parental illness, psychoeducative measures, and special support (e.g. self-help groups) as indicated by the family's particular needs.

Evidence for the Adverse Effect of Starvation on Bone Quality: A Review of the Literature

PubMed Central

Kueper, Janina; Beyth, Shaul; Liebergall, Meir; Kaplan, Leon; Schroeder, Josh E.

2015-01-01

Malnutrition and starvation's possible adverse impacts on bone health and bone quality first came into the spotlight after the horrors of the Holocaust and the ghettos of World War II. Famine and food restrictions led to a mean caloric intake of 200–800 calories a day in the ghettos and concentration camps, resulting in catabolysis and starvation of the inhabitants and prisoners. Severely increased risks of fracture, poor bone mineral density, and decreased cortical strength were noted in several case series and descriptive reports addressing the medical issues of these individuals. A severe effect of severely diminished food intake and frequently concomitant calcium- and Vitamin D deficiencies was subsequently proven in both animal models and the most common cause of starvation in developed countries is anorexia nervosa. This review attempts to summarize the literature available on the impact of the metabolic response to Starvation on overall bone health and bone quality. PMID:25810719

Comparison of heavy metal contamination during the last decade along the coastal sediment of Pakistan: Multiple pollution indices approach.

PubMed

Saher, Noor Us; Siddiqui, Asmat Saleem

2016-04-15

Heavy metals concentrations (Fe, Cu, Zn, Ni, Cr, Co, Pb, and Cd) were scrutinized during two monitoring years (2001 and 2011) in the coastal sediment of Pakistan. The status of metal contamination in coastal sediment was interpreted using sediment quality guidelines, and single and combined metal pollution indices. Ni, Cr, and Cd were recognized for their significant (p<0.05) intensification in the sediment during the last decade. Sediment quality guidelines recognized the frequent adverse biological effect of Ni and the occasional adverse biological effect of Cu, Cr, Pb and Cd. Single metal pollution indices (Igeo, EF, CF, and ER) revealed that sediment pollution is predominantly caused by Pb and Cd. Low to moderate contamination was appraised along the coast by multi-metal pollution indices (CD and PERI). Correlation study specifies that heavy metals were presented diverse affiliations and carriers for distribution in the sediment during the last decade. Copyright © 2016 Elsevier Ltd. All rights reserved.

Recommendations for Optimizing Tuberculosis Treatment: Therapeutic Drug Monitoring, Pharmacogenetics, and Nutritional Status Considerations.

PubMed

Choi, Rihwa; Jeong, Byeong Ho; Koh, Won Jung; Lee, Soo Youn

2017-03-01

Although tuberculosis is largely a curable disease, it remains a major cause of morbidity and mortality worldwide. Although the standard 6-month treatment regimen is highly effective for drug-susceptible tuberculosis, the use of multiple drugs over long periods of time can cause frequent adverse drug reactions. In addition, some patients with drug-susceptible tuberculosis do not respond adequately to treatment and develop treatment failure and drug resistance. Response to tuberculosis treatment could be affected by multiple factors associated with the host-pathogen interaction including genetic factors and the nutritional status of the host. These factors should be considered for effective tuberculosis control. Therefore, therapeutic drug monitoring (TDM), which is individualized drug dosing guided by serum drug concentrations during treatment, and pharmacogenetics-based personalized dosing guidelines of anti-tuberculosis drugs could reduce the incidence of adverse drug reactions and increase the likelihood of successful treatment outcomes. Moreover, assessment and management of comorbid conditions including nutritional status could improve anti-tuberculosis treatment response.

Safety pharmacology of acute MDMA administration in healthy subjects.

PubMed

Vizeli, Patrick; Liechti, Matthias E

2017-05-01

3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 ± 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA produced greater 'good drug effect' ratings than 75 mg. MDMA produced moderate and transient 'bad drug effect' ratings, which were greater in women than in men. MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, and body temperature >38°C in 33%, 29% and 19% of the subjects, respectively. These proportions of subjects with hypertension (>160 mmHg), tachycardia, and body temperature >38°C were all significantly greater after 125 mg MDMA compared with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by the List of Complaints were dose-dependent and more frequent in females. MDMA did not affect liver or kidney function at EOS 29 ± 22 days after use. No serious adverse events occurred. In conclusion, MDMA produced predominantly acute positive subjective drug effects. Bad subjective drug effects and other adverse effects were significantly more common in women. MDMA administration was overall safe in physically and psychiatrically healthy subjects and in a medical setting. However, the risks of MDMA are likely higher in patients with cardiovascular disease and remain to be investigated in patients with psychiatric disorders.

[The efficacy of intravenous lacosamide in psychiatric hospital].

PubMed

Vakula, I N; Bojko, E O; Vorona, U A; Storozhuk, J A; Nikiforova, E U; Nikiforova, D I; Glazunova, T I

2016-01-01

To evaluate the efficacy and tolerability of intravenous lacosamide (vimpat) in inpatients with frequent partial-onset seizures and affective and cognitive disorders. Fifteen patients were enrolled including 14 patients diagnosed with «organic personality disorder associated with epilepsy» (cryptogenic or symptomatic epilepsy with frequent partial-onset and/or secondary-generalized seizures (serial seizures in some cases) and 1 patient with a preliminary diagnosis of «organic schizophrenia-like disorder», which was changed for «organic personality disorder associated with epilepsy» after examination. Patients were treated with 2--3 antiepileptic drugs (AEDs), but no one of them received earlier lacosamide. Lacosamide was used intravenously in drops in the dose of 200 or 400 mg daily during 5 days. In 4 patients with marked personality disorders, the frequency of seizures decreased by 75%, no seizures were noted after 2--3 days of treatment in 11 patients. A positive effect of lacosamide on the affective sphere and quality-of-life was observed in 11 (73.4%) patients with epilepsy. Mild and moderate adverse effects were found only in 2 patients. It has been concluded that lacosamide demonstrates the high efficacy in patients with frequent drug-resistant seizures.

Some effects of alcohol and eye movements on cross-race face learning.

PubMed

Harvey, Alistair J

2014-01-01

This study examines the impact of acute alcohol intoxication on visual scanning in cross-race face learning. The eye movements of a group of white British participants were recorded as they encoded a series of own-and different-race faces, under alcohol and placebo conditions. Intoxication reduced the rate and extent of visual scanning during face encoding, reorienting the focus of foveal attention away from the eyes and towards the nose. Differences in encoding eye movements also varied between own-and different-race face conditions as a function of alcohol. Fixations to both face types were less frequent and more lingering following intoxication, but in the placebo condition this was only the case for different-race faces. While reducing visual scanning, however, alcohol had no adverse effect on memory, only encoding restrictions associated with sober different-race face processing led to poorer recognition. These results support perceptual expertise accounts of own-race face processing, but suggest the adverse effects of alcohol on face learning published previously are not caused by foveal encoding restrictions. The implications of these findings for alcohol myopia theory are discussed.

Carbonyl sulfide removal with compost and wood chip biofilters, and in the presence of hydrogen sulfide.

PubMed

Sattler, Melanie L; Garrepalli, Divya R; Nawal, Chandraprakash S

2009-12-01

Carbonyl sulfide (COS) is an odor-causing compound and hazardous air pollutant emitted frequently from wastewater treatment facilities and chemical and primary metals industries. This study examined the effectiveness of biofiltration in removing COS. Specific objectives were to compare COS removal efficiency for various biofilter media; to determine whether hydrogen sulfide (H2S), which is frequently produced along with COS under anaerobic conditions, adversely impacts COS removal; and to determine the maximum elimination capacity of COS for use in biofilter design. Three laboratory-scale polyvinyl chloride biofilter columns were filled with up to 28 in. of biofilter media (aged compost, fresh compost, wood chips, or a compost/wood chip mixture). Inlet COS ranged from 5 to 46 parts per million (ppm) (0.10-9.0 g/m3 hr). Compost and the compost/wood chip mixture produced higher COS removal efficiencies than wood chips alone. The compost and compost/wood chip mixture had a shorter stabilization times compared with wood chips alone. Fresh versus aged compost did not impact COS removal efficiency. The presence of H2S did not adversely impact COS removal for the concentration ratios tested. The maximum elimination capacity is at least 9 g/m3 hr for COS with compost media.

Fetal gender and pregnancy outcomes in Libya: a retrospective study

PubMed Central

Khalil, Mounir M.; Alzahra, Esgair

2013-01-01

Objective The relationship between pregnancy outcomes and fetal gender is well reported from different areas in the world, but not from Africa. In this study, we try to understand whether the recorded phenomenon of association of adverse pregnancy outcomes with a male fetus applies to our population. Materials and methods A total of 29,140 patient records from 2009 and 2010 were retrieved from Aljalaa Maternity Hospital, Tripoli, Libya. Analysis was carried out to find the correlation between fetal gender and different pregnancy outcomes. Results A male fetus was associated with an increased incidence of gestational diabetes mellitus (odds risk 1.4), preterm delivery (6.7% for males, 5.5% for females, odds risk 1.24), cesarean section (23.9% for males, 20% for females, odds risk 1.25), and instrumental vaginal delivery (4.4% for males, 3.1% for females, odds risk 1.48), p<0.005. Preeclampsia was more frequent among preterm females and postterm males, p<0.005. It was also more frequent in male-bearing primigravids, p<0.01. Conclusion We confirm the existence of an adverse effect of a male fetus on pregnancy and labor in our population. We recommend further research to understand the mechanisms and clinical implications of this phenomenon. PMID:23308081

Mechanical Ventilation-Related Safety Incidents in General Care Wards and ICU Settings.

PubMed

Kamio, Tadashi; Masamune, Ken

2018-05-29

Although the ICU is the most appropriate place to care for mechanically ventilated patients, a considerable number are ventilated in general medical care wards all over the world. However, adverse events focusing on mechanically ventilated patients in general care have not been explored. Data from the Japan Council for Quality Health Care database were analyzed. Patient safety incidents from January 2010 to November 2017 regarding mechanical ventilation were collected, and comparisons of patient safety incidents between ICUs/high care units (HCUs) and general care wards were made. We identified 261 adverse events (with at least 20 adverse events resulting in death) and 702 near-miss events related to mechanical ventilation in Japan between 2010 and 2017. Furthermore, among all adverse events, 19% (49 of 261 events) caused serious harm (residual disability or death). Human-factor issues were most frequent in both ICU/HCU and general care settings (55% and 53%, respectively), while knowledge-based errors were higher in the general care setting. Human-factor issues were the most frequent reasons in both settings, while knowledge-based error rates were higher in general care. Our results suggest that proper education and training is needed to minimize patient safety incidents in facilities without respiratory therapists. Copyright © 2018 by Daedalus Enterprises.

A safety evaluation of pirfenidone for the treatment of idiopathic pulmonary fibrosis.

PubMed

Anderson, Adam; Shifren, Adrian; Nathan, Steven D

2016-07-01

Pirfenidone is a novel oral anti-fibrotic agent approved for the treatment of idiopathic pulmonary fibrosis (IPF). Since IPF is a chronic and progressive disease most commonly encountered in an older population, therapeutic options should be not only effective, but also free from drug interactions and as safe and tolerable as possible. Comprehensive data from randomized controlled trials, meta-analyses, safety studies, and post-marketing data are available to assess the efficacy and safety of pirfenidone in the treatment of IPF. Information on efficacy, adverse events, drug tolerability and discontinuation rates both in clinical trials and real-world clinical experiences are reported. Pirfenidone has an abundance of data supporting its use in mild-to-moderate IPF. Observational evidence suggests a similar efficacy in severe IPF. In clinical trials, observational studies and real-world use, adverse events are frequent, though generally mild and well tolerated, especially with adequate patient education. Preventative strategies, along with timely and appropriate management of adverse events are critical in improving patient compliance, thereby ensuring the benefits of long-term treatment with pirfenidone.

A Review of the Novel Application and Potential Adverse Effects of Proton Pump Inhibitors.

PubMed

Yu, Li-Yuan; Sun, Lu-Ning; Zhang, Xue-Hui; Li, Yue-Qi; Yu, Lei; Yuan, Zi-Qing-Yun; Meng, Ling; Zhang, Hong-Wen; Wang, Yong-Qing

2017-05-01

Proton pump inhibitors (PPIs) are known as a class of pharmaceutical agents that target H + /K + -ATPase, which is located in gastric parietal cells. PPIs are widely used in the treatment of gastric acid-related diseases including peptic ulcer disease, erosive esophagitis and gastroesophageal reflux disease, and so on. These drugs present an excellent safety profile and have become one of the most commonly prescribed drugs in primary and specialty care. Except for gastric acid-related diseases, PPIs can also be used in the treatment of Helicobacter pylori infection, viral infections, respiratory system diseases, cancer and so on. Although PPIs are mainly used short term in patients with peptic ulcer disease, nowadays these drugs are increasingly used long term, and frequently for a lifetime, for instance in patients with typical or atypical symptoms of gastroesophageal reflux disease and in NSAID or aspirin users at risk of gastrotoxicity and related complications including hemorrhage, perforation and gastric outlet obstruction. Long-term use of PPIs may lead to potential adverse effects, such as osteoporotic fracture, renal damage, infection (pneumonia and clostridium difficile infection), rhabdomyolysis, nutritional deficiencies (vitamin B12, magnesium and iron), anemia and thrombocytopenia. In this article, we will review some novel uses of PPIs in other fields and summarize the underlying adverse reactions.

Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age.

PubMed

Blumer, Jeffrey L; Findling, Robert L; Shih, Weichung Joe; Soubrane, Christina; Reed, Michael D

2009-05-01

The goal was to evaluate the hypnotic efficacy of zolpidem at 0.25 mg/kg per day (maximum of 10 mg/day), compared with placebo, in children 6 through 17 years of age who were experiencing insomnia associated with attention-deficit/hyperactivity disorder. An 8-week, North American, multicenter, double-blind, placebo-controlled, parallel-group study was conducted. Patients underwent stratification according to age (6-11 years [N = 111] or 12-17 years [N = 90]) and were assigned randomly to receive treatment with the study drug or placebo (in a 2:1 ratio). The primary efficacy variable was latency to persistent sleep between weeks 3 and 6. Secondary efficacy variables also were assessed, and behavioral and cognitive components of attention-deficit/hyperactivity disorder were monitored. Safety was assessed on the basis of reports of adverse events, abnormal laboratory data, vital signs, and physical examination findings. The potential for next-day residual effects also was assessed. The baseline-adjusted mean change in latency to persistent sleep at week 4 did not differ significantly between the zolpidem and placebo groups (-20.28 vs -21.27 minutes). However, differences favoring zolpidem were observed for the older age group in Clinical Global Impression scores at weeks 4 and 8. No next-day residual effects of treatment were associated with zolpidem, and no rebound phenomena occurred after treatment discontinuation. Central nervous system and psychiatric disorders were the most-frequent treatment-emergent adverse events (>5%) that were observed more frequently with zolpidem than with placebo; these included dizziness, headache, and hallucinations. Ten (7.4%) patients discontinued zolpidem treatment because of adverse events. Zolpidem at a dose of 0.25 mg/kg per day to a maximum of 10 mg failed to reduce the latency to persistent sleep on polysomnographic recordings after 4 weeks of treatment in children and adolescents 6 through 17 years of age who had attention-deficit/hyperactivity disorder-associated insomnia.

Prescribing Errors Involving Medication Dosage Forms

PubMed Central

Lesar, Timothy S

2002-01-01

CONTEXT Prescribing errors involving medication dose formulations have been reported to occur frequently in hospitals. No systematic evaluations of the characteristics of errors related to medication dosage formulation have been performed. OBJECTIVE To quantify the characteristics, frequency, and potential adverse patient effects of prescribing errors involving medication dosage forms . DESIGN Evaluation of all detected medication prescribing errors involving or related to medication dosage forms in a 631-bed tertiary care teaching hospital. MAIN OUTCOME MEASURES Type, frequency, and potential for adverse effects of prescribing errors involving or related to medication dosage forms. RESULTS A total of 1,115 clinically significant prescribing errors involving medication dosage forms were detected during the 60-month study period. The annual number of detected errors increased throughout the study period. Detailed analysis of the 402 errors detected during the last 16 months of the study demonstrated the most common errors to be: failure to specify controlled release formulation (total of 280 cases; 69.7%) both when prescribing using the brand name (148 cases; 36.8%) and when prescribing using the generic name (132 cases; 32.8%); and prescribing controlled delivery formulations to be administered per tube (48 cases; 11.9%). The potential for adverse patient outcome was rated as potentially “fatal or severe” in 3 cases (0.7%), and “serious” in 49 cases (12.2%). Errors most commonly involved cardiovascular agents (208 cases; 51.7%). CONCLUSIONS Hospitalized patients are at risk for adverse outcomes due to prescribing errors related to inappropriate use of medication dosage forms. This information should be considered in the development of strategies to prevent adverse patient outcomes resulting from such errors. PMID:12213138

PTH prevents the adverse effects of focal radiation on bone architecture in young rats.

PubMed

Chandra, Abhishek; Lan, Shenghui; Zhu, Ji; Lin, Tiao; Zhang, Xianrong; Siclari, Valerie A; Altman, Allison R; Cengel, Keith A; Liu, X Sherry; Qin, Ling

2013-08-01

Radiation therapy is a common treatment regimen for cancer patients. However, its adverse effects on the neighboring bone could lead to fractures with a great impact on quality of life. The underlying mechanism is still elusive and there is no preventive or curative solution for this bone loss. Parathyroid hormone (PTH) is a current therapy for osteoporosis that has potent anabolic effects on bone. In this study, we found that focal radiation from frequent scans of the right tibiae in 1-month-old rats by micro-computed tomography severely decreased trabecular bone mass and deteriorated bone structure. Interestingly, PTH daily injections remarkably improved trabecular bone in the radiated tibiae with increases in trabecular number, thickness, connectivity, structure model index and stiffness, and a decrease in trabecular separation. Histomorphometric analysis revealed that radiation mainly decreased the number of osteoblasts and impaired their mineralization activity but had little effects on osteoclasts. PTH reversed these adverse effects and greatly increased bone formation to a similar level in both radiated and non-radiated bones. Furthermore, PTH protects bone marrow mesenchymal stem cells from radiation-induced damage, including a decrease in number and an increase in adipogenic differentiation. While radiation generated the same amount of free radicals in the bone marrow of vehicle-treated and PTH-treated animals, the percentage of apoptotic bone marrow cells was significantly attenuated in the PTH group. Taken together, our data demonstrate a radioprotective effect of PTH on bone structure and bone marrow and shed new light on a possible clinical application of anabolic treatment in radiotherapy. Copyright © 2013 Elsevier Inc. All rights reserved.

Kerato-lenticular ocular deposits and visual impairment with prolonged chlorpromazine use: A case series.

PubMed

Gowda, Guru S; Hegde, Aditya; Shanbhag, Vandita; Narayanaswamy, Janardhanan C; Jaisoorya, T S

2017-02-01

Chlorpromazine is a low potency "typical" antipsychotic agent used to treat schizophrenia. It continues to be prescribed frequently in India owing to its lower cost. There have been previous reports of ocular adverse effects with prolonged use of chlorpromazine. We report three patients who developed corneal and lenticular opacities secondary to prolonged chlorpromazine use leading to visual impairment. Early detection of ocular deposits and switching over to risperidone from chlorpromazine helped in the reversal of chlorpromazine- induced ocular side effects in one of them. The case series further adds evidence to the causative relationship between chlorpromazine and ocular side effects. Copyright © 2016 Elsevier B.V. All rights reserved.

[Neonatal bacterial infection by maternal-fetal contamination: for a change in approach? 1. Detection of Streptococcus agalactiae infection: methods and evaluation of results].

PubMed

Blond, M H; Gold, F; Pierre, F; Quentin, R; Aujard, Y

2001-10-01

Perinatal group B streptococcal infection has been the subject of numerous studies and despite guidelines established during the last decade remains a frequent disease with high mortality. The basic aim of the guidelines is to screen for Streptococcus agalactiae during the antepartum period in order to institute antibiotic therapy during delivery. A critical review of the literature highlights the real impact and adverse effect of these guidelines: difficult application (only two-thirds of all maternity units have a protocol and compliance is only 75%), maternal risks of antibiotic therapy (especially the emergence of resistant Gram negative bacteria), fetal risks (accentuation of neonatal sepsis with resistant strains, retarded neonatal infections, frequent use of antibiotics with a broader spectrum, higher frequency of nosocomial sepsis).

Immunotherapy for cow's milk allergy

PubMed Central

Takahashi, Masaya; Soejima, Kazukiko; Hatano, Yasuko; Minami, Hirotaka

2017-01-01

ABSTRACT Oral immunotherapy (OIT) is used regularly for young children with cow's milk (CM) allergy and has been shown to be effective in several studies. However, adverse events occur frequently during OIT. Furthermore, there are only 5 randomized controlled trial studies of CM-OIT and these are low-powered single center trials. Therefore, evidence levels are also low and sometimes frequent and severe allergic events occur during the OIT. Furthermore, there are no standardized protocols in pediatric allergy guidelines from several countries and studies with long-term follow-up observations and clinical tolerance defined as sustained unresponsiveness are rare. Additionally, clinical tolerance by OIT is generally not well defined and obscure. Thus, several problems remain to be resolved, however we hope OIT in combination with omalizumab and less allergenic heated CM products will resolve these problems in the future. PMID:28825866

Gabapentin for chronic neuropathic pain and fibromyalgia in adults

PubMed Central

Moore, R Andrew; Wiffen, Philip J; Derry, Sheena; McQuay, Henry J

2014-01-01

Background This review updates parts of two earlier Cochrane reviews investigating effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage pain, predominantly for chronic neuropathic pain, especially when the pain is lancinating or burning. Objectives To evaluate the analgesic effectiveness and adverse effects of gabapentin for chronic neuropathic pain management. Search methods We identified randomised trials of gabapentin in acute, chronic or cancer pain from MEDLINE, EMBASE, and CENTRAL. We obtained clinical trial reports and synopses of published and unpublished studies from Internet sources. The date of the most recent search was January 2011. Selection criteria Randomised, double-blind studies reporting the analgesic and adverse effects of gabapentin in neuropathic pain with assessment of pain intensity and/or pain relief, using validated scales. Participants were adults aged 18 and over. Data collection and analysis Two review authors independently extracted data. We calculated numbers needed to treat to benefit (NNTs), concentrating on IMM-PACT (Initiative on Methods, Measurement and Pain Assessment in Clinical Trials) definitions of at least moderate and substantial benefit, and to harm (NNH) for adverse effects and withdrawal. Meta-analysis was undertaken using a fixed-effect model. Main results Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of postherpetic neuralgia, painful diabetic neuropathy or mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7). These estimates of efficacy are more conservative than those reported in a previous review. Data from few studies and participants were available for other painful conditions. Adverse events occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo. There were insufficient data for comparisons with other active treatments. Authors’ conclusions Gabapentin provides pain relief of a high level in about a third of people who take if for painful neuropathic pain. Adverse events are frequent, but mostly tolerable. More conservative estimates of efficacy resulted from using better definitions of efficacy outcome at higher, clinically important, levels, combined with a considerable increase in the numbers of studies and participants available for analysis. PMID:21412914

Gabapentin for chronic neuropathic pain and fibromyalgia in adults.

PubMed

Moore, R Andrew; Wiffen, Philip J; Derry, Sheena; McQuay, Henry J

2011-03-16

This review updates parts of two earlier Cochrane reviews investigating effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage pain, predominantly for chronic neuropathic pain, especially when the pain is lancinating or burning. To evaluate the analgesic effectiveness and adverse effects of gabapentin for chronic neuropathic pain management. We identified randomised trials of gabapentin in acute, chronic or cancer pain from MEDLINE, EMBASE, and CENTRAL. We obtained clinical trial reports and synopses of published and unpublished studies from Internet sources. The date of the most recent search was January 2011. Randomised, double-blind studies reporting the analgesic and adverse effects of gabapentin in neuropathic pain with assessment of pain intensity and/or pain relief, using validated scales. Participants were adults aged 18 and over. Two review authors independently extracted data. We calculated numbers needed to treat to benefit (NNTs), concentrating on IMMPACT (Initiative on Methods, Measurement and Pain Assessment in Clinical Trials) definitions of at least moderate and substantial benefit, and to harm (NNH) for adverse effects and withdrawal. Meta-analysis was undertaken using a fixed-effect model. Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of postherpetic neuralgia, painful diabetic neuropathy or mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7). These estimates of efficacy are more conservative than those reported in a previous review. Data from few studies and participants were available for other painful conditions.Adverse events occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo.There were insufficient data for comparisons with other active treatments. Gabapentin provides pain relief of a high level in about a third of people who take if for painful neuropathic pain. Adverse events are frequent, but mostly tolerable. More conservative estimates of efficacy resulted from using better definitions of efficacy outcome at higher, clinically important, levels, combined with a considerable increase in the numbers of studies and participants available for analysis.

Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis

PubMed Central

Holtedahl, Robin; Brox, Jens Ivar; Tjomsland, Ole

2015-01-01

Objectives To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms. Design A systematic review and meta-analysis. Data sources and study selection We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. Data synthesis Effect sizes (ES) in the active and placebo arms in the trials’ primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered. Results We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R2 of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration. Conclusions The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated. PMID:25636794

Intermittent blood pressure control: potential consequences for outcome.

PubMed

Leenen, F H

1999-05-01

Although both blood pressure (BP) and left ventricular (LV) mass at initial evaluation predict future cardiovascular risk, the actual BP and LV mass achieved over years of treatment more clearly relate to cardiovascular event rates. Intermittent compliance or noncompliance is the major reason for uncontrolled hypertension and presumably persistent LV hypertrophy. In general, drugs with rapid onset and short duration of action are not desirable because this profile may lead to large variations in BP lowering effect during actual drug intake and rapid disappearance of the antihypertensive effect with missed doses. In addition, intermittent compliance per se introduces the potential for adverse events. For drugs requiring several dose-titrations (e.g., alpha1-blockers), restarting at full doses may lead to excessive drug action and symptomatic hypotension. For other drugs (e.g., short acting beta-blockers or clonidine-like drugs), sudden discontinuation with intermittent compliance may lead to rebound-enhanced sympathetic responsiveness after one to two days, resulting not only in side effects, but also in adverse events, particularly in patients with (silent) coronary artery disease. The rapid onset, short acting dihydropyridines cause intermittent BP control at each dosing, particularly at higher doses. This intermittent control of BP is even more apparent at dosing intervals that are long relative to the duration of action. Thus, sympathetic activation and potential for adverse events can be anticipated at each dosing unless these drugs are being taken frequently at relatively low doses. For diuretics, angiotensin-converting enzyme inhibitors and angiotensin I receptor blockers, no adverse effects have been identified with intermittent compliance. Intermittent BP control is, in general, not an appropriate approach to the management of hypertension and introduces additional risks depending on the type of antihypertensive drug. In contrast, drugs with slow onset and long duration of action provide a more consistent effect during actual drug intake and a more persistent effect during short periods of noncompliance.

Understanding older adults' medication decision making and behavior: A study on over-the-counter (OTC) anticholinergic medications.

PubMed

Holden, Richard J; Srinivas, Preethi; Campbell, Noll L; Clark, Daniel O; Bodke, Kunal S; Hong, Youngbok; Boustani, Malaz A; Ferguson, Denisha; Callahan, Christopher M

2018-03-06

Older adults purchase and use over-the-counter (OTC) medications with potentially significant adverse effects. Some OTC medications, such as those with anticholinergic effects, are relatively contraindicated for use by older adults due to evidence of impaired cognition and other adverse effects. To inform the design of future OTC medication safety interventions for older adults, this study investigated consumers' decision making and behavior related to OTC medication purchasing and use, with a focus on OTC anticholinergic medications. The study had a cross-sectional design with multiple methods. A total of 84 adults participated in qualitative research interviews (n = 24), in-store shopper observations (n = 39), and laboratory-based simulated OTC shopping tasks (n = 21). Simulated shopping participants also rank-ordered eight factors on their importance for OTC decision making. Findings revealed that many participants had concerns about medication adverse effects, generally, but were not aware of age-related risk associated with the use of anticholinergic medications. Analyses produced a map of the workflow of OTC-related behavior and decision making as well as related barriers such as difficulty locating medications or comparing them to an alternative. Participants reported effectiveness, adverse effects or health risks, and price as most important to their OTC medication purchase and use decisions. A persona analysis identified two types of consumers: the habit follower, who frequently purchased OTC medications and considered them safe; and the deliberator, who was more likely to weigh their options and consider alternatives to OTC medications. A conceptual model of OTC medication purchase and use is presented. Drawing on study findings and behavioral theories, the model depicts dual processes for OTC medication decision making - habit-based and deliberation-based - as well as the antecedents and consequences of decision making. This model suggests several design directions for consumer-oriented interventions to promote OTC medication safety. Copyright © 2018 Elsevier Inc. All rights reserved.

Phytomedicine in Joint Disorders

PubMed Central

Dragos, Dorin; Gilca, Marilena; Gaman, Laura; Vlad, Adelina; Iosif, Liviu; Stoian, Irina; Lupescu, Olivera

2017-01-01

Chronic joint inflammatory disorders such as osteoarthritis and rheumatoid arthritis have in common an upsurge of inflammation, and oxidative stress, resulting in progressive histological alterations and disabling symptoms. Currently used conventional medication (ranging from pain-killers to biological agents) is potent, but frequently associated with serious, even life-threatening side effects. Used for millennia in traditional herbalism, medicinal plants are a promising alternative, with lower rate of adverse events and efficiency frequently comparable with that of conventional drugs. Nevertheless, their mechanism of action is in many cases elusive and/or uncertain. Even though many of them have been proven effective in studies done in vitro or on animal models, there is a scarcity of human clinical evidence. The purpose of this review is to summarize the available scientific information on the following joint-friendly medicinal plants, which have been tested in human studies: Arnica montana, Boswellia spp., Curcuma spp., Equisetum arvense, Harpagophytum procumbens, Salix spp., Sesamum indicum, Symphytum officinalis, Zingiber officinalis, Panax notoginseng, and Whitania somnifera. PMID:28275210

[Hypogonadism, a serious complication of chronic renal insufficiency].

PubMed

Zofková, I; Bubenícek, P; Sotorník, I

2007-06-01

Hypogonadism is a frequent complication in patients with chronic renal insufficiency (CHRI). From a pathogenetic point of view, it is a disorder at the level of the hypothalamus caused by central inhibition of the pulsatile generation of gonadotropin releasing hormone (GnRH) and by a primary disorder of gonads. The cause of hypogonadism in dialysed patients is not completely known. The effect of inhibition of erythropoietin production is believed to be one of the factors, as well as the adverse effects of complicated therapeutic procedures and malnutrition. In men, the affection manifests itself as a disorder of sexual functions, inhibition ofspermatogenesis, premature andropause and severe fatigue syndrome. Menstruation disorders, premature menopause and anovulation cycles are frequent symptoms in dialysed women. Androgen or estrogen substitution improves the quality of life in both sexes and slows down the loss of bone mass. Complete remission of hypogonadism is obtained, in the majority of patients, by renal transplant. The overview study deals with the pathogenesis, diagnosis and treatment of hypogonadism in dialysed patients.

Cause-and-effect analysis of risk management files to assess patient care in the emergency department.

PubMed

White, Andrew A; Wright, Seth W; Blanco, Roberto; Lemonds, Brent; Sisco, Janice; Bledsoe, Sandy; Irwin, Cindy; Isenhour, Jennifer; Pichert, James W

2004-10-01

Identifying the etiologies of adverse outcomes is an important first step in improving patient safety and reducing malpractice risks. However, relatively little is known about the causes of emergency department-related adverse outcomes. The objective was to describe a method for identification of common causes of adverse outcomes in an emergency department. This methodology potentially can suggest ways to improve care and might provide a model for identification of factors associated with adverse outcomes. This was a retrospective analysis of 74 consecutive files opened by a malpractice insurer between 1995 and 2000. Each risk-management file was analyzed to identify potential causes of adverse outcomes. The main outcomes were rater-assigned codes for alleged problems with care (e.g., failures of communication or problems related to diagnosis). About 50% of cases were related to injuries or abdominal complaints. A contributing cause was found in 92% of cases, and most had more than one contributing cause. The most frequent contributing categories included failure to diagnose (45%), supervision problems (31%), communication problems (30%), patient behavior (24%), administrative problems (20%), and documentation (20%). Specific relating factors within these categories, such as lack of timely resident supervision and failure to follow policies and procedures, were identified. This project documented that an aggregate analysis of risk-management files has the potential to identify shared causes related to real or perceived adverse outcomes. Several potentially correctable systems problems were identified using this methodology. These simple, descriptive management tools may be useful in identifying issues for problem solving and can be easily learned by physicians and managers.

Zoledronic acid in pediatric metabolic bone disorders

PubMed Central

Mahan, John D.

2017-01-01

Zoledronic acid (ZA), a highly potent intravenous bisphosphonate (BP), has been increasingly used in children with primary and secondary osteoporosis due to its convenience of shorter infusion time and less frequent dosing compared to pamidronate. Many studies have also demonstrated beneficial effects of ZA in other conditions such as hypercalcemia of malignancy, fibrous dysplasia (FD), chemotherapy-related osteonecrosis (ON) and metastatic bone disease. This review summarizes pharmacologic properties, mechanism of action, dosing regimen, and therapeutic outcomes of ZA in a variety of metabolic bone disorders in children. Several potential novel uses of ZA are also discussed. Safety concerns and adverse effects are also highlighted. PMID:29184807

Serious gaming: A tool to educate health care providers about domestic violence.

PubMed

Mason, Robin; Turner, Linda

2018-05-10

Due to many adverse health effects, victims of domestic violence are frequently seen in the health care system. Yet, health care providers may lack the training to assist them. Online curricula can be an effective instructional tool. Our competency-based, serious video game, Responding to Domestic Violence in Clinical Settings, was designed to address health care providers' knowledge gaps through 17 modules, each a half hour in length. Nearly 9,000 participants completed at least one module; nursing students completed the most modules, approximately five hours of instruction. This serious video game-based curriculum is useful in helping health providers and students learn about Domestic Violence.

Synthetic Cannabis Overdose and Withdrawal in a Young Adult: A Case Report, Commentary on Regulation, and Review of the Literature.

PubMed

Samaan, John; Ferrer, Gerardo F; Akinyemi, Boye; Junquera, Patricia; Oms, Juan; Dumenigo, Rhaisa

2016-01-01

Introduction . Marijuana has been used for its psychotropic effects including enhanced relaxation and perceptual alterations. However, the use of synthetic marijuana (SM) leads to more frequent and drastic side effects than the typical use of regular marijuana, owing to the fact that SM has a shorter duration and an earlier peak of action. Despite all the potential adverse health effects associated with SM use, current health policies on SM are very limited. It is believed that the popularity of SM has increased, due to its easy accessibility in the US and lack of detection in typical urine drug screens for THC. Case Report . One case presented is of a young adult patient, with histories of recurrent synthetic cannabis and recreational cannabis use, who had developed drastic physiological and psychiatric symptoms, including the development of acute-onset psychosis. Conclusion/Discussion . This case, as many others nationwide, exemplifies the impact of synthetic cannabinoid use and abuse in adolescents. Side effects and adverse health consequences of synthetic cannabinoid use warrant stricter regulations and policies in order to decrease psychiatric hospital admissions and associated healthcare costs.

Oral amiodarone: historical overview and development.

PubMed

Pollak, P T

1998-01-01

To review the historical development of amiodarone and the changing perceptions of the drug, and discuss its electrophysiologic, pharmacologic, and pharmacokinetic properties. Review of relevant literature. In the 1970s and 1980s a plethora of new antiarrhythmic agents, including amiodarone, was introduced. Amiodarone is predominately a class III antiarrhythmic, but also possesses class I, II, and IV effects. By 1977 it was described as the ideal antiarrhythmic agent. However, clinicians underestimated potential difficulties caused by misunderstanding its variable absorption, slow initial response at nonloading dosages, and extended half-life. Elevated dosages also produced frequent adverse effects. Thus, early enthusiasm for the drug's efficacy was gradually replaced by a focus on its toxicity. The 1990s witnessed reacceptance of the agent as more logical initial regimens and lower maintenance dosages decreased adverse effects, and amiodarone emerged as one of the few drugs effective in suppressing and preventing arrhythmias that does not increase mortality. Remaining challenges include delineation of an optimal oral regimen, identification of markers useful in clinical monitoring, and elucidation of the relationship between dose-tissue concentration and response and dose-toxicity associations. Amiodarone is an increasingly valuable component of today's antiarrhythmic therapy.

Cutaneous Adverse Effects of Neurologic Medications.

PubMed

Bahrani, Eman; Nunneley, Chloe E; Hsu, Sylvia; Kass, Joseph S

2016-03-01

Life-threatening and benign drug reactions occur frequently in the skin, affecting 8 % of the general population and 2-3 % of all hospitalized patients, emphasizing the need for physicians to effectively recognize and manage patients with drug-induced eruptions. Neurologic medications represent a vast array of drug classes with cutaneous side effects. Approximately 7 % of the United States (US) adult population is affected by adult-onset neurological disorders, reflecting a large number of patients on neurologic drug therapies. This review elucidates the cutaneous reactions associated with medications approved by the US Food and Drug Administration (FDA) to treat the following neurologic pathologies: Alzheimer disease, amyotrophic lateral sclerosis, epilepsy, Huntington disease, migraine, multiple sclerosis, Parkinson disease, and pseudobulbar affect. A search of the literature was performed using the specific FDA-approved drug or drug classes in combination with the terms 'dermatologic,' 'cutaneous,' 'skin,' or 'rash.' Both PubMed and the Cochrane Database of Systematic Reviews were utilized, with side effects ranging from those cited in randomized controlled trials to case reports. It behooves neurologists, dermatologists, and primary care physicians to be aware of the recorded cutaneous adverse reactions and their severity for proper management and potential need to withdraw the offending medication.

Circadian Desynchrony Promotes Metabolic Disruption in a Mouse Model of Shiftwork

PubMed Central

Barclay, Johanna L.; Husse, Jana; Bode, Brid; Naujokat, Nadine; Meyer-Kovac, Judit; Schmid, Sebastian M.; Lehnert, Hendrik; Oster, Henrik

2012-01-01

Shiftwork is associated with adverse metabolic pathophysiology, and the rising incidence of shiftwork in modern societies is thought to contribute to the worldwide increase in obesity and metabolic syndrome. The underlying mechanisms are largely unknown, but may involve direct physiological effects of nocturnal light exposure, or indirect consequences of perturbed endogenous circadian clocks. This study employs a two-week paradigm in mice to model the early molecular and physiological effects of shiftwork. Two weeks of timed sleep restriction has moderate effects on diurnal activity patterns, feeding behavior, and clock gene regulation in the circadian pacemaker of the suprachiasmatic nucleus. In contrast, microarray analyses reveal global disruption of diurnal liver transcriptome rhythms, enriched for pathways involved in glucose and lipid metabolism and correlating with first indications of altered metabolism. Although altered food timing itself is not sufficient to provoke these effects, stabilizing peripheral clocks by timed food access can restore molecular rhythms and metabolic function under sleep restriction conditions. This study suggests that peripheral circadian desynchrony marks an early event in the metabolic disruption associated with chronic shiftwork. Thus, strengthening the peripheral circadian system by minimizing food intake during night shifts may counteract the adverse physiological consequences frequently observed in human shift workers. PMID:22629359

The impact of altitude on hospitalization and hospital mortality from pandemic 2009 influenza A (H1N1) virus pneumonia in Mexico.

PubMed

Pérez-Padilla, Rogelio; García-Sancho, Cecilia; Fernández, Rosario; Franco-Marina, Francisco; López-Gatell, Hugo; Bojórquez, Ietza

2013-01-01

To determine the effect of altitude of residence on influenza A (H1N1). We analyzed 207 135 officially notified of influenza-like illness (ILI) cases, 23 048 hospitalizations and 573 deaths during the first months of the novel pandemic influenza A H1N1 virus, to examine if residents of high altitude had more frequently these adverse outcomes. Adjusted rates for hospitalization and hospital mortality rates increased with altitude, probably due to hypoxemia.

[Constitutional syndrome associated to metformin induced hepatotoxicity].

PubMed

de la Poza Gómez, Gema; Rivero Fernández, Miguel; Vázquez Romero, Manuel; Angueira Lapeña, Teresa; Arranz de la Mata, Gemma; Boixeda de Miquel, Daniel

2008-12-01

Metformin is an oral antidiabetic agent frequently used to manage type II diabetes. This drug produces nonspecific gastrointestinal symptoms in 5-20% of patients and, more rarely, has also been associated with severe adverse effects such as lactic acidosis. Only a few isolated cases of hepatotoxicity due to this drug have been documented. We report the case of an 83-year-old man with constitutional syndrome and hepatic biochemical alterations, which were attributed to metformin after ruling out an oncologic etiology and observing complete clinical and biochemical resolution after withdrawal of the drug.

Induction therapy with linezolid/clarithromycin combination for Mycobacterium chelonae skin infections in immunocompromised hosts.

PubMed

Parize, P; Hamelin, A; Veziris, N; Morand, P C; Guillemain, R; Lortholary, O; Dupin, N

2016-01-01

The optimal management of Mycobacterium chelonae disease in immunocompromised patients remains unclear. A combination of antimicrobial agents is recommended as monotherapy with clarithromycin has been associated with clinical failures due to acquired resistance. We aim to report the efficacy and tolerability of linezolid in association with clarithromycin for the treatment of M. chelonae infections in immunocompromised patients. We describe four immunocompromised patients treated by linezolid and clarithromycin for cutaneous M. chelonae disease. This combination was associated with rapid clinical efficacy in all patients with no relapse observed after a median follow-up of 2.25 years (1.4 years). However, this treatment was responsible for frequent adverse events including thrombocytopaenia, myalgia and mitochondrial toxicity. All adverse effects were reversible after linezolid discontinuation. We therefore suggest linezolid/clarithromycin combination as the initial therapeutic strategy for M. chelonae skin infections in immunocompromised patients. © 2015 European Academy of Dermatology and Venereology.

Transfusion-Associated Circulatory Overload: Evidence-Based Strategies to Prevent, Identify, and Manage a Serious Adverse Event.

PubMed

Henneman, Elizabeth A; Andrzejewski, Chester; Gawlinski, Anna; McAfee, Kelley; Panaccione, Thomas; Dziel, Kimberly

2017-10-01

Transfusion-associated circulatory overload (TACO) is a potentially life-threatening complication of blood transfusion and is associated with increased morbidity, length of stay (hospital and intensive care unit), and hospital costs. Bedside nurses play a key role in the prevention, identification, and reporting of this complication. A common misperception is that the most frequently encountered serious adverse event during transfusion is a hemolytic reaction in a patient who receives ABO-incompatible blood. In fact, the incidence of TACO-related fatalities is higher than fatalities caused by ABO-related hemolytic reactions. Surveillance and evidence-based strategies such as clinical decision support systems have the potential to reduce the incidence of TACO and mitigate its effects. Practical suggestions for conducting bedside transfusion surveillance and future directions for improving transfusion care are presented. ©2017 American Association of Critical-Care Nurses.

Systemic vasculitis associated with vemurafenib treatment: Case report and literature review.

PubMed

Mirouse, Adrien; Savey, Léa; Domont, Fanny; Comarmond, Cloé; Barete, Stéphane; Plaisier, Emmanuelle; Rouvier, Philippe; Cacoub, Patrice; Saadoun, David

2016-11-01

Vemurafenib, an inhibitor of mutated B-rapidly accelerated fibrosarcoma, is frequently used in the treatment of melanoma and Erdheim-Chester disease (ECD) patients. Inflammatory adverse effects have been increasingly reported after vemurafenib treatment. We report 6 cases of vemurafenib-associated vasculitis, of whom a personal case of a 75-year-old man with history of ECD who developed purpura and rapidly progressive pauci-immune glomerulonephritis during treatment with vemurafenib. In the 5 others cases from the literature, all patients presented skin vasculitis, and with joint involvement in 60% of them. Vemurafenib treatment was stopped (n = 3), continued at reduced doses (n = 1), or continued at the same dose (n = 2). Three patients (50%) received corticosteroids combined with cyclophosphamide (n = 1), and all achieved remission of vasculitis. One patient experienced vasculitis relapse after vemurafenib therapy was restarted. Systemic vasculitis is a rare vemurafenib-associated adverse event that may be life-threatening.

Analysis of contributing factors associated to related patients safety incidents in Intensive Care Medicine.

PubMed

Martín Delgado, M C; Merino de Cos, P; Sirgo Rodríguez, G; Álvarez Rodríguez, J; Gutiérrez Cía, I; Obón Azuara, B; Alonso Ovies, Á

2015-01-01

To explore contributing factors (CF) associated to related critical patients safety incidents. SYREC study pos hoc analysis. A total of 79 Intensive Care Departments were involved. The study sample consisted of 1.017 patients; 591 were affected by one or more incidents. The CF were categorized according to a proposed model by the National Patient Safety Agency from United Kingdom that was modified. Type, class and severity of the incidents was analyzed. A total 2,965 CF were reported (1,729 were associated to near miss and 1,236 to adverse events). The CF group more frequently reported were related patients factors. Individual factors were reported more frequently in near miss and task related CF in adverse events. CF were reported in all classes of incidents. The majority of CF were reported in the incidents classified such as less serious, even thought CF patients factors were associated to serious incidents. Individual factors were considered like avoidable and patients factors as unavoidable. The CF group more frequently reported were patient factors and was associated to more severe and unavoidable incidents. By contrast, individual factors were associated to less severe and avoidable incidents. In general, CF most frequently reported were associated to near miss. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Cross-informant agreement about bullying and victimization among eight-year-olds: whose information best predicts psychiatric caseness 10-15 years later?

PubMed

Rønning, John A; Sourander, Andre; Kumpulainen, Kirsti; Tamminen, Tuula; Niemelä, Solja; Moilanen, Irma; Helenius, Hans; Piha, Jorma; Almqvist, Fredrik

2009-01-01

To examine cross-informant agreement and whose information (parents, teachers, children) about childhood bullying and victimization carry the strongest weight to late adolescent psychiatric outcome. The importance of frequency of bullying in such predictions is addressed. Information from 2,713 boys about bullying and victimization at the age of eight was correlated with information about psychiatric disorder at 18-23. Agreement between informants was poor. Teachers reported higher levels of frequent bullying than others, whereas children reported the highest percentage of victimization. All three informant groups' reports of "frequent bullying" predicted later psychiatric disorder. Teachers' reports of "frequent victimization" was the strongest predictor of later psychiatric disorder. Informants' report about "infrequent bullying" showed at most a rather low risk of adverse outcome. When the associations between bullying/victimization and psychiatric outcome were adjusted with total psychopathology score at age 8, none of the associations remained significant. "Frequent bullying" behaviour of boys is a marker of present and later psychopathology. The education system and school health-care service in mid- childhood are of great importance for the early detection of bullying and prevention of later adverse outcomes. A closer integration of these systems in the context of school should be promoted.

Vaccine hypersensitivity--update and overview.

PubMed

Fritsche, Philipp J; Helbling, Arthur; Ballmer-Weber, Barbara K

2010-05-01

Concerns about possible reactions to vaccines or vaccinations are frequently raised. However, the rate of reported vaccine-induced adverse events is low and ranges between 4.8-83.0 per 100,000 doses of the most frequently used vaccines. The number of true allergic reactions to routine vaccines is not known; estimations range from 1 per 500,000 to 1 per 1,000,000 doses for most vaccines. When allergens such as gelatine or egg proteins are components of the formulation, the rate for serious allergic reactions may be higher. Nevertheless, anaphylactic, potentially life-threatening reactions to vaccines are still a rare event (approximately 1 per 1,500,000 doses). The variety of reported vaccine-related adverse events is broad. Most frequently, reactions to vaccines are limited to the injection site and result from a non specific activation of the inflammatory system by, for example, aluminium salts or the active microbial components. If allergy is suspected, an accurate examination followed by algorithms is the key for correct diagnosis, treatment and the decision regarding revaccination in patients with immediate-type reactions to vaccines.

The Association between Psychiatric Comorbidities and Outcomes for Inpatients with Traumatic Brain Injury.

PubMed

Brandel, Michael G; Hirshman, Brian R; McCutcheon, Brandon A; Tringale, Kathryn; Carroll, Kate; Richtand, Neil M; Perry, William; Chen, Clark C; Carter, Bob S

2017-03-01

It is well established that traumatic brain injury (TBI) is associated with the development of psychiatric disorders. However, the impact of psychiatric disorders on TBI outcome is less well understood. We examined the outcomes of patients who experienced a traumatic subdural hemorrhage and whether a comorbid psychiatric disorder was associated with a change in outcome. A retrospective observational study was performed in the California Office of Statewide Health Planning and Development (OSHPD) and the Nationwide Inpatient Sample (NIS). Patients hospitalized for acute subdural hemorrhage were identified using International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes. Patients with coexisting psychiatric diagnoses were identified. Outcomes studied included mortality and adverse discharge disposition. In OSPHD, diagnoses of depression (OR = 0.64, p < 0.001), bipolar disorder (OR = 0.45, p < 0.05), and anxiety (OR = 0.37, p < 0.001) were associated with reduced mortality during hospitalization for TBI, with a trend toward psychosis (OR = 0.56, p = 0.08). Schizophrenia had no effect. Diagnoses of psychosis (OR = 2.12, p < 0.001) and schizophrenia (OR = 2.60, p < 0.001) were associated with increased adverse discharge. Depression and bipolar disorder had no effect, and anxiety was associated with reduced adverse discharge (OR = 0.73, p = 0.01). Results were confirmed using the NIS. Analysis revealed novel associations between coexisting psychiatric diagnoses and TBI outcomes, with some subgroups having decreased mortality and increased adverse discharge. Potential mechanisms include pharmacological effects of frequently prescribed psychiatric medications, the pathophysiology of individual psychiatric disorders, or under-coding of psychiatric illness in the most severely injured patients. Because pharmacological mechanisms, if validated, might lead to improved outcome in TBI patients, further studies may provide significant public health benefit.

Postmarketing comparison of labetalol and propranolol in hypertensive patients.

PubMed

Due, D L; Giguere, G C; Plachetka, J R

1986-01-01

A survey was conducted to compare the safety and effectiveness of labetalol and propranolol under routine conditions of clinical use. Patients received either labetalol (n = 805) or propranolol (n = 135) twice daily, according to package insert instructions, for six weeks. Every two weeks the patients were evaluated and weight, heart rate, blood pressure, dose, and adverse symptoms were recorded. Both treatment groups experienced a significant decline in blood pressure at six weeks; blood pressure decreased by 24/15 mmHg in the labetalol patients and by 20/14 mmHg in the propranolol patients. Heart rate decreased significantly in both groups, but the drop in the propranolol group was greater than in the labetalol group. Significantly more propranolol-treated patients reported fatigue (15.2% versus 6.3%), impotence (9.0% versus 3.2%), bad dreams (2.3% versus 0.3%), and cold extremities (2.3% versus 0%). Dizziness was reported more frequently by the labetalol group (9.1% versus 3.8%). Overall, both drugs were safe and effective in treating hypertension, but complaints of beta-blocker-associated side effects were more frequent with propranolol.

[Current treatment strategy in malignant pleural effusion].

PubMed

Türler, A; Walter, M; Schmitz-Rixen, T

1996-01-01

Malignant pleural effusions are a grave consequence of advanced cancer disease. The successful suppression of pleural fluid reaccumulation can make a major contribution to the management and palliative care of patients with disseminated cancer. Many treatment concepts have been reported in the literature. The recommended therapy in malignant pleural effusions consists of intrapleural instillation of a sclerotic agent to produce pleurodesis. Different substances have been used, including tetracyclines, cytostatic agents, fibrin, talc, Corynebacterium parvum, cytokines and others. We reviewed the most frequently used techniques of pleurodesis in order to define the most effective treatment concept. In 15 prospective randomized trials the success rates varied from 13% with bleomycin to 100% with talc or Corynebacterium parvum. Talc was superior to other agents in 6 of 6, Corynebacterium parvum in 3 of 4 and bleomycin or tetracycline only in 3 of 8 studies. Adverse effects were frequently observed with cytostatic agents, but were very rare in the case of talc or fibrin instillation. Comparing the recently published data pleurodesis with talc appears to be the most effective treatment strategy, followed by Corynebacterium parvum, bleomycin and tetracycline.

Acupuncture Therapy for the Treatment of Myelosuppression after Chemotherapy: A Literature Review over the Past 10 Years.

PubMed

Fu, Hongwei; Chen, Bo; Hong, Shouhai; Guo, Yi

2015-06-01

The aim of this study is to review current studies on the effect of acupuncture therapy on bone marrow suppression after chemotherapy. The authors of the present paper have searched related literature over the past 10 years at home and abroad, analyzing the features and the effects of acupuncture therapy (including acupuncture, moxibustion, point injection, point application, etc.) for treating myelosuppression after tumor chemotherapy. We also discuss the year of publication, document type, acupuncture therapy, acupoint selection, and adverse effects with figures. We analyzed 159 articles related to acupuncture therapy from 2004 to 2013, and the analysis revealed that point injection was the most frequently used therapy for clinical applications, and that Zusanli (ST36) was the most frequently used acupoint. The results showed that some problems regarding the design method, acupoint selection, and acupuncture intervention measure existed in those research studies. We hope to provide readers with an overall and objective understanding of acupuncture and moxibustion therapy for treating myelosuppression after tumor chemotherapy. Copyright © 2015. Published by Elsevier B.V.

[Regional Study of Patient Safety Incidents (ERIDA) in the Emergency Services].

PubMed

Alcaraz-Martínez, J; Aranaz-Andrés, J M; Martínez-Ros, C; Moreno-Reina, S; Escobar-Álvaro, L; Ortega-Liarte, J V

2016-01-01

Evaluate the patient safety incidents that occur in the emergency departments of our region. Observational study conducted in all the hospital emergency departments in the Regional Health Service of Murcia. After systematic random sampling, data were collected during care and a week later by telephone survey. Health professionals of each service were trained and collected the information, following the methodology of the National Study of Adverse Events Related to Hospitalization -ENEAS- and the Adverse Events Related to Spanish Hospital Emergency Department Care -EVADUR-. A total of 393 samples were collected, proportional to the cases treated in each hospital. In 10 cases (3.1%) the complaint was a previous safety incident. At least one incident was detected in 47 patients (11.95%; 8.7 to 15.1%). In 3 cases there were 2 incidents, bringing the number of incidents to 50. Regarding the impact, the 51% of incidents caused harm to the patients. The effects more frequent in patients were the need for repeat visits (9 cases), and mismanagement of pain (8 cases). In 24 cases (51.1%) health care was not affected, although 3 cases required an additional test, 11 cases required further consultation, and led to hospitalisation in 2 cases. The most frequent causal factors of these incidents were medication (14) and care (12). The incidents were considered preventable in 60% of cases. A rate of incidents in the emergency departments, representative of the region, has been obtained. The implications of the results for the population means that 12 out of every 100 patients treated in emergency departments have an adverse event, and 7 of these are avoidable. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Meta-analysis of the Efficacy and Safety of Latanoprost Monotherapy in Patients With Angle-closure Glaucoma.

PubMed

Chen, Ru; Yang, Ke; Zheng, Zhong; Ong, Moh-Lim; Wang, Ning-Li; Zhan, Si-Yan

2016-03-01

To systematically evaluate the safety and efficacy of latanoprost monotherapy for the treatment of patients with angle-closure glaucoma. We searched EMBASE, Medline, Cochrane Library, Chinese Journal Full-text Database (CNKI), Chinese Science and Technology Periodical Database (VIP), and Wang Fang using the search terms "latanoprost" (or its commercial name, Xalatan) and "angle-closure glaucoma." Resulting articles were then screened using preset inclusion criteria. Subgroup and sensitivity analyses were performed to evaluate the impact of research population, research type (blinded or controlled), and withdrawal/loss to follow-up. A total of 17 studies (n=807) were included in this meta-analysis. The primary outcome measure was intraocular pressure (IOP). Changes in the mean, peak, and trough IOP from baseline were used as effect measures. As I statistic revealed statistical heterogeneity, the random-effects model was applied. With the exception of 2 non-Asian populations from Australia and Peru, all 13 countries included in this study were from Asia. Latanoprost reduced mean IOP by 7.9 mm Hg (32.4%), peak IOP by 7.4 mm Hg (29.8%), and trough IOP by 7.9 mm Hg (32.5%). The most frequent ocular adverse effects were ocular hyperemia, discomfort (including eye irritation, ocular discomfort, foreign body sensation, and itching), and blurred vision with a total incidence rate of 9.4%, 8.7%, and 5.2%, respectively. Systemic adverse effects encompass rhinitis, dizziness, headache, and nonspecific skin pigmentation. Latanoprost is effective at reducing the IOP of patients with angle-closure glaucoma. Adverse reactions associated with latanoprost were mainly ocular in nature.

Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

PubMed

Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

2017-10-01

Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation.

PubMed

Smith-Merry, Jennifer; Caple, Andrew

2014-03-01

Adverse events in mental health care occur frequently and cause significant distress for those who experience them, derailing treatment and sometimes leading to death. These events are clustered around particular aspects of care and treatment and are therefore avoidable if practices in these areas are strengthened. The research reported in this article takes as its starting point coronial recommendations made in relation to mental health. We report on those points and processes in treatment and discharge where coronial recommendations are most frequently made. We then examine the legislative requirements around these points and processes in three Australian States. We find that the key areas that need to be strengthened to avoid adverse events are assessment processes, communication and information transfer, documentation, planning and training. We make recommendations for improvements in these key areas.

Guillain–Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States

PubMed Central

Ojha, Rohit P; Jackson, Bradford E; Tota, Joseph E; Offutt-Powell, Tabatha N; Singh, Karan P; Bae, Sejong

2014-01-01

Post-marketing surveillance studies provide conflicting evidence about whether Guillain–Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain–Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain–Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR ≥2, and Χ2 ≥ 4. Guillain–Barre syndrome was listed as an adverse event in 45 of 14 822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain–Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination. PMID:24013368

Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States.

PubMed

Ojha, Rohit P; Jackson, Bradford E; Tota, Joseph E; Offutt-Powell, Tabatha N; Singh, Karan P; Bae, Sejong

2014-01-01

Post-marketing surveillance studies provide conflicting evidence about whether Guillain-Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain-Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR≥2, and Χ2≥4. Guillain-Barre syndrome was listed as an adverse event in 45 of 14,822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination.

A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery.

PubMed

Berdah, Stéphane V; Mariette, Christophe; Denet, Christine; Panis, Yves; Laurent, Christophe; Cotte, Eddy; Huten, Nöel; Le Peillet Feuillet, Eliane; Duron, Jean-Jacques

2014-10-27

Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures. This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test. Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%). This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection. ClinicalTrials.gov NCT00813397. Registered 19 December 2008.

[Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward].

PubMed

Tribiño, Gabriel; Maldonado, Carlos; Segura, Omar; Díaz, Jorge

2006-03-01

Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. Intensive follow-ups for a cohort of patients were conducted for a five month period in order to detect ADRs; different ways to classify them, according to literature, were considered as well. Information was collected using the INVIMA reporting format, and causal probability was evaluated with the Naranjo algorithm. Direct costs were calculated from the perspective of payer, based on the following costs: additional hospital stay, medications, paraclinical tests, additional procedures, patient displacement to intermediate or intensive care units, and other costs. Of 836 patients admitted to the service, 268 adverse drug reactions were detected in 208 patients (incidence proportion 25.1%, occurence rate 0.32). About the ADRs found, 74.3% were classified as probable, 92.5% were type A, and 81.3% were moderate. The body system most often affected was the circulatory system (33.9%). Drugs acting on the blood were most frequently those ones associated with adverse reactions (37.6%). The costs resulting from medical care of adverse drug reactions varied from COL dollar 93,633,422 (USD dollar 35,014.92) to COL dollar 122,155,406 (USD dollar 45,680.94), according to insurance type, during the study period. Adverse drug reactions have a significant negative health and financial impact on patient welfare. Because of the substantial resources required for their medical care and the significant proportion of preventable adverse reactions, active programs of institutional pharmacovigilance are highly recommended.

A study of side-effects of Pandemrix® influenza (H1N1) vaccine on board a Norwegian naval vessel.

PubMed

Munch, Johan Storm; Johnsen, Bjørn Helge; Birkeland, Ingelin; Finne, Morten; Utkilen, Torun; Bøe, Tommy; Mjølhus, Gry; Sommerfelt-Pettersen, Jan

2010-01-01

The frigate His Norwegian Majesty's ship (HNoMS) Fridtjof Nansen was participating in operations in the Gulf of Aden in support of the EU mission tasked with protecting vessels from the threat of piracy. The crew was therefore prioritized and given the first batch of Influenza A (H1N1) vaccine (Pandemrix(®)). To investigate the type, frequency, and intensity of side effects after whole-crew vaccination with Pandemrix vaccine in healthy subjects in a controlled environment. A hundred and thirty-three members of the crew were vaccinated, and then they participated in the study. The side effects of the vaccination were evaluated through a survey. Seventy-five per cent of the vaccinated sailors reported adverse reactions to the vaccine, with 9% not being able to perform their daily duties for one day. Muscle pain, headaches, malaise, and fatigue were the most frequent symptoms reported. The vaccination program using Pandemrix H1N1 vaccine resulted in a high rate of side effects, which were generally mild and resolved within a few days. No serious lasting side effects of the vaccination were reported or registered. The adverse effects of the vaccination did not affect the operational capacity of the vessel.

Comparison of cefuroxime axetil and phenoxymethyl penicillin for the treatment of children with solitary erythema migrans.

PubMed

Arnez, M; Radsel-Medvescek, A; Pleterski-Rigler, D; Ruzić-Sabljić, E; Strle, F

1999-12-10

To compare the clinical efficacy and drug-related adverse effects of 14 days of treatment with cefuroxime axetil 30 mg/kg/day or phenoxymethyl penicillin 100,000 IU/kg/day in the treatment of children with erythema migrans. Consecutive patients younger than 15 years, referred to our institution in 1996 with solitary erythema migrans and without prior antibiotic therapy, were included in this prospective study. Basic demographic features and clinical data were collected by questionnaire. The efficacy of the treatment of acute disease, development of major and/or minor manifestations of Lyme borreliosis and drug-related adverse effects were surveyed at follow-up visits during the first year after the initiation of antibiotic treatment. Forty-six patients received cefuroxime axetil (group C) and 44, phenoxymethyl penicillin (group P). The two groups differed in terms of age (patients in group C were younger), but no other differences in demographic and clinical pre-treatment characteristics were present. The clinical course during the post-treatment period revealed no significant differences between the two groups: the duration of erythema migrans (7.1 +/- 7.5 days in group C, 10.6 +/- 19.3 days in group P) and the appearance of minor manifestations of Lyme borreliosis (8.8% in group C, 9.1% in group P) were comparable; no major manifestations were recorded. Twelve months after antibiotic treatment all patients were free of symptoms. The patients treated with cefuroxime axetil had more drug-related adverse effects than did those treated with phenoxymethyl penicillin (26.1% versus 6.8%, p = 0.0301). "Herxheimer's reaction" at the beginning of treatment was identified more often in group C than in group P, but the difference was not statistically significant. Cefuroxime axetil and phenoxymethyl penicillin are equally effective in the treatment of children with solitary erythema migrans; however drug-related adverse effects were more frequently observed with cefuroxime axetil.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

PubMed

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

Adverse drug events related to mood and emotion in paediatric patients treated for ADHD: A meta-analysis.

PubMed

Pozzi, Marco; Carnovale, Carla; Peeters, Gabriëlla G A M; Gentili, Marta; Antoniazzi, Stefania; Radice, Sonia; Clementi, Emilio; Nobile, Maria

2018-05-22

ADHD is frequently comorbid with anxiety and mood disorders, which may increase the severity of inattention and hyperactivity symptoms. Emotional symptoms (anxiety, irritability, mood lability) also affect patients without comorbidity or emerge as adverse drug events. The influence of ADHD drugs on emotional symptoms demands investigation to improve therapies. Systematic review of trials reporting adverse events in patients pharmacologically treated for ADHD. Meta-analysis of the occurrence of irritability, anxiety, apathy, reduced talk, sadness, crying, emotional lability, biting nails, staring, perseveration, euphoria. Meta-regression analysis. Forty-five trials were meta-analysed. The most frequently reported outcomes were irritability, anxiety, sadness, and apathy. Methylphenidates, especially immediate-release formulations, were most studied; amphetamines were half as studied and were predominantly mixed amphetamine salts. Reports on atomoxetine were scant. Meta-analysis showed that methylphenidates reduced the risk of irritability, anxiety, euphoria, whereas they worsened the risk of apathy and reduced talk; amphetamines worsened the risk of emotional lability. Factors influencing risks were study year and design, patients' sex and age, drug dose and release formulation. Possible discrepancy between adverse events as indicated in clinical trials and as summarised herein. Confounding due to the aggregation of drugs into groups; uninvestigated sources of bias; incomplete lists of adverse events; lack of observations on self-injury. Methylphenidates appeared safer than amphetamines, although younger patients and females may incur higher risks, especially with high-dose, immediate-release methylphenidates. Only atomoxetine holds a black-box warning, but amphetamines and methylphenidates also did not show a safe profile regarding mood and emotional symptoms. Copyright © 2018. Published by Elsevier B.V.

Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine.

PubMed

Zaccara, Gaetano; Giovannelli, Fabio; Maratea, Dario; Fadda, Valeria; Verrotti, Alberto

2013-09-01

Analysis of overall tolerability and neurological adverse effects (AEs) of eslicarbazepine acetate (ESL), lacosamide (LCM) and oxcarbazepine (OXC) from double-blind, placebo-controlled trials. Indirect comparisons of patients withdrawing because of AEs, and the incidence of some vestibulocerebellar AEs between these three antiepileptic dugs (AEDs). We searched MEDLINE for all randomized, double-blind, placebo-controlled trials investigating therapeutic effects of fixed oral doses of ESL, LCM and OXC in patients with drug resistant epilepsy. Withdrawal rate due to AEs, percentages of patients with serious AEs, and the proportion of patients experiencing any neurological AE, nausea and vomiting were assessed for their association with the experimental drug. Analyses were performed between recommended daily doses of each AED according to the approved summary of product characteristics (SPC). Risk differences were used to evaluate the association of any AE [99% confidence intervals (CIs)] or study withdrawals because of AEs (95% CIs) with the experimental drug. Indirect comparisons between withdrawal rate and AEs dizziness, coordination abnormal/ataxia and diplopia were estimated according to network meta-analysis (Net-MA). Eight randomized, placebo-controlled, double-blind trials (4 with ESL, 3 with LCM, and 1 with OXC) were included in our analysis. At high doses (OXC 1200mg, ESL 1200mg and LCM 400mg) there was an increased risk of AE-related study withdrawals compared to placebo for all drugs. Several AEs were associated with the experimental drug. Both number and frequency of AEs were dose-related. At high recommended doses, patients treated with OXC withdrew from the experimental treatment significantly more frequently than patients treated with ESL and LCM. Furthermore, the AEs coordination abnormal/ataxia and diplopia were significantly more frequently observed in patients treated with OXC compared to patients treated with LCM and ESL. The overall tolerability of AEDs and the incidence of several neurological AEs were clearly dose-dependent. Indirect comparisons between these AEDs, taking into account dose-effect, showed that OXC may be associated with more frequent neurological AEs than LCM and ESL. Copyright © 2013 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events.

PubMed

Haller, Christine A; Anderson, Ilene B; Kim, Susan Y; Blanc, Paul D

2002-01-01

There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.

Impact of Chronic Nitrate Therapy in Patients With Ischemic Heart Failure.

PubMed

Moreira-Silva, Sofia; Urbano, Joana; Nogueira-Silva, Luís; Bettencourt, Paulo; Pimenta, Joana

2016-09-01

There is a lack of knowledge on the effects of nitrates alone in heart failure (HF). We aimed to assess the impact of nitrates use in the occurrence of ischemic events in patients with ischemic HF attending an HF clinic. We performed a retrospective analysis of a cohort of 632 patients managed in an HF clinic between January 2000 and December 2011. Patients with ischemic etiology were selected (n = 290). Patients were classified according to chronic nitrates use (n = 83 nitrates users vs n = 194) and followed up for 5 years for the occurrence of fatal or nonfatal myocardial infarction or stroke. Nitrates users had more frequently diabetes, dyslipidemia, and higher body mass index but were less frequently treated with statins. Thirty adverse events were recorded (n = 16 in nitrates group). Variables significantly associated with the occurrence of the end point in univariate analysis were arterial hypertension, diabetes, and nitrates use. Male gender, beta-blockers, statin, and clopidogrel use had a protective effect on the occurrence of the end point. In multivariate analysis, nitrates use remained an independent predictor of adverse outcome when adjusted for each of the variables: arterial hypertension, gender, diabetes, beta-blocker, and clopidogrel use; however, when adjusted for statin use, nitrates were no longer associated with the outcome. Long-term nitrates use in patients with ischemic HF was associated with higher occurrence of ischemic events, defined as fatal or nonfatal myocardial infarction or stroke. Our results, although from a retrospective analysis, do not support a role for chronic nitrate use in HF. © The Author(s) 2016.

Toxicological effects of short-term resuspension of metal-contaminated freshwater and marine sediments.

PubMed

Fetters, Kyle J; Costello, David M; Hammerschmidt, Chad R; Burton, G Allen

2016-03-01

Sediments in navigation-dominated waterways frequently are contaminated with a variety of particle-associated pollutants and are subject to frequent short-term resuspension events. There is little information documenting whether resuspension of metal-contaminated sediments has adverse ecological effects on resident aquatic organisms. Using a novel laboratory approach, the authors examined the mobilization of Zn, Cu, Cd, Pb, Ni, and Cr during resuspension of 1 freshwater and 2 coastal marine sediments and whether resuspension and redeposition resulted in toxicity to model organisms. Sediment flux exposure chambers were used to resuspend metal-contaminated sediments from 1 site in Lake DePue, Illinois (USA), and 2 sites in Portsmouth Naval Shipyard, Maine (USA). Short-term (4-h) resuspension of sediment at environmentally relevant suspended particulate matter concentrations (<1 g/L) resulted in metal mobilization to water that was sediment and metal specific. Overall, the net release of metals from suspended particles was limited, likely because of scavenging by organic matter and Fe oxides that formed during sediment interaction with oxic water. Minimal toxicity to organisms (survival of Hyalella azteca and Daphnia magna; survival, growth, and tissue metal concentration of Neanthes arenaceodentata; bioluminescence of Pyrocystis lunula) was observed during 4-h exposure to resuspended sediments and during 4-d to 10-d post-exposure recovery periods in uncontaminated water. Redeposited suspended particles exhibited increased metal bioavailability and toxicity to H. azteca, highlighting the potential for adverse ecological impacts because of changes in metal speciation. It is important to consider interactions between organisms' life histories and sediment disturbance regimes when assessing risks to ecosystems. © 2015 SETAC.

A randomized, comparative study of dual therapy (doxycycline-rifampin) versus triple therapy (doxycycline-rifampin-levofloxacin) for treating acute/subacute brucellosis.

PubMed

Hasanain, Ahmad; Mahdy, Reem; Mohamed, Asmaa; Ali, Mostafa

2016-01-01

The aim of this study was to compare both the efficacy and safety profile of the WHO-recommended, dual therapy (doxycycline-rifampin) to a quinolone-based, triple therapy (doxycycline-rifampin-levofloxacin) for treating acute/subacute brucellosis. We studied 107 consecutive, naïve patients with acute/subacute brucellosis admitted to Assiut University Hospital. Patients were randomly allocated to receive the dual therapy of doxycycline-rifampin (group-A) or to receive the triple therapy of doxycycline-rifampin-levofloxacin (group-B). Acute/subacute brucellosis was diagnosed based on the presence of: (1) contact with animals or fresh animal products, (2) suggestive clinical manifestations of less than one-year duration, and (3) positive antibody titer (1:160) by standard tube agglutination test. There was no significant difference between the two groups regarding their demographic data. Fever was the most frequent manifestation (96.3%). Epigastric pain was the most frequent adverse effect of treatment (12.1%). Group-A patients had a significantly higher relapse rate compared to group-B patients (22.6% versus 9.3%, p-value=0.01). The rate of treatment adverse effects was higher among group-B patients, although not reaching statistical significance (20.4% versus 11.3%, p-value=0.059). Adding levofloxacin to the dual therapy for acute/subacute brucellosis (doxycycline-rifampin) may increase its efficacy in terms of lowering the relapse rate of the disease. Further, larger scale studies are needed before considering modifying the standard, dual therapy for brucellosis. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

Factors influencing antibiotic-prescribing decisions among inpatient physicians: a qualitative investigation

PubMed Central

Livorsi, D; Comer, AR; Matthias, MS; Perencevich, EN; Bair, MJ

2016-01-01

Objective To understand the professional and psychosocial factors that influence physicians' antibiotic-prescribing habits in the inpatient setting. Design We conducted semi-structured interviews with 30 inpatient physicians. Interviews consisted of open-ended questions and flexible probes based on participants' responses. Interviews were audio recorded, transcribed, de-identified, and reviewed for accuracy and completeness. Data were analyzed using emergent thematic analysis. Setting Two teaching hospitals in Indianapolis, IN Participants Thirty inpatient physicians (10 physicians-in-training, 20 supervising staff) Results Participants recognized that antibiotics are over-used, and many admitted to prescribing antibiotics even when the clinical evidence of infection was uncertain. Over-prescription was largely driven by anxiety about missing an infection while potential adverse effects of antibiotics did not strongly influence decision-making. Participants did not routinely disclose potential adverse effects of antibiotics to inpatients. Physicians-in-training were strongly influenced by the antibiotic prescribing behavior of their supervising staff physicians. Participants sometimes questioned their colleagues' antibiotic-prescribing decisions but frequently avoided providing direct feedback or critique, citing obstacles of hierarchy, infrequent face-to-face encounters, and the awkwardness of these conversations. Conclusion There is a physician-based culture of prescribing antibiotics, which involves over-using antibiotics and not challenging colleagues' decisions. The potential adverse effects of antibiotics do not strongly influence decision-making in this sample. A better understanding of these factors could be leveraged in future efforts to improve antibiotic-prescribing in the inpatient setting. PMID:26078017

Fungicides affect Japanese beetle Popillia japonica (Coleoptera: Scarabaeidae) egg hatch, larval survival and detoxification enzymes.

PubMed

Obear, Glen R; Adesanya, Adekunle W; Liesch, Patrick J; Williamson, R Chris; Held, David W

2016-05-01

Larvae of the Japanese beetle, Popillia japonica (Coleoptera: Scarabaeidae), have a patchy distribution in soils, which complicates detection and management of this insect pest. Managed turf systems are frequently under pest pressure from fungal pathogens, necessitating frequent fungicide applications. It is possible that certain turfgrass fungicides may have lethal or sublethal adverse effects on eggs and larvae of P. japonica that inhabit managed turf systems. In this study, eggs and first-, second- and third-instar larvae were treated with the fungicides chlorothalonil and propiconazole, and survival was compared with that of untreated controls as well as positive controls treated with the insecticide trichlorfon. Chlorothalonil reduced survival of first-instar larvae treated directly and hatched from treated eggs. Propiconazole delayed egg hatch, reduced the proportion of eggs that successfully hatched and reduced survival of first-instar larvae treated directly and hatched from treated eggs. Sublethal doses of the fungicides lowered the activities of certain detoxification enzymes in third-instar grubs. Fungicide applications to turfgrass that coincide with oviposition and egg hatch of white grubs may have sublethal effects. This work is applicable both to high-maintenance turfgrass such as golf courses, where applications of pesticides are more frequent, and to home lawn services, where mixtures of multiple pesticides are commonly used. © 2015 Society of Chemical Industry.

New life to an old treatment: pegylated Interferon beta 1a in the management of multiple sclerosis.

PubMed

Ortiz, Miguel Angel; Espino-Paisan, Laura; Nunez, Concepcion; Alvarez-Lafuente, Roberto; Urcelay, Elena

2018-02-25

In the 1990s, the betainterferons and glatiramer acetate were introduced for treating relapsing-remitting multiple sclerosis. These medications have a demonstrated record of efficacy and safety, although they require frequent administration via injection and are only partially effective. The optimization of treatment in patients who do not respond adequately to this first-line therapy is essential for attaining the best long-term outcomes. Switching to the recently approved emergent therapies is a strategy to consider for treatment of patients with a suboptimal response. This review summarizes the mechanisms of action, clinical benefits, and safety profiles of current multiple sclerosis disease-modifying therapies, including highly efficacious monoclonal antibodies or convenient oral therapies. Although the first-line interferon beta exhibits a favorable benefit-to-risk profile, treatment compliance is compromised potentially due to its known adverse events and frequent injectable administration. Less frequent dosing and improved pharmacological properties have been achieved by reaction of interferon beta with chemically activated polyethylene glycol. Provided that none of the available therapies shows better effectiveness for all outcomes and their safety in clinical practice is a fundamental concern, the pegylated form of interferon beta seems to keep its place as a competitive therapeutic option. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Survey of advertising for nutritional supplements in health and bodybuilding magazines.

PubMed

Philen, R M; Ortiz, D I; Auerbach, S B; Falk, H

1992-08-26

The use of food supplements by the general public is poorly quantified, and little information on this subject is available in the medical literature. We surveyed 12 recent issues of popular health and bodybuilding magazines (1) to quantify the number of advertisements for food supplements, the number of products advertised, and the number and type of ingredients in these products; (2) to identify the purported health benefits of these products; and (3) as a preliminary effort to identify areas for future research. We counted 89 brands, 311 products, and 235 unique ingredients, the most frequent of which were unspecified amino acids; the most frequently promoted health benefit was muscle growth. We also found many unusual or unidentifiable ingredients, and 22.2% of the products had no ingredients listed in their advertisements. Health professionals may not be aware of how popular food supplements are or of a particular supplement's potential effects or side effects. In addition, patients may be reluctant to discuss their use of these products with traditional medical practitioners. We recommend that routine history taking include specific questions about patients' use of food supplements and that any possible adverse effects or side effects be reported to public health authorities.

TOPK inhibitor induces complete tumor regression in xenograft models of human cancer through inhibition of cytokinesis.

PubMed

Matsuo, Yo; Park, Jae-Hyun; Miyamoto, Takashi; Yamamoto, Shinji; Hisada, Shoji; Alachkar, Houda; Nakamura, Yusuke

2014-10-22

TOPK (T-lymphokine-activated killer cell-originated protein kinase) is highly and frequently transactivated in various cancer tissues, including lung and triple-negative breast cancers, and plays an indispensable role in the mitosis of cancer cells. We report the development of a potent TOPK inhibitor, OTS964 {(R)-9-(4-(1-(dimethylamino)propan-2-yl)phenyl)-8-hydroxy-6-methylthieno[2,3-c]quinolin-4(5H)-one}, which inhibits TOPK kinase activity with high affinity and selectivity. Similar to the knockdown effect of TOPK small interfering RNAs (siRNAs), this inhibitor causes a cytokinesis defect and the subsequent apoptosis of cancer cells in vitro as well as in xenograft models of human lung cancer. Although administration of the free compound induced hematopoietic adverse reactions (leukocytopenia associated with thrombocytosis), the drug delivered in a liposomal formulation effectively caused complete regression of transplanted tumors without showing any adverse reactions in mice. Our results suggest that the inhibition of TOPK activity may be a viable therapeutic option for the treatment of various human cancers. Copyright © 2014, American Association for the Advancement of Science.

Fungal Infections: Their Diagnosis and Treatment in Transplant Recipients

PubMed Central

Van Thiel, David H.; George, Magdalena; Moore, Christopher M.

2012-01-01

Systemic fungal infections typically occur in individuals who are seriously ill with recognized risk factors such as those frequently found in transplant recipients. Unfortunately, they are often diagnosed late, when the efficacy of the available treatments is low, often less than 50%, and the cost in terms of lives lost, hospital length of stay, and total hospital costs is substantially increased. The application of antifungal therapies associated with reported efficacy rates greater than 50% are those used prophylactically. When used prophylactically, these infections are reduced in greater than 95% of the expected cases. The choice of a prophylactic agent should be based upon its ease of administration, lack of adverse effects, reduced likelihood of potential drug interactions, and its efficacy in patients with established risk factors and comorbid disease processes that include renal, hepatic, and chronic pulmonary disease. The indications for the use of currently available antifungal agents, their adverse effects, drug interactions, ease of dosing, and applicability in patients with preexisting disease states, and especially in liver transplant recipients, are presented in this paper. PMID:22966464

Health Effects of Energy Drinks on Children, Adolescents, and Young Adults

PubMed Central

Seifert, Sara M.; Schaechter, Judith L.; Hershorin, Eugene R.

2011-01-01

OBJECTIVE: To review the effects, adverse consequences, and extent of energy drink consumption among children, adolescents, and young adults. METHODS: We searched PubMed and Google using “energy drink,” “sports drink,” “guarana,” “caffeine,” “taurine,” “ADHD,” “diabetes,” “children,” “adolescents,” “insulin,” “eating disorders,” and “poison control center” to identify articles related to energy drinks. Manufacturer Web sites were reviewed for product information. RESULTS: According to self-report surveys, energy drinks are consumed by 30% to 50% of adolescents and young adults. Frequently containing high and unregulated amounts of caffeine, these drinks have been reported in association with serious adverse effects, especially in children, adolescents, and young adults with seizures, diabetes, cardiac abnormalities, or mood and behavioral disorders or those who take certain medications. Of the 5448 US caffeine overdoses reported in 2007, 46% occurred in those younger than 19 years. Several countries and states have debated or restricted energy drink sales and advertising. CONCLUSIONS: Energy drinks have no therapeutic benefit, and many ingredients are understudied and not regulated. The known and unknown pharmacology of agents included in such drinks, combined with reports of toxicity, raises concern for potentially serious adverse effects in association with energy drink use. In the short-term, pediatricians need to be aware of the possible effects of energy drinks in vulnerable populations and screen for consumption to educate families. Long-term research should aim to understand the effects in at-risk populations. Toxicity surveillance should be improved, and regulations of energy drink sales and consumption should be based on appropriate research. PMID:21321035

Headache in essential thrombocythaemia

PubMed Central

Frewin, R; Dowson, A

2012-01-01

Headache is frequently reported as one of the neurological manifestations of essential thrombocythaemia (ET) and other myeloproliferative neoplasms. It is associated with considerable morbidity; yet, it is a frequently under-recognised symptom. In patients with ET, headaches may be attributable to the disease, to the prescribed ET treatment, or unrelated to ET. The majority of headaches in ET are self-limiting and can be managed with standard headache therapies such as paracetamol, but it is vital that the clinician managing these conditions is able to recognise the headaches with a more sinister pathology. In this article, we will review the incidence and management of headaches in ET, whether they are primarily related to the disease or a result of its treatment. Identification of specific headache types in patients with ET may enable physicians to employ the most effective headache medication. This would enhance the patient-physician relationship, increasing patient compliance and thus reducing the risk of adverse outcomes. PMID:22889110

Effect of HIV infection on tolerability and bacteriologic outcomes of tuberculosis treatment.

PubMed

Bliven-Sizemore, E E; Johnson, J L; Goldberg, S; Burman, W J; Villarino, M E; Chaisson, R E

2012-04-01

Two international, multicenter Phase 2 clinical trials examining fluoroquinolone-containing regimens in adults with smear-positive pulmonary tuberculosis (TB), conducted from July 2003 to March 2007. Both trials enrolled human immunodeficiency virus (HIV) infected participants who were not receiving antiretroviral therapy (ART) at TB treatment initiation. To assess the impact of HIV infection on TB treatment outcomes in Phase 2 clinical trials. Cross-protocol analysis comparing the safety, tolerability and outcomes of anti-tuberculosis treatment by HIV status. Of 750 participants who received at least one dose of study treatment, 123 (16%) were HIV-infected. Treatment completion rates were similar by HIV status (81% infected vs. 85% non-infected), as were rates of week 8 culture conversion (66% infected vs. 63% non-infected), and treatment failure (5% infected vs. 3% non-infected). Among HIV-infected participants, treatment failure detected using liquid media was more frequent in those treated thrice weekly (14% thrice weekly vs. 2% daily, P = 0.03). HIV-infected participants more frequently experienced an adverse event during the intensive phase treatment than non-HIV-infected participants (30% vs. 15%, P < 0.01). HIV-infected persons not receiving ART had more adverse events during the intensive phase of anti-tuberculosis treatment, but tolerated treatment well. Failure rates were higher among HIV-infected persons treated with thrice-weekly intensive phase therapy.

Preventability of adverse effects of analgesics: analysis of spontaneous reports.

PubMed

Cazacu, Irina; Miremont-Salamé, Ghada; Mogosan, Cristina; Fourrier-Réglat, Annie; Loghin, Felicia; Haramburu, Françoise

2015-05-01

The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors. This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012. The 141 cases selected for the analysis included 16 cases of medication errors (11.3%) and 15 addiction cases (10.6%). In total, 214 ADRs were registered, for which 173 analgesic medicines were suspected. The most frequent ADRs reported were nervous system disorders (26.6%), psychiatric disorders (15.0%), and skin and subcutaneous tissue disorders (12.1%). Tramadol alone or in combination (17.3%), followed by morphine (15%), fentanyl (9.8%), and paracetamol (8.7%) were the most frequently involved analgesics. More than half of the cases (54.6%) were serious and led to hospitalization or prolonged hospitalization. Preventability was determined for 134 cases (95%): 51.5% were considered as preventable, 26.1% not preventable, and 22.4% not assessable. The main contributing factors for the preventable cases included negligence of recommendations for analgesic use and failure to consider patients' risk factors when prescribing. A significant number of analgesic ADRs could be prevented, and being aware of their contributing factors promotes efficient analgesia with minimum risks to the patients.

Descriptive epidemiology of chronic childhood adversity in Mexican adolescents.

PubMed

Benjet, Corina; Borges, Guilherme; Medina-Mora, María Elena; Zambrano, Joaquín; Cruz, Carlos; Méndez, Enrique

2009-11-01

To estimate the prevalence of adversity (neglect and abuse, parental loss, parental psychopathology, economic adversity, and serious physical illness), the interrelatedness of adversities, and their socio-demographic correlates. This is a multistage probability survey of 3005 adolescents aged 12-17 years residing in Mexico City. Youth were administered the computer-assisted adolescent version of the World Mental Health Composite International Diagnostic Interview in their homes. The childhood and posttraumatic stress disorder sections provided information regarding adversity. Descriptive and logistic regression analyses were performed considering the multistage and weighted sample design. A total of 68% of adolescents have experienced at least one type of chronic childhood adversity, whereas almost 7% have experienced four of more. The most frequent adversity is economic adversity followed by witnessing domestic violence. Boys experience more neglect than girls, and girls experience more sexual abuse than boys. Family dysfunction adversities tend to clump together such that youth exposed to abuse of any form also report witnessing domestic violence and parental mental pathology. Youth whose parents have divorced are likely to experience economic adversity. Parental death is independent of experiencing other childhood adversities. Older adolescents, school drop-outs, those with young mothers, those with more siblings, and those whose parents have less education are more likely to experience adversity. Although most adolescents have experienced some adversity, a small group is exposed to many adversities. Understanding the distribution of adversities may help us to identify at-risk youth and to better interpret the findings from studies on the role of adversity in diverse health outcomes.

Genotoxic and carcinogenic effects of non-ionizing electromagnetic fields.

PubMed

Kocaman, Adem; Altun, Gamze; Kaplan, Arife Ahsen; Deniz, Ömür Gülsüm; Yurt, Kıymet Kübra; Kaplan, Süleyman

2018-05-01

New technologies in electronics and communications are continually emerging. An increasing use of these electronic devices such as mobile phone, computer, wireless fidelity connectors or cellular towers is raising questions concerning whether they have an adverse effect on the body. Exposure to electromagnetic fields (EMF) is frequently suggested to have adverse health effects on humans and other organisms. This idea has been reported in many studies. In contrast, the therapeutic effects of EMF on different organs have also been reported. Research findings are inconsistent. This has given rise to very profound discrepancies. The duration and frequency of mobile phone calls and the association observed with various health effects has raised serious concerns due to the frequency with which these devices are used and the way they are held close to the head. The present review assesses the results of in vitro, in vivo, experimental, and epidemiological studies. The purpose of the study is to assess data concerning the carcinogenic and genotoxic effects of non-ionizing EMF. The major genotoxic and carcinogenic effects of EMF, divided into subsections as low frequency effects and radiofrequency effects, were reviewed. The inconsistent results between similar studies and the same research groups have made it very difficult to make any comprehensive interpretation. However, evaluation of current studies suggests that EMF may represent a serious source of concern and may be hazardous to living organisms. Copyright © 2018 Elsevier Inc. All rights reserved.

Size-Dependent Effects of Gold Nanoparticles Uptake on Maturation and Antitumor Functions of Human Dendritic Cells In Vitro

PubMed Central

Tomić, Sergej; Đokić, Jelena; Vasilijić, Saša; Ogrinc, Nina; Rudolf, Rebeka; Pelicon, Primož; Vučević, Dragana; Milosavljević, Petar; Janković, Srđa; Anžel, Ivan; Rajković, Jelena; Rupnik, Marjan Slak; Friedrich, Bernd; Čolić, Miodrag

2014-01-01

Gold nanoparticles (GNPs) are claimed as outstanding biomedical tools for cancer diagnostics and photo-thermal therapy, but without enough evidence on their potentially adverse immunological effects. Using a model of human dendritic cells (DCs), we showed that 10 nm- and 50 nm-sized GNPs (GNP10 and GNP50, respectively) were internalized predominantly via dynamin-dependent mechanisms, and they both impaired LPS-induced maturation and allostimulatory capacity of DCs, although the effect of GNP10 was more prominent. However, GNP10 inhibited LPS-induced production of IL-12p70 by DCs, and potentiated their Th2 polarization capacity, while GNP50 promoted Th17 polarization. Such effects of GNP10 correlated with a stronger inhibition of LPS-induced changes in Ca2+ oscillations, their higher number per DC, and more frequent extra-endosomal localization, as judged by live-cell imaging, proton, and electron microscopy, respectively. Even when released from heat-killed necrotic HEp-2 cells, GNP10 inhibited the necrotic tumor cell-induced maturation and functions of DCs, potentiated their Th2/Th17 polarization capacity, and thus, impaired the DCs' capacity to induce T cell-mediated anti-tumor cytotoxicity in vitro. Therefore, GNP10 could potentially induce more adverse DC-mediated immunological effects, compared to GNP50. PMID:24802102

Metabolism-Activated Multitargeting (MAMUT): An Innovative Multitargeting Approach to Drug Design and Development.

PubMed

Mátyus, Péter; Chai, Christina L L

2016-06-20

Multitargeting is a valuable concept in drug design for the development of effective drugs for the treatment of multifactorial diseases. This concept has most frequently been realized by incorporating two or more pharmacophores into a single hybrid molecule. Many such hybrids, due to the increased molecular size, exhibit unfavorable physicochemical properties leading to adverse effects and/or an inappropriate ADME (absorption, distribution, metabolism, and excretion) profile. To avoid this limitation and achieve additional therapeutic benefits, here we describe a novel multitargeting strategy based on the synergistic effects of a parent drug and its active metabolite(s). The concept of metabolism-activated multitargeting (MAMUT) is illustrated using a number of examples. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Intravenous immunoglobulin therapy for refractory recurrent pericarditis.

PubMed

del Fresno, M Rosa; Peralta, Julio E; Granados, Miguel Ángel; Enríquez, Eugenia; Domínguez-Pinilla, Nerea; de Inocencio, Jaime

2014-11-01

Recurrent pericarditis is a troublesome complication of idiopathic acute pericarditis and occurs more frequently in pediatric patients after cardiac surgery (postpericardiotomy syndrome). Conventional treatment with nonsteroidal antiinflammatory drugs, corticosteroids, and colchicine is not always effective or may cause serious adverse effects. There is no consensus, however, on how to proceed in those patients whose disease is refractory to conventional therapy. In such cases, human intravenous immunoglobulin, immunosuppressive drugs, and biological agents have been used. In this report we describe 2 patients with refractory recurrent pericarditis after cardiac surgery who were successfully treated with 3 and 5 monthly high-dose (2 g/kg) intravenous immunoglobulin until resolution of the effusion. Our experience supports the effectiveness and safety of this therapy. Copyright © 2014 by the American Academy of Pediatrics.

Endocrine active agents: implications of adverse and non-adverse changes.

PubMed

Foster, Paul M D; McIntyre, Barry S

2002-01-01

The US Environmental Protection Agency (EPA) is currently in the process of developing screening and testing methodologies for the assessment of agents that may possess endocrine-like activity--the so-called endocrine disruptors. Moreover, the EPA has signaled its intention of placing information arising from such studies on the worldwide web. This has created significant interest in how such information may be used in risk assessment and by policymakers and the public in the potential regulation or deselection of specific chemical agents. The construction of lists of endocrine disruptors, although fulfilling the requirements of some parties, is really of little use when the nature of the response, the dose level employed, and the lifestage of the test species used are not given. Thus, we have already seen positive in vitro information available on the interaction with a receptor being used as a key indicator when the results of large, high quality in vivo studies showing no adverse changes have been ignored. Clearly a number of in vitro systems are available to ascertain chemical interaction with specific (mainly steroid) hormone receptors including a number of reporter gene assays. These assays only provide indicators of potential problems and should not be, in isolation, indicators of toxicity. Likewise, short-term in vivo screens such as the uterotrophic and Hershberger studies are frequently conducted in castrated animals and thus indicate the potential for a pharmacological response in vivo rather than an adverse effect. A number of new end points have been added to standard rodent testing protocols in the belief of providing more sensitivity to detect endocrine related changes. These include the measurement of anogenital distance (AGD), developmental landmarks [vaginal opening (VO), preputial separation (PPS)], and in some studies the counting of nipples and areolae on males. AGD, VO, and PPS are all affected by the size of the pup in which they are measured and should always be compared using bodyweight as a covariate. The historical control database for such changes is gradually growing, albeit that if pups are not individually identified it becomes problematic to associate any change with a specific malformation or to assess whether a delay or advance in, for example, developmental landmarks is biologically significant. Agents that significantly reduce AGD in males (it is an androgen-dependent variable) frequently have other more adverse changes associated with this end point (eg, reproductive tract malformations), but a 2 to 3% change in AGD although measurable is unlikely to be biologically of importance and in isolation would not necessarily be considered adverse. Retention of thoracic nipples in male rat pups is also an indicator of impaired androgen status. Recent studies have also shown that this retention for some endocrine active chemicals is permanent. Thus, the presence of a permanent structural change that is rarely found in adult control animals could be considered a malformation and therefore a developmental adverse effect on which risk assessment decisions could be made. The advent of multigeneration reproduction studies as the definitive studies for the assessment of the dose-response relationships and risk assessment for endocrine disruptors has shown that current testing protocols may be inadequate to reliably detect the adverse effects of concern as only 1 adult/sex/litter is examined. A number of the effects on reproductive development although, due to an in utero exposure, will not be manifest until after puberty or at adulthood. The use of only a limited number of animals to examine such changes, particularly for weaker acting materials indicates that some agents may have been examined in well-conducted, modern protocols but have insufficient power to detect low incidence phenomena (eg, a 5% incidence of malformations).

Management of statin-intolerant patient.

PubMed

Arca, M; Pigna, G; Favoccia, C

2012-06-01

Large scale clinical trials have undoubtedly demonstrated that statins are effective in reducing cardiovascular events and all-cause mortality in almost all patient populations. Also the short and long-term safety of statin therapy has been well established in the majority of treated patients. Nevertheless, intolerance to statins must be frequently faced in the clinical practice. The most commonly observed adverse effects of statins are muscle symptoms and elevation of hepatic aminotransferase and creatinine kinase (CK) levels. Overall, myalgia (muscle pain with or without plasma CK elevations) and a single abnormally elevated liver function test constitute approximately two-thirds of reported adverse events during statin therapy. These side effects raise concerns in the patients and are likely to reduce patient's adherence and, consequently, the cardiovascular benefit. Therefore, it is mandatory that clinicians improve knowledge on the clinical aspects of side effects of statins and the ability to manage patients with intolerance to statins. Numerous different approaches to statin-intolerant patients have been suggested, but an evidence-based consensus is difficult to be reached due to the lack of controlled trials. Therefore, it might be useful to review protocols and procedures to control statin intolerance. The first step in managing intolerant patients is to determine whether the adverse events are indeed related to statin therapy. Then, the switching to another statin or lower dosage, the alternate dosing options and the use of non-statin compounds may be practical strategies. However, the cardiovascular benefit of these approaches has not been established, so that their use has to be employed after a careful clinical assessment of each patient.

Effect of scalp blocks with levobupivacaine on recovery profiles after craniotomy for aneurysm clipping: a randomized, double-blind, and controlled study.

PubMed

Hwang, Jin-Young; Bang, Jae-Seung; Oh, Chang-Wan; Joo, Jin-Deok; Park, Seong-Joo; Do, Sang-Hwan; Yoo, Yong-Jae; Ryu, Jung-Hee

2015-01-01

This study was conducted to evaluate the effect of scalp blocks using levobupivacaine on recovery profiles including postoperative pain, patient-controlled analgesia (PCA) consumption, postoperative nausea and vomiting (PONV), and other adverse events in patients undergoing frontoparietal craniotomy for aneurysm clipping. Fifty-two patients scheduled for elective frontoparietal craniotomy for unruptured aneurysm clipping were enrolled. After surgery, scalp blocks were performed using normal saline (group C, n = 26) or 0.75% levobupivacaine (group L, n = 26). Postoperative pain scores and PCA consumption were recorded for 72 hours after recovery of consciousness. The time from patient recovery to the first use of PCA drug and rescue analgesics, the requirement for vasoactive agents, and adverse effects related to PCA and local anesthetics also were recorded. Postoperative pain scores and PCA consumption in group L were lower than in group C (P < .05). The time intervals from patient recovery to the first use of PCA drug (P < .001) and rescue analgesics (P = .038) was longer in group L than in group C. Additionally, less antihypertensive agent was required (P = .017), and PONV occurred less frequently (P = .039) in group L than in group C. Scalp blocks with 0.75% levobupivacaine improved recovery profiles in that it effectively lowered postoperative pain and PCA consumption without severe adverse events and also reduced the requirement for a postoperative antihypertensive agent and the incidence of PONV in patients who underwent frontoparietal craniotomy for aneurysm clipping. Copyright © 2015 Elsevier Inc. All rights reserved.

Illicit drug use and adverse birth outcomes: is it drugs or context?

PubMed

Schempf, Ashley H; Strobino, Donna M

2008-11-01

Prenatal drug use is commonly associated with adverse birth outcomes, yet no studies have controlled for a comprehensive set of associated social, psychosocial, behavioral, and biomedical risk factors. We examined the degree to which adverse birth outcomes associated with drug use are due to the drugs versus surrounding factors. Data are from a clinical sample of low-income women who delivered at Johns Hopkins Hospital between 1995 and 1996 (n = 808). Use of marijuana, cocaine, and opiates was determined by self-report, medical record, and urine toxicology screens at delivery. Information on various social, psychosocial, behavioral, and biomedical risk factors was gathered from a postpartum interview or the medical record. Multivariable regression models of birth outcomes (continuous birth weight and low birth weight ([LBW] < 2,500 g)) were used to assess the effect of drug use independent of associated factors. In unadjusted results, all types of drug use were related to birth weight decrements and increased odds of LBW. However, only the effect of cocaine on continuous birth weight remained significant after adjusting for all associated factors (-142 g, p = 0.05). No drug was significantly related to LBW in fully adjusted models. About 70% of the unadjusted effect of cocaine use on continuous birth weight was explained by surrounding psychosocial and behavioral factors, particularly smoking and stress. Most of the unadjusted effects of opiate use were explained by smoking and lack of early prenatal care. Thus, prevention efforts that aim to improve newborn health must also address the surrounding context in which drug use frequently occurs.

Clinical study of the safety and effectiveness of a novel over-the-counter bleaching tray system

PubMed Central

Ghalili, K Michael; Khawaled, Kamal; Rozen, Doran; Afsahi, Veda

2014-01-01

We investigated color change, gingival irritation, and tooth sensitivity in patients undergoing at-home vital tooth bleaching with a novel over-the-counter bleaching tray system. Tooth color shade in anterior teeth, supragingival plaque and gingivitis in Ramfjord teeth, as well as visual assessment of teeth gingival tissues and mucosa were evaluated in-office prior to treatment, after two consecutive applications of the 9% hydrogen peroxide bleaching product, after eight applications (10 minutes/day for 3 days at home), and after ten applications (50 minutes exposure over 5 days). Color stability was evaluated at 3 months after completing the treatment regimen. Over-the-counter bleaching products can be used by the patient at home without dentist supervision, but are frequently associated with gingival irritation and tooth sensitivity despite low concentrations of peroxide agents. Our investigations showed that the treatment is tolerable and safe with a low incidence of adverse effects. Any adverse effects associated with use of the whitening gel and tray are temporary, easily controlled, and often disappear within minutes of treatment. Statistical analysis revealed significant improvement in teeth whitening following treatment (mean color change of seven shades) and at three months after treatment. PMID:24591847

What is the role of steroids in pneumonia therapy?

PubMed

Póvoa, Pedro; Salluh, Jorge I F

2012-04-01

This review evaluates the potential benefits as well as adverse effects from adjunctive therapy with systemic steroids in patients with pneumonia: either mild-to-moderate or severe, community-acquired or hospital-acquired, of bacterial or of viral origin (in particular H1N1 viral infection). Steroids potentially modulate the marked and persistent activation of the immune system in pneumonia. However, several recent randomized controlled trials and large prospective observational studies have repeatedly shown that steroids had no impact on survival, the clinical event of interest, but in severe pneumonia some studies pointed to potential harmful effect. In addition, adverse effects, namely hyperglycemia, superinfections, as well as increased length-of-stay, were frequent findings in the steroid-treated patients. According to the current evidence, there are no data to support the well tolerated use of systemic steroids as a standard of care in pneumonia, neither in mild-to-moderate and severe, nor in bacterial and viral infection. Clinical and basic research should work together to improve trial designs to identify reliable surrogate markers of outcome, in particular of mortality. This may improve the patient selection and facilitate the identification of subgroups that can benefit from adjunctive steroid therapy.

An overview on safety issues related to erythropoiesis-stimulating agents for the treatment of anaemia in patients with chronic kidney disease.

PubMed

Del Vecchio, Lucia; Locatelli, Francesco

2016-08-01

Erythropoiesis stimulating agents (ESA) are effective drugs, which have been used for decades in patients with chronic kidney disease (CKD) with few side effects. More recently, concern has been raised around their safety, from higher cardiovascular and thrombosis risk to cancer progression and increased mortality. We made a literature search on PubMed looking for adverse effects of ESA in CKD patients. The topics covered are cardiovascular adverse events, thrombosis, increased mortality, hypertension, cancer progression, diabetic retinopathy, pure red cell aplasia and anaphylactic reactions. Concerns around ESA therapy have questioned treatment indications in high-risk CKD patients (those with cancer, diabetes and cardiovascular comorbidities). A more cautious approach has then prevailed. In our opinion, intermediate Hb values (Hb 10-12 g/dl) should be aimed with ESA therapy, being more cautious in high-risk patients. As a consequence, IV iron is administered more frequently. However, excessive iron use may cause iron overload and in rare cases severe anaphylactic reactions. There are expectations of new erythropoietic agents, such as those manipulating the hypoxia-inducible transcription factors (HIF) system. Differing from ESAs, they stimulate the production of endogenous EPO, avoiding over-physiological plasmatic levels.

Use of strong opioids for chronic pain in osteoarthritis: an insight into the Latin American reality.

PubMed

Ruiz Iban, Miguel Angel; Benavides, Javier; Forero, Juan Pablo; Bittelman, Sacha; Martinez, Rafael; Mite, Miguel Angel; Diaz Heredia, Jorge; Ulloa, Sergio; Lizárraga Ferrand, Mauro Marcelo

2018-01-01

Osteoarthritis is the most common cause of arthritis and one of the main causes of chronic pain. Although opioids are frequently employed for chronic pain treatment, their usage for osteoarthritis pain remains controversial due to the associated adverse effects. Most guidelines reserve their use for refractory pain in patients with hip and knee osteoarthritis. The situation is even more complex in Latin America, where the prevalence of insufficient pain treatment is high because of the limited availability and use of strong opioids. Areas covered: In this article we review the epidemiology of osteoarthritis, its socioeconomic burden, its impact as a chronic pain cause and the pharmacological treatment options, giving emphasis to the role of strong opioids, their safety and efficacy, especially in Latin American countries, where restrictions regulate their usage. Expert commentary: Usage of strong opioids is safe and effective in the short-term management of osteoarthritis with moderate to severe pain, when other pharmacological treatments are inadequate and surgery is contraindicated, provided their use adheres to existing guidelines. Educational programs for patients and physicians and further research on treating chronic pain with opioids should be implemented to reduce adverse effects and improve care quality.

Shammah (Smokeless Tobacco) and Public Health

PubMed Central

Bakdash, Abdulsallam

2017-01-01

Shammah is a preparation of smokeless tobacco (ST) that is frequently used in the Arabian Peninsula, especially in Saudi Arabia. A mixture of powdered tobacco, lime, ash, black pepper, oils and flavorings, shammah in is placed in the buccal cavity or lower labial vestibule of the mouth. The user (or dipper) spits out insoluble debris. ST is linked to a number of harmful effects such as dental disease, oral cancer, oesophagus cancer, and pancreas cancer. It also causes adverse reproductive effects including stillbirth, premature birth and low birth weight. The importation of ST products is prohibited in Saudi Arabia. Legislative action to combat the use of ST (moist snuff and chewing tobacco) in Saudi Arabia appeared in 1990. The actual percentage use may be higher than reported since shammah is illegal in Saudi Arabia and there may be some unwillingness to admit to its use. Data on ST use in the Arabian Peninsula are sparse. Most studies conducted there focused on the prevalence of shammah use among adolescents rather than among adults. This review paper aimed to understand the pattern of use of shammah and its adverse health effects. It also aimed to provide suitable epidemiological data for public health policy makers. PMID:28610400

Pirfenidone in idiopathic pulmonary fibrosis: real-life experience from a German tertiary referral center for interstitial lung diseases.

PubMed

Oltmanns, Ute; Kahn, Nicolas; Palmowski, Karin; Träger, Annette; Wenz, Heinrich; Heussel, Claus Peter; Schnabel, Philipp A; Puderbach, Michael; Wiebel, Matthias; Ehlers-Tenenbaum, Svenja; Warth, Arne; Herth, Felix J F; Kreuter, Michael

2014-01-01

Pirfenidone is a novel antifibrotic drug for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). However, adverse events may offset treatment benefits and compliance. To assess recent course of disease, adverse events and compliance in patients who started pirfenidone. In an observational cohort study, 63 patients with mild-to-moderate IPF who started pirfenidone between May 2011 and June 2013 were reviewed. Pulmonary function, adverse events and treatment compliance were recorded at each clinic visit. Disease progression was defined as a reduction of vital capacity ≥10% and/or diffusion capacity (DLCO) ≥15%. Follow-up time on pirfenidone treatment was 11 (±7) months. Sixty-six percent of the patients continued with pirfenidone monotherapy and 34% of the patients received pirfenidone combined with corticosteroids (CCS) and/or N-acetylcysteine (NAC). There was a nonsignificant reduction in mean decline of percent predicted forced vital capacity after treatment start (0.7 ± 10.9%) compared to the pretreatment period (6.6 ± 6.7%, p = 0.098). Sixty-two percent of the patients had stable disease on pirfenidone treatment. Adverse events affected 85% of the patients, leading to discontinuation of pirfenidone in 20%. Adverse events and treatment discontinuation were seen more frequently in patients with concomitant CCS and/or NAC treatment. Adverse events affect the majority of patients treated with pirfenidone, but are mostly manageable with supportive measures. In this heterogeneous patient group, a nonsignificant effect of pirfenidone treatment on pulmonary function was seen, underlining the need for more data on patient selection criteria and efficacy of pirfenidone, particularly in patients with coexistent emphysema and concomitant NAC/CCS treatment.

Tolerability of sirolimus: a decade of experience at a single cardiac transplant center.

PubMed

Thibodeau, Jennifer T; Mishkin, Joseph D; Patel, Parag C; Kaiser, Patricia A; Ayers, Colby R; Mammen, Pradeep P A; Markham, David W; Ring, William Steves; Peltz, Matthias; Drazner, Mark H

2013-01-01

Sirolimus is used in cardiac transplant recipients to prevent rejection, progression of cardiac allograft vasculopathy, and renal dysfunction. However, sirolimus has many potential side effects and its tolerability when used outside of clinical trials is not well established. We describe a decade of experience with sirolimus in cardiac transplant recipients at our institution. We retrospectively reviewed records of all adult cardiac transplant recipients living between September 1999 and February 2010 (n = 329) and identified 67 patients (20%) who received sirolimus. The indications for sirolimus were cardiac allograft vasculopathy (67%), renal dysfunction (25%), rejection (4%), and intolerability of tacrolimus (3%). One-third of patients discontinued sirolimus at a median (25th, 75th percentiles) of 0.9 (0.2, 1.6) yr of duration. Over 70% of subjects experienced an adverse event attributed to sirolimus. Adverse events were associated with higher average sirolimus levels (9.1 ng/mL vs. 7.1 ng/mL, p = 0.004). We conclude that sirolimus is frequently used in cardiac transplant recipients (20%) and commonly causes side effects, often necessitating discontinuation. Higher average sirolimus levels were associated with adverse events, suggesting that tolerability may improve if levels are maintained within the lower end of the current therapeutic range; however, the improvement in tolerability would need to be balanced with the potential for decreased efficacy. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The impact of severe mental disorders and psychotropic medications on sexual health and its implications for clinical management

PubMed Central

Montejo, Angel L.; Montejo, Laura; Baldwin, David S.

2018-01-01

Sexual dysfunction often accompanies severe psychiatric illness and can be due to both the mental disorder itself and the use of psychotropic treatments. Many sexual symptoms resolve as the mental state improves, but treatment‐related sexual adverse events tend to persist over time, and are unfortunately under‐recognized by clinicians and scarcely investigated in clinical trials. Treatment‐emergent sexual dysfunction adversely affects quality of life and may contribute to reduce treatment adherence. There are important differences between the various compounds in the incidence of adverse sexual effects, associated with differences in mechanisms of action. Antidepressants with a predominantly serotonergic activity, antipsychotics likely to induce hyperprolactinaemia, and mood stabilizers with hormonal effects are often linked to moderate or severe sexual dysfunction, including decreased libido, delayed orgasm, anorgasmia, and sexual arousal difficulties. Severe mental disorders can interfere with sexual function and satisfaction, while patients wish to preserve a previously satisfactory sexual activity. In many patients, a lack of intimate relationships and chronic deterioration in mental and physical health can be accompanied by either a poor sexual life or a more frequent risky sexual behaviour than in the general population. Here we describe the influence of psychosis and antipsychotic medications, of depression and antidepressant drugs, and of bipolar disorder and mood stabilizers on sexual health, and the optimal management of patients with severe psychiatric illness and sexual dysfunction. PMID:29352532

Differences in Characteristics of Aviation Accidents During 1993-2012 Based on Aircraft Type

NASA Technical Reports Server (NTRS)

Evans, Joni K.

2015-01-01

Civilian aircraft are available in a variety of sizes, engine types, construction materials and instrumentation complexity. For the analysis reported here, eleven aircraft categories were developed based mostly on aircraft size and engine type, and these categories were applied to twenty consecutive years of civil aviation accidents. Differences in various factors were examined among these aircraft types, including accident severity, pilot characteristics and accident occurrence categories. In general, regional jets and very light sport aircraft had the lowest rates of adverse outcomes (injuries, fatal accidents, aircraft destruction, major accidents), while aircraft with twin (piston) engines or with a single (piston) engine and retractable landing gear carried the highest incidence of adverse outcomes. The accident categories of abnormal runway contact, runway excursions and non-powerplant system/component failures occur frequently within all but two or three aircraft types. In contrast, ground collisions, loss of control - on ground/water and powerplant system/component failure occur frequently within only one or two aircraft types. Although accidents in larger aircraft tend to have less severe outcomes, adverse outcome rates also differ among accident categories. It may be that the type of accident has as much or more influence on the outcome as the type of aircraft.

Questions about complementary and alternative medicine to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive pilot study.

PubMed

Schjøtt, Jan; Erdal, Hilde

2014-02-14

Provision of clinically relevant information about complementary and alternative medicine (CAM) to health care professionals is not well described. The aim of the study was to assess questions about CAM to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). All question-answers pairs (QAPs) in the RELIS database indexed with alternative medicine from 2005-2010 constituted the study material. A randomly selected sample of 100 QAPs was characterized with regard to type of question (category, patient-specific or general), occupation and workplace of enquirer, the type of information search performed (simple or advanced), and if the answers contained information to provide factual or consultative replies (facts about or advice on clinical use of CAM, respectively). Proportions were compared with Fisher's exact test with significance at the 0.05 level. One thousand and thirty-eight (7.7%) out of 13 482 questions involved CAM. Eighty-two out of 100 questions concerned products containing one or more herbs, vitamins and minerals as well as other substances. Thirty-eight out of 100 questions concerned the category documentation (substance identification and/or literature reports about clinical effects), 36 interactions, 16 adverse effects, 9 pregnancy and lactation, and 1 question concerned contraindications. Sixty-three questions were patient-specific and 37 general. Fifty-four questions came from physicians, 33 from pharmacists and 13 from others (including nurses, midwives, students, CAM practitioners, and the public). Pharmacists asked more frequently about interactions while physicians asked more frequently about adverse effects (p < 0.05). Seventy-six of the questions came from outside hospital, mainly general practice and community pharmacies. Fifty-nine answers were based on a simple and 41 on an advanced information search. Thirty-three factual and 38 consultative answers were provided. In 29 answers, search provided no information. Lack of information to provide an answer was not significantly different between patient-specific (31.7%) and general questions (24.3%). General practice and community pharmacies are the main sources for questions about CAM to RELIS. Physicians are concerned about adverse effects while pharmacists are concerned about interactions. Lack of information to provide answers to patient-specific and general questions about CAM represents a problem.

Questions about complementary and alternative medicine to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive pilot study

PubMed Central

2014-01-01

Background Provision of clinically relevant information about complementary and alternative medicine (CAM) to health care professionals is not well described. The aim of the study was to assess questions about CAM to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). Methods All question-answers pairs (QAPs) in the RELIS database indexed with alternative medicine from 2005-2010 constituted the study material. A randomly selected sample of 100 QAPs was characterized with regard to type of question (category, patient-specific or general), occupation and workplace of enquirer, the type of information search performed (simple or advanced), and if the answers contained information to provide factual or consultative replies (facts about or advice on clinical use of CAM, respectively). Proportions were compared with Fisher’s exact test with significance at the 0.05 level. Results One thousand and thirty-eight (7.7%) out of 13 482 questions involved CAM. Eighty-two out of 100 questions concerned products containing one or more herbs, vitamins and minerals as well as other substances. Thirty-eight out of 100 questions concerned the category documentation (substance identification and/or literature reports about clinical effects), 36 interactions, 16 adverse effects, 9 pregnancy and lactation, and 1 question concerned contraindications. Sixty-three questions were patient-specific and 37 general. Fifty-four questions came from physicians, 33 from pharmacists and 13 from others (including nurses, midwives, students, CAM practitioners, and the public). Pharmacists asked more frequently about interactions while physicians asked more frequently about adverse effects (p < 0.05). Seventy-six of the questions came from outside hospital, mainly general practice and community pharmacies. Fifty-nine answers were based on a simple and 41 on an advanced information search. Thirty-three factual and 38 consultative answers were provided. In 29 answers, search provided no information. Lack of information to provide an answer was not significantly different between patient-specific (31.7%) and general questions (24.3%). Conclusions General practice and community pharmacies are the main sources for questions about CAM to RELIS. Physicians are concerned about adverse effects while pharmacists are concerned about interactions. Lack of information to provide answers to patient-specific and general questions about CAM represents a problem. PMID:24529279

The pharmacist and adverse drug reaction reporting.

PubMed

Pearson, K

1982-08-01

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

Comparison of propranolol and practolol in the management of hyperthyroidism.

PubMed

Murchison, L E; Bewsher, P D; Chesters, M I; Ferrier, W R

1976-04-01

Twenty-one hyperthyroid patients participated in an 8-week double-blind crossover trial of propranolol and practolol, and the effecte of these drugs on the clinical and metabolic features of the disease were studied. Propranolol was marginally more effective than practolol, as measured by the hyperthyroid diagnostic index and anxiety scale. Propranolol produced a significant reduction in the serum concentration ratio of tri-iodothyronine to thyroxine, compatible with partial inhibition of peripheral deiodination of thyroxine. Adverse reactions occurred more frequently with propranolol than with practolol. In veiw of the efficacy of practoloo, further trials in hyperthyroid patients of newer beta1-adrenoceptor antagonists, preferably without partial agonist activity, are indicated.

Pesticide poisoning in a preschool child: a case study examining neurocognitive and neurobehavioral effects.

PubMed

Riccio, Cynthia A; Avila, Leonor; Ash, Michael J

2010-04-01

Exposure to environmental toxins, such as pesticides, has been shown to have adverse effects in humans, particularly neurological effects. Cases of acute pesticide poisoning occur less frequently and are less well documented; specific deficits (e.g., in processing speed, working memory) have not consistently been discussed. This is a case study of a preschooler who underwent a neuropsychological assessment due to a pesticide poisoning. His parents reported attention, speech, social, and gross and fine motor concerns after the poisoning. A number of methods and measures were used, including observational data, neuropsychological, and behavioral and social-emotional measures. Consistent with past research, results from the assessment demonstrated the subtle and not-so-subtle effects of acute pesticide poisoning. Implications of the findings are discussed.

Frequent hemodialysis with NxStage system in pediatric patients receiving maintenance hemodialysis.

PubMed

Goldstein, Stuart L; Silverstein, Douglas M; Leung, Jocelyn C; Feig, Daniel I; Soletsky, Beth; Knight, Cathy; Warady, Bradley A

2008-01-01

Recent evidence from adult hemodialysis (HD) patient studies reveal improved biochemical control and reported health-related quality of life after transition from conventional thrice weekly to daily home maintenance HD treatment. Published pediatric frequent dialysis experiences demonstrate similar improvement but all used conventional HD machines, which employ a treated municipal water supply, thereby frequently exposing patients to proinflammatory components. We report our pediatric experience with six-times-weekly HD using the NxStage system, which uses sterile dialysis fluid to provide dialysis in the home or center setting. Four patients (weight range 38-61.4 kg) completed the 16-week study. Patients exhibited progressive reductions in casual pretreatment systolic and diastolic blood pressures, discontinuation of antihypertensive medications, and decreased blood pressure load by ambulatory blood pressure monitoring. Mean serum phosphorus improved without change in phosphorus binder medication, and all three patients with a normalized protein catabolic rate <1 g/kg per day at the beginning of the study improved to a normalized protein catabolic rate (nPCR) of >1.1 g/kg per day. Patients reported no adverse effects. Variable changes in proinflammatory cytokine levels were observed. We suggest that frequent HD with the NxStage system be considered for children who would benefit from home-based maintenance dialysis.

Utility values associated with advanced or metastatic non-small cell lung cancer: data needs for economic modeling.

PubMed

Brown, Jacqueline; Cook, Keziah; Adamski, Kelly; Lau, Jocelyn; Bargo, Danielle; Breen, Sarah; Chawla, Anita

2017-04-01

Cost-effectiveness analyses often inform healthcare reimbursement decisions. The preferred measure of effectiveness is the quality adjusted life year (QALY) gained, where the quality of life adjustment is measured in terms of utility. Areas covered: We assessed the availability and variation of utility values for health states associated with advanced or metastatic non-small cell lung cancer (NSCLC) to identify values appropriate for cost-effectiveness models assessing alternative treatments. Our systematic search of six electronic databases (January 2000 to August 2015) found the current literature to be sparse in terms of utility values associated with NSCLC, identifying 27 studies. Utility values were most frequently reported over time and by treatment type, and less frequently by disease response, stage of disease, adverse events or disease comorbidities. Expert commentary: In response to rising healthcare costs, payers increasingly consider the cost-effectiveness of novel treatments in reimbursement decisions, especially in oncology. As the number of therapies available to treat NSCLC increases, cost-effectiveness analyses will play a key role in reimbursement decisions in this area. Quantifying the relationship between health and quality of life for NSCLC patients via utility values is an important component of assessing the cost effectiveness of novel treatments.

Review of deutetrabenazine: a novel treatment for chorea associated with Huntington's disease.

PubMed

Dean, Marissa; Sung, Victor W

2018-01-01

Deutetrabenazine was recently approved for the treatment of chorea in Huntington's disease (HD) and is the first deuterated medication that has been US Food and Drug Administration (FDA)-approved for therapeutic use. In this article, we review deutetrabenazine's drug design, pharmacokinetics, drug interactions, efficacy, adverse events, comparison with tetrabenazine, dosage, and administration. Deutetrabenazine is a deuterated form of tetrabenazine and is a vesicular monoamine transporter 2 (VMAT2) inhibitor. The substitution of deuterium for hydrogen at key positions in the tetrabenazine molecule allows a longer drug half-life and less frequent daily dosing. Deutetrabenazine is administered twice daily up to a maximum daily dose of 48 mg, which corresponds to a similar daily dose of 100 mg of tetrabenazine. In a Phase III clinical trial (First-HD), there was a statistically significant improvement of chorea in HD subjects, as well as improvements in global impression of change as assessed by both patients and clinicians. This improvement was seen without significant adverse effects as the overall tolerability profile of deutetrabenazine was similar to placebo. Somnolence was the most commonly reported symptom in the deutetrabenazine group. In a study where subjects converted from tetrabenazine to deutetrabenazine in an open-label fashion (ARC-HD) and indirect comparison studies between tetrabenazine and deutetrabenazine, there is a suggestion that while efficacy for chorea is similar, the data may slightly favor tetrabenazine, but adverse effects and tolerability strongly favor deutetrabenazine. These data have not been replicated in true head-to-head studies. Current evidence supports that deutetrabenazine is an effective therapeutic treatment option for chorea in HD and may provide a more favorable adverse effect profile than tetrabenazine. However, more data are needed, particularly in the form of head-to-head studies between deutetrabenazine and other treatment options as well as longer term clinical experience with deutetrabenazine.

Balancing the benefits and risks of disease-modifying therapy in patients with multiple sclerosis.

PubMed

Sørensen, Per Soelberg

2011-12-01

Balancing efficacy versus burden of therapy is essential for the choice of disease-modifying therapy in every MS patient. The first-line therapies, interferon-? and glatiramer acetate, have well-established efficacy and present no major safety concerns. Certain second-line therapies, such as natalizumab, offer potentially greater efficacy, but are associated with an increased level of risk. Over the last year, the first two oral treatments of relapsing-remitting multiple sclerosis, cladribine and fingolimod, have been marketed in certain countries, although cladribine was subsequently withdrawn. In the Phase III clinical development programme, both drugs appeared effective and reasonably safe. However, there were cases of serious adverse events (malignancies and fatal infections) whose relationship with treatment was unclear. Specific postmarketing studies will be necessary to assess the risks of these new oral therapies. Indeed, both natalizumab and mitoxantrone are known today to be associated with rare adverse drug reactions (progressive multifocal leukoencephalopathy for natalizumab and treatment-related leukaemia for mitoxantrone), which were not identified before the treatments were approved. The use of therapies carrying potential serious risks is justified in patients who cannot be treated effectively with safe first-line therapies, but probably not in the average relapsing-remitting multiple sclerosis or clinical isolated syndrome patient. Pivotal Phase III clinical trials, on which basis drug approval is generally granted, are designed to demonstrate clinical efficacy and reveal frequently occurring adverse effects of a new drug. However, post-approval trials with extensive patient exposure are needed to generate knowledge of more patient-specific clinical effectiveness and long-term safety, in particular with respect to rare adverse reactions. Other post-approval measures, such as risk management programmes, pharmacovigilance studies, or phased launch of the drug, may be useful to ensure that risks associated with new treatments are identified and minimised. The final evaluation of the benefits to risks balance of a drug should be made in every patient by weighing benefits in disease activity and progression, quality of life and health economy against both commonly occurring mild side-effects and rare potentially life-threatening adverse drug effects. This decision should be shared between the physician and patient, who may not share the same perceptions of acceptable risk. Copyright © 2011 Elsevier B.V. All rights reserved.

Ophthalmic adverse drug reactions to systemic drugs: a systematic review.

PubMed

Miguel, Ana; Henriques, Filipe; Azevedo, Luís Filipe; Pereira, Altamiro Costa

2014-03-01

To perform a comprehensive and systematic review regarding ophthalmic adverse drug reactions (ADRs) to systemic drugs to: (i) systematically summarize existing evidence, (ii) identify areas, ophthalmic ADRs or drugs that lacked systematization or assessment (namely drugs with original studies characterizing specific ophthalmic ADRs but without causality assessment nor without meta-analysis). Systematic review of several electronic databases (last search 1/7/2012): Medline, SCOPUS, ISI web of knowledge, ISI Conference Proceedings, International Pharmaceutical Abstracts and Google scholar. Search query included: eye, ocular, ophthalmic, ophthalmology, adverse and reaction. Inclusion criteria were: (i) Primary purpose was to assess an ophthalmic ADR to a systemic medication; (ii) Patient evaluation performed by an ophthalmologist; (iii) Studies that specified diagnostic criteria for an ocular ADR. Different types of studies were included and analyzed separately. Two independent reviewers assessed eligibility criteria, extracted data and evaluated risk of bias. From 562 studies found, 32 were included (1 systematic review to sildenafil, 11 narrative reviews, 1 trial, 1 prospective study, 6 transversal studies, 6 spontaneous reports and 6 case series). Drugs frequently involved included amiodarone, sildenafil, hydroxychloroquine and biphosphonates. Frequent ophthalmic ADRs included: keratopathy, dry eye and retinopathy. To increase evidence about ophthalmic ADRs, there is a need for performing specific systematic reviews, applying strictly the World Health Organization's (WHO) definition of ADR and WHO causality assessment of ADRs. Some ophthalmic ADRs may be frequent, but require ophthalmological examination; therefore, ophthalmologists' education and protocols of collaboration between other specialties whenever they prescribe high-risk drugs are suggestions for the future. Copyright © 2014 John Wiley & Sons, Ltd.

Peroxide as a Novel Treatment for Ecchymoses

PubMed Central

Sroa, Novie; Campbell, Shannon M.; Bechtel, Mark A.; Mitch Opremcak, E.

2010-01-01

Ecchymoses, commonly known as bruises, frequently occur after injury to the skin causes extravasation of red blood cells into interstitial tissue. This extravasation can lead to an inflammatory cascade. The case report presented details one patient who displayed rapid improvement in the pain and appearance of a partially treated bruise on her thigh after an eight-hour application of hydrogen peroxide 15% carbamide gel under occlusion. Hydrogen peroxide 15% carbamide gel may represent a novel treatment for ecchymoses. This potential new treatment for bruises needs to be studied further to detail its adverse effects, safety profile, and efficacy profile. PMID:21103315

Orthodontic–periodontics interdisciplinary approach

PubMed Central

Vinod, K.; Reddy, Y. Giridhar; Reddy, Vinay P.; Nandan, Hemant; Sharma, Meenakshi

2012-01-01

In this present era, when a significant number of patients seeking orthodontic treatment are adults, importance of multidisciplinary treatment approach cannot be overemphasized. Higher susceptibility of plaque accumulation in patients undergoing orthodontic treatment makes involvement of periodontist almost unavoidable. Also, orthodontic treatment frequently results in undesirable periodontal changes which require immediate attention. More recently, orthodontics has been used as an adjunct to periodontics to increase connective tissue support and alveolar bone height. The purpose of this article is to review the adverse effects of orthodontic treatment on the periodontal tissues and to discuss the mutually beneficial relationship shared between the two specialties. PMID:22628956

Adverse events among Ontario home care clients associated with emergency room visit or hospitalization: a retrospective cohort study

PubMed Central

2013-01-01

Background Home care (HC) is a critical component of the ongoing restructuring of healthcare in Canada. It impacts three dimensions of healthcare delivery: primary healthcare, chronic disease management, and aging at home strategies. The purpose of our study is to investigate a significant safety dimension of HC, the occurrence of adverse events and their related outcomes. The study reports on the incidence of HC adverse events, the magnitude of the events, the types of events that occur, and the consequences experienced by HC clients in the province of Ontario. Methods A retrospective cohort design was used, utilizing comprehensive secondary databases available for Ontario HC clients from the years 2008 and 2009. The data were derived from the Canadian Home Care Reporting System, the Hospital Discharge Abstract Database, the National Ambulatory Care Reporting System, the Ontario Mental Health Reporting System, and the Continuing Care Reporting System. Descriptive analysis was used to identify the type and frequency of the adverse events recorded and the consequences of the events. Logistic regression analysis was used to examine the association between the events and their consequences. Results The study found that the incident rate for adverse events for the HC clients included in the cohort was 13%. The most frequent adverse events identified in the databases were injurious falls, injuries from other than a fall, and medication-related incidents. With respect to outcomes, we determined that an injurious fall was associated with a significant increase in the odds of a client requiring long-term-care facility admission and of client death. We further determined that three types of events, delirium, sepsis, and medication-related incidents were associated directly with an increase in the odds of client death. Conclusions Our study concludes that 13% of clients in homecare experience an adverse event annually. We also determined that an injurious fall was the most frequent of the adverse events and was associated with increased admission to long-term care or death. We recommend the use of tools that are presently available in Canada, such as the Resident Assessment Instrument and its Clinical Assessment Protocols, for assessing and mitigating the risk of an adverse event occurring. PMID:23800280

Perampanel. Just another anticonvulsant for partial epilepsy: no progress.

PubMed

2014-07-01

Nearly a dozen antiepileptic drugs have been shown to prevent attacks in patients with partial epilepsy, whether used alone, or in combination when successive single-agent well-conducted treatments have failed. Perampanel (Fycompa, Eisai) an AMPA glutamate receptor antagonist, has been granted marketing authorisation in the European Union and United States, for use in combination with other antiepileptic drugs in patients aged 12 years or older with partial epilepsy. Perampanel has not been compared with other antiepileptic drugs in clinical trials. Its evaluation is based on three comparative, double-blind, placebo-controlled trials, in which perampanel was added to other antiepileptic drugs considered to be inadequately effective. In these trials, after 19 weeks of treatment, its efficacy was only modest: the response rate was at best only about 20% higher than with placebo. Indirect comparison, albeit inherently unreliable, suggests that perampanel is no better than other antiepileptic drugs. Perampanel has frequent and often dose-dependent adverse effects; they mainly include irritability, aggression, impaired alertness and coordination, and weight gain. Cardiac disorders were observed during a long-term trial of perampanel. This possible adverse effect requires further study. Perampanel led to stunted growth in experimental animals. It is not known whether adolescents are also at risk. Perampanel does not appear to be a potent inducer or inhibitor of the cytochrome P450 enzyme system, but its drug interaction profile requires further evaluation. In animal studies, perampanel exposure resulted in increased perinatal mortality. In practice, there is no evidence that perampanel represents a therapeutic advance for patients with partial epilepsy. In addition to its known adverse effects, there are concerns over possible long-term cardiac toxicity and a deleterious effect on growth. Other acceptable solutions, based on better-known drugs, should be discussed with epileptic patients.

Are media warnings about the adverse health effects of modern life self-fulfilling? An experimental study on idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF).

PubMed

Witthöft, Michael; Rubin, G James

2013-03-01

Medically unsubstantiated 'intolerances' to foods, chemicals and environmental toxins are common and are frequently discussed in the media. Idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF) is one such condition and is characterized by symptoms that are attributed to exposure to electromagnetic fields (EMF). In this experiment, we tested whether media reports promote the development of this condition. Participants (N=147) were randomly assigned to watch a television report about the adverse health effects of WiFi (n=76) or a control film (n=71). After watching their film, participants received a sham exposure to a WiFi signal (15 min). The principal outcome measure was symptom reports following the sham exposure. Secondary outcomes included worries about the health effects of EMF, attributing symptoms to the sham exposure and increases in perceived sensitivity to EMF. 82 (54%) of the 147 participants reported symptoms which they attributed to the sham exposure. The experimental film increased: EMF related worries (β=0.19; P=.019); post sham exposure symptoms among participants with high pre-existing anxiety (β=0.22; P=.008); the likelihood of symptoms being attributed to the sham exposure among people with high anxiety (β=.31; P=.001); and the likelihood of people who attributed their symptoms to the sham exposure believing themselves to be sensitive to EMF (β=0.16; P=.049). Media reports about the adverse effects of supposedly hazardous substances can increase the likelihood of experiencing symptoms following sham exposure and developing an apparent sensitivity to it. Greater engagement between journalists and scientists is required to counter these negative effects. Copyright © 2012 Elsevier Inc. All rights reserved.

Exercise and physical activity in systemic lupus erythematosus: A systematic review with meta-analyses.

PubMed

O'Dwyer, Tom; Durcan, Laura; Wilson, Fiona

2017-10-01

Systemic lupus erythematosus (SLE) associates with enhanced cardiovascular (CV) risk frequently unexplained by traditional risk factors. Physical inactivity, common in SLE, likely contributes to the burden of CV risk and may also be a factor in co-morbid chronic fatigue. This systematic review evaluates whether exercise has a deleterious effect on disease activity in SLE, and explores effects on CV function and risk factors, physical fitness and function and health-related measures. A systematic review, with meta-analyses, was conducted; quasi-randomised and randomised controlled trials in SLE comparing at least one exercise group to controls were included. MEDLINE/PubMed, EMBASE, PEDro, AMED, CINAHL, The Cochrane Central Register of Controlled Trials, and relevant conference abstracts were searched. Random-effects meta-analyses were used to pool extracted data as mean differences. Heterogeneity was evaluated with χ 2 test and I 2 , with p < 0.05 considered significant. The search identified 3068 records, and 31 full-texts were assessed for eligibility. Eleven studies, including 469 participants, were included. Overall risk of bias of these studies was unclear. Exercise interventions were reported to be safe, while adverse effects were rare. Meta-analyses suggest that exercise does not adversely affect disease activity, positively influences depression, improves cardiorespiratory capacity and reduces fatigue, compared to controls. Exercise programmes had no significant effects on CV risk factors compared to controls. Therapeutic exercise programmes appear safe, and do not adversely affect disease activity. Fatigue, depression and physical fitness were improved following exercise-based interventions. A multimodal approach may be suggested, however the optimal exercise protocol remains unclear. Copyright © 2017 Elsevier Inc. All rights reserved.

Cutaneous Manifestations of Diabetes Mellitus: A Review.

PubMed

Lima, Ana Luiza; Illing, Tanja; Schliemann, Sibylle; Elsner, Peter

2017-08-01

Diabetes mellitus is a widespread endocrine disease with severe impact on health systems worldwide. Increased serum glucose causes damage to a wide range of cell types, including endothelial cells, neurons, and renal cells, but also keratinocytes and fibroblasts. Skin disorders can be found in about one third of all people with diabetes and frequently occur before the diagnosis, thus playing an important role in the initial recognition of underlying disease. Noninfectious as well as infectious diseases have been described as dermatologic manifestations of diabetes mellitus. Moreover, diabetic neuropathy and angiopathy may also affect the skin. Pruritus, necrobiosis lipoidica, scleredema adultorum of Buschke, and granuloma annulare are examples of frequent noninfectious skin diseases. Bacterial and fungal skin infections are more frequent in people with diabetes. Diabetic neuropathy and angiopathy are responsible for diabetic foot syndrome and diabetic dermopathy. Furthermore, antidiabetic therapies may provoke dermatologic adverse events. Treatment with insulin may evoke local reactions like lipohypertrophy, lipoatrophy and both instant and delayed type allergy. Erythema multiforme, leukocytoclastic vasculitis, drug eruptions, and photosensitivity have been described as adverse reactions to oral antidiabetics. The identification of lesions may be crucial for the first diagnosis and for proper therapy of diabetes.

Treatment of Congenital Toxoplasmosis: Safety of the Sulfadoxine-Pyrimethamine Combination in Children Based on a Method of Causality Assessment.

PubMed

Teil, Julie; Dupont, Damien; Charpiat, Bruno; Corvaisier, Stéphane; Vial, Thierry; Leboucher, Gilles; Wallon, Martine; Peyron, François

2016-06-01

The treatment of newborns and infants with congenital toxoplasmosis is standard practice. Some observational studies have examined safety in newborns, but most of these failed to provide sufficient details for a provisional assessment of causality. The aim of this study was to evaluate the clinical and biological adverse effects of the combination of sulfadoxine-pyrimethamine. Sixty-five children treated for 1 year with a combination of sulfadoxine-pyrimethamine (1 dose every 10 days) for congenital toxoplasmosis were followed up to evaluate abnormal hematological values and potential adverse events using a standardized method of causality assessment. Nine patients (13.8%) presented at least 1 adverse clinical event that was nonspecific, such as diarrhea on the day of drug administration, vomiting and agitation. In 1 patient, erythema appeared at the end of the treatment and resolved within 10 days. None of these events was attributed to the treatment. Six patients (9.2%) developed an adverse hematological event (neutropenia, n = 3; eosinophilia, n = 2 and both anemia and eosinophilia, n = 1) that was considered to be possibly related to the sulfadoxine-pyrimethamine combination. Four treatments were temporarily interrupted, and toxicity was observed after readministration of treatment in 1 case only. However, none of these adverse events was life threatening. According to our results and previously published data, the combination of sulfadoxine-pyrimethamine seems to be well tolerated. However, the sample size of our study was too small to rule out the risk of less frequent, but nevertheless severe, reactions and, in particular, of hypersensitivity reactions.

Objectives and methodology of BIOBADASER phase iii.

PubMed

Sanchez-Piedra, Carlos; Hernández Miguel, M Victoria; Manero, Javier; Roselló, Rosa; Sánchez-Costa, Jesús Tomás; Rodríguez-Lozano, Carlos; Campos, Cristina; Cuende, Eduardo; Fernández-Lopez, Jesús Carlos; Bustabad, Sagrario; Martín Domenech, Raquel; Pérez-Pampín, Eva; Del Pino-Montes, Javier; Millan-Arcineas, Ana Milena; Díaz-González, Federico; Gómez-Reino, Juan Jesús

2017-09-18

Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Refractory obstetrical antiphospholipid syndrome: Features, treatment and outcome in a European multicenter retrospective study.

PubMed

Mekinian, Arsène; Alijotas-Reig, Jaume; Carrat, Fabrice; Costedoat-Chalumeau, Nathalie; Ruffatti, Amelia; Lazzaroni, Maria Grazia; Tabacco, Sara; Maina, Aldo; Masseau, Agathe; Morel, Nathalie; Esteve-Valverde, Enrique Esteve; Ferrer-Oliveras, Raquel; Andreoli, Laura; De Carolis, Sara; Josselin-Mahr, Laurence; Abisror, Noémie; Nicaise-Roland, Pascale; Tincani, Angela; Fain, Olivier

2017-07-01

To describe the consecutive pregnancy outcome and treatment in refractory obstetrical antiphospholipid syndrome (APS). Retrospective multicenter open-labelled study from December 2015 to June 2016. We analyzed the outcome of pregnancies in patients with obstetrical APS (Sydney criteria) and previous adverse obstetrical event despite low-dose aspirin and low-molecular weight heparin LMWH (LMWH) conventional treatment who experienced at least one subsequent pregnancy. Forty nine patients with median age 27years (23-32) were included from 8 European centers. Obstetrical APS was present in 71%, while 26% had obstetrical and thrombotic APS. Lupus anticoagulant was present in 76% and triple antiphospholipid antibody (APL) positivity in 45% of patients. Pregnancy loss was noted in 71% with a median age of gestation of 11 (8-21) weeks. The presence of APS non-criteria features (35% vs 17% in pregnancies without adverse obstetrical event; p=0.09), previous intrauterine death (65% vs 38%; p=0.06), of LA (90% vs 65%; p=0.05) were more frequent in pregnancies with adverse pregnancy outcome, whereas isolated recurrent miscarriage profile was more frequent in pregnancies without any adverse pregnancy outcome (15% vs 41%; p=0.04). In univariate analysis considering all pregnancies (index and subsequent ones), an history of previous intrauterine death was associated with pregnancy loss (odds-ratio 2.51 (95% CI 1.274.96); p=0.008), whereas previous history of prematurity related to APS (odds-ratio 0.13 95%CI 0.04 0.41, P=0.006), steroids use during the pregnancy (odds-ratio 0.30 95% CI 0.11-0.82, p=0.019) and anticardiolipids isolated profile (odds-ratio 0.51 95% CI 0.26-1.03, p=0.0588) were associated with favorable outcome. In multivariate analysis, only previous history of prematurity, steroids use and anticardiolipids isolated profiles were associated with live-birth pregnancy. The main features of refractory obstetrical APS were the high rates of LA and triple APL positivity. Steroids could be effective in this APS profile, but prospective studies are necessary. Copyright © 2017 Elsevier B.V. All rights reserved.

Preventing falls in hospital.

PubMed

Pearce, Lynne

2017-01-31

Essential facts Falls are the most frequently reported adverse events in hospitals, especially among older patients. According to the Royal College of Physicians (RCP) more than 240,000 falls are reported in acute hospitals and mental health trusts in England and Wale.

[Epidemiology of the hospital adverse events in Catalonia, Spain: a first step for the patient safety improvement].

PubMed

Bañeres, Joaquim; Orrego, Carola; Navarro, Laura; Casas, Lidia; Banqué, Marta; Suñol, Rosa

2014-07-01

It has been published that hospital adverse events are an important source of morbidity and mortality in different countries and settings. The aim of this study was to evaluate the frequency, magnitude, distribution and degree of preventability of adverse events in the Autonomous Community of Catalonia (Spain). We conducted a retrospective cohort study of 4,790 hospital discharges that were selected by simple random sampling after stratified multistage sampling in 15 hospitals in Catalonia. 38.25% of patients had positive risk criteria (screening phase). We identified 356 cases of adverse events, which represent a 7.4% (95%CI: 6.7% to 8.1%). Of these, 43.5% (155 cases) were considered preventable. This study confirms that adverse events in hospitals in Catalonia are frequent, and generate a significant impact on morbidity and mortality. As in other studies, corroborated that a high proportion of these adverse events are considered preventable. It was possible to identify priority areas to focus improvement efforts. Copyright © 2014. Published by Elsevier Espana.

The adverse health effects of synthetic cannabinoids with emphasis on psychosis-like effects.

PubMed

van Amsterdam, Jan; Brunt, Tibor; van den Brink, Wim

2015-03-01

Cannabis use is associated with an increased risk of psychosis in vulnerable individuals. Cannabis containing high levels of the partial cannabinoid receptor subtype 1 (CB1) agonist tetrahydrocannabinol (THC) is associated with the induction of psychosis in susceptible subjects and with the development of schizophrenia, whereas the use of cannabis variants with relatively high levels of cannabidiol (CBD) is associated with fewer psychotic experiences. Synthetic cannabinoid receptor agonists (SCRAs) are full agonists and often more potent than THC. Moreover, in contrast to natural cannabis, SCRAs preparations contain no CBD so that these drugs may have a higher psychosis-inducing potential than cannabis. This paper reviews the general toxicity profile and the adverse effects of SCRAs with special emphasis on their psychosis-inducing risk. The review shows that, compared with the use of natural cannabis, the use of SCRAs may cause more frequent and more severe unwanted negative effects, especially in younger, inexperienced users. Psychosis and psychosis-like conditions seem to occur relatively often following the use of SCRAs, presumably due to their high potency and the absence of CBD in the preparations. Studies on the relative risk of SCRAs compared with natural cannabis to induce or evoke psychosis are urgently needed. © The Author(s) 2015.

Media use by children younger than 2 years.

PubMed

Brown, Ari

2011-11-01

In 1999, the American Academy of Pediatrics (AAP) issued a policy statement addressing media use in children. The purpose of that statement was to educate parents about the effects that media--both the amount and the content--may have on children. In one part of that statement, the AAP recommended that "pediatricians should urge parents to avoid television viewing for children under the age of two years." The wording of the policy specifically discouraged media use in this age group, although it is frequently misquoted by media outlets as no media exposure in this age group. The AAP believed that there were significantly more potential negative effects of media than positive ones for this age group and, thus, advised families to thoughtfully consider media use for infants. This policy statement reaffirms the 1999 statement with respect to media use in infants and children younger than 2 years and provides updated research findings to support it. This statement addresses (1) the lack of evidence supporting educational or developmental benefits for media use by children younger than 2 years, (2) the potential adverse health and developmental effects of media use by children younger than 2 years, and (3) adverse effects of parental media use (background media) on children younger than 2 years.

Differentiating high priority pathway-based toxicity from non ...

EPA Pesticide Factsheets

The ToxCast chemical screening approach enables the rapid assessment of large numbers of chemicals for biological effects, primarily at the molecular level. Adverse outcome pathways (AOPs) offer a means to link biomolecular effects with potential adverse outcomes at the level of the individual or population, thus enhancing the utility of the ToxCast effort for hazard assessment. Thus, efforts are underway to develop AOPs relevant to the pathway perturbations detected in ToxCast assays. However, activity (?‘hits’) determined for chemical-assay pairs may reflect target-specific activity relevant to a molecular initiating event of an AOP, or more generalized cell stress and cytotoxicity-mediated effects. Previous work identified a ?‘cytotoxic burst’ phenomenon wherein large numbers of assays begin to respond at or near concentrations that elicit cytotoxicity. The concentration range at which the “burst” occurs is definable, statistically. Consequently, in order to focus AOP development on the ToxCast assay targetswhich are most sensitive and relevant to pathway-specific effects, we conducted a meta-analysis to identify which assays were frequently responding at concentrations well below the cytotoxic burst. Assays were ranked by the fraction of chemical hits below the burst concentration range compared to the number of chemicals tested, resulting in a preliminary list of potentially important, target-specific assays. After eliminating cytotoxicity a

Add-on lacosamide: a retrospective study on the relationship between serum concentration, dosage, and adverse events.

PubMed

Hillenbrand, Barbara; Wisniewski, Ilona; Jürges, Uta; Steinhoff, Bernhard J

2011-11-01

We performed a retrospective study in patients with poorly controlled epilepsy treated with add-on lacosamide (LCM) to investigate the relationship of LCM-related adverse events with LCM serum concentration and weight-dependent dosage. We collected serum concentrations, weight-related dosages, and occurrences of the seven most frequent adverse events according to the randomized double-blind, placebo-controlled trials. Seventy of 131 patients could be sufficiently evaluated. LCM serum concentrations and weight-related dosages in patients with and without typical adverse events did not differ significantly. Closer analysis of the data suggested that dizziness as the leading adverse event occurred significantly more often if LCM was combined with classic sodium channel blockers. There was a significant correlation between LCM serum concentrations and co-medication, so there is still evidence for dependent variables that might have a relevant impact in individual cases. However, our data do not allow definition of a safety range for LCM. Copyright © 2011 Elsevier Inc. All rights reserved.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis

PubMed Central

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-01-01

Introduction: Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar®), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups “41-65” (39.07%) and “over 65” (27.9%) were the most affected. Conclusions: Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed. PMID:24347984

Human exposures to tilmicosin reported to poison centres, Texas, 1998-2003.

PubMed

Forrester, Mathias B

2005-05-01

Tilmicosin, or 20-deoxo-20-(3,5-dimethylpiperidin-1-yl)-desmycosin, is a macrolide antibiotic primarily utilized in livestock. This study examined 46 human exposure calls involving tilmicosin received by Texas poison centres during 1998-2003. The majority (91%) of the calls were received from northern and central Texas. All of the cases were unintentional exposures. The most frequent route of exposure was parenteral (48%). The majority of the patients were males (80%) and adults (84%). Only 46% of the patients were managed outside of health care facilities. Some sort of adverse medical outcome was reported in 93% of parenteral exposures and 54% of other-route exposures. However, only 21% of parenteral exposures and 15% of other-route exposures involved medical outcomes that were judged to be moderate or worse. No deaths were reported. The most frequently reported clinical effects among parenteral cases were dermal (79%), while only 9% of other-route exposures had dermal effects. Cardiovascular clinical effects were observed in a single case of parenteral exposure and a single case of other-route exposure. Although the majority of cases were managed with the assistance of health care facilities, the medical outcomes were usually not serious. Outcome depended on the route of exposure.

Thoughts and acts of aggression/violence toward others reported in association with varenicline.

PubMed

Moore, Thomas J; Glenmullen, Joseph; Furberg, Curt D

2010-09-01

Thoughts and acts of aggression/violence toward others have been reported in postmarketing surveillance of varenicline, an aid to smoking cessation. To identify the common characteristics of these thoughts and acts of aggression/violence toward others and assess the likely relationship to varenicline treatment. We obtained 78 adverse event reports from the Food and Drug Administration MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; 4 additional cases were reported in clinical trials, and 3 others came from the published literature. We used psychiatric diagnostic criteria and an adverse event causality assessment tool to identify 26 case reports for study. The selected cases described 10 events with assault, 9 cases of homicidal ideation, and 7 cases of other thoughts or acts of aggression/violence. The most frequent common characteristics were (1) inexplicable and unprovoked event, (2) the victim was anyone nearby, (3) no indication of a prior history of similar behavior in the patient, and (4) early onset of psychiatric adverse effects, often before stopping smoking. Where dechallenge/rechallenge information was available, psychiatric adverse effects resolved in 13/14 (93%) cases after discontinuation. The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the accumulating scientific evidence that varenicline is associated with thoughts and acts of aggression/violence. We recommend that physicians and pharmacists ensure that all patients are informed of possible psychiatric symptoms of varenicline, including violent and aggressive thoughts. All patients should be advised to contact a health-care provider immediately if these symptoms occur and varenicline should be discontinued without delay.

Syncope paradox in the outcome of patients with pulmonary thromboembolism: short-term and midterm outcome.

PubMed

Seyyedi, Seyyed-reza; Jenab, Yaser; Tokaldany, Masoumeh Lotfi; Shirani, Shapoor; Sadeghian, Saeed; Jalali, Arash

2016-01-01

We compare the early and midterm outcomes of pulmonary thromboembolism (PTE) in patients with and without syncope in our single-center registry. Between December 2006 and May 2013, 351 consecutive patients (mean age = 60.21 ± 16.91 years, 55.3% male) with confirmed acute symptomatic PTE were divided in with and without syncope groups. Groups were compared in terms of the effect of syncope on 30-day mortality and adverse events, and mortality in a median follow-up time of 16.9 months. From 351 patients, 39 (11.1%) had syncope and 312 (88.9%) did not. Syncope group had less frequently chest pain (30.8% vs 51.4%; P value = 0.015). Also, the rates of 30-day adverse events and mortality were 12.8% and 5.1% for the group with syncope, and 14.4% and 10.3% for the group without syncope, respectively, with no significant difference. At follow up, 65 patients died and mortality was 18.5% for 351 patients (5.1% in the group with syncope and 20.2% for the other group). After adjustment for confounding factors, the effect of syncope on 30-day adverse events and mortality remained non-significant and on the midterm mortality was significant, showing that the presence of syncope was associated with lower midterm mortality (P value = 0.038). Among PTE patients in our registry, 11.1% presented with syncope. Relationship between syncope and 30-day adverse events and mortality remained non-significant after adjustments for other factors. However, in midterm follow up, patients with syncope were significantly at decreased risk of mortality compared to those without syncope. © 2014 John Wiley & Sons Ltd.

Phase II Evaluation of Gefitinib in Patients With Newly Diagnosed Grade 4 Astrocytoma: Mayo/North Central Cancer Treatment Group Study N0074

DOE Office of Scientific and Technical Information (OSTI.GOV)

Uhm, Joon H., E-mail: uhm.joon@mayo.ed; Ballman, Karla V.; Wu Wenting

2011-06-01

Purpose: Amplification of the epidermal growth factor receptor (EGFR) gene represents one of the most frequent gene alterations in glioblastoma (GBM). In the current study, we evaluated gefitinib, a potent EGFR inhibitor, in the treatment of adults with newly diagnosed GBM. Methods and Materials: Ninety-eight patients (96 evaluable) were accrued between May 18, 2001, and August 2, 2002. All were newly diagnosed GBM patients who were clinically and radiographically stable/improved after radiation treatment (enrollment within 5 weeks of radiation completion). No prior chemotherapy was permitted. EGFR amplification/mutation, as assessed by fluorescence in situ hybridization and immunohistochemistry, was not required formore » treatment with gefitinib but was studied when tissues were available. Gefitinib was administered at 500 mg each day; for patients receiving dexamethasone or enzyme-inducing (CYP3A4) agents, dose was escalated to a maximum of 1,000 mg QD. Treatment cycles were repeated at 4-week intervals with brain magnetic resonance imaging at 8-week intervals. Results: Overall survival (OS; calculated from time of initial surgery) at 1 year (primary end point) with gefitinib was 54.2%, which was not statistically different compared with that of historical control population (48.9%, data from three previous Phase III North Central Cancer Treatment Group studies of newly diagnosed GBM patients). Progression-free survival (PFS) at 1 year post-RT (16.7%) was also not significantly different to that of historical controls (30.3%). Clinical outcome was not affected by EGFR status (amplification or vIII mutation). Fatigue (41%), rash (62%), and loose stools (58%) constituted the most frequent adverse events, the majority of these being limited to Grade 1/2. Of note, the occurrence of drug-related adverse effects, such as loose stools was associated with improved OS. Conclusions: In our evaluation of nearly 100 patients with newly diagnosed GBM, treatment with adjuvant gefitinib post-radiation was not associated with significant improvement in OS or PFS. However, patients who experienced gefitinib-associated adverse effects (rash/diarrhea) did demonstrate improved OS.« less

Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy.

PubMed

Ravaud, Alain; Motzer, Robert J; Pandha, Hardev S; George, Daniel J; Pantuck, Allan J; Patel, Anup; Chang, Yen-Hwa; Escudier, Bernard; Donskov, Frede; Magheli, Ahmed; Carteni, Giacomo; Laguerre, Brigitte; Tomczak, Piotr; Breza, Jan; Gerletti, Paola; Lechuga, Mariajose; Lin, Xun; Martini, Jean-Francois; Ramaswamy, Krishnan; Casey, Michelle; Staehler, Michael; Patard, Jean-Jacques

2016-12-08

Sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy. In this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. The primary end point was disease-free survival, according to blinded independent central review. Secondary end points included investigator-assessed disease-free survival, overall survival, and safety. The median duration of disease-free survival was 6.8 years (95% confidence interval [CI], 5.8 to not reached) in the sunitinib group and 5.6 years (95% CI, 3.8 to 6.6) in the placebo group (hazard ratio, 0.76; 95% CI, 0.59 to 0.98; P=0.03). Overall survival data were not mature at the time of data cutoff. Dose reductions because of adverse events were more frequent in the sunitinib group than in the placebo group (34.3% vs. 2%), as were dose interruptions (46.4% vs. 13.2%) and discontinuations (28.1% vs. 5.6%). Grade 3 or 4 adverse events were more frequent in the sunitinib group (48.4% for grade 3 events and 12.1% for grade 4 events) than in the placebo group (15.8% and 3.6%, respectively). There was a similar incidence of serious adverse events in the two groups (21.9% for sunitinib vs. 17.1% for placebo); no deaths were attributed to toxic effects. Among patients with locoregional clear-cell renal-cell carcinoma at high risk for tumor recurrence after nephrectomy, the median duration of disease-free survival was significantly longer in the sunitinib group than in the placebo group, at a cost of a higher rate of toxic events. (Funded by Pfizer; S-TRAC ClinicalTrials.gov number, NCT00375674 .).

Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

PubMed Central

2010-01-01

Background Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications, precautions for use, drug interaction or adverse effects spontaneously (P < 0.001). In 48% of the Australian presentations, general practitioners reported the pharmaceutical representatives failed to mention information on PBS listings to general practitioners. Conclusions Information on indications and dosages were usually provided by pharmaceutical representatives in Australia and Malaysia. However, risk and harmful effects of medicines were often missing in their presentations. Effective control of medicines information provided by pharmaceutical representatives is needed. PMID:21118551

An evolutionary concept of polycystic ovarian disease: does evolution favour reproductive success over survival?

PubMed

Gleicher, Norbert; Barad, David

2006-05-01

Polycystic ovarian disease (PCOD) is currently considered as possibly the most frequent cause of female infertility. It is also closely associated with syndrome XX, which, in turn, is closely linked with premature and excessive mortality. Considering these adverse effects on reproductive success and human survival, the evolutionary survival of PCOD, itself considered by many to be a genetically transmitted condition, would, on first glance, appear surprising, since evolution usually discriminates against both of these traits. However, an analysis of some recently reported characteristics of the condition calls for the reconsideration of PCOD as a condition which, from an evolutionary viewpoint, favours decreased reproductive success. Indeed, the reported observations that patients with PCOD will resume spontaneous ovulation with even relatively minor weight loss, and experience later menopause than controls, suggests exactly the opposite. Under an evolutionary concept, PCOD can thus be seen as a 'fertility storage condition' which in fact favours human reproductive success and allows the human species to maintain fertility even during adverse environmental circumstances, such as famines.

Herbal medicine use among urban residents in Lagos, Nigeria

PubMed Central

2011-01-01

Background Over three-quarter of the world's population is using herbal medicines with an increasing trend globally. Herbal medicines may be beneficial but are not completely harmless. This study aimed to assess the extent of use and the general knowledge of the benefits and safety of herbal medicines among urban residents in Lagos, Nigeria. Methods The study involved 388 participants recruited by cluster and random sampling techniques. Participants were interviewed with a structured open- and close-ended questionnaire. The information obtained comprises the demography and types of herbal medicines used by the respondents; indications for their use; the sources, benefits and adverse effects of the herbal medicines they used. Results A total of 12 herbal medicines (crude or refined) were used by the respondents, either alone or in combination with other herbal medicines. Herbal medicines were reportedly used by 259 (66.8%) respondents. 'Agbo jedi-jedi' (35%) was the most frequently used herbal medicine preparation, followed by 'agbo-iba' (27.5%) and Oroki herbal mixture® (9%). Family and friends had a marked influence on 78.4% of the respondents who used herbal medicine preparations. Herbal medicines were considered safe by half of the respondents despite 20.8% of those who experienced mild to moderate adverse effects. Conclusions Herbal medicine is popular among the respondents but they appear to be ignorant of its potential toxicities. It may be necessary to evaluate the safety, efficacy and quality of herbal medicines and their products through randomised clinical trial studies. Public enlightenment programme about safe use of herbal medicines may be necessary as a means of minimizing the potential adverse effects. PMID:22117933

The validation of an invitro colonic motility assay as a biomarker for gastrointestinal adverse drug reactions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Keating, Christopher, E-mail: C.Keating@sheffield.ac.u; Martinez, Vicente; Ewart, Lorna

Motility-related gastrointestinal adverse drug reactions (GADRs), such as constipation and diarrhea, are some of the most frequently reported adverse events associated with the clinical development of new chemical entities, and for marketed drugs. However, biomarkers capable of detecting such GADRs are lacking. Here, we describe an in vitro assay developed to detect and quantify changes in intestinal motility as a surrogate biomarker for constipation/diarrhea-type GADRs. In vitro recordings of intraluminal pressure were used to monitor the presence of colonic peristaltic motor complexes (CPMCs) in mouse colonic segments. CPMC frequency, contractile and total mechanical activity were assessed. To validate the assay,more » two experimental protocols were conducted. Initially, five drugs with known gastrointestinal effects were tested to determine optimal parameters describing excitation and inhibition as markers for disturbances in colonic motility. This was followed by a 'blinded' evaluation of nine drugs associated with or without clinically identified constipation/diarrhea-type GADRs. Concentration-response relationships were determined for these drugs and the effects were compared with their maximal free therapeutic plasma concentration in humans. The assay detected stimulatory and inhibitory responses, likely correlating to the occurrence of diarrhea or constipation. Concentration-related effects were identified and potential mechanisms of action were inferred for several drugs. Based on the results from the fourteen drugs assessed, the sensitivity of the assay was calculated at 90%, with a specificity of 75% and predictive capacity of 86%. These results support the potential use of this assay in screening for motility-related GADRs during early discovery phase, safety pharmacology assessment.« less

Antibiotic Self-Medication among Non-Medical University Students in Punjab, Pakistan: A Cross-Sectional Survey

PubMed Central

Gillani, Ali Hassan; Ji, Wenjing; Hussain, Waqar; Imran, Ali; Chang, Jie; Yang, Caijun; Fang, Yu

2017-01-01

Background: Antibiotic resistance is a global threat. Scarce knowledge about safe and appropriate antibiotic use is coupled with frequent self-administration, e.g., in China. This repeated self-medication poses potential risk in terms of antibiotic resistance. Low-resource countries are facing an elevated burden of antibiotic self-medication as compared to developed ones. Thus, this study focused on evaluating the pervasiveness of antibiotic self-medication in 3 universities of Southern Punjab, Pakistan. Methods: We conducted a descriptive cross-sectional survey in three government sector universities of Southern Punjab, Pakistan. The study was carried out with self-administered paper-based questionnaires. Data was analyzed using SPSS version 18.0 (IBM, Chicago, IL, USA). Results: Seven hundred twenty-seven students out of 750 (response rate 97%) with a mean age ± SD of 23.0 ± 3.4 years agreed to participate in the study. The proportion of females was slightly greater (52%) compared with males (48%), and almost one-third of the respondents (36%) were in their 2nd year of university. Out of the total, 58.3% practiced self-medication in the preceding six months, and 326 (45%) confirmed the use of antibiotics. Metronidazole was the most frequently self-medicated antibiotic (48%). Out of the total, 72% demonstrated awareness regarding the side effects of antibiotics. Diarrhea was the well-known adverse effect (38%). Forty-three percent affirmed having antibiotic resistance knowledge, and 30% knew that the irregular use of antibiotics would lead to increased antibiotic resistance. Conclusion: Despite having ample awareness of the adverse antibiotic reactions, self-medication among the university students was high and antibiotic resistance was a fairly unknown term. PMID:28961191

MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.

PubMed

Goetz, Matthew P; Toi, Masakazu; Campone, Mario; Sohn, Joohyuk; Paluch-Shimon, Shani; Huober, Jens; Park, In Hae; Trédan, Olivier; Chen, Shin-Cheh; Manso, Luis; Freedman, Orit C; Garnica Jaliffe, Georgina; Forrester, Tammy; Frenzel, Martin; Barriga, Susana; Smith, Ian C; Bourayou, Nawel; Di Leo, Angelo

2017-11-10

Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.

Antibiotic Self-Medication among Non-Medical University Students in Punjab, Pakistan: A Cross-Sectional Survey.

PubMed

Gillani, Ali Hassan; Ji, Wenjing; Hussain, Waqar; Imran, Ali; Chang, Jie; Yang, Caijun; Fang, Yu

2017-09-29

Background : Antibiotic resistance is a global threat. Scarce knowledge about safe and appropriate antibiotic use is coupled with frequent self-administration, e.g., in China. This repeated self-medication poses potential risk in terms of antibiotic resistance. Low-resource countries are facing an elevated burden of antibiotic self-medication as compared to developed ones. Thus, this study focused on evaluating the pervasiveness of antibiotic self-medication in 3 universities of Southern Punjab, Pakistan. Methods : We conducted a descriptive cross-sectional survey in three government sector universities of Southern Punjab, Pakistan. The study was carried out with self-administered paper-based questionnaires. Data was analyzed using SPSS version 18.0 (IBM, Chicago, IL, USA). Results : Seven hundred twenty-seven students out of 750 (response rate 97%) with a mean age ± SD of 23.0 ± 3.4 years agreed to participate in the study. The proportion of females was slightly greater (52%) compared with males (48%), and almost one-third of the respondents (36%) were in their 2nd year of university. Out of the total, 58.3% practiced self-medication in the preceding six months, and 326 (45%) confirmed the use of antibiotics. Metronidazole was the most frequently self-medicated antibiotic (48%). Out of the total, 72% demonstrated awareness regarding the side effects of antibiotics. Diarrhea was the well-known adverse effect (38%). Forty-three percent affirmed having antibiotic resistance knowledge, and 30% knew that the irregular use of antibiotics would lead to increased antibiotic resistance. Conclusion : Despite having ample awareness of the adverse antibiotic reactions, self-medication among the university students was high and antibiotic resistance was a fairly unknown term.

Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse.

PubMed

Swank, Kimberley A; Wu, Eileen; Kortepeter, Cindy; McAninch, Jana; Levin, Robert L

The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016. Forty-eight cases of serious cardiac adverse events associated with loperamide use composed the case series. The most frequently reported cardiac adverse events were syncope (n = 24), cardiac arrest (n = 13), QT-interval prolongation (n = 13), ventricular tachycardia (n = 10), and TdP (n = 7). There were 10 cases that resulted in death. Of the 48 cases, the most commonly reported reasons for use can be characterized as drug abuse (n = 22) and diarrhea treatment (n = 17). More than one-half of the 48 cases were reported after 2010. Of the 22 drug abuse cases, the median daily dose was 250 mg (range 70 mg to 1600 mg) and events occurred as early as 6 hours after a dose and as long as 18 months after initiation of loperamide. Thirteen of the 22 cases reported using loperamide for euphoric or analgesic effects, and 9 reported use to prevent opioid withdrawal symptoms. The FAERS case reports provide evidence to suggest that high doses of loperamide are associated with TdP and other serious cardiac adverse events. The majority of cases in this series occurred in the setting of drug abuse for the purpose of preventing opioid withdrawal or to produce euphoric effects. It is important for both clinicians and patients to be aware of this potential risk, because prompt therapy and discontinuation of the offending agent are often essential to management and prevention of loperamide-induced cardiac arrhythmias. Published by Elsevier Inc.

The incidence and cost of cardiac surgery adverse events in Australian (Victorian) hospitals 2003-2004.

PubMed

Ehsani, Jonathon Pouya; Duckett, Stephen J; Jackson, Terri

2007-12-01

The aim of this study was to estimate the incidence of adverse events in acute surgical admissions for cardiac disease in admitted episodes in the year 2003-2004 and to estimate the cost of these complications to the Victorian health system. Cardiac surgery adverse events are among the most frequent and significant contributors to the morbidity, mortality and cost associated with hospitalisation. Patient-level costing data set for major Victorian public hospitals in 2003-2004 was analysed for adverse events using C-prefixed markers, denoting complications that arose during the course of hospital treatment for cardiac surgery diagnosis related groups (DRGs). The cost of adverse events was estimated by linear regression modelling, adjusted for age and co-morbidity. A total of 16,766 multi-day cardiac disease cases were identified, of whom 6,181 (36.85%) had at least one adverse event. Patients with adverse events stayed approximately 7 days longer and had four times the case fatality rate than those without. After adjustment for age and co-morbidity, the presence of an adverse event adds AUS$5,751. The sum of the total cost of adverse events for each DRG was AUS$42.855 million, representing 21.6% of total expenditure on cardiac surgery and adding 27.5% in broad terms to the cardiac surgery budget.

[Safety profile of dolutegravir].

PubMed

Rivero, Antonio; Domingo, Pere

2015-03-01

Integrase inhibitors are the latest drug family to be added to the therapeutic arsenal against human immunodeficiency virus infection. Drugs in this family that do not require pharmacological boosting are characterized by a very good safety profile. The latest integrase inhibitor to be approved for use is dolutegravir. In clinical trials, dolutegravir has shown an excellent tolerability profile, both in antiretroviral-naïve and previously treated patients. Discontinuation rates due to adverse effects were 2% and 3%, respectively. The most frequent adverse effects were nausea, headache, diarrhea and sleep disturbance. A severe hypersensitivity reaction has been reported in only one patient. In patients coinfected with hepatropic viruses, the safety profile is similar to that in patients without coinfection. The lipid profile of dolutegravir is similar to that of raltegravir and superior to those of Atripla® and darunavir/ritonavir. Dolutegravir induces an early, predictable and non-progressive increase in serum creatinine of around 10% of baseline values in treatment-naïve patients and of 14% in treatment-experienced patients. This increase is due to inhibition of tubular creatinine secretion through the OCT2 receptor and does not lead to a real decrease in estimated glomerular filtration rate with algorithms that include serum creatinine. The effect of the combination of dolutegravir plus Kivexa(®) on biomarkers of bone remodeling is lower than that of Atripla(®). Dolutegravir has an excellent tolerability profile with no current evidence of long-term adverse effects. Its use is accompanied by an early and non-progressive increase in serum creatinine due to OCT2 receptor inhibition. In combination with abacavir/lamivudine, dolutegravir has a lower impact than enofovir/emtricitabine/efavirenz on bone remodelling markers. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Lifestyle counseling in overweight truck and bus drivers - Effects on dietary patterns and physical activity.

PubMed

Puhkala, Jatta; Kukkonen-Harjula, Katriina; Aittasalo, Minna; Mansikkamäki, Kirsi; Partinen, Markku; Hublin, Christer; Kärmeniemi, Paula; Sallinen, Mikael; Olkkonen, Seppo; Tokola, Kari; Ojala, Anna; Nygård, Clas-Håkan; Fogelholm, Mikael

2016-12-01

We studied dietary patterns, physical activity (PA), and monthly goal setting in a weight reduction intervention in long-distance professional drivers. The study was conducted in Finland in 2009-2012. Male drivers with waist circumference > 100 cm were randomized to a lifestyle counseling (LIFE, N = 55) and a reference (REF, N = 58) group. During 12 months, LIFE participated in 6 face-to-face and 7 telephone counseling sessions on diet and PA. Dietary patterns were assessed using an index combining food diary and counselor interview, and PA with the number of daily steps using a pedometer. Monthly lifestyle goals, perceived facilitators and barriers, and adverse effects of PA in the LIFE participants were monitored using counselors' log books. Forty-seven (85%) LIFE participants completed the 12-month program. After 12 months, the mean dietary index score improved by 12% (p = 0.002, N = 24), and the number of daily steps increased by 1811 steps (median; p = 0.01, N = 22). The most frequent dietary goals dealt with meal frequency, plate model, and intake of vegetables, fruits, and berries. The most common PA mode was walking. Typical facilitators to reach monthly lifestyle goals were support from family and friends and ailment prevention; typical barriers were working schedules and ailments. Adverse effects, most commonly musculoskeletal pain, occurred among 83% of the LIFE participants. Positive changes in lifestyle habits were observed during counseling. Monthly lifestyle counseling combining face-to-face and phone contacts seemed appropriate to long-distance drivers. Barriers for reaching lifestyle changes, and adverse effects of PA were common and need to be addressed when planning counseling. Clinical Trials NCT00893646.

Useful biomarkers for assessing the adverse health effects of PCBs in allergic children: pediatric molecular epidemiology.

PubMed

Tsuji, Mayumi

2015-01-01

The incidences of childhood allergies have been increasing in recent years in many parts of the world. The development of allergic disorders is attributed to a complex series of interactions between individuals' genetic backgrounds and their immune and psychoneurotic responses to environmental factors. Among the various possible environmental causes of childhood allergies, the early exposure of developing infants to air pollutants and the presence of persistent chemical pollutants such as pesticides have been suggested most frequently. Therefore, it is very important to obtain epidemiological evidence of direct associations between clearly defined adverse health effects and exposure to low levels of pollutants. However, there are no useful biomarkers for assessing such associations. Thus, we planned to establish reliable health-related biomarkers that could be used to investigate these relationships in children. The serum concentrations of several sub-types of polychlorinated biphenyl (PCB) congeners were found to be significantly correlated with interleukin (IL)-8 mRNA expression among asthmatic children. In addition, IL-22 mRNA expression was found to be particularly useful for detecting the effects of environmental pollutants, especially PCB congeners, in a sub-population of vulnerable children who exhibited positive immunoglobulin E (IgE) responses to milk or egg. Furthermore, we detected significant differences in IL-22 mRNA expression between the IgE-negative non-asthmatic subjects and the asthmatic children who exhibited positive IgE reactions toward egg or milk. In conclusion, IL-8 and IL-22 mRNA expressions could be useful biomarkers for detecting sub-populations of children who are particularly vulnerable to the adverse health effects of environmental pollutants, especially PCBs.

Subthalamus stimulation in Parkinson disease: Accounting for the bilaterality of contacts.

PubMed

Lemaire, Jean-Jacques; Pereira, Bruno; Derost, Philippe; Vassal, François; Ulla, Miguel; Morand, Dominique; Coll, Guillaume; Gabrillargues, Jean; Marques, Ana; Debilly, Bérangère; Coste, Jérôme; Durif, Franck

2016-01-01

Deep brain stimulation (DBS) in Parkinson's disease uses bi-hemispheric high-frequency stimulation within the subthalamus, however, the specific impacts of bilaterality of DBS are still not clear. Thus, we aimed to study the individual-level clinical impact of locations of right-left contact pair-up accounting for each subthalamic nucleus (STN) anatomy. Contact locations and effects at 1 year were studied retrospectively in an unselected series of 53 patients operated between 2004 and 2010. Location of contacts was defined relatively to the main axis of STN used to map longitudinal and transversal positions, and STN membership (out meaning out-of-STN). Contact pairings were described via three methods: (i) Unified contact location (UCL) collapsing DBS into an all-in-one contact; (ii) balance of contact pair-up (BCPU), defined as symmetric or asymmetric regardless of laterality; (iii) hemisphere-wise most frequent contact pair-up (MFCP) regardless of BCPU. Clinical data were: mean levodopa equivalent dose, Unified Parkinson's Disease Rating Scale (UPDRS) motor score III without medication, UPDRS II and III speech sub-scores, UPDRS II freezing sub-score, 1 year versus preoperative values, with and without levodopa. Ad-hoc two-sided tests were used for statistical analysis. Worsening speech, was more frequent for UCL_out patients and when the left MFCP contact was rear and/or superolateral, however, it less frequent for BCPU-asymmetric patients. Worsening freezing was more frequent when the right MFCP contact was rear and superolateral. These results point to strategies for minimizing dysarthria and freezing as adverse effects of DBS.

Subthalamus stimulation in Parkinson disease: Accounting for the bilaterality of contacts

PubMed Central

Lemaire, Jean-Jacques; Pereira, Bruno; Derost, Philippe; Vassal, François; Ulla, Miguel; Morand, Dominique; Coll, Guillaume; Gabrillargues, Jean; Marques, Ana; Debilly, Bérangère; Coste, Jérôme; Durif, Franck

2016-01-01

Background: Deep brain stimulation (DBS) in Parkinson's disease uses bi-hemispheric high-frequency stimulation within the subthalamus, however, the specific impacts of bilaterality of DBS are still not clear. Thus, we aimed to study the individual-level clinical impact of locations of right-left contact pair-up accounting for each subthalamic nucleus (STN) anatomy. Methods: Contact locations and effects at 1 year were studied retrospectively in an unselected series of 53 patients operated between 2004 and 2010. Location of contacts was defined relatively to the main axis of STN used to map longitudinal and transversal positions, and STN membership (out meaning out-of-STN). Contact pairings were described via three methods: (i) Unified contact location (UCL) collapsing DBS into an all-in-one contact; (ii) balance of contact pair-up (BCPU), defined as symmetric or asymmetric regardless of laterality; (iii) hemisphere-wise most frequent contact pair-up (MFCP) regardless of BCPU. Clinical data were: mean levodopa equivalent dose, Unified Parkinson's Disease Rating Scale (UPDRS) motor score III without medication, UPDRS II and III speech sub-scores, UPDRS II freezing sub-score, 1 year versus preoperative values, with and without levodopa. Ad-hoc two-sided tests were used for statistical analysis. Results: Worsening speech, was more frequent for UCL_out patients and when the left MFCP contact was rear and/or superolateral, however, it less frequent for BCPU-asymmetric patients. Worsening freezing was more frequent when the right MFCP contact was rear and superolateral. Conclusions: These results point to strategies for minimizing dysarthria and freezing as adverse effects of DBS. PMID:27990316

A hierarchical anatomical classification schema for prediction of phenotypic side effects

PubMed Central

Kanji, Rakesh

2018-01-01

Prediction of adverse drug reactions is an important problem in drug discovery endeavors which can be addressed with data-driven strategies. SIDER is one of the most reliable and frequently used datasets for identification of key features as well as building machine learning models for side effects prediction. The inherently unbalanced nature of this data presents with a difficult multi-label multi-class problem towards prediction of drug side effects. We highlight the intrinsic issue with SIDER data and methodological flaws in relying on performance measures such as AUC while attempting to predict side effects.We argue for the use of metrics that are robust to class imbalance for evaluation of classifiers. Importantly, we present a ‘hierarchical anatomical classification schema’ which aggregates side effects into organs, sub-systems, and systems. With the help of a weighted performance measure, using 5-fold cross-validation we show that this strategy facilitates biologically meaningful side effects prediction at different levels of anatomical hierarchy. By implementing various machine learning classifiers we show that Random Forest model yields best classification accuracy at each level of coarse-graining. The manually curated, hierarchical schema for side effects can also serve as the basis of future studies towards prediction of adverse reactions and identification of key features linked to specific organ systems. Our study provides a strategy for hierarchical classification of side effects rooted in the anatomy and can pave the way for calibrated expert systems for multi-level prediction of side effects. PMID:29494708

A hierarchical anatomical classification schema for prediction of phenotypic side effects.

PubMed

Wadhwa, Somin; Gupta, Aishwarya; Dokania, Shubham; Kanji, Rakesh; Bagler, Ganesh

2018-01-01

Prediction of adverse drug reactions is an important problem in drug discovery endeavors which can be addressed with data-driven strategies. SIDER is one of the most reliable and frequently used datasets for identification of key features as well as building machine learning models for side effects prediction. The inherently unbalanced nature of this data presents with a difficult multi-label multi-class problem towards prediction of drug side effects. We highlight the intrinsic issue with SIDER data and methodological flaws in relying on performance measures such as AUC while attempting to predict side effects.We argue for the use of metrics that are robust to class imbalance for evaluation of classifiers. Importantly, we present a 'hierarchical anatomical classification schema' which aggregates side effects into organs, sub-systems, and systems. With the help of a weighted performance measure, using 5-fold cross-validation we show that this strategy facilitates biologically meaningful side effects prediction at different levels of anatomical hierarchy. By implementing various machine learning classifiers we show that Random Forest model yields best classification accuracy at each level of coarse-graining. The manually curated, hierarchical schema for side effects can also serve as the basis of future studies towards prediction of adverse reactions and identification of key features linked to specific organ systems. Our study provides a strategy for hierarchical classification of side effects rooted in the anatomy and can pave the way for calibrated expert systems for multi-level prediction of side effects.

[Effects of urban noise on mental health].

PubMed

Belojević, G; Jakovljević, B; Kocijancić, R; Pjerotić, L; Dimitrijević, J

1995-01-01

The results of the latest studies on the effects of urban noise on mental health are presented in this paper. Numerous psychiatric symptoms have been frequently noticed in the population of the settlements with a high level of urban noise: fatigue, headaches, tension, anxiety, irritability, bad concentration, insomnia, whith a consequently high consumption of psychotropic medicines. Higher admission rates in psychiatric hospitals have been noticed from noisy areas in comparison with low noise regions. By use of diagnostic psychiatric interviews it has been shown as well, that in sensitive categories of population positive correlation can be expected between the number of persons with mental disorder and the level of environmental noise. Noise annoyance and sleep disturbance, namely shortening or absence of the sleep phase 4 and REM, are the basic negative psychological effects of noise, with an adverse effect on mental health in general.

[Air pollution and cardiovascular toxicity: known risks].

PubMed

Kostrzewa, A; Filleul, L; Eilstein, D; Harrabi, I; Tessier, J F

2004-03-01

Review of studies about epidemiological and physiopathological knowledge of ambient air particles short-term cardio-vascular effects. CURRENTS AND STRONG POINTS: Many studies, in contrasted countries for pollution's sources, meteorological conditions or socio-demographical characteristics, have shown health effects due to ambient air particles. After having studied mainly the respiratory effects of particulate air pollution, epidemiologists are now interested in the cardio-vascular effects of ambient air particles. In fact, serious effects seem to exist in fragile people which can get to emergency department visits, hospitalisation and even death. In addition, studies have shown less serious effects, but likely to be frequent (cardiac symptoms, and stoppages for cardio-vascular causes, notably). The exact mechanism by which particles have cardio-vascular adverse health effects is unknown, but experimental and epidemiological studies have led to several hypotheses: local pulmonary effects seem to be followed by systemic effects, which would be responsible for effects on the electrical activity of the heart through cardiac autonomic dysfunction and effects on the blood supply to the heart. The objective of this work is to summarise epidemiological and physiopathological knowledge about the cardio-vascular effects of ambient air particles. To evaluate the real importance of cardio-vascular effects due to particulate air pollution and to identify their exact mechanism, a more precise knowledge of detailed causes of deaths and hospitalisations and a better knowledge of less serious effects, but likely to be frequent, is necessary. Equally, a detailed identification of fragile people is essential for developing preventive actions.

Adaptation to vestibular disorientation. VIII, "Coriolis" vestibular stimulation and the influence of different visual surrounds.

DOT National Transportation Integrated Search

1967-08-01

Disorientation caused by 'Coriolis' vestibular reactions has been cited frequently as a significant factor in flying safety. In addition, personnel who maintain rotating radar towers may also be adversely affected by 'Coriolis' problems. In the study...

[Doping, sport and addiction--any links?].

PubMed

Foucart, J; Verbanck, P; Lebrun, P

2015-01-01

Sport is widely encouraged as it is beneficial for health. However, high-performance sport is more and more associated to rather suspicious practices; doping is one of the best example. From a physician point of view, the use of doping agents is obviously a major concern because taking such products often induce serious adverse effects on health. The present manuscript aims to inform physicians about the most frequent doping practices. It also points out that intensive sport can generate an "addictive" behavior sharing with "common"addictions a loss of practice control, a lack of interest in other activities and even a sport's practice detrimental to athlete's health. Analysis of the doping issue needs to take this reality into account as some doping products display an established " addictive" effect.

Description and management of cutaneous side effects during erlotinib and cetuximab treatment in lung and colorectal cancer patients: a prospective and descriptive study of 19 patients.

PubMed

de Noronha e Menezes, Nuno Miguel Bouças Vasconcelos; Lima, Ricardo; Moreira, Ana; Varela, Paulo; Barroso, Ana; Baptista, Armando; Parente, Bárbara

2009-01-01

Erlotinib and cetuximab are human epidermal growth factor receptor inhibitors (EGFRI) that are approved in monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Papulopustular eruptions are the most frequent adverse effect, their occurrence being associated with increased survival in some studies. We describe 19 patients who presented with a rash located mainly to the face and trunk, without presence of comedones, shortly after initiation of EGFRI therapy. We present our algorithm to manage these patients and their respective responses. We also report other therapeutic options and cutaneous alterations that may be seen.

Pediatric Bipolar Disorder: Combination Pharmacotherapy, Adverse Effects, and Treatment of High-Risk Youth.

PubMed

Chang, Kiki D

2016-01-01

Treating bipolar disorder in pediatric patients is challenging because data from rigorous trials of pharmacotherapy in this population are still not plentiful enough. Furthermore, the treatment of children and adolescents is complicated by the frequent need to combine pharmacotherapies to address all bipolar symptoms as well as this population's elevated risk for experiencing side effects. Additionally, young patients with depressive episodes who are at high risk for developing bipolar disorder need careful treatment to prevent or delay the emergence of mania. Despite these challenges, clinicians should evaluate the existing pediatric literature, extrapolate evidence obtained from adult patients, and draw from clinical experience to guide treatment decisions for children and adolescents with bipolar disorder. © Copyright 2016 Physicians Postgraduate Press, Inc.

[Reaven's metabolic syndrome X in the families of individuals with premature cerebrovascular attacks].

PubMed

Vaverková, H; Ficker, L; Vlachová, I; Chudácková, J; Novotný, D; Budíková, M

1993-08-01

In families of subjects with premature ischaemic cerebrovascular attacks (a total of 45 families with 190 members) the authors detected a high incidence of dyslipidaemia, arterial hypertension, impaired glucose tolerance and non-insulin dependent diabetes mellitus, frequently with striking cumulation. The authors investigated therefore the relationship of the insulin level as an indirect reflection of insulin resistance with these risk factors. The fasting insulin levels correlated significantly positively with triglyceride levels, apolipoprotein B, atherogenic indices and negatively with HDL-cholesterol. The probands and siblings with arterial hypertension had significantly higher fasting insulin levels, as compared with subjects without hypertension which was due to a more frequent incidence of overweight. Patients with an impaired glucose tolerance and NIDDM had significantly higher fasting insulin levels and insulin levels after two hours (the latter value was not assessed in diabetes) and unfavourable "atherogenic" lipid and lipoprotein values, as compared with subjects without glucose intolerance and the control group. Overweight (BMI > 26) had an adverse impact on all investigated indicators of lipid and carbohydrate metabolism whereby a W/H ratio > 0.85 as a manifestation of central obesity further accentuated this adverse effect. The authors draw from these results therapeutic conclusions as regards the mentioned risk factors in these families. They emphasize the importance of non-pharmacological intervention of the metabolic X syndrome by weight reduction and more physical activity not only in families of subjects with early atherosclerosis but in the entire population which has a high prevalence of cardiovascular diseases.

The AXL receptor tyrosine kinase is associated with adverse prognosis and distant metastasis in esophageal squamous cell carcinoma

PubMed Central

Wong, Li-Fan; Lee, Jang-Ming

2016-01-01

Esophageal squamous cell carcinoma (ESCC) is a frequently recurrent deadly cancer for which no efficient targeted drug exists. AXL is an adverse prognostic factor in some cancers. Strong clinical evidence to support the prognostic role of AXL in ESCC is lacking. A total of 116 patients diagnosed with operable primary ESCC were enrolled. Both AXL and HER2 expression were detected by immunohistochemistry (IHC) in esophageal tissue and were correlated with the clinical outcome of patients. The efficacy of the AXL targeted drug foretinib was also evaluated in ESCC cells. Expression of AXL was found in about 80 % of ESCC tissue, and was significantly correlated with progression of tumor (P<0.001), increased risk of death (Hazard ratio HR [95 % CI=2.09[1.09-4.04], P=0.028], and distant metastasis (odds ratio OR [95 %CI]=3.96 (1.16-13.60), P=0.029). The adverse clinical impact of AXL was more evident when cumulatively expressed with HER2. In cell model, ESCC cells were more sensitive to AXL inhibitor foretinib than to the HER2 inhibitor lapatinib. Meanwhile, the AXL inhibitor foretinib showed a synergistic effect with HER2 inhibitors and the potential to overcome drug resistance to lapatinib. We thus concluded that AXL is a strong adverse prognostic factor for ESCC. Therapeutic agents targeting AXL have great potential to improve prognosis of ESCC patients. PMID:27172793

[Characterization of adverse drug reactions in adults over 44 years of age in Bogota, January-December, 2012].

PubMed

Chaves, Marlén

2015-01-01

In Colombia, aging of the population is a reality and elders consume more drugs than the young do. Consequently, they are more exposed to adverse drug reactions. To characterize suspected adverse drug reactions in adults over 44 years of age in Bogota in 2012. We conducted a pharmacological surveillance study that included 470 reports of adverse drug events and associated problems with the use of drugs in adults over 44 years old included in the database of Bogotá´s pharmacosurveillance program. We evaluated 470 reports of adverse drug events and associated problems with the use of drugs in adults over 44 years of age. From these, 432 reports (91.9%) were classified as suspected adverse drug reactions and 28 (6%), as associated problems with the use of drugs. The incidence rate for adverse drug events reported in Bogotá was 22.5 for every 100,000 elders, which increased in direct proportion to patients´ age. The most frequently reported drug was antibacterials with 94 notifications (20%). The organ system with the highest number of alterations was the skin and annexes with 21.2% of cases. Regarding severity assessment, 69.5% of adverse drug reactions were moderate, and as for causality, most adverse drug reactions were classified as possible, with 45.8% of the reports. The characterization of adverse drug reactions in older adults in Bogotá is similar to that reported in the literature for this population age group.

Development and evaluation of sediment quality guidelines for Florida coastal waters

USGS Publications Warehouse

MacDonald, Donald D.; Carr, R. Scott; Calder, Fred D.; Long, Edward R.; Ingersoll, Christopher G.

1996-01-01

The weight-of-evidence approach to the development of sediment quality guidelines (SQGs) was modified to support the derivation of biological effects-based SQGs for Florida coastal waters. Numerical SQGs were derived for 34 substances, including nine trace metals, 13 individual polycyclic aromatic hydrocarbons (PAHs), three groups of PAHs, total polychlorinated biphenyls (PCBs), seven pesticides and one phthalate ester. For each substance, a threshold effects level (TEL) and a probable effects level (PEL) was calculated. These two values defined three ranges of chemical concentrations, including those that were (1) rarely, (2) occasionally or (3) frequently associated with adverse effects. The SQGs were then evaluated to determine their degree of agreement with other guidelines (an indicator of comparability) and the percent incidence of adverse effects within each concentration range (an indicator of reliability). The guidelines also were used to classify (using a dichotomous system: toxic, with one or more exceedances of the PELs or non-toxic, with no exceedances of the TELs) sediment samples collected from various locations in Florida and the Gulf of Mexico. The accuracy of these predictions was then evaluated using the results of the biological tests that were performed on the same sediment samples. The resultant SQGs were demonstrated to provide practical, reliable and predictive tools for assessing sediment quality in Florida and elsewhere in the southeastern portion of the United States.

MDMA, methamphetamine and their combination: possible lessons for party drug users from recent preclinical research.

PubMed

Clemens, Kelly J; McGregor, Iain S; Hunt, Glenn E; Cornish, Jennifer L

2007-01-01

The substituted amphetamines 3,4-methylenedioxymethamphetamine (MDMA, 'Ecstasy') and methamphetamine (METH, 'ice', 'speed') are increasingly popular drugs amongst party-drug users. Studies with humans have investigated the acute and possible long-term adverse effects of these drugs, yet outcomes of such studies are often ambiguous due to a variety of confounding factors. Studies employing animal models have value in determining the acute and long-term effects of MDMA and METH on brain and behaviour. Self-administration studies show that intravenous METH is a particularly potent reinforcer in rats and other species. In contrast, MDMA appears to have powerful effects in enhancing social behaviour in laboratory animals. Brief exposure to MDMA or METH may produce long-term reductions in dopamine, serotonin and noradrenaline in the brain and alterations in the density of various receptor and transporter proteins. However it is still unclear, particularly in the case of MDMA, whether this reflects a 'neurotoxic' effect of the drug. Lasting alterations in social behaviour, anxiety, depressive symptoms and memory have been demonstrated in laboratory rats given MDMA or METH and this matches long-term changes reported in some human studies. Recent laboratory studies suggest that MDMA/METH combinations may produce greater adverse neurochemical and behavioural effects than either drug alone. This is of some concern given recent evidence that party drug users may be frequently exposed to this combination of drugs.

[Prevalence of hyperimmunization against tetanus and systematic adverse reactions to tetanus toxoid in children].

PubMed

Szenborn, Leszek; Saraczyńska, Elzbieta; Ilnicki, Lucjan

2008-01-01

during the last 30 years we have observed only two children (aged 6 and 3 years) with systemic reactions after tetanus vaccine, given unnecessarily 5 and 10 months after appropriate primary immunization. The adverse reactions after tetanic toxoid appear to be directly related to excessive titre of protecting antibodies. The aim of this paper is to investigate the concentration of tetanus antibodies, which may help to define the risk of adverse reactions. tests were carried out in 190 children (86 male, 104 female) aged 7 (n=95) and 14 (n=95) years. Antibodies to tetanus toxoid were determined using a commercial EIA. all examined children had protective concentration of tetanus antibodies (above 0.01 IU/ml; range from 0.1 to 6.0 IU/mL). There were significant differences between antibodies concentrations (GMC) in children aged 7 and 14 years (0.93 vs. 1,76 IU/ml; p=0.048). The antibodies concentrations above 1 IU/ml which indicate long term protection were more frequently observed in children aged 14 than those aged 7 years (73 vs. 59%; not statistically significant). Only 6.84% of all examined children (n=190) had high antibodies concentration above 5 IU/ml, which could increase the risk of side effects if the next booster would be given during the next 5 years. children in Poland are only slightly exposed to risk of severe side effects after vaccination against tetanus. The tetanus immunity in examined children can be assessed as very good.

Multinomial modeling and an evaluation of common data-mining algorithms for identifying signals of disproportionate reporting in pharmacovigilance databases.

PubMed

Johnson, Kjell; Guo, Cen; Gosink, Mark; Wang, Vicky; Hauben, Manfred

2012-12-01

A principal objective of pharmacovigilance is to detect adverse drug reactions that are unknown or novel in terms of their clinical severity or frequency. One method is through inspection of spontaneous reporting system databases, which consist of millions of reports of patients experiencing adverse effects while taking one or more drugs. For such large databases, there is an increasing need for quantitative and automated screening tools to assist drug safety professionals in identifying drug-event combinations (DECs) worthy of further investigation. Existing algorithms can effectively identify problematic DECs when the frequencies are high. However these algorithms perform differently for low-frequency DECs. In this work, we provide a method based on the multinomial distribution that identifies signals of disproportionate reporting, especially for low-frequency combinations. In addition, we comprehensively compare the performance of commonly used algorithms with the new approach. Simulation results demonstrate the advantages of the proposed method, and analysis of the Adverse Event Reporting System data shows that the proposed method can help detect interesting signals. Furthermore, we suggest that these methods be used to identify DECs that occur significantly less frequently than expected, thus identifying potential alternative indications for these drugs. We provide an empirical example that demonstrates the importance of exploring underexpected DECs. Code to implement the proposed method is available in R on request from the corresponding authors. kjell@arboranalytics.com or Mark.M.Gosink@Pfizer.com Supplementary data are available at Bioinformatics online.

[Sleep disorders and impaired sleep as adverse drug reactions of psychotropic drugs: an evaluation of data of summaries of product characteristics].

PubMed

Gahr, Maximilian; Connemann, Bernhard J; Zeiss, René; Fröhlich, Albrecht

2018-03-02

 Psychopharmacotherapy is essential in the treatment of many mental disorders. Adverse drug reactions (ADR) have impact on compliance and tolerability. Sleep disorders or impaired sleep may occur as ADRs of psychopharmacotherapy. Sleep disorders are associated with an increased risk for physical and mental illness and may impair cognition, impulse control, emotion regulation and mood. Objective of the following study was the systematic presentation of type and risk of sleep disorders/impairments of sleep of frequently prescribed psychotropic drugs.  Psychotropic agents that are most frequently prescribed in Germany were identified by using the Arzneiverordnungs-Report 2016. Summaries of product characteristics (SmPC) of corresponding original products were analyzed regarding presence and frequency of sleep disorders/impairments of sleep according to the International Classification of Sleep Disorders 3 (ICSD-3).  N = 64 SmPCs were analyzed. In most of the analyzed SmPCs, at least one sleep disorder (50/64; 78 %) was listed. At least one SmPC with a corresponding ADR was found in the categories insomnia (52 %), parasomnias (33 %), and sleep-related movement disorders (20 %); sleep-related breathing disorders (6 %) and central disorders of hypersomnolence (5 %) were rarely listed; circadian rhythm sleep-wake disorder was not found. The SmPCs of the four most frequently prescribed agents (citalopram > venlafaxine > mirtazapine > sertraline) listed insomnia as an ADR. Nearly all analysed hypnotics (except chloral hydrate) were associated with nightmares.  Most of the psychotropic agents frequently prescribed in Germany may induce sleep disorders/impairments of sleep. The four most frequently prescribed agents were antidepressants and all of the corresponding SmPCs listed insomnia as a possible ADR. Sleep disorders should be taken seriously as possible ADRs of psychopharmacotherapy. © Georg Thieme Verlag KG Stuttgart · New York.

Abuse and Misuse of Selected Dietary Supplements Among Adolescents: a Look at Poison Center Data

PubMed Central

Morgan, Jill A.; Lardieri, Allison B.; Kishk, Omayma A.; Klein-Schwartz, Wendy

2017-01-01

OBJECTIVE The use of dietary supplements has increased and is associated with adverse effects. Indications for use include recreation, body image concerns, mood enhancement, or control of medical conditions. The risk of adverse effects may be enhanced if agents are used improperly. The objective of this study was to determine the frequency of abuse and misuse of 4 dietary substances among adolescents reported nationally to poison centers. Secondary outcomes included an assessment of medical outcomes, clinical effects, location of treatments provided, and treatments administered. METHODS This descriptive retrospective review assessed data concerning the use of garcinia (Garcinia cambogia), guarana (Paullinia cupana), salvia (Salvia divinorum), and St John's wort (Hypericum perforatum) among adolescents reported nationally to poison centers from 2003 to 2014. Adolescents with a singlesubstance exposure to one of the substances of interest coded as intentional abuse or misuse were included. Poison center calls for drug information or those with unrelated clinical effects were excluded. Data were collected from the National Poison Data System. RESULTS There were 84 cases: 7 cases of Garcinia cambogia, 28 Paullinia cupana, 23 Salvia divinorum, and 26 Hypericum perforatum. Garcinia cambogia was used more frequently by females (100% versus 0%), and Paullinia cupana and Salvia divinorum were used more frequently by males (61% versus 36% and 91% versus 9%, respectively). Abuse, driven by Salvia divinorum, was more common overall than misuse. Abuse was also more common among males than females (p <0.001). Use of these agents fluctuated over time. Overall, use trended down since 2010, except for Garcinia cambogia use. In 62 cases (73.8%), the medical outcome was minor or had no effect or was judged as nontoxic or minimally toxic. Clinical effects were most common with Paullinia cupana and Salvia divinorum. Treatment sites included emergency department (n = 33; 39.3%), non-healthcare facility (n = 24; 28.6%), admission to a health care facility (n = 8; 9.5%), and other/unknown (n = 19; 22.6%). CONCLUSIONS Abuse and misuse of these dietary supplements was uncommon, and outcomes were mild. Further research should be performed to determine use and outcomes of abuse/misuse of other dietary supplements in this population. PMID:29290737

The pros and cons of phytoestrogens

PubMed Central

Patisaul, Heather B.; Jefferson, Wendy

2011-01-01

Phytoestrogens are plant derived compounds found in a wide variety of foods, most notably soy. A litany of health benefits including a lowered risk of osteoporosis, heart disease, breast cancer, and menopausal symptoms, are frequently attributed to phytoestrogens but many are also considered endocrine disruptors, indicating that they have the potential to cause adverse health effects as well. Consequently, the question of whether or not phytoestrogens are beneficial or harmful to human health remains unresolved. The answer is likely complex and may depend on age, health status, and even the presence or absence of specific gut microflora. Clarity on this issue is needed because global consumption is rapidly increasing. Phytoestrogens are present in numerous dietary supplements and widely marketed as a natural alternative to estrogen replacement therapy. Soy infant formula now constitutes up to a third of the US market, and soy protein is now added to many processed foods. As weak estrogen agonists/antagonists with molecular and cellular properties similar to synthetic endocrine disruptors such as Bisphenol A (BPA), the phytoestrogens provide a useful model to comprehensively investigate the biological impact of endocrine disruptors in general. This review weighs the evidence for and against the purported health benefits and adverse effects of phytoestrogens. PMID:20347861

Apatinib is effective for treatment of advanced hepatocellular carcinoma.

PubMed

Kong, Yinlong; Sun, Lin; Hou, Zhenyu; Zhang, Yongqiang; Chen, Ping; Cui, Yunlong; Zhu, Xiaolin; Song, Tianqiang; Li, Qiang; Li, Huikai; Zhang, Ti; Qin, Lunxiu

2017-12-01

As treatment options for hepatocellular carcinoma (HCC) are currently limited, we evaluated the efficacy and safety of oral apatinib, a VEGFR-2 inhibitor, on patients with advanced HCC. Twenty-two patients from Tianjin Medical University Cancer Institute and Hospital were enrolled for evaluation. Apatinib was administered at 500 mg/day or 250 mg/day continuously. Clinical endpoints were time to disease progression (TTP), overall survival (OS), and safety. The median TTP of treated patients was 10.4 months (95% CI 3.4 -17.5). At the last follow-up, 50% patients had survived longer than 11.4 months from the first dose. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) rates were 0%, 40.9%, 40.9%, and 18.2%, respectively. The most common apatinib-related adverse events were hand-foot skin reaction (HFSR) (81.8%) and diarrhea (77.3%). Hypertension (27.3%) and HFSR (13.6%) were the most frequent grade 3/4 adverse events. In summary, results of this small study indicate that apatinib is well tolerated and extremely effective for the treatment of advanced HCC. It is therefore imperative to design and carry out well-controlled clinical trials to confirm its efficacy.

A new oral contraceptive regimen for endometriosis management: preliminary experience with 24/4-day drospirenone/ethinylestradiol 3 mg/20 mcg.

PubMed

Mabrouk, Mohamed; Solfrini, Serena; Frascà, Clarissa; Del Forno, Simona; Montanari, Giulia; Ferrini, Giulia; Paradisi, Roberto; Seracchioli, Renato

2012-06-01

We report our preliminary experience with the use of a low-dose oral contraceptive containing Drospirenone/Ethinylestradiol 3 mg/20 mcg, both in cyclic and continuous regimen for endometriosis management. A total of 93 women were retrospectively included: 52 were treated by medical therapy (exclusive combined oral contraceptives (COC)-users), while 41 were submitted to surgery followed by postoperative therapy (postoperative COC-users). A clinical examination was performed at baseline and at 6-months follow-up. Presence and intensity of endometriosis-related symptoms were assessed by a visual analogue scale. Presence and dimension of endometriotic lesions were evaluated by transvaginal ultrasonography. Adverse effects and tolerability were analysed. In exclusive COC-users, significant reductions in dysmenorrhoea and dyspareunia scores and in endometrioma mean diameter were observed at follow-up. In postoperative COC-users, anatomical and symptom recurrence rates at follow-up were 4.9% and 17%, respectively. The most frequent adverse effects were spotting and headache. No difference between cyclic and continuous regimen in terms of symptom relief, lesion progression and tolerability was observed. From our preliminary experience, Drospirenone/Ethinylestradiol 3 mg/20 mcg seems to be promising in endometriosis management.

The syndemics of childhood diarrhoea: A biosocial perspective on efforts to combat global inequities in diarrhoea-related morbidity and mortality

PubMed Central

Bulled, Nicola; Singer, Merrill; Dillingham, Rebecca

2014-01-01

Diarrhoea remains the second leading cause of death in children under 5 years. Moreover, morbidity as a result of diarrhoea is high particularly in marginalized communities. Frequent bouts of diarrhoea have deleterious and irreversible effects on physical and cognitive development. Children are especially vulnerable given their inability to mount an active immune response to pathogen exposure. Biological limitations are exacerbated by the long term effects of poverty, including reduced nutrition, poor hygiene, and deprived home environments. Drawing from available literature, this paper uses syndemic theory to explore the role of adverse biosocial interactions in increasing the total disease burden of enteric infections in low-resources populations and assess the limitations of recent global calls to action. The syndemic perspective describes situations in which adverse social conditions, including inequality, poverty, and other forms of political and economic oppression, play a critical role in facilitating disease-disease interactions. Given the complex micro and macro nature of childhood diarrhoea including interactions between pathogens, disease conditions and social environments, the syndemic perspective offers a way forward. While rarely the focus of health interventions, technologically advanced biomedical strategies are likely to be more effective if coupled with interventions that address the social conditions of disparity. PMID:25005132

Current research on pharmacologic and regenerative therapies for osteoarthritis

PubMed Central

Zhang, Wei; Ouyang, Hongwei; Dass, Crispin R; Xu, Jiake

2016-01-01

Osteoarthritis (OA) is a degenerative joint disorder commonly encountered in clinical practice, and is the leading cause of disability in elderly people. Due to the poor self-healing capacity of articular cartilage and lack of specific diagnostic biomarkers, OA is a challenging disease with limited treatment options. Traditional pharmacologic therapies such as acetaminophen, non-steroidal anti-inflammatory drugs, and opioids are effective in relieving pain but are incapable of reversing cartilage damage and are frequently associated with adverse events. Current research focuses on the development of new OA drugs (such as sprifermin/recombinant human fibroblast growth factor-18, tanezumab/monoclonal antibody against β-nerve growth factor), which aims for more effectiveness and less incidence of adverse effects than the traditional ones. Furthermore, regenerative therapies (such as autologous chondrocyte implantation (ACI), new generation of matrix-induced ACI, cell-free scaffolds, induced pluripotent stem cells (iPS cells or iPSCs), and endogenous cell homing) are also emerging as promising alternatives as they have potential to enhance cartilage repair, and ultimately restore healthy tissue. However, despite currently available therapies and research advances, there remain unmet medical needs in the treatment of OA. This review highlights current research progress on pharmacologic and regenerative therapies for OA including key advances and potential limitations. PMID:26962464

Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

PubMed

Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

2014-01-01

A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

Deuterium Tetrabenazine for Tardive Dyskinesia.

PubMed

Cummings, Michael A; Proctor, George J; Stahl, Stephen M

2018-01-01

Tardive dyskinesia remains a significant, potentially stigmatizing or crippling adverse effect for any patient treated with an antipsychotic medication. While second- and third-generation antipsychotics have exhibited lower annual incidence rates for tardive dyskinesia than classic or first-generation agents, 3.9% versus 5.5%, the estimated incidence rate is only modestly lower. When coupled with the fact that second- and third-generation antipsychotic medications have come to be employed in treating a wider range of disorders (e.g., autism spectrum disorders, mood disorders, personality disorders, etc.), it is clear that the population of patients exposed to the risk of tardive dyskinesia has expanded. On April 3, 2017, the U.S. Food and Drug Administration (FDA) approved a deuterated version of tetrabenazine (Xenozine®) for the treatment of the involuntary choreic movements associated with Huntington's disease. More recent data, however, have indicated that deuterium tetrabenazine or deutetrabenazine (Austedo®) is effective in treating tardive dyskinesia. Moreover, like the other derivative of tetrabenazine, valbenazine (Ingrezza®), deutetrabenazine offers less frequent dosing and a better short-term adverse effect profile than that of tetrabenazine. Longer use in a broader range of patients, however, will be required to identify risks and benefits not found in short-term trials, as well as optimal use parameters for treatment of tardive dyskinesia.

Impact of mycotoxins on human health in developing countries.

PubMed

Shephard, G S

2008-02-01

Adverse human health effects from the consumption of mycotoxins have occurred for many centuries. Although mycotoxin contamination of agricultural products still occurs in the developed world, the application of modern agricultural practices and the presence of a legislatively regulated food processing and marketing system have greatly reduced mycotoxin exposure in these populations. At the mycotoxin contamination levels generally found in food products traded in these market economies, adverse human health effects have largely been overcome. However, in the developing world, where climatic and crop storage conditions are frequently conducive to fungal growth and mycotoxin production, much of the population relies on subsistence farming or on unregulated local markets. The extent to which mycotoxins affect human health is difficult to investigate in countries whose health systems lack capacity and in which resources are limited. Aflatoxin B(1), the toxin on which major resources have been expended, has long been linked to liver cancer, yet its other effects, such as immune suppression and growth faltering previously observed in veterinary studies, are only now being investigated and characterized in human populations. The extent to which factors such as immune suppression contribute to the overall burden of infectious disease is difficult to quantify, but is undoubtedly significant. Thus, food safety remains an important opportunity for addressing current health problems in developing countries.

The efficacy and safety of alectinib in the treatment of ALK+ NSCLC: a systematic review and meta-analysis

PubMed Central

Chen, Yuqing; Qian, Ruolan; Liu, Sihan; You, Danming; Zhang, Jian; Luo, Peng

2018-01-01

Background Alectinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor approved by the US Food and Drug Administration to treat crizotinib-refractory non-small cell lung cancer. We performed this meta-analysis to synthesize the results of different clinical trials to evaluate the efficacy and safety of alectinib. Methods A search of 3 databases, including PubMed, Web of Science, and the Cochrane Library, was performed from the inception of each database through September 5, 2017. We have pooled the overall response rate (ORR), disease control rate, progression-free survival, and intracranial ORR to evaluate the efficacy of alectinib. Discontinuation rate, rate of dose reduction or interruption due to adverse events as well as the incidence of several adverse events were aggregated to evaluate its safety. Results A total of 8 studies with 626 patients have been included in our study. The pooled efficacy parameters are as follows: ORR 70% (95% CI: 57% to 82%), disease control rate 88% (95% CI: 82% to 94%), progression-free survival 9.36 months (95% CI: 7.38% to 11.34%), and intracranial ORR 52% (95% CI: 45% to 59%). ALK inhibitor-naïve patients tend to have better responses than crizotinib-pretreated patients. The aggregate discontinuation rate is 7% (95% CI: 4% to 10%), and the pooled rate of dose reduction or interruption is 33% (95% CI: 24% to 42%). The incidences of most adverse events were relatively low, while the incidences of 2 frequently reported adverse events, myalgia (18%) and anemia (25%), were even higher than with the first-generation ALK inhibitor crizotinib. Conclusion Generally, alectinib is a drug with preferable efficacy and tolerable adverse effects, and it is suitable for the treatment of intracranial metastases. PMID:29535535

The efficacy and safety of alectinib in the treatment of ALK+ NSCLC: a systematic review and meta-analysis.

PubMed

Fan, Junsheng; Xia, Zengfei; Zhang, Xiaoli; Chen, Yuqing; Qian, Ruolan; Liu, Sihan; You, Danming; Zhang, Jian; Luo, Peng

2018-01-01

Alectinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor approved by the US Food and Drug Administration to treat crizotinib-refractory non-small cell lung cancer. We performed this meta-analysis to synthesize the results of different clinical trials to evaluate the efficacy and safety of alectinib. A search of 3 databases, including PubMed, Web of Science, and the Cochrane Library, was performed from the inception of each database through September 5, 2017. We have pooled the overall response rate (ORR), disease control rate, progression-free survival, and intracranial ORR to evaluate the efficacy of alectinib. Discontinuation rate, rate of dose reduction or interruption due to adverse events as well as the incidence of several adverse events were aggregated to evaluate its safety. A total of 8 studies with 626 patients have been included in our study. The pooled efficacy parameters are as follows: ORR 70% (95% CI: 57% to 82%), disease control rate 88% (95% CI: 82% to 94%), progression-free survival 9.36 months (95% CI: 7.38% to 11.34%), and intracranial ORR 52% (95% CI: 45% to 59%). ALK inhibitor-naïve patients tend to have better responses than crizotinib-pretreated patients. The aggregate discontinuation rate is 7% (95% CI: 4% to 10%), and the pooled rate of dose reduction or interruption is 33% (95% CI: 24% to 42%). The incidences of most adverse events were relatively low, while the incidences of 2 frequently reported adverse events, myalgia (18%) and anemia (25%), were even higher than with the first-generation ALK inhibitor crizotinib. Generally, alectinib is a drug with preferable efficacy and tolerable adverse effects, and it is suitable for the treatment of intracranial metastases.

The impact of childhood adversities on anxiety and depressive disorders in adulthood.

PubMed

Marackova, Marketa; Prasko, Jan; Matousek, Stanislav; Latalova, Klara; Hruby, Radovan; Holubova, Michaela; Slepecky, Milos; Vrbova, Kristyna; Grambal, Ales

2016-12-01

The childhood adversities model is generally accepted as a predictor of adult psychopathology vulnerability. It stems from child development theories, but the question remains as of how well solid research supports it. The aim of this article is to give a review of the studies concerning childhood adversities and their impact on the development of anxiety disorders and major depressive disorder in adulthood. A computerized search of the MEDLINE database of publications up to 31 March 2016 was done, using the keywords "childhood adversities, abuse, maltreatment, bullying" and "anxiety disorders, depressive disorder". No backward time constraints were used. Non-original studies, conference abstracts, books and book chapters, commentaries, and dissertations were excluded. The influence of childhood adversities on later age psychopathology is examined in five categories: the negative family atmosphere, abuse, loss of a close person, the social difficulties, and problems at school (including, most importantly bullying). The majority of studies confirmed the connection between childhood adversities and anxiety and depression disorders in adulthood. The character of the adversities is not, apparently, a specific predictor for a concrete psychopathology. Multiple adversities are more frequently connected with depressive and anxiety disorders in adulthood, cumulating together in broader adverse context. Childhood adversities were found to increase vulnerability to the distress, depression, fear and anxiety later in the life. However, specific correlations between a given childhood adversity and a specific form of depression or anxiety disorder were either not found or weak. This is in line with the generally accepted view considering each of these factors a non-specific stressor increasing vulnerability to mood and affect disorders later in life.

Preventing falls in hospital.

PubMed

Pearce, Lynne

2017-01-04

Falls are the most frequent adverse event reported in hospitals, usually affecting older patients. Every year, more than 240,000 falls are reported in acute hospitals and mental health trusts in England and Wales, equivalent to more than 600 per day, according to the Royal College of Physicians (RCP).

Development of left-turn lane guidelines for signalized and unsignalized intersections.

DOT National Transportation Integrated Search

2004-01-01

It is generally accepted that the level of service (LOS) at intersections significantly affects the overall LOS of the road system. It is also known that the LOS at an intersection can be adversely affected by frequently allowing left-turning vehicle...

Historical Perspectives in the Care of Patients with Enterocutaneous Fistula

DTIC Science & Technology

2010-09-01

correct hypercatabolism and cachexia that are frequently present. Phase 2, or the investigational phase, involves imaging such as a fistulo- gram and...fluid losses, electrolytes, or nutrients, although they highlight how far we have come. The adverse results of malnutrition to include cachexia

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

PubMed

Ryu, JiHyeon; Lee, HeeYoung; Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

2015-01-01

We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

PubMed Central

Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

2015-01-01

Objective We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Methods Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Results Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). Conclusions We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization–Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results. PMID:26544039

Quantifying the Risk of Analgesic-Related Adverse Events After Knee Arthroscopy.

PubMed

Gonzales, Jeff; Lovald, Scott T; Lau, Edmund C; Ong, Kevin L

Opioids are frequently used as part of multimodal pain management protocols for knee arthroscopy; however, their use may be associated with opioid-related adverse events. The purpose of this study was to evaluate the risk of potential analgesic-related complications after knee arthroscopy using a nationally representative database. Using 2010\\endash 2012 Medicare claims data, patients undergoing knee arthroscopy procedures (including ligament repair, meniscectomy, and chondroplasty) were identified. The risk of complications related to typical modalities of analgesia, including opioids, within 90 days following surgery was assessed using multivariate Cox regression. Based on follow-up of 16,567 cases, respiratory complications (bradypnea, pulmonary insufficiency, asphyxia, and hypoxemia) were the most frequently diagnosed complications ( n = 418; 2.52%), followed by postoperative nausea and vomiting ( n = 174; 1.05%) and urinary retention complications ( n = 166; 1.00%). Risk factors including older age, male gender, lower socioeconomic status, and a high number of comorbidities were associated with development of postsurgical complications.

[Safety study of long-term video-electroencephalogram monitoring].

PubMed

Ley, M; Vivanco, R; Massot, A; Jiménez, J; Roquer, J; Rocamora, R

2014-01-01

The increased morbidity and mortality and poorer quality of life associated with drug-resistant epilepsy justify admitting patients to epilepsy monitoring units (EMU). These units employ methods that promote the occurrence of seizures, which involves a risk of secondary adverse events. The aim of our study is to characterise and quantify these adverse events in a Spanish EMU. A descriptive, longitudinal and retrospective study of patients admitted consecutively to our EMU. Patients admitted due to status epilepticus, clusters of seizures, or as participants in a clinical trial were excluded. We included 175 patients, of whom 92.1% (161) did not suffer any adverse events. Status epilepticus was present in 3.4% (6); 1.7% (3) had traumatic injury, 1.7% (3) had interictal or postictal psychosis, and 1.1% (2) had cardiorespiratory impairment. There were no risk factors associated with these adverse events. The most frequently-identified adverse events were status epilepticus, traumatic injury, interictal or postictal psychosis, and cardiorespiratory disorders. The frequency of these adverse events was similar to that seen in international literature. The complications detected do not contraindicate VEEGM. Copyright © 2012 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

Glucocorticoids for Management of Polymyalgia Rheumatica and Giant Cell Arteritis.

PubMed

Matteson, Eric L; Buttgereit, Frank; Dejaco, Christian; Dasgupta, Bhaskar

2016-02-01

Diagnosis of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) is based on typical clinical, histologic, and laboratory features. Ultrasonographic imaging in PMR with assessment especially of subdeltoid bursitis can aid in diagnosis and in following response to treatment. In GCA, diagnosis and disease activity are supported with ultrasonographic, MRI, or [(18)F]fluorodeoxyglucose PET evaluation of large vessels. Glucocorticoids are the primary therapy for PMR and GCA. Methotrexate may be used in patients at high risk for glucocorticoid adverse effects and patients with frequent relapse or needing protracted therapy. Other therapeutic approaches including interleukin 6 antagonists are under evaluation. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluating the Use of Ketamine for Pain Control With Sickle Cell Crisis in Pregnancy: A Report of 2 Cases.

PubMed

Gimovsky, Alexis C; Fritton, Kate; Viscusi, Eugene; Roman, Amanda

2018-01-01

Sickle cell crises occur frequently during pregnancy and are difficult to treat, even with high-dose opioids. Analgesia with ketamine has been suggested as an alternative, but its use during pregnancy is underreported. Two pregnant patients with uncontrolled sickle cell pain were treated with ketamine. Patient A reported no decrease in her pain, but her opioid requirements decreased. Patient B's pain resolved during ketamine administration. No serious maternal or neonatal adverse effects occurred. Ketamine may be considered as an adjunct analgesic in pregnant patients with sickle cell pain, although prospective clinical data are needed to fully assess its efficacy.

[Use of new antidiabetics in the elderly population].

PubMed

Besse, Sarah; Besse, Arun; Jornayvaz, François R

2016-06-01

Over the last few years, we have noticed the arrival on the market of new antidiabetic treatments. These represent an potential advantage because of the increase in the prevalence of type 2 diabetes, particularly in the elderly population. Nevertheless, elderly patients have a number of frailties that should be considered in the treatment of this condition. There is a lack of literature in this population as elderly are frequently excluded from randomized controlled trials. Therefore, guidelines were developed based on the consensus of experts in geriatrics and diabetology for this specific population. We have to consider the potential benefits and adverse effects of the new antidiabetics in older patients.

The importance of communication in sustaining hope at the end of life.

PubMed

Hawthorn, Maureen

How can health professionals, especially those working in busy environments, foster hope and communicate effectively and therapeutically with patients at the end of their lives? Many authors agree that failure to comprehend the essence of what patients are communicating, either verbally or non-verbally, can adversely affect the level of support that health professionals can offer, and risks increasing patients' suffering and isolation, leaving them feeling hopeless. Anxiety and fear frequently invoke hopelessness and often cause patients to reject advice and important information given by clinicians. This article focuses on the importance of therapeutic communication in sustaining hope for patients at the end of life.

[Hiatal hernia and reflux disease--long-term results following fundoplication and consequences in therapeutic failures].

PubMed

Ackermann, C; Margreth, L; Muller, C; Harder, F

1987-01-01

10 to 20 years (median 15.1 years) after fundoplication for primary reflux disease 257 patients were questioned about their symptoms. Data of 163 patients could be analyzed. 21.4% of the patients have persistent or recurrent reflux symptoms, about half of them (9.8%) need medical treatment. Adverse side-effects of the fundoplication are frequent: dysphagia in 28.2%, gas-bloat in 50.3%. Using the Visick criteria for classification we found Visick grade I and II for 75.5%, grade III for 17.2%, and IV for 7.4%. Diagnostic and therapeutic concepts in case of failed reflux control are discussed.

Design and evaluation of a simple signaling device for live traps

USGS Publications Warehouse

Benevides, F.L.; Hansen, H.; Hess, S.C.

2008-01-01

Frequent checks of live traps require enormous amounts of labor and add human scents associated with repeated monitoring, which may reduce capture efficiency. To reduce efforts and increase efficiency, we developed a trap-signaling device with long-distance reception, durability in adverse weather, and ease of transport, deployment, and use. Modifications from previous designs include a normally open magnetic switch and a mounting configuration to maximize reception. The system weighed <225 g, was effective ???17.1 km, and failed in <1% of trap-nights. Employing this system, researchers and wildlife managers may reduce the amount of effort checking traps while improving the welfare of trapped animals.

Intracavitary Therapeutics for Pleural Malignancies.

PubMed

Murthy, Vivek; Mangalick, Keshav; Sterman, Daniel H

2018-03-01

Pleural malignancies remain a serious therapeutic challenge, and are frequently refractory to standard treatment; however, they have the advantage of occurring in an enclosed cavity readily accessible for examination, biopsy, and serial sampling. Novel therapeutics can be administered via intracavitary delivery to maximize efficacy by targeting the site of involvement and potentially mitigating the adverse effects of systemic therapies. The easy accessibility of the pleural space lends itself well to repeated sampling and analysis to determine efficacy and toxicity of a given treatment paradigm. These factors support the rationale for delivery of novel therapeutics directly into the pleural space. Copyright © 2017 Elsevier Inc. All rights reserved.

Outpatient anesthesia for oral surgery in a juvenile with Leigh disease.

PubMed

Ellis, Zachary; Bloomer, Charles

2005-01-01

We report a case of anesthesia for elective outpatient third molar extraction in a juvenile with Leigh disease, a progressive neurodegenerative disorder related to respiratory chain deficiency. This syndrome usually presents in infancy and is characterized by nervous system dysfunction and respiratory abnormalities. Anesthesia has been reported to aggravate respiratory symptoms and frequently precipitate respiratory failure. Preoperative swallowing difficulty or respiratory symptoms should be carefully diagnosed, because they can be a warning sign of postoperative complications or mortality. Adverse effects of anesthesia may quickly lead into metabolic acidosis. Anesthetics should be carefully chosen that do not interfere with mitochondrial respiration, which can lead to lactic acidosis.

Transmission of viral hepatitis by blood and blood derivatives: current risks, past heritage.

PubMed

Prati, D

2002-11-01

For more than 40 years in the history of transfusion medicine, transmission of viral hepatitis from infected donors to recipients has been a frequent and serious adverse effect of the administration of blood components and plasma derivatives. This epidemic is now over, at least in developed and resource-rich countries. Hence, the attention of clinicians and investigators now focuses mainly on the measures to reduce the residual risk, on the possible emergence of novel or undiscovered agents causing post-transfusion hepatitis, and on the long-term outcome of patients who became infected more than ten years ago. The present article reviews these issues.

The electrophysiologic properties of esmolol, a short acting beta-blocker.

PubMed

Greenspan, A M; Spielman, S R; Horowitz, L N; Laddu, A; Senior, S

1988-04-01

Although beta-blockers have established efficacy in treating ventricular ectopy and PSVT, their applicability for acute antiarrhythmic interventions in patients with organic heart disease or COPD, is frequently limited by negative inotropic or bronchospastic side effects. The development of an ultrashort acting beta-blocker with rapid reversibility of its side effects would widen their applicability. Therefore, we tested the electrophysiologic properties of such a new short acting beta-blocker, esmolol, in 14 patients (10 with organic heart disease) with a mean EF of 47.6 +/- 17%, undergoing standard clinical electrophysiologic studies for various indications. Like most other beta-blockers, esmolol's major direct effects were on sinus node function and AV nodal conduction characteristics; significantly prolonging sinus cycle length, cycle length to Wenckebach and AH interval in sinus rhythm and at a paced cycle length of 600 ms. In contrast to most other beta-blockers, following termination of its infusion, esmolol shortened parameters of sinus node function and AV nodal refractoriness, with respect to the control values, suggesting a possible rebound phenomena. These effects occurred within 5 min of terminating the intravenous drug infusion. Esmolol had no significant effect on systolic blood pressure, electrocardiographic intervals and had rare adverse reactions. We conclude that esmolol is an ultra-short acting beta-blocker, with typical direct electrophysiologic effects on sinus node and AV nodal function, and a possible rebound phenomena following its discontinuation that may make it particularly suited to acute antiarrhythmic interventions in patients susceptible to adverse beta-blocker side effects.

Learning from failure in health care: frequent opportunities, pervasive barriers.

PubMed

Edmondson, A C

2004-12-01

The notion that hospitals and medical practices should learn from failures, both their own and others', has obvious appeal. Yet, healthcare organisations that systematically and effectively learn from the failures that occur in the care delivery process, especially from small mistakes and problems rather than from consequential adverse events, are rare. This article explores pervasive barriers embedded in healthcare's organisational systems that make shared or organisational learning from failure difficult and then recommends strategies for overcoming these barriers to learning from failure, emphasising the critical role of leadership. Firstly, leaders must create a compelling vision that motivates and communicates urgency for change; secondly, leaders must work to create an environment of psychological safety that fosters open reporting, active questioning, and frequent sharing of insights and concerns; and thirdly, case study research on one hospital's organisational learning initiative suggests that leaders can empower and support team learning throughout their organisations as a way of identifying, analysing, and removing hazards that threaten patient safety.

Learning from failure in health care: frequent opportunities, pervasive barriers

PubMed Central

Edmondson, A

2004-01-01

The notion that hospitals and medical practices should learn from failures, both their own and others', has obvious appeal. Yet, healthcare organisations that systematically and effectively learn from the failures that occur in the care delivery process, especially from small mistakes and problems rather than from consequential adverse events, are rare. This article explores pervasive barriers embedded in healthcare's organisational systems that make shared or organisational learning from failure difficult and then recommends strategies for overcoming these barriers to learning from failure, emphasising the critical role of leadership. Firstly, leaders must create a compelling vision that motivates and communicates urgency for change; secondly, leaders must work to create an environment of psychological safety that fosters open reporting, active questioning, and frequent sharing of insights and concerns; and thirdly, case study research on one hospital's organisational learning initiative suggests that leaders can empower and support team learning throughout their organisations as a way of identifying, analysing, and removing hazards that threaten patient safety. PMID:15576689

[Systemic safety following intravitreal injections of anti-VEGF].

PubMed

Baillif, S; Levy, B; Girmens, J-F; Dumas, S; Tadayoni, R

2018-03-01

The goal of this manuscript is to assess data suggesting that intravitreal injection of anti-vascular endothelial growth factors (anti-VEGFs) could result in systemic adverse events (AEs). The class-specific systemic AEs should be similar to those encountered in cancer trials. The most frequent AE observed in oncology, hypertension and proteinuria, should thus be the most common expected in ophthalmology, but their severity should be lower because of the much lower doses of anti-VEGFs administered intravitreally. Such AEs have not been frequently reported in ophthalmology trials. In addition, pharmacokinetic and pharmacodynamic data describing systemic diffusion of anti-VEGFs should be interpreted with caution because of significant inconsistencies reported. Thus, safety data reported in ophthalmology trials and pharmacokinetic/pharmacodynamic data provide robust evidence that systemic events after intravitreal injection are very unlikely. Additional studies are needed to explore this issue further, as much remains to be understood about local and systemic side effects of anti-VEGFs. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Frequent Exertion and Frequent Standing at Work, by Industry and Occupation Group - United States, 2015.

PubMed

Shockey, Taylor M; Luckhaupt, Sara E; Groenewold, Matthew R; Lu, Ming-Lun

2018-01-12

Repeated exposure to occupational ergonomic hazards, such as frequent exertion (repetitive bending or twisting) and frequent standing, can lead to injuries, most commonly musculoskeletal disorders (1). Work-related musculoskeletal disorders have been estimated to cost the United States approximately $2.6 billion in annual direct and indirect costs (2). A recent literature review provided evidence that prolonged standing at work also leads to adverse health outcomes, such as back pain, physical fatigue, and muscle pain (3). To determine which industry and occupation groups currently have the highest prevalence rates of frequent exertion at work and frequent standing at work, CDC analyzed data from the 2015 National Health Interview Survey (NHIS) Occupational Health Supplement (OHS) regarding currently employed adults in the United States. By industry, the highest prevalence of both frequent exertion and frequent standing at work was among those in the agriculture, forestry, fishing, and hunting industry group (70.9%); by occupation, the highest prevalence was among those in the construction and extraction occupation group (76.9%). Large differences among industry and occupation groups were found with regard to these ergonomic hazards, suggesting a need for targeted interventions designed to reduce workplace exposure.

The role of donor characteristics and post-granulocyte colony-stimulating factor white blood cell counts in predicting the adverse events and yields of stem cell mobilization.

PubMed

Chen, Shu-Huey; Yang, Shang-Hsien; Chu, Sung-Chao; Su, Yu-Chieh; Chang, Chu-Yu; Chiu, Ya-Wen; Kao, Ruey-Ho; Li, Dian-Kun; Yang, Kuo-Liang; Wang, Tso-Fu

2011-05-01

Granulocyte colony-stimulating factor (G-CSF) is now widely used for stem cell mobilization. We evaluated the role of post-G-CSF white blood cell (WBC) counts and donor factors in predicting adverse events and yields associated with mobilization. WBC counts were determined at baseline, after the third and the fifth dose of G-CSF in 476 healthy donors. Donors with WBC ≥ 50 × 10(3)/μL post the third dose of G-CSF experienced more fatigue, myalgia/arthralgia, and chills, but final post-G-CSF CD34(+) cell counts were similar. Although the final CD34(+) cell count was higher in donors with WBC ≥ 50 × 10(3)/μL post the fifth G-CSF, the incidence of side effects was similar. Females more frequently experienced headache, nausea/anorexia, vomiting, fever, and lower final CD34(+) cell count than did males. Donors with body mass index (BMI) ≥ 25 showed higher incidences of sweat and insomnia as well as higher final CD34(+) cell counts. Donor receiving G-CSF ≥ 10 μg/kg tended to experience bone pain, headache and chills more frequently. Multivariate analysis indicated that female gender is an independent factor predictive of the occurrence of most side effects, except for ECOG > 1 and chills. Higher BMI was also an independent predictor for fatigue, myalgia/arthralgia, and sweat. Higher G-CSF dose was associated with bone pain, while the WBC count post the third G-CSF was associated with fatigue only. In addition, one donor in the study period did not complete the mobilization due to suspected anaphylactoid reaction. Observation for 1 h after the first injection of G-CSF is required to prevent complications from unpredictable side effects.

[Effect of stress and intesity of mobile phone using on the health and subjective symptoms in GSM workers].

PubMed

Szyjkowska, Agata; Gadzicka, Elżbieta; Szymczak, Wiesław; Bortkiewicz, Alicja

2017-07-26

There are no available data on the health consequences that may result from the synergistic effects of electromagnetic fields (EMF) and stress. Understanding the mechanisms of the simultaneous exposure will make it possible to develop procedures to minimize adverse health effects in professionals using mobile phones. A questionnaire survey was conducted in 600 randomly selected people to obtain data on their health status and the prevalence of subjective symptoms related to the mobile phones using. Among them, there were 208 GSM Network employees, to whom the Perceived Stress Scale and Assessment of Stress at Work Questionnaire were sent. Eighty-nine completed questionnaires were returned (response rate - 42.8%). The mean age of respondents was 30.3 years (standard deviation (SD) = 7.7), time of occupational use of mobile phone - 4.1 years (SD = 1.7), the level of occupational stress - 95.3 (SD = 19.1). A significant percentage of people (62.8%) complained of the frequent difficulties in coping with problems of everyday life, and 57.4% had a fairly frequent problems with managing their own affairs. Significant differences in the life stress were detected between groups with different time of phone use (p = 0.03), and in occupational stress level, significant differences were noted between the 2 groups differing in the length of the conversation (p = 0.05). The risk of headache, associated (odds ratio (OR) = 4.2, p = 0.008) or not associated (OR = 2.97, p = 0.04) with calls on mobile phone, adjusted for stress, was significantly higher in people speaking via mobile more than 60 min/day than in those talking less. The study indicates that both stressors acting at the same time (EMF from cell phone and stress) adversely affect the well-being of workers and increase the risk of subjective symptoms. Med Pr 2017;68(5):617-628. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

The effects of exenatide twice daily compared to insulin lispro added to basal insulin in Latin American patients with type 2 diabetes: A retrospective analysis of the 4B trial.

PubMed

de Lapertosa, Silvia Beatriz Gorban; Frechtel, Gustavo; Hardy, Elise; Sauque-Reyna, Leobardo

2016-12-01

Socioeconomic changes in Latin American countries have led to an increased prevalence of type 2 diabetes (T2D). We examined the effects of exenatide twice daily (BID) or insulin lispro, each added to insulin glargine, in Latin American patients with T2D. This was a subgroup analysis of patients from Argentina and Mexico in the 4B study (N=114). Patients with glycated hemoglobin (HbA1c) of 7.0-10.0% (53-86mmol/mol) after 12weeks of intensive basal insulin optimization were randomized to exenatide BID or thrice-daily insulin lispro added to insulin glargine and metformin. After 30weeks, addition of exenatide BID or insulin lispro resulted in significant (P<0.0001) reductions in HbA1c (exenatide BID: -0.9% [-10mmol/mol]; insulin lispro: -1.2% [-13mmol/mol]). Weight was stable in the exenatide BID group (-0.1kg) and increased significantly (+3.4kg; P<0.0001) with insulin lispro. Major and minor hypoglycemia occurred less frequently (40 vs. 253 events) with exenatide BID compared with insulin lispro. Gastrointestinal adverse events of nausea, diarrhea, and vomiting occurred more frequently with exenatide BID than with insulin lispro. Both exenatide BID and prandial insulin lispro, each added to basal insulin glargine, were effective at reducing HbA1c in Latin American patients. Treatment with exenatide BID resulted in stable weight but more gastrointestinal adverse events. Treatment with insulin lispro resulted in weight gain and an increased risk of hypoglycemia. These findings support the addition of exenatide BID to insulin glargine as an option for Latin American patients unable to achieve glycemic control on basal insulin alone. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Incidence and outcomes of uveitis in juvenile rheumatoid arthritis, a synthesis of the literature.

PubMed

Carvounis, Petros E; Herman, David C; Cha, Stephen; Burke, James P

2006-03-01

Juvenile rheumatoid arthritis (JRA) is the most common systemic cause of pediatric uveitis in Europe and North America. Uveitis is commonly perceived as a frequent sequela of JRA and JRA-associated uveitis is commonly considered to have a complicated course with frequent adverse visual outcomes. We performed a systematic literature search for series of consecutive patients with JRA (as defined by the American College of Rheumatology criteria) reporting on the frequency of uveitis and/or complications of uveitis, published between January 1980 and December 2004. The main outcome measures were: the cumulative incidence of uveitis in JRA, the cumulative incidence of adverse visual outcome and that of complications in JRA-associated uveitis. Additionally, the influence of gender, presence of antinuclear antibody (ANA) and disease onset subtype to the likelihood of developing uveitis were examined. Analysis of pooled data from the 26 eligible series suggested a cumulative incidence of uveitis in JRA of 8.3% [95% confidence intervals (CI), 7.5-9.1%]. The cumulative incidence of uveitis varied according to geographic location, being highest in Scandinavia, then the US, then Asia and lowest in India. JRA-associated uveitis was more common in pauciarticular than polyarticular onset patients [odds ratio (OR) = 3.2, 95% CI, 2.33-4.36] and in ANA-positive than ANA-negative patients (OR = 3.18, 95% CI, 2.22-4.54). Female gender was only a weak risk factor for the development of uveitis in JRA patients (OR = 1.69, 95% CI 1.09-2.62) and was not statistically significant after considering disease onset subtypes. In JRA-associated uveitis the cumulative incidence of cumulative incidence of adverse outcome (visual acuity < 20/40 OU) was 9.2% (95% CI: 4.7-15.8) of cataracts 20.5% (95% CI: 15.5-26.3), of glaucoma 18.9% (95% CI: 14.4-24.2) and of band keratopathy 15.7% (95% CI: 10.9-21.7). The cumulative incidence of uveitis in JRA varies according to geographic location, presence of ANA, type of JRA onset and gender. Uveitis, adverse visual outcome, and complications in JRA are less frequent than commonly accepted.

Association of nutritional status-related indices and chemotherapy-induced adverse events in gastric cancer patients.

PubMed

Seo, Seung Hee; Kim, Sung-Eun; Kang, Yoon-Koo; Ryoo, Baek-Yeol; Ryu, Min-Hee; Jeong, Jae Ho; Kang, Shin Sook; Yang, Mihi; Lee, Jung Eun; Sung, Mi-Kyung

2016-11-18

Malnutrition in gastrectomized patients receiving chemotherapy is associated with the susceptibility to chemotherapy-related adverse events. This study evaluated pre-operative nutritional status-related indices associated with adverse events in post-operation gastric cancer patients receiving chemotherapy. Medical records of 234 gastrectomized patients under adjuvant tegafur/gimeracil/oteracil chemotherapy with extended lymph node dissection were analyzed. Nutritional status assessment included Patient-Generated Subjective Global Assessment (PG-SGA), body weight, body mass index, serum albumin concentration, and Nutrition Risk Index (NRI). Chemotherapy-originated adverse events were determined using Common Terminology Criteria for Adverse Events. PG-SGA indicated 59% of the patients were malnourished, and 27.8% of the patients revealed serious malnutrition with PG-SGA score of ≥9. Fifteen % of patients lost ≥10% of the initial body weight, 14.5% of the patients had hypoalbuminemia (<3.5 g/dL), and 66.2% had NRI score less than 97.5 indicating moderate to severe malnutrition. Hematological adverse events were present in 94% (≥grade 1) and 16.2% (≥grade 3). Non-hematological adverse events occurred in 95.7% (≥grade1) and 16.7% (≥grade 3) of the patients. PG-SGA and NRI score was not associated with treatment-induced adverse events. Multivariate analyses indicated that female, low body mass index, and hypoalbuminemia were independent risk factors for grade 3/4 hematological adverse events. Age was an independent risk factor for grade 3/4 non-hematological adverse events. Neutropenia was the most frequently occurring adverse event, and associated risk factors were female, total gastrectomy, and hypoalbuminemia. Hypoalbuminemia, not PG-SGA or NRI may predict chemotherapy-induced adverse events in gastrectomized cancer patients.

The Changing Drug Culture: Emerging Drugs of Abuse and Legal Highs.

PubMed

Albertson, Timothy E; Chenoweth, James A; Colby, Daniel K; Sutter, Mark E

2016-02-01

In recent years, there has been a large increase in the number of synthetic drugs used recreationally. One class of drugs is synthetic cannabinoids, which are sprayed onto herbal preparations and marketed under names such as K2 and spice. Others include amphetaminelike compounds, such as cathinones (eg, bath salts) and methylenedioxymethamphetamine (MDMA) (eg, ecstasy, Molly). New hallucinogens, such as Bromo-Dragonfly, and hallucinogens that have been used for centuries, such as Salvia divinorum, also are gaining popularity. Because these substances are sold labeled as not for human consumption and because the chemicals in them frequently change, they often are unregulated, and many users consider them legal, although they are not. Their use often goes undetected because testing for them is not included in routine drug screening. Nonetheless, these substances can be associated with significant toxicities, often because their concentrations are unpredictable. Adverse effects of synthetic cannabinoids include psychosis and other effects. Amphetaminelike drugs have stimulant effects and can cause hyponatremia and seizures. The new hallucinogens can cause serious vasoconstriction with ischemia. Clinicians, especially those working with adolescents and young adults (ie, the main users of these drugs), should be aware of these new substances and counsel patients about their adverse effects. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Endomorphin derivatives with improved pharmacological properties.

PubMed

Varamini, Pegah; Blanchfield, Joanne T; Toth, Istvan

2013-01-01

Centrally acting opioids, such as morphine, are the most frequently used analgesic agents for the treatment of severe pain. However, their usefulness is limited by the production of a range of adverse effects such as constipation, respiratory depression, tolerance and physical dependence. In addition, opioids generally exhibit poor efficacy against neuropathic pain. Endomorphin-1 and -2, two endogenous opioid peptides, have been shown to produce potent antinociception in rodent models of acute and neuropathic pain with less undesirable side effects than opioid alkaloids. However, native endomorphins are poorly suited to clinical applications without modifications. Like all small peptides, endomorphins suffer from poor metabolic stability and a relative inability to penetrate the gastro-intestinal mucosa and blood-brain-barrier. Since the discovery of endomorphins in 1997, a huge number of endomorphin analogs have been designed and synthesized with the aim of developing compounds with improved barrier penetration and resistance to enzymatic degradation. In this review we describe various strategies that have been adopted so far to conquer the major drawbacks associated with endomorphins. They include chemical modifications to produce locally or globally-restricted peptide analogs in addition to application of peptidase inhibitors, which is of minor importance compared to the former strategy. Diverse approaches that resulted in the design and synthesis of pharmacologically active endomorphin analogs with less adverse effects are also discussed giving an insight into the development of opioid peptides with an improved side effect profile.

The therapeutic effect of OK-432 (picibanil) sclerotherapy for benign neck cysts.

PubMed

Kim, Myung Gu; Kim, Sun Gon; Lee, Jun Ho; Eun, Young Gyu; Yeo, Seung Geun

2008-12-01

In general, benign neck cysts are treated by surgical excision. This can present technical difficulties and frequent recurrences, because of insufficient surgery. Sclerosing agents such as OK-432 have been tested for the nonsurgical treatment of these cysts. We have assessed the efficacy of OK-432 sclerotherapy for benign neck cysts. The study group consisted of 75 patients (42 men, 33 women) diagnosed with and treated for benign neck cysts between March 2001 and December 2007 by intralesional injection of OK-432. The liquid content of each cyst was aspirated as much as possible, and the same volume of OK-432 solution was injected. Patients were assessed by ultrasonography or computerized tomography, and therapeutic outcomes and adverse effects were evaluated by patient age, sex, cyst type, and number of injections. Of the 75 treated patients, 31 (41.3%) showed total shrinkage, seven (9.3%) showed near-total shrinkage (>90% of cyst volume), five (6.6%) showed marked shrinkage (>70% of cyst volume), and 17 (22.7%) showed partial shrinkage (<70% of cyst volume). No response was seen in 15 patients (20%). Despite repeated sclerotherapy, eight patients (10.7%) showed recurrences. Minor adverse effects of therapy included fever, localized pain, and odynophagia but these complications spontaneously disappeared within several days. OK-432 sclerotherapy is a safe and effective primary alternative to surgery in patients with benign neck cysts.

Low-dose thromboxane A2 receptor stimulation promotes closure of the rat ductus arteriosus with minimal adverse effects.

PubMed

Yokota, Tomohiro; Aida, Takashi; Ichikawa, Yasuhiro; Fujita, Takayuki; Yokoyama, Utako; Minamisawa, Susumu

2012-08-01

Patent ductus arteriosus (PDA) is a common life-threatening complication among premature infants. Although cyclooxygenase inhibitors are frequently used to treat PDA, as they inhibit the synthesis of prostaglandin E(2), the most potent vasodilator in the ductus arteriosus (DA), their efficacy is often limited. As thromboxane A(2) (TXA(2)) induces vascular contraction via the TXA(2) receptor (TP), we hypothesized that TP stimulation would promote DA closure. To measure the inner diameter of the vessels, a rapid whole-body freezing method was used. Injection of the selective TP agonists U46619 and I-BOP constricted the fetal DA at embryonic day 19 (e19) and e21 in a dose-dependent manner. Of note, U46619 also exerted a vasoconstrictive effect on two different types of postnatal PDA models: premature PDA and hypoxia-induced PDA. We also found that U46619 constricted the ex vivo DA ring to a greater extent than it constricted the ex vivo aorta. Furthermore, we found that U46619 at lower concentrations (up to 0.05 mg/g of body weight) had a minimal vasoconstrictive effect on other vessels and did not induce microthrombosis in the pulmonary capillary arteries. Low-dose TP stimulation constricts the DA with minimal adverse effects at least in rat neonates and our results could point to an alternative potent vasoconstrictor for PDA.

Radiofrequency ablation of pulmonary tumors near the diaphragm.

PubMed

Iguchi, T; Hiraki, T; Gobara, H; Fujiwara, H; Sakurai, J; Matsui, Y; Mitsuhashi, T; Toyooka, S; Kanazawa, S

To retrospectively evaluate the feasibility, safety, and efficacy of radiofrequency ablation (RFA) of lung tumors located near the diaphragm. A total of 26 patients (15 men, 11 women; mean age, 61.5 years±13.0 [SD]) with a total of 29 lung tumors near the diaphragm (i.e., distance<10mm) were included. Mean tumor diameter was 11.0mm±5.3 (SD) (range, 2-23mm). Efficacy of RFA, number of adverse events and number of adverse events with a grade≥3, based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0, were compared between patients with lung tumors near the diaphragm and a control group of patients with more distally located lung tumors (i.e., distance≥10mm). RFA was technically feasible for all tumors near the diaphragm. Four grade 3 adverse events (1 pneumothorax requiring pleurodesis and 3 phrenic nerve injuries) were observed. No grade≥4 adverse events were reported. The median follow-up period for tumors near the diaphragm was 18.3 months. Local progression was observed 3.3 months after RFA in 1 tumor. The technique efficacy rates were 96.2% at 1 year and 96.2% at 2 years and were not different, from those observed in control subjects (186 tumors; P=0.839). Shoulder pain (P<0.001) and grade 1 pleural effusion (P<0.001) were more frequently observed in patients with lung tumor near the diaphragm. The rates of grade≥3 adverse events did not significantly differ between tumors near the diaphragm (4/26 sessions) and the controls (7/133 sessions) (P=0.083). RFA is a feasible and effective therapeutic option for lung tumors located near the diaphragm. However, it conveys a higher rate of shoulder pain and asymptomatic pleural effusion by comparison with more distant lung tumors. Copyright © 2017 Éditions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

[Reactions to food].

PubMed

Halvorsen, R; Eggesb M; Botten, G

1995-12-10

Adverse reactions to food occur in about 1-2% of the population, but are reported more frequently by patients. Most reactions to food are not caused by allergy. IgE-mediated food reactions are well known and of major clinical significance owing to their potentially dangerous, even life-threatening character. Adverse reactions to food can also be caused by immunological mechanisms other than IgE-mediated reactions such as, enzyme deficiencies, active pharmacological substances in food and psychological mechanisms. Double-blind provocation is the only way to diagnose a positive reaction to a food item with some certainty. Regretably no objective measures for food reactions exist.

Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM).

PubMed

Erdal, Ane; Flo, Elisabeth; Aarsland, Dag; Ballard, Clive; Slettebo, Dagrun D; Husebo, Bettina S

2018-05-03

Chronic pain and depression often co-occur, and pain may exacerbate depression in people with dementia. The objective of this study was to assess the efficacy and safety of analgesic treatment for depression in nursing home patients with advanced dementia and clinically significant depressive symptoms. We conducted a multicentre, parallel-group, double-blind, placebo-controlled trial in 47 nursing homes, including 162 nursing home patients aged ≥ 60 years with dementia (Mini-Mental State Examination ≤ 20) and depression (Cornell Scale for Depression in Dementia ≥ 8). Patients were randomised to receive active analgesic treatment (paracetamol or buprenorphine transdermal system) or identical placebo for 13 weeks. The main outcome measure was the change in depression (Cornell Scale for Depression in Dementia) from baseline to 13 weeks, assessed using linear mixed models with fixed effects for time, intervention and their interaction in the models. Secondary outcomes were to assess whether any change in depression was secondary to change in pain (Mobilisation-Observation-Behaviour-Intensity-Dementia-2 Pain Scale) and adverse events. The mean depression change was - 0.66 (95% confidence interval - 2.27 to 0.94) in the active group (n = 80) and - 3.30 (- 4.68 to -1.92) in the placebo group (n = 82). The estimated treatment effect was 2.64 (0.55-4.72, p = 0.013), indicating that analgesic treatment had no effect on depressive symptoms from baseline to 13 weeks while placebo appeared to ameliorate depressive symptoms. There was no significant reduction in pain in the active treatment group (paracetamol and buprenorphine combined) vs. placebo; however, a subgroup analysis demonstrated a significant reduction in pain for paracetamol vs. placebo [by - 1.11 (- 2.16 to - 0.06, p = 0.037)] from week 6 to 13 without a change in depression. Buprenorphine did not have significant effects on depression [3.04 (- 0.11 to 6.19), p = 0.059] or pain [0.47 (- 0.77 to 1.71), p = 0.456] from 0 to 13 weeks. Thirty-five patients were withdrawn from the study because of adverse reactions, deterioration or death: 25 (31.3%) during active treatment [23 (52.3%) who received buprenorphine], and ten (12.2%) in the placebo group. The most frequently occurring adverse events were psychiatric (17 adverse reactions) and neurological (14 adverse reactions). Analgesic treatment did not reduce depression while placebo appeared to improve depressive symptoms significantly by comparison, possibly owing to the adverse effects of active buprenorphine. The risk of adverse events warrants caution when prescribing buprenorphine for people with advanced dementia. ClinicalTrials.gov NCT02267057 (registered 7 July, 2014) and Norwegian Medicines Agency EudraCT 2013-002226-23.

[Benzodiazepines and forensic aspects].

PubMed

Michel, L; Lang, J-P

2003-01-01

Adverse effects of benzodiazepines are well known since the first one was used in 1958 (chlordiazepoxide). The literature collects study-cases or rarely controlled studies concerning side effects or paradoxical reactions to benzodiazepines. They mostly described drowsiness and behavioral disinhibition, including increased well-being feeling but also hostility, rage access with feeling of invulnerability, serious crimes and sometimes homicides. Delusional, manic, confusional or depressive states are also pointed out. Rate for aggressive behaviour is 0.3 to 0.7% but distinction should be done between accidental or "idiosyncratic" reaction and voluntary sought disinhibition, clearly more frequent. No benzodiazepine has any specificity for these adverse effects but pharmacology, doses, associated drugs (or alcohol) and psychopathology interact to produce hazardous psychic states. Pharmacology: GABA induces a decrease in serotonin compound and vigilance. Pharmacokinetic: first dose effect or over-dose effect, short half-life, lipophily, affinity, digestive absorption, active metabolites interact. Psychopathology: age, alcohol association, psychological status (high initial level of hostility, impulsivity, frustration, personality disorder and depressive status). External conditions: chronic illness, affective and professional frustrations, physical or psychic exhaustion contribute also. Some benzodiazepines (flunitrazepam, diazepam, clorazepate, triazolam, alprazolam, lorazepam, for example) are more often concerned for pharmacokinetics characteristics but also prescription habits. Forensic aspects should be considered in case of homicide. Especially, reality of benzodiazepines consumption and awareness of the potential paradoxical reaction should be precisely evaluated. Special focus on voluntary induced disinhibition has to be done for forensic considerations. Relationship but also crime facilitations are sometimes consciously sought. Some benzodiazepines have already been identified for this use: flunitrazepam, clorazepate but also triazolam and temazepam in UK, alprazolam in USA. Flunitrazepam is prohibited in USA and considered as narcotics in France. A Swedish study showed that violent acts were more frequent and serious in juvenile offenders taking flunitrazepam/alcohol than other young offenders staying in the same correctional institution. They recommended classification of flunitrazepam as narcotic. A study from Belgium with drug addicts concluded in the same way and asked for an increased information of professionals and a more efficient control of the delivery. Before concluding to idiosyncratic effect, and then possibly to penal irresponsibility, the forensic approach should consider: firstly the reality of the benzodiazepines absorption and implication in committing violence (urine test, chronology, amnesia); secondly, the association of unusual behaviour and converging circumstances (pharmacological, pharmacokinetic, psychopathology, external conditions); thirdly the consumer's knowledge of the disinhibition effect. In our prison practice, we have to be particularly cautious as population frequently associates personality disorder, drug addiction and high level of frustration related to penitential context. Special information should be given to inmates when benzodiazepines are prescribed, but more extensively, a preventive strategy should be adopted in general population.

Immediate ecotoxicological effects of short-lived oil spills on marine biota

PubMed Central

Brussaard, Corina P. D.; Peperzak, Louis; Beggah, Siham; Wick, Lukas Y.; Wuerz, Birgit; Weber, Jan; Samuel Arey, J.; van der Burg, Bart; Jonas, Arjen; Huisman, Johannes; van der Meer, Jan Roelof

2016-01-01

Marine environments are frequently exposed to oil spills as a result of transportation, oil drilling or fuel usage. Whereas large oil spills and their effects have been widely documented, more common and recurrent small spills typically escape attention. To fill this important gap in the assessment of oil-spill effects, we performed two independent supervised full sea releases of 5 m3 of crude oil, complemented by on-board mesocosm studies and sampling of accidentally encountered slicks. Using rapid on-board biological assays, we detect high bioavailability and toxicity of dissolved and dispersed oil within 24 h after the spills, occurring fairly deep (8 m) below the slicks. Selective decline of marine plankton is observed, equally relevant for early stages of larger spills. Our results demonstrate that, contrary to common thinking, even small spills have immediate adverse biological effects and their recurrent nature is likely to affect marine ecosystem functioning. PMID:27041738

Immediate ecotoxicological effects of short-lived oil spills on marine biota.

PubMed

Brussaard, Corina P D; Peperzak, Louis; Beggah, Siham; Wick, Lukas Y; Wuerz, Birgit; Weber, Jan; Samuel Arey, J; van der Burg, Bart; Jonas, Arjen; Huisman, Johannes; van der Meer, Jan Roelof

2016-04-04

Marine environments are frequently exposed to oil spills as a result of transportation, oil drilling or fuel usage. Whereas large oil spills and their effects have been widely documented, more common and recurrent small spills typically escape attention. To fill this important gap in the assessment of oil-spill effects, we performed two independent supervised full sea releases of 5 m(3) of crude oil, complemented by on-board mesocosm studies and sampling of accidentally encountered slicks. Using rapid on-board biological assays, we detect high bioavailability and toxicity of dissolved and dispersed oil within 24 h after the spills, occurring fairly deep (8 m) below the slicks. Selective decline of marine plankton is observed, equally relevant for early stages of larger spills. Our results demonstrate that, contrary to common thinking, even small spills have immediate adverse biological effects and their recurrent nature is likely to affect marine ecosystem functioning.

Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study.

PubMed

Cable, Ritchard G; Glynn, Simone A; Kiss, Joseph E; Mast, Alan E; Steele, Whitney R; Murphy, Edward L; Wright, David J; Sacher, Ronald A; Gottschall, Jerry L; Tobler, Leslie H; Simon, Toby L

2012-04-01

Blood donors are at risk of iron deficiency. We evaluated the effects of blood donation intensity on iron and hemoglobin (Hb) in a prospective study. Four cohorts of frequent and first-time or reactivated (FT/RA) blood donors (no donation in 2 years), female and male, totaling 2425, were characterized and followed as they donated blood frequently. At enrollment and the final visit, ferritin, soluble transferrin receptor (sTfR), and Hb were determined. Models to predict iron deficiency and Hb deferral were developed. Iron depletion was defined at two levels: iron deficiency erythropoiesis (IDE) [log(sTfR/ferritin) ≥ 2.07] and absent iron stores (AIS; ferritin < 12 ng/mL). Among returning female FT and RA donors, 20 and 51% had AIS and IDE at their final visit, respectively; corresponding proportions for males were 8 and 20%. Among female frequent donors who returned, 27 and 62% had AIS and IDE, respectively, while corresponding proportions for males were 18 and 47%. Predictors of IDE and/or AIS included a higher frequency of blood donation in the past 2 years, a shorter interdonation interval, and being female and young; conversely, taking iron supplements reduced the risk of iron depletion. Predictors of Hb deferral included female sex, black race, and a shorter interdonation interval. There is a high prevalence of iron depletion in frequent blood donors. Increasing the interdonation interval would reduce the prevalence of iron depletion and Hb deferral. Alternatively, replacement with iron supplements may allow frequent donation without the adverse outcome of iron depletion. © 2011 American Association of Blood Banks.

Toxic stress and child refugees.

PubMed

Murray, John S

2018-01-01

The purpose of this article was to describe the phenomenon of toxic stress and its impact on the physical and mental health of child refugees. Almost two decades ago, researchers found that recurring adverse childhood events (ACEs; e.g., physical, psychological, and sexual abuse, neglect, and household dysfunction such as substance abuse, mental illness, and criminal behavior) were associated with a significant increase in serious illnesses during adulthood. Illnesses include heart, lung, and liver disease, cancer, and bone fractures. The scientists reported that experiencing four or more ACEs during childhood significantly increases the risk for toxic stress. Toxic stress is defined as the exposure to extreme, frequent, and persistent adverse events without the presence of a supportive caretaker. There is a paucity of literature related to toxic stress and child refugees. However, it has been clearly established that the prolonged brutal and traumatizing war in Syria is having a profound impact on the physical and mental health of child refugees at a distressing rate. Prevention of toxic stress should be a primary goal of all pediatric healthcare professionals working with child refugees. While this seems daunting given the population, and the seemingly insurmountable stressors they experience, some basic interventions should be considered. Providing basic anticipatory guidance to parents and caregivers of child refugees, to encourage positive parenting and strengthening support networks, will be highly effective in developing the requisite buffers that mitigate the effects of stress and avoid toxic stress. Efforts should also be focused on addressing caregiver stress and improving their ability to provide safe, reliable, and nurturing care that will help to mitigate any stress response experienced by a child. It is critical that greater awareness be placed on the effects of toxic stress on child refugees who are exposed to significant adverse events early in life. © 2017 Wiley Periodicals, Inc.

Review of hypoxaemia in anaesthetized horses: predisposing factors, consequences and management.

PubMed

Auckburally, Adam; Nyman, Görel

2017-05-01

To discuss how hypoxaemia might be harmful and why horses are particularly predisposed to developing it, to review the strategies that are used to manage hypoxaemia in anaesthetized horses, and to describe how successful these strategies are and the adverse effects associated with them. Google Scholar and PubMed, using the search terms horse, pony, exercise, anaesthesia, hypoxaemia, oxygen, mortality, morbidity and ventilation perfusion mismatch. Although there is no evidence that hypoxaemia is associated with increased morbidity and mortality in anaesthetized horses, most anaesthetists would agree that it is important to recognise and prevent or treat it. Favourable anatomical and physiological adaptations of a horse for exercise adversely affect gas exchange once the animal is recumbent. Hypoxaemia is recognised more frequently in horses than in other domestic species during general anaesthesia, although its incidence in healthy horses remains unreported. Management of hypoxaemia in anaesthetized horses is challenging and often unsuccessful. Positive pressure ventilation strategies to address alveolar atelectasis in humans have been modified for implementation in recumbent anaesthetized horses, but are often accompanied by unpredictable and unacceptable cardiopulmonary adverse effects, and some strategies are difficult or impossible to achieve in adult horses. Furthermore, anticipated beneficial effects of these techniques are inconsistent. Increasing the inspired fraction of oxygen during anaesthesia is often unsuccessful since much of the impairment in gas exchange is a direct result of shunt. Alternative approaches to the problem involve manipulation of pulmonary blood away from atelectatic regions of the lung to better ventilated areas. However, further work is essential, with particular focus on survival associated with general anaesthesia in horses, before any technique can be accepted into widespread clinical use. Copyright © 2017 Association of Veterinary Anaesthetists and American College of Veterinary Anesthesia and Analgesia. Published by Elsevier Ltd. All rights reserved.

Prospective, randomized, and controlled trial on ketamine infusion during bilateral axillo-breast approach (BABA) robotic or endoscopic thyroidectomy: Effects on postoperative pain and recovery profiles

PubMed Central

Kim, Dong-Ho; Choi, June Young; Kim, Byoung-Gook; Hwang, Jin-Young; Park, Seong-Joo; Oh, Ah-Young; Jeon, Young-Tae; Ryu, Jung-Hee

2016-01-01

Abstract Background: Robotic or endoscopic thyroidectomy using bilateral axillo-breast approach (BABA) is frequently performed for excellent cosmesis. However, postoperative pain is remained as concerns due to the extent tissue dissection and tension during the operation. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist that reduces acute postoperative pain. We evaluated the effects of intraoperative ketamine infusion on postoperative pain control and recovery profiles following BABA robotic or endoscopic thyroidectomy. Methods: Fifty-eight adult patients scheduled for BABA robotic or endoscopic thyroidectomy were randomized into a control group (n = 29) and ketamine group (n = 29). Following induction of anesthesia, patients in each group were infused with the same volume of saline or ketamine solution (1 mg/kg bolus, 60 μg/kg/h continuous infusion). Total intravenous anesthesia with propofol and remifentanil was used to induce and maintain anesthesia. Pain scores (101-point numerical rating scale, 0 = no pain, 100 = the worst imaginable pain), the consumption of rescue analgesics, and other postoperative adverse effects were assessed at 1, 6, 24, and 48 hours postoperatively. Results: Patients in the ketamine group reported lower pain scores than those in the control group at 6 hours (30 [30] vs 50 [30]; P = 0.017), 24 hours (20 [10] vs 30 [20]; P < 0.001), and 48 hours (10 [10] vs 20 [15]; P < 0.001) in neck area. No statistically significant differences were found between the 2 groups in terms of the requirements for rescue analgesics or the occurrence of adverse events. Conclusion: Intravenous ketamine infusion during anesthesia resulted in lower postoperative pain scores following BABA robotic or endoscopic thyroidectomy, with no increase in adverse events. PMID:27930531

Prospective, randomized, and controlled trial on ketamine infusion during bilateral axillo-breast approach (BABA) robotic or endoscopic thyroidectomy: Effects on postoperative pain and recovery profiles: A consort compliant article.

PubMed

Kim, Dong-Ho; Choi, June Young; Kim, Byoung-Gook; Hwang, Jin-Young; Park, Seong-Joo; Oh, Ah-Young; Jeon, Young-Tae; Ryu, Jung-Hee

2016-12-01

Robotic or endoscopic thyroidectomy using bilateral axillo-breast approach (BABA) is frequently performed for excellent cosmesis. However, postoperative pain is remained as concerns due to the extent tissue dissection and tension during the operation. Ketamine is a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist that reduces acute postoperative pain. We evaluated the effects of intraoperative ketamine infusion on postoperative pain control and recovery profiles following BABA robotic or endoscopic thyroidectomy. Fifty-eight adult patients scheduled for BABA robotic or endoscopic thyroidectomy were randomized into a control group (n = 29) and ketamine group (n = 29). Following induction of anesthesia, patients in each group were infused with the same volume of saline or ketamine solution (1 mg/kg bolus, 60 μg/kg/h continuous infusion). Total intravenous anesthesia with propofol and remifentanil was used to induce and maintain anesthesia. Pain scores (101-point numerical rating scale, 0 = no pain, 100 = the worst imaginable pain), the consumption of rescue analgesics, and other postoperative adverse effects were assessed at 1, 6, 24, and 48 hours postoperatively. Patients in the ketamine group reported lower pain scores than those in the control group at 6 hours (30 [30] vs 50 [30]; P = 0.017), 24 hours (20 [10] vs 30 [20]; P < 0.001), and 48 hours (10 [10] vs 20 [15]; P < 0.001) in neck area. No statistically significant differences were found between the 2 groups in terms of the requirements for rescue analgesics or the occurrence of adverse events. Intravenous ketamine infusion during anesthesia resulted in lower postoperative pain scores following BABA robotic or endoscopic thyroidectomy, with no increase in adverse events.

Another Setting for Stewardship: High Rate of Unnecessary Antimicrobial Use in a VA Long-Term Care Facility

PubMed Central

Peron, Emily P.; Hirsch, Amy A.; Jury, Lucy A.; Jump, Robin L.P.; Donskey, Curtis J.

2015-01-01

BACKGROUND/OBJECTIVE Antimicrobials are frequently prescribed in long-term care facilities (LTCFs). In order to develop effective stewardship interventions, there is a need for data on current patterns of unnecessary antimicrobial prescribing among LTCF residents. The objective of this study was to examine the frequency of, reasons for, and adverse effects of unnecessary antimicrobial use in our Veterans Affairs (VA) LTCF. DESIGN Retrospective chart review. SETTING Cleveland VA Medical Center LTCF. PARTICIPANTS Randomly selected patients receiving antimicrobial therapy from October 1, 2008 to March 31, 2009. MEASUREMENTS Days of necessary and unnecessary antimicrobial therapy determined using Infectious Diseases Society of America guidelines, syndromes treated with unnecessary antimicrobials, and the frequency of development of Clostridium difficile infection (CDI), colonization or infection with antimicrobial resistant pathogens, and other adverse effects. RESULTS Of 1351 days of therapy prescribed in 100 regimens, 575 days (42.5%) were deemed unnecessary. Of the 575 unnecessary days of therapy, 334 (58%) were for antimicrobial regimens that were entirely unnecessary (n=42). Asymptomatic bacteriuria was the most common reason for entirely unnecessary regimens (n=21), resulting in 173 days of unnecessary therapy. Regimens that were partially unnecessary resulted in 241 (42%) days of unnecessary therapy, with longer than recommended treatment duration accounting for 226 (94%) unnecessary days of therapy. Within 30 days of completing the antimicrobial regimens, 5 patients developed CDI, 5 had colonization or infection with antimicrobial-resistant pathogens, and 10 experienced other adverse drug events. CONCLUSIONS In our VA LTCF, 43% of all days of antimicrobial therapy were unnecessary. Our findings suggest that antimicrobial stewardship interventions in LTCFs should focus on improving adherence to recommended treatment durations and eliminating inappropriate treatment of asymptomatic bacteriuria. PMID:23405923

Climate Change, Wildland Fires and Public Health

NASA Astrophysics Data System (ADS)

Cascio, W. E.

2016-12-01

Climate change is contributing to an increase in the severity of wildland fires. The annual acreage burned in the U.S. has risen steadily since 1985, and the fire season has lengthened. Wildland fires impair air quality by producing massive quantities of particulate air pollutants and ozone precursors. Together particles and ozone exposures increase the risk of premature death and acute and chronic cardiovascular and respiratory morbidity among vulnerable individuals. Future wildfires are predicted to be larger, more severe and more frequent in some regions of the U.S and will contribute to an even greater proportion of the ambient air pollution, the disease burden and healthcare costs.While the projected magnitude of the public health impact of climate change-related wildfire events is uncertain, it is clear that the proportion of the U.S. population vulnerable to the adverse health effects of wildland fire and its smoke is increasing. An aging population with chronic respiratory diseases and increasing obesity and diabetes that heralds more cardiovascular disease will increase the vulnerability of the population to the adverse effects of wildfire smoke and associated stressors. Additionally, physiological changes attendant to aging decrease the capacity of aged-adults to tolerate wildfire smoke, heat, humidity, evacuation and recovery. Expansion of our cities into the wildland-urban interface is also placing a greater proportion of the population in closer proximity to wildland fire emissions with its associated health risks. The public health community has an opportunity to contribute to the broader national effort to mitigate climate change and wildland fire risk by working closely with the healthcare community to facilitate adaptive responses to climate change. Adaptation will increase the resilience of individuals and their communities and is anticipated to help mitigate the adverse health effects of wildland fire. This abstract does not reflect USEPA policy.

The Role of Topical Brimonidine Tartrate Gel as a Novel Therapeutic Option for Persistent Facial Erythema Associated with Rosacea.

PubMed

Johnson, Andrew William; Johnson, Sandra Marchese

2015-09-01

Rosacea is a chronic inflammatory skin condition that commonly presents with persistent facial erythema with or without the coincident presence of flushing, telangiectasias, inflammatory papules or pustules, phymatous changes, or ocular involvement. Patients often present with a constellation of various signs and symptoms of the disease, and an individualized treatment plan should be tailored to a patient's unique clinical presentation. Previously available medications for rosacea have all targeted the inflammatory erythematous papules and pustules frequently associated with the disease, leaving a therapeutic gap for the common manifestation of persistent facial erythema. Brimonidine tartrate 0.33% gel was approved by the US Food and Drug Administration in August 2013 as the first medication available for the topical treatment of persistent facial erythema associated with rosacea. Brimonidine gel is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive effects, which leads to significant reduction of persistent facial erythema in the majority of patients when applied once daily. Based on large-scale clinical trials and post-marketing reports, brimonidine gel has maintained a good safety profile with a minority of patients experiencing adverse effects from its use, most of which are cutaneous in nature, mild-to-moderate in degree, occur early after initiation of treatment, often resolve spontaneously with continued use, and generally resolve after discontinuation of use. Among the reported adverse effects, two distinct manifestations of worsened erythema have been described. Brimonidine gel can be integrated into a treatment regimen along with concomitant therapies for facial papules and pustules with no increased risk of adverse events with combination therapy. Education about optimal application methods, setting reasonable expectations for treatment, and minimizing inflammation are important factors for the successful use of brimonidine gel as part of a patient's overall rosacea treatment regimen.

Is endoscopic papillary large balloon dilation safe for treating large CBD stones?

PubMed

Shim, Chan Sup; Kim, Ji Wan; Lee, Tae Yoon; Cheon, Young Koog

2016-01-01

In recent years, endoscopic papillary large balloon dilation (EPLBD) with endoscopic sphincterotomy (EST) has been shown to be an effective technique for the removal of large or difficult common bile duct (CBD) stones, as an alternative to EST. Reviewing the literature published since 2003, it is understood that EPLBD has fewer associated overall complications than EST. Bleeding occurred less frequently with EPLBD than with EST. There was no significant difference in postendoscopic retrograde cholangiopancreatography pancreatitis or perforation. Recent accumulated results of EPLBD with or even without EST suggest that it is a safe and effective procedure for the removal of large or difficult bile duct stones without any additional risk of severe adverse events, when performed under appropriate guidelines. Since use of a larger balloon can tear the sphincter as well as the bile duct, possibly resulting in bleeding and perforation, a balloon size that is equal to or smaller in diameter than the diameter of the native distal bile duct is recommended. The maximum transverse diameter of the stone and the balloon-stone diameter ratio have a tendency to affect the success or failure of complete removal of stones by large balloon dilation to prevent adverse effects such as perforation and bleeding. One should take into account the size of the native bile duct, the size and burden of stones, the presence of stricture of distal bile duct, and the presence of the papilla in or adjacent to a diverticulum. Even though the results of EPLBD indicate that it is a relatively safe procedure in patients with common duct stones with a dilated CBD, the recommended guidelines should be followed strictly for the prevention of major adverse events such as bleeding and perforation.

Safety of treatment options for spondyloarthritis: a narrative review.

PubMed

D'Angelo, Salvatore; Carriero, Antonio; Gilio, Michele; Ursini, Francesco; Leccese, Pietro; Palazzi, Carlo

2018-05-01

Spondyloarthritis (SpA) are chronic inflammatory diseases with overlapping pathogenic mechanisms and clinical features. Treatment armamentarium against SpA includes non-steroidal anti-inflammatory drugs, glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs, including sulfasalazine, methotrexate, leflunomide, cyclosporine), targeted synthetic DMARDs (apremilast) and biological DMARDs (TNF inhibitors, anti-IL 12/23 and anti-IL-17 agents). Areas covered: A narrative review of published literature on safety profile of available SpA treatment options was performed. Readers will be provided with a comprehensive overview on frequent and rare adverse events associated with each drug listed in current SpA treatment recommendations. Expert opinion: The overall safety profile of such molecules is good and serious adverse events are rare but need to be promptly recognized and treated. However, the monitoring of adverse events is a major challenge for clinicians because it is not adequately addressed by current treatment recommendations. A tailored treatment is crucial and rheumatologists must accurately select patients in order to identify those more susceptible to develop adverse events.

Real-Life Use of Neurohormonal Antagonists and Loop Diuretics in Chronic Heart Failure: Analysis of Serial Biomarker Measurements and Clinical Outcome.

PubMed

Brankovic, Milos; Akkerhuis, K Martijn; van Boven, Nick; Manintveld, Olivier; Germans, Tjeerd; Brugts, Jasper; Caliskan, Kadir; Umans, Victor; Constantinescu, Alina; Kardys, Isabella

2017-11-06

We determined the temporal effects of neurohormonal antagonists and loop diuretics on serially assessed (3-monthly) cardiorenal biomarkers, functional status, and clinical outcomes in 250 patients with chronic heart failure (CHF) with reduced ejection fraction. In blood, we measured NT-proBNP, troponin T, C-reactive protein, creatinine, cystatin C; in urine, N-acetyl-beta-d-glucosaminidase and kidney-injury-molecule-1. Angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) were inversely associated with cardiac impairment, inflammation, and renal tubular damage, but not with glomerular dysfunction. Diuretics were associated with worse biomarker profiles and with a hazard ratio for adverse clinical outcome of 1.12 (95% confidence interval: 1.03-1.22) per 40 mg higher doses. ACE-inhibitors/ARBs were more frequently downtitrated and diuretics more frequently uptitrated in patients who experienced endpoints than in those who did not. In conclusion, a decrease or withholding of ACE-inhibitors/ARBs solely based on glomerular function is not justified because of the beneficial effects on the heart, inflammation, and renal tubules. Higher and increased diuretic doses mark progression towards endstage CHF. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Confounders in interpreting pathology for safety and risk assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wolf, Douglas C.; Mann, Peter C.

2005-02-01

The contribution of pathology to toxicity assessment is invaluable but often not clearly understood. Pathology endpoints are the central response around which human health risk assessment is frequently determined; therefore, it is important that the general toxicology community understand current concepts and nomenclature of toxicologic pathology. Toxicologic pathology encompasses the study of changes in tissue morphology that help define the risk of exposure to xenobiotics. Toxicologic pathology is a discipline that has changed and adapted over time including methods of analysis and nomenclature of lesions. As risk assessments are updated for chemicals in commerce, frequently the older literature must bemore » reviewed and reevaluated. When interpreting pathology data from animal studies, it is important to consider the biological significance of a lesion as well as its relationship to the ultimate adverse health effect. Assessing the potential for a chemical to cause harm to humans must include the examination of the entire pathology database in context of the study design, the mode of action of the chemical of concern, and using the most current interpretation of a lesion to determine the significance for human health effects of a particular tissue response.« less

Lemons and Leases in the Used Business Aircraft Market.

ERIC Educational Resources Information Center

Gilligan, Thomas W.

2004-01-01

Given adverse selection, durable goods that trade less frequently depreciate more quickly. Consistent with this prediction, I find an inverse relationship between depreciation and trading volume for less reliable brands of used business aircraft. Additionally, recent theoretical analyses suggest that leasing, by increasing the average quality of…

Trauma and Its Impact on Children

ERIC Educational Resources Information Center

Diamanduros, Terry D.; Tysinger, P. Dawn; Tysinger, Jeffrey

2018-01-01

Exposure to traumatic experiences in childhood is more frequent than uncommon and can have a significant impact on the development and social-emotional health of children and adolescents. A recent national study revealed that approximately 34 million children in the United States had experienced at least one of nine adverse childhood experiences…

MEASUREMENT OF OXIDATIVE STRESS PARAMETERS USING LIQUID CHROMATOGRAPHY - TANDEM MASS SPECTROSCOPY (LC-MS/MS)

EPA Science Inventory

What is the study?
An invited review article. Measurement of oxidative stress parameters using liquid chromatography-tandem mass spectroscopy (LC-MS/MS)
Why was it done?
Although oxidative stress is frequently cited as a cause of various adverse biological eff...

One Health and Cyanobacteria in Freshwater Systems: Animal Illnesses and Deaths are Sentinel Events for Human Health Risks

EPA Science Inventory

Harmful cyanobacterial blooms have adversely impacted human and animal health for thousands of years. Recently, the health impacts of harmful cyanobacteria blooms are becoming more frequently detected and reported. However, reports of human and animal illnesses or deaths associat...

Impacts of 17α-ethynylestradiol exposure on metabolite profiles of zebrafish (Danio rerio) liver cells

EPA Science Inventory

Endocrine disrupting chemicals (EDCs) that are frequently detected in bodies of water downstream from sewage treatment facilities can have adverse impacts on fish and other aquatic organisms. To properly assess risk(s) from EDCs, tools are needed that can establish linkages from ...

Aversion, Awareness, and Attraction: Investigating Claims of Hyperacusis in the Williams Syndrome Phenotype

ERIC Educational Resources Information Center

Levitin, Daniel J.; Cole, Kristen; Lincoln, Alan; Bellugi, Ursula

2005-01-01

Background: Williams syndrome (WS), a neurodevelopmental disorder, is characterized by pervasive cognitive deficits alongside a relative sparing of auditory perception and cognition. A frequent characteristic of the phenotype is adverse reactions to, and/or fascination with, certain sounds. Previously published reports indicate that people with WS…

Building Educational Resilience. Fastback 430.

ERIC Educational Resources Information Center

Wang, Margaret C.; Haertel, Geneva D.; Walberg, Herbert J.

The number of children at risk of school failure because of poverty, illness, divorce, drug and alcohol abuse, frequent relocation, and other adverse circumstances is increasing. Although some teachers may feel as though these problems are beyond them, research points to educators' actions that can alleviate such problems by fostering educational…

Genetic polymorphism in three glutathione s-transferase genes and breast cancer risk

DOE Office of Scientific and Technical Information (OSTI.GOV)

Woldegiorgis, S.; Ahmed, R.C.; Zhen, Y.

The role of the glutathione S-transferase (GST) enzyme family is to detoxify environmental toxins and carcinogens and to protect organisms from their adverse effects, including cancer. The genes GSTM1, GSTP1, and GSTT1 code for three GSTs involved in the detoxification of carcinogens, such as polycyclic aromatic hydrocarbons (PAHs) and benzene. In humans, GSTM1 is deleted in about 50% of the population, GSTT1 is absent in about 20%, whereas the GSTP1 gene has a single base polymorphism resulting in an enzyme with reduced activity. Epidemiological studies indicate that GST polymorphisms increase the level of carcinogen-induced DNA damage and several studies havemore » found a correlation of polymorphisms in one of the GST genes and an increased risk for certain cancers. We examined the role of polymorphisms in genes coding for these three GST enzymes in breast cancer. A breast tissue collection consisting of specimens of breast cancer patients and non-cancer controls was analyzed by polymerase chain reaction (PCR) for the presence or absence of the GSTM1 and GSTT1 genes and for GSTP1 single base polymorphism by PCR/RFLP. We found that GSTM1 and GSTT1 deletions occurred more frequently in cases than in controls, and GSTP1 polymorphism was more frequent in controls. The effective detoxifier (putative low-risk) genotype (defined as presence of both GSTM1 and GSTT1 genes and GSTP1 wild type) was less frequent in cases than controls (16% vs. 23%, respectively). The poor detoxifier (putative high-risk) genotype was more frequent in cases than controls. However, the sample size of this study was too small to provide conclusive results.« less

Does the clinical use of ethanol-based hand sanitizer elevate blood alcohol levels? A prospective study.

PubMed

Miller, Michael A; Rosin, Alex; Levsky, Marc E; Patel, Manish M; Gregory, Timothy J D; Crystal, Chad S

2006-11-01

Ethanol-based hand sanitizers (EBHSs) are used in most health care facilities in the United States. Infection control personnel advocate the use of generous quantities of EBHS before and after contact with patients. Although it is assumed that little systemic absorption of ethanol occurs during EBHS use, many alcohols are absorbed to varying degrees via the transdermal route. Ethanol intoxication by employees in the medical workplace is a potentially serious finding, and it is of forensic and medical-legal importance to elucidate the effects of frequent use of EBHS upon serum blood ethanol levels (BELs). To investigate the effect of frequent use of EBHS upon serum blood ethanol concentrations, we prospectively studied 5 volunteers undergoing frequent application of EBHS. Enrolled subjects applied 5 mL of the product (62% denatured ethyl alcohol manufactured by Kimberley-Clark, Roswell, GA) to both hands and rubbed until dry. This activity was repeated 50 times over 4 hours. Participants had their blood drawn before as well as after completing the study. Each participant was without alcohol exposure during the 12 hours preceding the study. Five volunteers were enrolled. All had an initial blood ethanol level of less than 5 mg/dL. All 5 participants completed the 4-hour study. There were no noted adverse reactions during the study. Blood ethanol level upon completion of the 50 applications of EBHS was less than 5 mg/dL in all 5 study participants. The results of this study demonstrate that use of ethanol-based hand sanitizers, when frequently used in accordance with labeling, do not raise serum blood ethanol levels.

Lansoprazole 15 mg once daily for 14 days is effective for treatment of frequent heartburn: results of 2 randomized, placebo-controlled, double-blind studies.

PubMed

Kushner, Pamela R; Snoddy, Andrew M; Gilderman, Larry; Peura, David A

2009-07-01

To investigate the efficacy and safety of a 14-day treatment period with lansoprazole 15 mg for frequent heartburn in patients who are likely to select a nonprescription medication before consulting a prescriber. Adults with untreated frequent heartburn > or = 2 days a week over the past month were recruited for 2 identical multicenter, double-blind studies conducted with a 1-week screening and heartburn medication washout, a 1-week placebo run-in, a 2-week placebo-controlled treatment, and a 1-week placebo follow-up. After the washout and placebo run-in, subjects were randomly assigned to receive lansoprazole 15 mg or placebo once daily for 14 days in a double-blind fashion. Antacid tablets were permitted as rescue medication. Endpoints included percentage of 24-hour days without heartburn (primary), percentage of night-times without heartburn, and percentage of subjects without heartburn during day 1 of treatment (secondary endpoints). Data were collected daily via an interactive voice response system. In studies 1 and 2, 282 and 288 subjects, respectively, were randomly assigned to lansoprazole, and 282 in each study received placebo. The mean percentage of days without heartburn was greater among lansoprazole recipients compared with placebo recipients (P < 0.0001). Significantly more subjects treated with lansoprazole also reported no night-time heartburn and no heartburn during day 1 of the 14-day treatment. Adverse events were infrequent and were similar for lansoprazole and placebo groups. During the 14-day treatment period in a population with frequent heartburn who were likely to select a medication without consulting a prescriber, lansoprazole 15 mg once daily showed rapid and sustained effectiveness throughout a 24-hour period and was well tolerated.

Dietary Supplements: Knowledge and Adverse Event Reporting Among American Medical Society for Sports Medicine Physicians.

PubMed

Pascale, Blaise; Steele, Clay; Attipoe, Selasi; OʼConnor, Francis G; Deuster, Patricia A

2016-03-01

Certain dietary supplements (DSs) used by military populations pose a threat to overall readiness. This study assessed members of the American Medical Society for Sports Medicine (AMSSM) regarding their knowledge of DS use among their patients and reporting of suspected adverse events. A thirteen-question retrospective, cross-sectional, Web-based survey sought data on practices regarding DSs and adverse event reporting. Anonymous Web-based survey. Military and civilian sports medicine physicians. The primary finding of the study was how frequently practitioners report adverse events associated with DS use. A total of 311 physicians responded to the survey. Only 51% of respondents had a reliable source for information on DS safety and 58% routinely discussed DS use with their patients. Although a majority (71%) of respondents had encountered adverse events associated with DS use, few of those (10%) confirmed reporting such events. Reasons that physicians did not report adverse events were lack of knowledge regarding where to report (68%), how to report (61%), and availability of time (9%). Our results indicate that some AMSSM physicians are familiar with DSs and have encountered adverse events associated with their use. However, reporting of these adverse events to the appropriate agency is minimal at best. The significant gaps in physician knowledge regarding how and where to report such events indicate a need to educate physicians on this subject. The findings of this survey indicate the need for provider education on reporting adverse events associated with DS use. Although reporting of adverse events is essential for removing harmful DSs from the market, a majority of physicians have limited knowledge on this issue. Moreover, the survey provides insight into the barriers to physician reporting of adverse events.

Adverse events during rotary-wing transport of mechanically ventilated patients: a retrospective cohort study

PubMed Central

Seymour, Christopher W; Kahn, Jeremy M; Schwab, C William; Fuchs, Barry D

2008-01-01

Introduction Patients triaged to tertiary care centers frequently undergo rotary-wing transport and may be exposed to additional risk for adverse events. The incidence of physiologic adverse events and their predisposing factors in mechanically ventilated patients undergoing aeromedical transport are unknown. Methods We performed a retrospective review of flight records of all interfacility, rotary-wing transports to a tertiary care, university hospital during 2001 to 2003. All patients receiving mechanical ventilation via endotracheal tube or tracheostomy were included; trauma, scene flights, and fixed transports were excluded. Data were abstracted from patient flight and hospital records. Adverse events were classified as either major (death, arrest, pneumothorax, or seizure) or minor (physiologic decompensation, new arrhythmia, or requirement for new sedation/paralysis). Bivariate associations between hospital and flight characteristics and the presence of adverse events were examined. Results Six hundred eighty-two interfacility flights occurred during the period of review, with 191 patients receiving mechanical ventilation. Fifty-eight different hospitals transferred patients, with diagnoses that were primarily cardiopulmonary (45%) and neurologic (37%). Median flight distance and time were 42 (31 to 83) km and 13 (8 to 22) minutes, respectively. No major adverse events occurred during flight. Forty patients (22%) experienced a minor physiologic adverse event. Vasopressor requirement prior to flight and flight distance were associated with the presence of adverse events in-flight (P < 0.05). Patient demographics, time of day, season, transferring hospital characteristics, and ventilator settings before and during flight were not associated with adverse events. Conclusion Major adverse events are rare during interfacility, rotary-wing transfer of critically ill, mechanically ventilated patients. Patients transferred over a longer distance or transferred on vasopressors may be at greater risk for minor adverse events during flight. PMID:18498659

The Role of Medication in Supporting Emotional Wellbeing in Young People with Long-Term Needs

PubMed Central

Gray, Nicola J.; Wood, Damian M.

2017-01-01

Young people frequently use and access prescribed medications for a range of health problems. Medications aimed at treating both common health problems and long-term physical and mental health needs in adolescence can have a significant effect on a young person’s emotional well-being. We use a series of case studies to illustrate the challenges for healthcare professionals supporting young people with medication use. The studies illustrate the efficacy and limitations of medication on improving emotional well-being by alleviating illness and distress, and how this efficacy must be balanced against both the adverse effects and the burden of treatment. There are specific challenges for medication management during adolescence including issues of adherence/concordance, facilitating autonomy and participation in decision making, and promoting independence. PMID:29099742

Natural remedies for non-steroidal anti-inflammatory drug-induced toxicity.

PubMed

Simon, Jerine Peter; Evan Prince, Sabina

2017-01-01

The liver is an important organ of the body, which has a vital role in metabolic functions. The non-steroidal anti-inflammatory drug (NSAID), diclofenac causes hepato-renal toxicity and gastric ulcers. NSAIDs are noted to be an agent for the toxicity of body organs. This review has elaborated various scientific perspectives of the toxicity caused by diclofenac and its mechanistic action in affecting the vital organ. This review suggests natural products are better remedies than current clinical drugs against the toxicity caused by NSAIDs. Natural products are known for their minimal side effects, low cost and availability. On the other hand, synthetic drugs pose the danger of adverse effects if used frequently or over a long period. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Amiodarone-associated bilateral vestibulopathy.

PubMed

Gürkov, Robert; Manzari, Leonardo; Blödow, Alexander; Wenzel, Angela; Pavlovic, Dusan; Luis, Leonal

2018-03-01

Bilateral vestibulopathy (BVP) is a debilitating disorder characterized by the hypofunction of both vestibular end organs or nerves. The most frequent identifiable causes of BVP are ototoxic drug effects, infectious and autoimmune disorders. The majority of cases, however, remain idiopathic. Medical records of patients diagnosed with idiopathic BVP were examined in five dizziness clinics. We identified 126 patients with "idiopathic" BVP. Out of these, 15 patients had a history of Amiodarone treatment before the diagnosis of BVP, resulting in a 12% prevalence. The present report supports the hypothesis that Amiodarone can cause BVP. Vestibular examination in patients taking Amiodarone and suffering from balance-related symptoms are recommended, to recognize this adverse effect as early as possible and allow for an informed judgement on a potential dose reduction or withdrawal for recovery of the vestibular function.

Integrating fluoroquinolones into the hospital formulary.

PubMed

Bertino, J S

2001-10-01

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

Television viewing associated with adverse dietary outcomes in children ages 2-6.

PubMed

Ford, C; Ward, D; White, M

2012-12-01

The aim of this paper was to systematically review the evidence for the association between television viewing and diet in children ages 2-6. Data sources included PubMed, PsycINFO, EMBASE, ERIC, SportDISCUS, Sociological Abstracts, Web of Science and hand searches of reference lists of relevant articles. Twelve studies were reviewed in which the relationship between television viewing and diet was assessed in children between the ages of 2 and 6. All but one study reported significant relationship between television viewing time and adverse dietary outcomes. Parent-reported television viewing time was used to assay child television viewing in all included studies. Food frequency survey was the most frequent method of dietary assessment, and parent served as proxies for children in all studies. Lower fruit and/or vegetable intake was the most frequently reported dietary outcome, followed by increased energy intake with increased television viewing. The majority of studies reported adverse dietary outcomes with as little as 1 h of daily television exposure. While these results are consistent with recommendations from child health advocates to limit television viewing in young children, they also suggest that further efforts to limit television viewing in young children may be needed to aid in obesity prevention. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

Real-World Assessment of Renal and Bone Safety among Patients with HIV Infection Exposed to Tenofovir Disoproxil Fumarate-Containing Single-Tablet Regimens.

PubMed

Nkhoma, Ella T; Rosenblatt, Lisa; Myers, Joel; Villasis-Keever, Angelina; Coumbis, John

2016-01-01

Tenofovir disoproxil fumarate (TDF)-containing antiretroviral regimens have been associated with an increased incidence of renal and bone adverse outcomes. Here, we estimated the real-world incidence of renal and bone adverse outcomes among patients with HIV infection receiving different TDF-containing single-tablet regimens (STRs). This cohort study used US health insurance data spanning the years 2008-2014. We identified HIV-infected patients aged ≥18 years (all HIV patients) and those with ≥6 months of continuous enrollment prior to initiating efavirenz/emtricitabine/TDF (EFV/FTC/TDF), rilpivirine/FTC/TDF (RPV/FTC/TDF) or elvitegravir/cobicistat/FTC/TDF (EVG/COBI/FTC/TDF). Renal adverse outcomes were identified using renal International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. Bone adverse outcomes were identified using ICD-9-CM diagnosis codes for fracture. Incidence rates (IRs) and associated 95% confidence intervals (CIs) were estimated assuming a Poisson distribution, and outcomes between STRs were compared using IR ratios (IRRs) and IR differences (IRDs). We identified 9876 and 10,383 eligible patients for the renal and fracture analyses, respectively. Observed IRs for renal adverse outcomes were 9.7, 10.5, 13.6, and 18.0 per 1000 person-years among those receiving EFV/FTC/TDF, RPV/FTC/TDF, or EVG/COBI/FTC/TDF, or all HIV patients, respectively. Corresponding values for IRs of fracture were 3.4, 3.6, 7.2, and 4.4 per 1000 person-years, respectively. Renal adverse outcomes with EFV/FTC/TDF were significantly less frequent than with EVG/COBI/FTC/TDF (IRD -3.96; 95% CI: -7.31, -1.06). No IRR differences were identified for the renal analysis. Fractures with EFV/FTC/TDF were significantly less frequent than with EVG/COBI/FTC/TDF (IRR 0.47; 95% CI: 0.27, 0.81 and IRD -3.85; 95% CI: -5.02, -2.78). In this large real-world database, observed IRs for renal adverse outcomes with TDF-containing STRs were lower or similar to those for all HIV patients, with the lowest IRs observed among patients receiving EFV/FTC/TDF. Compared with all HIV patients, the observed IR for fracture was higher with EVG/COBI/FTC/TDF, comparable with RPV/FTC/TDF, and lower with EFV/FTC/TDF.

Assessment of the use of sialogogues in the clinical management of patients with xerostomia.

PubMed

Chainani-Wu, Nita; Gorsky, Meir; Mayer, Priscilla; Bostrom, Alan; Epstein, Joel B; Silverman, Sol

2006-01-01

This study was conducted to assess the clinical efficacy and adverse effects of pilocarpine, bethanechol and cevimeline in patients with xerostomia. In this open-label crossover assessment in 20 patients with xerostomia, a one- to two-week course of each medication with a one-week washout period was prescribed. Side effects, symptoms, whole stimulated and unstimulated saliva were measured. Each sialogogue was found to increase saliva and decrease symptoms. A mixed-effects analysis showed a greater increase in stimulated saliva on bethanechol compared to pilocarpine (0.106, p = 0.0272). Increased sweating was the most common side effect, experienced more frequently with pilocarpine as compared to bethanechol (p = 0.0588) or cevimeline (p = 0.0143). A carryover effect beyond the washout period was seen. Effects on saliva and side effects vary between sialogogues, suggesting a benefit of trials with different sialogogues to determine individual patient preference. The observed carryover effect suggests that intermittent treatment may be an alternative to continuous treatment with sialogogues.

Nitrous Oxide 70% for Procedural Analgosedation in a Pediatric Emergency Department With or Without Intranasal Fentanyl?: Analgesic Efficacy and Adverse Events if Combined With Intranasal Fentanyl.

PubMed

Seiler, Michelle; Landolt, Markus A; Staubli, Georg

2017-07-03

Nitrous oxide 70% (N20 70%) is an excellent medication for procedural analgosedation in a pediatric emergency department. However, its analgesic efficacy remains uncertain for painful procedures; therefore, a combination with intranasal fentanyl (INF), an opioid, was suggested. This study aimed at observing and assessing the analgesic efficacy and rate of adverse events using N20 70% with and without INF. Children who received N20 70% in a tertiary children's hospital emergency department from January 1, 2014 to June 30, 2015 were included in this observational study with prospective data collection. Physicians decided individually whether INF was administered. Medical staff documented the child's behavior during the procedure, adverse events, and satisfaction rate. A total of 442 children were included; 206 (46.6%) received INF. Group differences regarding patient behavior were not statistically significant; however, N20 70% application time was longer in the INF group (P = .02). Nausea was the most frequent adverse event with 13.1% in the INF group versus 8.1% without INF. Inadequate procedural analgosedation was documented only in the INF group, affecting 1.8% of all patients (P = .002). In contrast, anxiety was exclusively observed in the group without INF, which was presumably misjudged pain (P = .03); the satisfaction rate in the INF group was 95.6% compared with 98.7% without INF. Because of the study design and limitations, no conclusions about adding INF to N20 70% can be made. Additional research is needed to investigate the effect of combining N20 70% with INF.

Insect Venom Immunotherapy: Analysis of the Safety and Tolerance of 3 Buildup Protocols Frequently Used in Spain.

PubMed

Gutiérrez Fernández, D; Moreno-Ancillo, A; Fernández Meléndez, S; Domínguez-Noche, C; Gálvez Ruiz, P; Alfaya Arias, T; Carballada González, F; Alonso Llamazares, A; Marques Amat, L; Vega Castro, A; Antolín Amérigo, D; Cruz Granados, S; Ruiz León, B; Sánchez Morillas, L; Fernández Sánchez, J; Soriano Gomis, V; Borja Segade, J; Dalmau Duch, G; Guspi Bori, R; Miranda Páez, A

2016-01-01

Hymenoptera venom immunotherapy (VIT) is an effective treatment but not one devoid of risk, as both local and systemic adverse reactions may occur, especially in the initial phases. We compared the tolerance to 3 VIT buildup protocols and analyzed risk factors associated with adverse reactions during this phase. We enrolled 165 patients divided into 3 groups based on the buildup protocol used (3, 4, and 9 weeks). The severity of systemic reactions was evaluated according to the World Allergy Organization model. Results were analyzed using exploratory descriptive statistics, and variables were compared using analysis of variance. Adverse reactions were recorded in 53 patients (32%) (43 local and 10 systemic). Local reactions were immediate in 27 patients (63%) and delayed in 16 (37%). The severity of the local reaction was slight/moderate in 15 patients and severe in 13. Systemic reactions were grade 1-2. No significant association was found between the treatment modality and the onset of local or systemic adverse reactions or the type of local reaction. We only found a statistically significant association between severity of the local reaction and female gender. As for the risk factors associated with systemic reactions during the buildup phase, we found no significant differences in values depending on the protocol used or the insect responsible. The buildup protocols compared proved to be safe and did not differ significantly from one another. In the population studied, patients undergoing the 9-week schedule presented no systemic reactions. Therefore, this protocol can be considered the safest approach.

Adverse drug reactions amongst adult patients admitted in Lagos State University Teaching Hospital Lagos, Nigeria.

PubMed

Aderemi-Williams, R I; Awodele, O; Boyle, C A

2015-01-01

Adverse drug reaction (ADR) is a global drug therapy problem. It has been rated as one of the top leading causes of morbidity and mortality. In Nigeria, not much is known about ADRs especially with the existing weak post marketing surveillance for monitoring drug use, and its effect on the population. The study is aimed at determining the incidence of ADRs, presentations of ADRs, classes of drugs that frequently cause ADRs and predictors of ADRs in adult medical in-patients in LASUTH. A retrospective study of six hundred and twenty four (624) case notes of all patients admitted to the medical wards in LASUTH between January 1, 2009 and December 31, 2009 was carried out. Information obtained included age, gender, and adverse drug reaction and drug details. The results obtained were analyzed using SPSS version 16 statistical software. Level of significance was set at p ≤ 0.05. A total of 624 case notes consisting of 358 males and 266 females were assessed. The number of patients who experienced adverse drug reactions was 67 (n = 624, 10.7%). The incidence rate of ADRs in LASUTH from the study was 10.7 per 100 patients' population. Most of the ADRs observed were type A reactions (97.8%). Mostly implicated classes of drugs were antidiabetics (26.7%) and NSAIDs (29.3%). The incidence rate of ADRs was 10.7%. ADRs which are predictable and preventable occur in hospitalized patients, such may be prevented or minimized by implementing measures to target specific drugs that are commonly suspected.

Frequency of Extrapyramidal Adverse Reactions in Schizophrenic Outpatients Treated with Risperidone, Olanzapine, Quetiapine or Haloperidol : Results of the EIRE Study.

PubMed

Bobes, Julio; Rejas, J; Garcia-Garcia, M; Rico-Villademoros, F; García-Portilla, M P; Madrigal, M; Hernández, G

2002-09-01

The EIRE (Estudio de Investigaciön de Resultados en Esquizofrenia - Outcomes Research Study in Schizophrenia) study was initiated in order to assess the frequency of adverse reactions [extrapyramidal symptoms (EPS), hyperprolactinaemia, sexual dysfunction and weight gain] caused by atypical antipsychotics and haloperidol in patients with schizophrenia during routine treatment in clinical practice. This paper presents the results of the assessment of extrapyramidal adverse reactions. Outpatients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV), criteria and receiving a single antipsychotic (risperidone, olanzapine, quetiapine or haloperidol) for at least 4 weeks were consecutively recruited. In this cross-sectional and non-interventional study data were collected in a single visit; this included demographic and clinical characteristics, current antipsychotic and concomitant treatment, and data on several adverse effects listed in a modified version of the UKU (Udvalg for Kliniske Undersogelser - Committee on Clinical Investigations) scale. For paired comparisons of the frequency of adverse reactions between treatments the Chi-squared (χ 2 ) test was used. For estimation of the risk of a given adverse reaction with a given treatment a logistic regression method was used. 636 evaluable patients (of 669 recruited) were assessed. The frequency of EPS with haloperidol (78.3% of the cases) was higher than with risperidone (55.1%), quetiapine (39.5%) and olanzapine (35.8%) [χ 2 : p < 0.05], and the difference between risperidone and olanzapine was also statistically significant (χ 2 : p < 0.05). Very similar results were obtained in the individualised analysis of the items as regards the occurrence of akathisia, which was also more frequent in the haloperidol (36.8%) and risperidone (19.7%) groups than in the olanzapine (11.4%) and quetiapine (2.6%) groups (χ 2 : p < 0.05). Olanzapine, quetiapine and risperidone also showed a lower risk of EPS than haloperidol when adjusting by dose. Our results suggest that the atypical antipsychotics studied are less likely to induce extrapyramidal adverse reactions compared with haloperidol in stabilised patients, although these reactions are still common.

Surveillance of contrast-media-induced hypersensitivity reactions using signals from an electronic medical recording system.

PubMed

Kim, Min-Hye; Park, Chang-Han; Kim, Duk-In; Kim, Kyung-Mook; Kim, Hui-Kyu; Lim, Kyu-Hyoung; Song, Woo-Jung; Lee, Sang-Min; Kim, Sae-Hoon; Kwon, Hyouk-Soo; Park, Heung-Woo; Yoon, Chang-Jin; Cho, Sang-Heon; Min, Kyung-Up; Kim, You-Young; Chang, Yoon-Seok

2012-03-01

Contrast-media (CM) hypersensitivity is a well-known adverse drug reaction. Surveillance of adverse drug reactions usually depends on spontaneous reports. However, the rate of spontaneous reports is low. Recent progress in information technology enables the electronic search on signals of adverse drug reactions from electronic medical recording (EMR) systems. To analyze the incidence and clinical characteristics of CM hypersensitivity using an EMR-based surveillance system. The surveillance system used signals from standardized terms within the international classification of nursing practice terms that can indicate symptoms of CM hypersensitivity and from the order codes for procedures that used contrast media, antihistamine, and epinephrine. The search strategy was validated by allergists comparing the electronic search strategy versus manually reviewing medical charts over one month. The main study covered for one year period. Detection rate of the electronic search method was 0.9% (7/759), while that of the manual search method was 0.8% (6/759). EMR-based electronic search method was highly efficient: reduced the charts that needed to be reviewed by 96% (28/759). The sensitivity of electronic screening was 66.7%, specificity was 99.6%, and the negative predictive value was 99.7%. CM hypersensitivity reactions were noted in 266 among 12,483 cases (2.1%). Urticaria was the most frequent symptom (74.4%). CT was the most frequent procedure (3.6%) that induced CM hypersensitivity. A surveillance system using EMR may be a useful tool in the study of drug hypersensitivity epidemiology and may be used in an adverse drug reaction alarm system and as a clinical, decision making support system. Copyright © 2012 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

The impact of hyperandrogenism in female obesity and cardiometabolic diseases associated with polycystic ovary syndrome.

PubMed

Barber, Thomas M; Vojtechova, Petra; Franks, Stephen

2013-09-01

Polycystic ovary syndrome (PCOS) is a common condition characterized by reproductive and hyperandrogenic features and is often associated with obesity and metabolic dysfunction. Overall, women with PCOS have a substantially greater prevalence of metabolic syndrome than women from the general population. Furthermore, PCOS per se (independent of its frequent association with obesity) often confers cardiometabolic risk (including insulin resistance), and its concurrence with obesity often represents a metabolic "double-whammy" from the adverse effects of PCOS and obesity. The introduction of the Rotterdam diagnostic criteria for PCOS in 2003 has broadened the scope of this condition. The Rotterdam diagnostic criteria have also introduced two new phenotypic subgroups (including normoandrogenemic women with PCOS) that have provided novel insights into a potential role for hyperandrogenism in the development of adverse cardiometabolic risk in women with PCOS. Based on evidence from cross-sectional and interventional studies, hyperandrogenism, obesity, and cardiometabolic risk in women appear to be linked through complex and multidirectional pathways. Furthermore, data from obese women without a formal diagnosis of PCOS also suggest that these interrelationships often exist in female obesity per se (in milder forms than occurs in PCOS). Data from female-to-male transsexuals are particularly informative because these show direct effects of hyperandrogenism (induced through exogenous use of androgenic therapies) on fat distribution and cardiometabolic risk in women. A challenge for the future will be to disentangle and improve our understanding of this complex pathogenic web, thereby facilitating novel and targeted therapies for the hyperandrogenic and adverse cardiometabolic manifestations of PCOS.

Impact of Continuous Administration of Tolvaptan on Preventing Medium-Term Worsening Renal Function and Long-Term Adverse Events in Heart Failure Patients with Chronic Kidney Disease.

PubMed

Nakano, Yusuke; Mizuno, Tomofumi; Niwa, Toru; Mukai, Kentaro; Wakabayashi, Hirokazu; Watanabe, Atsushi; Ando, Hirohiko; Takashima, Hiroaki; Murotani, Kenta; Waseda, Katsuhisa; Amano, Tetsuya

2018-01-27

Tolvaptan (TLV) has an inhibiting effect for worsening renal function (WRF) in acute decompensated heart failure (HF) patients. However, there are limited data regarding the effect of continuous TLV administration on medium-term WRF.This was a retrospective observational study in hospitalized HF patients with chronic kidney disease (CKD). TLV was administered to those patients with fluid retention despite standard HF therapy. We compared 34 patients treated with TLV (TLV group) to 33 patients treated with conventional HF therapy with high-dose loop diuretics (furosemide ≥ 40 mg) (Loop group). Clinical outcomes, including the incidence of medium-term WRF, defined as increase of serum creatinine > 0.3 mg/dL, at 6 months after discharge and adverse events rate, were evaluated.Baseline patient characteristics were not different between the TLV and Loop group. The TLV group consisted of less frequent use of loop diuretics and carperitide compared with the Loop group. The incidence of medium-term WRF was significantly lower in the TLV group than in the Loop group (3.2% versus 31.0%, P = 0.002). Multivariate logistic analysis showed that the TLV non-user was an independent predictor of medium-term WRF. Kaplan-Meier analysis revealed that the long-term event-free survival was significantly higher in the TLV group (log-rank P = 0.01).Continuous administration of TLV may reduce the risk of medium-term WRF, resulting possibility in improvement of long-term adverse outcomes in HF patients with CKD.

Thalidomide induces haematologic responses in patients with β-thalassaemia.

PubMed

Chen, Jiangming; Zhu, Weijian; Cai, Ning; Bu, Shengdi; Li, Jinyan; Huang, Lan

2017-11-01

This study aimed to evaluate the clinical and laboratory outcomes of a group of patients with β-thalassaemia major or intermedia treated with thalidomide. Clinical and laboratory data were obtained by analysing medical records of β-thalassaemia patients. Using the self-control method, the levels of haemoglobin (Hb), foetal haemoglobin (HbF), white blood cells (WBC) and platelets were detected before and after the treatment, and adverse reactions were recorded. Data from the medical records of 9 patients were analysed. The median haemoglobin levels of these patients increased from 5.13 ± 2.15 g/dL before treatment to 10.38 ± 1.19 g/dL after treatment. The average spleen size decreased from a pretreatment length of 8.19 ± 3.10 to 5.49 ± 1.80 cm below the costal margin after treatment. The mean HbF levels increased from a pretreatment value of 35.67% ± 26.82% to 75.67% ± 14.64% after treatment in the 9 patients for whom these measurements were available. All patients no longer needed transfusions by 1 month after treatment. No serious adverse reactions were observed in any of the thalidomide-treated patients. In this study, thalidomide showed an outstanding effect on β-thalassaemia patients who required frequent red-cell transfusions. Thalidomide increased haemoglobin levels without causing serious adverse reactions, but the long-term curative outcomes and other side effects should be observed continuously. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Dose-Effect Relationships for Adverse Events After Cranial Radiation Therapy in Long-term Childhood Cancer Survivors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dijk, Irma W.E.M. van, E-mail: i.w.vandijk@amc.uva.nl; Cardous-Ubbink, Mathilde C.; Pal, Helena J.H. van der

Purpose: To evaluate the prevalence and severity of clinical adverse events (AEs) and treatment-related risk factors in childhood cancer survivors treated with cranial radiation therapy (CRT), with the aim of assessing dose-effect relationships. Methods and Materials: The retrospective study cohort consisted of 1362 Dutch childhood cancer survivors, of whom 285 were treated with CRT delivered as brain irradiation (BI), as part of craniospinal irradiation (CSI), and as total body irradiation (TBI). Individual CRT doses were converted into the equivalent dose in 2-Gy fractions (EQD{sub 2}). Survivors had received their diagnoses between 1966 and 1996 and survived at least 5 yearsmore » after diagnosis. A complete inventory of Common Terminology Criteria for Adverse Events grade 3.0 AEs was available from our hospital-based late-effect follow-up program. We used multivariable logistic and Cox regression analyses to examine the EQD{sub 2} in relation to the prevalence and severity of AEs, correcting for sex, age at diagnosis, follow-up time, and the treatment-related risk factors surgery and chemotherapy. Results: There was a high prevalence of AEs in the CRT group; over 80% of survivors had more than 1 AE, and almost half had at least 5 AEs, both representing significant increases in number of AEs compared with survivors not treated with CRT. Additionally, the proportion of severe, life-threatening, or disabling AEs was significantly higher in the CRT group. The most frequent AEs were alopecia and cognitive, endocrine, metabolic, and neurologic events. Using the EQD{sub 2}, we found significant dose-effect relationships for these and other AEs. Conclusion: Our results confirm that CRT increases the prevalence and severity of AEs in childhood cancer survivors. Furthermore, analyzing dose-effect relationships with the cumulative EQD{sub 2} instead of total physical dose connects the knowledge from radiation therapy and radiobiology with the clinical experience.« less

A novel prognostic model in myeloma based on co-segregating adverse FISH lesions and the ISS: analysis of patients treated in the MRC Myeloma IX trial.

PubMed

Boyd, K D; Ross, F M; Chiecchio, L; Dagrada, G P; Konn, Z J; Tapper, W J; Walker, B A; Wardell, C P; Gregory, W M; Szubert, A J; Bell, S E; Child, J A; Jackson, G H; Davies, F E; Morgan, G J

2012-02-01

The association of genetic lesions detected by fluorescence in situ hybridization (FISH) with survival was analyzed in 1069 patients with newly presenting myeloma treated in the Medical Research Council Myeloma IX trial, with the aim of identifying patients associated with the worst prognosis. A comprehensive FISH panel was performed, and the lesions associated with short progression-free survival and overall survival (OS) in multivariate analysis were +1q21, del(17p13) and an adverse immunoglobulin heavy chain gene (IGH) translocation group incorporating t(4;14), t(14;16) and t(14;20). These lesions frequently co-segregated, and there was an association between the accumulation of these adverse FISH lesions and a progressive impairment of survival. This observation was used to define a series of risk groups based on number of adverse lesions. Taking this approach, we defined a favorable risk group by the absence of adverse genetic lesions, an intermediate group with one adverse lesion and a high-risk group defined by the co-segregation of >1 adverse lesion. This genetic grouping was independent of the International Staging System (ISS) and so was integrated with the ISS to identify an ultra-high-risk group defined by ISS II or III and >1 adverse lesion. This group constituted 13.8% of patients and was associated with a median OS of 19.4 months.

An 'Early Warning System' for the prevention of dredging potential impacts on sensitive areas

NASA Astrophysics Data System (ADS)

Piermattei, Viviana; Martellucci, Riccardo; Pierattini, Alberto; Bonamano, Simone; Paladini de Mendoza, Francesco; Albani, Marta; Stefanì, Chiara; Madonia, Alice; Fersini, Giorgio; Marcelli, Marco

2016-04-01

Coastal marine ecosystems are increasingly subject to multiple pressures and stressors produced by the effects of human activities. Intense and frequent disturbances which affect marine environment can derive from dredging activity, which is a fundamental management for most ports and harbours. The potential environmental effects of dredging procedures are generally due to the excavation of material from the sea bottom and the relocation elsewhere for disposal, overflow from the dredger and loss of material from pipelines during transport. Depending on the location and the intensity of these activities the marine environment, particularly sensitive areas, may be affected by dredging. The main environmental effects can be associated with suspended sediments and increases in turbidity into the water column, which can have adverse effects on marine animals and plants by reducing light penetration and by physical disturbance. For this reason it is fundamental to implement a real time monitoring system to control and prevent negative effects, enabling a rapid response to adverse water quality conditions and a fast activation of mitigation procedures, in agreement with all the reference authorities. In this work we present the development of an innovative 'Early Warning System' based on fixed stations, ad hoc in situ surveys and forecasting models, which was applied to a dredging activity carried out in the Gulf of Gaeta (Latium, Italy). It represents an extension of the C-CEMS (Civitavecchia Coastal Environmental Monitoring System) network, which is operative in the Tyrrhenian sea since 2005.

Preterm Versus Term Children: Analysis of Sedation/Anesthesia Adverse Events and Longitudinal Risk.

PubMed

Havidich, Jeana E; Beach, Michael; Dierdorf, Stephen F; Onega, Tracy; Suresh, Gautham; Cravero, Joseph P

2016-03-01

Preterm and former preterm children frequently require sedation/anesthesia for diagnostic and therapeutic procedures. Our objective was to determine the age at which children who are born <37 weeks gestational age are no longer at increased risk for sedation/anesthesia adverse events. Our secondary objective was to describe the nature and incidence of adverse events. This is a prospective observational study of children receiving sedation/anesthesia for diagnostic and/or therapeutic procedures outside of the operating room by the Pediatric Sedation Research Consortium. A total of 57,227 patients 0 to 22 years of age were eligible for this study. All adverse events and descriptive terms were predefined. Logistic regression and locally weighted scatterplot regression were used for analysis. Preterm and former preterm children had higher adverse event rates (14.7% vs 8.5%) compared with children born at term. Our analysis revealed a biphasic pattern for the development of adverse sedation/anesthesia events. Airway and respiratory adverse events were most commonly reported. MRI scans were the most commonly performed procedures in both categories of patients. Patients born preterm are nearly twice as likely to develop sedation/anesthesia adverse events, and this risk continues up to 23 years of age. We recommend obtaining birth history during the formulation of an anesthetic/sedation plan, with heightened awareness that preterm and former preterm children may be at increased risk. Further prospective studies focusing on the etiology and prevention of adverse events in former preterm patients are warranted. Copyright © 2016 by the American Academy of Pediatrics.

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial.

PubMed

Egbring, Marco; Far, Elmira; Roos, Malgorzata; Dietrich, Michael; Brauchbar, Mathis; Kullak-Ublick, Gerd A; Trojan, Andreas

2016-09-06

The well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy. The aim of the study was to evaluate the effects of a mobile app on patient-reported daily functional activity in a supervised and unsupervised setting. We conducted a randomized controlled study of 139 breast cancer patients undergoing chemotherapy. Patient status was self-measured using Eastern Cooperative Oncology Group scoring and Common Terminology Criteria for Adverse Events. Participants were randomly assigned to a control group, an unsupervised group that used a mobile app to record data, or a supervised group that used the app and reviewed data with a physician. Primary outcome variables were change in daily functional activity and symptoms over three outpatient visits. Functional activity scores declined in all groups from the first to second visit. However, from the second to third visit, only the supervised group improved, whereas the others continued to decline. Overall, the supervised group showed no significant difference from the first (median 90.85, IQR 30.67) to third visit (median 84.76, IQR 18.29, P=.72). Both app-using groups reported more distinct adverse events in the app than in the questionnaire (supervised: n=1033 vs n=656; unsupervised: n=852 vs n=823), although the unsupervised group reported more symptoms overall (n=4808) in the app than the supervised group (n=4463). The mobile app was associated with stabilized daily functional activity when used under collaborative review. App-using participants could more frequently report adverse events, and those under supervision made fewer and more precise entries than unsupervised participants. Our findings suggest that patient well-being and awareness of chemotherapy adverse effects can be improved by using a mobile app in collaboration with the treating physician. ClinicalTrials.gov NCT02004496; https://clinicaltrials.gov/ct2/show/NCT02004496 (Archived by WebCite at http://www.webcitation.org/6k68FZHo2).

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial

PubMed Central

Egbring, Marco; Far, Elmira; Roos, Malgorzata; Dietrich, Michael; Brauchbar, Mathis; Kullak-Ublick, Gerd A

2016-01-01

Background The well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy. Objective The aim of the study was to evaluate the effects of a mobile app on patient-reported daily functional activity in a supervised and unsupervised setting. Methods We conducted a randomized controlled study of 139 breast cancer patients undergoing chemotherapy. Patient status was self-measured using Eastern Cooperative Oncology Group scoring and Common Terminology Criteria for Adverse Events. Participants were randomly assigned to a control group, an unsupervised group that used a mobile app to record data, or a supervised group that used the app and reviewed data with a physician. Primary outcome variables were change in daily functional activity and symptoms over three outpatient visits. Results Functional activity scores declined in all groups from the first to second visit. However, from the second to third visit, only the supervised group improved, whereas the others continued to decline. Overall, the supervised group showed no significant difference from the first (median 90.85, IQR 30.67) to third visit (median 84.76, IQR 18.29, P=.72). Both app-using groups reported more distinct adverse events in the app than in the questionnaire (supervised: n=1033 vs n=656; unsupervised: n=852 vs n=823), although the unsupervised group reported more symptoms overall (n=4808) in the app than the supervised group (n=4463). Conclusions The mobile app was associated with stabilized daily functional activity when used under collaborative review. App-using participants could more frequently report adverse events, and those under supervision made fewer and more precise entries than unsupervised participants. Our findings suggest that patient well-being and awareness of chemotherapy adverse effects can be improved by using a mobile app in collaboration with the treating physician. ClinicalTrial ClinicalTrials.gov NCT02004496; https://clinicaltrials.gov/ct2/show/NCT02004496 (Archived by WebCite at http://www.webcitation.org/6k68FZHo2) PMID:27601354

Ceftazidime-induced thrombocytopenia.

PubMed

Domingo-Chiva, E; Díaz-Rangel, M; Monsalve-Naharro, J Á; Cuesta-Montero, P; Catalá-Ripoll, J V; García-Martínez, E M

2017-12-01

Ceftazidime is an antibiotic belonging to the group of third generation cephalosporins, frequently used in clinical practice for its broad antibacterial spectrum. A case report is presented on a 78-year-old man who entered the intensive care unit due to respiratory failure secondary to nosocomial pneumonia in the postoperative period of a laparoscopic hepatic bisegmentectomy for a hepatocarcinoma. It required invasive mechanical ventilation and was treated with ceftazidime, developing a progressive decrease in platelet count after the onset of this drug and after re-exposure to it, not coinciding with the introduction of other drugs. The adverse reaction was reported to the Spanish pharmacosurveillance system and according to the Naranjo algorithm the causal relationship was probable. Since no case of ceftazidime-induced thrombocytopenia was found in the literature, we consider knowledge of it relevant as an adverse effect to be taken into account given its potential severity, especially when it cannot be explained by other causes. Copyright © 2017 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Asymptomatic bacteriuria: when to screen and when to treat.

PubMed

Nicolle, Lindsay E

2003-06-01

Asymptomatic bacteriuria is common. Populations with structural or functional abnormalities of the genitourinary tract may have an exceedingly high prevalence of bacteriuria, but even healthy individuals frequently have positive urine cultures. Asymptomatic bacteriuria is seldom associated with adverse outcomes. Pregnant women and individuals who are to undergo traumatic genitourinary interventions are at risk for complications of bacteriuria and benefit from screening and treatment programs. Although screening is recommended for renal transplant recipients, the benefits for these patients are less clear. For other populations, including most bacteriuric individuals, negative outcomes attributable to asymptomatic bacteriuria have not been described. Treatment of asymptomatic bacteriuria in these patients is not beneficial and, in fact, may be associated with harmful outcomes, such as increased short-term frequency of symptomatic infection, adverse drug effects, and reinfection with organisms of increased antimicrobial resistance. Screening for asymptomatic bacteriuria and treatment is recommended for only selected groups where benefit has been shown. Many research questions still need to be addressed. Different populations have unique risk factors, and the benefits and risks of different management approaches for asymptomatic bacteriuria must continue to be addressed systematically in appropriate clinical trials.

Fretting and Corrosion in Modular Shoulder Arthroplasty: A Retrieval Analysis

PubMed Central

Panzram, Benjamin

2016-01-01

Tribocorrosion in taper junctions of retrieved anatomic shoulder arthroplasty implants was evaluated. A comparison of the tribocorrosion between cobalt-chromium and titanium alloy stems was conducted and the observations were correlated with the individual's clinical data. Adverse effects caused by metal debris and subsequent elevated serum metal ion levels are frequently reported in total hip arthroplasty. In total shoulder arthroplasty, to date only a small number of retrieval analyses are available and even fewer address the issue of tribocorrosion at the taper junctions. A total of 36 retrieved hemiarthroplasties and total shoulder arthroplasties were assessed using the modified Goldberg score. The prevalence of fretting and corrosion was confirmed in this cohort. Titanium stems seem to be more susceptible to damage caused by tribocorrosion than cobalt-chromium stems. Furthermore, stemless designs offered less tribocorrosion at the taper junction than stemmed designs. A weak correlation between time to revision and increased levels of tribocorrosion was seen. Whether or not tribocorrosion can lead to adverse clinical reactions and causes failure of shoulder arthroplasties remains to be examined. PMID:27433471

Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review.

PubMed

Golder, Su; Wright, Kath; Rodgers, Mark

2014-10-13

Research has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase. However, it is unknown whether adverse effects terms are present in the database records of articles that contain adverse effects data of medical devices, and thus, to what extent the development of an adverse effects search filter for medical devices may be feasible. A case study systematic review of a medical device was selected. The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used in the analysis. For each included study, the corresponding database record on MEDLINE and Embase was assessed to measure the presence or absence of adverse effects terms in the title, abstract or indexing. The performance of each potential adverse effects search term was also measured and compared. There were 82 publications (49 studies) included in the systematic review with 51 of these indexed on MEDLINE and 55 on Embase. Ninety-four percent (48/51) of the records on MEDLINE and 95% (52/55) of the records on Embase contained at least one adverse effects related search term. The wide variety of adverse effects terms included in the title, abstract or indexing of bibliographic records, and the lack of any individual high-performing search terms suggests that a combination of terms in different fields is required to identify adverse effects of medical devices. In addition, the most successful search terms differed from the most successful terms for identifying adverse drug effects. The search filters currently available for adverse drug effects are not necessarily useful for searching adverse effects data of medical devices. The presence of adverse effects terms in the bibliographic records of articles on medical devices, however, indicates that combinations of adverse effects search terms may be useful in search strategies in MEDLINE and Embase. The results, therefore, suggest that not only a search filter for the adverse effects of medical devices is feasible, but also that it should be a research priority.

Are adverse effects incorporated in economic models? An initial review of current practice.

PubMed

Craig, D; McDaid, C; Fonseca, T; Stock, C; Duffy, S; Woolacott, N

2009-12-01

To identify methodological research on the incorporation of adverse effects in economic models and to review current practice. Major electronic databases (Cochrane Methodology Register, Health Economic Evaluations Database, NHS Economic Evaluation Database, EconLit, EMBASE, Health Management Information Consortium, IDEAS, MEDLINE and Science Citation Index) were searched from inception to September 2007. Health technology assessment (HTA) reports commissioned by the National Institute for Health Research (NIHR) HTA programme and published between 2004 and 2007 were also reviewed. The reviews of methodological research on the inclusion of adverse effects in decision models and of current practice were carried out according to standard methods. Data were summarised in a narrative synthesis. Of the 719 potentially relevant references in the methodological research review, five met the inclusion criteria; however, they contained little information of direct relevance to the incorporation of adverse effects in models. Of the 194 HTA monographs published from 2004 to 2007, 80 were reviewed, covering a range of research and therapeutic areas. In total, 85% of the reports included adverse effects in the clinical effectiveness review and 54% of the decision models included adverse effects in the model; 49% included adverse effects in the clinical review and model. The link between adverse effects in the clinical review and model was generally weak; only 3/80 (< 4%) used the results of a meta-analysis from the systematic review of clinical effectiveness and none used only data from the review without further manipulation. Of the models including adverse effects, 67% used a clinical adverse effects parameter, 79% used a cost of adverse effects parameter, 86% used one of these and 60% used both. Most models (83%) used utilities, but only two (2.5%) used solely utilities to incorporate adverse effects and were explicit that the utility captured relevant adverse effects; 53% of those models that included utilities derived them from patients on treatment and could therefore be interpreted as capturing adverse effects. In total, 30% of the models that included adverse effects used withdrawals related to drug toxicity and therefore might be interpreted as using withdrawals to capture adverse effects, but this was explicitly stated in only three reports. Of the 37 models that did not include adverse effects, 18 provided justification for this omission, most commonly lack of data; 19 appeared to make no explicit consideration of adverse effects in the model. There is an implicit assumption within modelling guidance that adverse effects are very important but there is a lack of clarity regarding how they should be dealt with and considered in modelling. In many cases a lack of clear reporting in the HTAs made it extremely difficult to ascertain what had actually been carried out in consideration of adverse effects. The main recommendation is for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that 'all relevant outcomes' should include some consideration of adverse events.

Adverse effects of aromatherapy: a systematic review of case reports and case series.

PubMed

Posadzki, Paul; Alotaibi, Amani; Ernst, Edzard

2012-01-01

This systematic review was aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects. Aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.

[The Phenotype of Chronic Obstructive Pulmonary Disease With Frequent Exacerbations in the Aspect of Long-term Percutaneous Coronary Intervention Results].

PubMed

Zafiraki, V K; Namitokov, A M; Skaletsky, K V; Kosmacheva, E D; Shulzhenko, L V; Ramazanov, J M; Omarov, A A; Pershukov, I V

2017-03-01

To evaluate the results of percutaneous coronary interventions (PCI) in patients with coronary heart disease (CHD) and chronic obstructive pulmonary disease (COPD), depending on the frequency of exacerbations of COPD. We enrolled in this prospective study 103 patients with CHD and COPD who underwent PCI (n=103) including 25 who satisfied criteria of COPD phenotype with frequent exacerbations (main group). Analysis included comparison of rates and times to major adverse cardiac events (MACE - myocardial infarction, stroke, cardiac death, repeat revascularization) in the main group and other patients. Clinical and functional features of patients with major adverse cardiac events were also analyzed. Study groups did not differ significantly on demographic characteristics and the presence of comorbidity. MACE frequency was almost 2 times higher in the main group (relative risk 1.87; 95% confidence interval (CI) 1.1-3.3). There was a tendency to higher rate of MACE among patients with history of more or equal 1 COPD exacerbations in a year (40% vs. 24%, p=0.09). The following clinical and functional characteristics of COPD, were associated with MACE in remote period after PCI: frequency of exacerbations, results of the COPD Assessment Test, exercise capacity, forced expiratory volume in 1 sec. Conclusion/ COPD phenotype with frequent exacerbations in patients with CHD undergoing PCI is associated with increased risk and earlier occurrence of MACE.

Frequent plateletpheresis does not clinically significantly decrease platelet counts in donors.

PubMed

Katz, Louis; Palmer, Kim; McDonnell, Emily; Kabat, Andy

2007-09-01

In October 2005, the US Food and Drug Administration (FDA) issued draft guidance on collecting platelets (PLTs) by automated methods. The FDA proposed limiting collections to 24 components, rather than 24 procedures, annually with up to 3 components per procedure. The rationale was from literature suggesting frequent PLT collection resulted in significant declines in donor PLT counts. Additional requirements for minimal interdonation intervals were proposed. Plateletpheresis records at a regional blood center with predonation PLT counts were used to assess the impact of the restriction on PLT collections. They were reviewed to demonstrate the effects of collection frequency, number of products collected, and interdonation interval on donor PLT counts. Total protein and albumin levels were compared in a subset of 24-times-per-year PLT donors and control whole-blood donors. A limit of 24 components would require replacement of approximately 20 percent of the donor base to recover lost components. No clinically important decrease in PLT counts before donation was seen in donors donating multiple PLT components up to 24 times per year, regardless of interdonation interval. No frequent donor was deferred for a PLT count less than 150 x 10(9) per L. Short interdonation intervals were associated with statistically but not clinically important decreases in PLT counts. Protein levels were not distinguishable between PLT donors and controls. The proposed restrictions are not required to prevent thrombocytopenia in frequent PLT donors and would adversely impact the supply of apheresis PLTs. Protein levels are maintained in these high-frequency donors.

Adverse experiences in childhood, adulthood neighbourhood disadvantage and health behaviours.

PubMed

Halonen, Jaana I; Vahtera, Jussi; Kivimäki, Mika; Pentti, Jaana; Kawachi, Ichiro; Subramanian, S V

2014-08-01

Early life adversities may play a role in the associations observed between neighbourhood contextual factors and health behaviours. We examined whether self-reported adverse experiences in childhood (parental divorce, long-term financial difficulties, serious conflicts, serious/chronic illness or alcohol problem in the family, and frequent fear of a family member) explain the association between adulthood neighbourhood disadvantage and co-occurrence of behavioural risk factors (smoking, moderate/heavy alcohol use, physical inactivity). Study population consisted of 31 271 public sector employees from Finland. The cross-sectional associations were analysed using two-level cumulative logistic regression models. Childhood adverse experiences were associated with the sum of risk factors (cumulative OR 1.32 (95% CI 1.25 to 1.40) among those reporting 3-6 vs 0 adversities). Adverse experiences did not attenuate the association between neighbourhood disadvantage and risk factors; this cumulative OR was 1.52 (95% CI 1.43 to 1.62) in the highest versus lowest quartile of neighbourhood disadvantage when not including adversities, and 1.50 (95% CI 1.40 to 1.60) when adjusted for childhood adversities. In adversity-stratified analyses those reporting 3-6 adversities had 1.60-fold (95% CI 1.42 to 1.80) likelihood of risk factors if living in the neighbourhood of the highest disadvantage, while in those with fewer adversities this likelihood was 1.09-1.34-fold (95% CI 0.98 to 1.53) (p interaction 0.07). Childhood adverse experiences and adulthood neighbourhood disadvantage were associated with behavioural risk factors. Childhood experiences did not explain associations between neighbourhood disadvantage and the risk factors. However, those with more adverse experiences may be susceptible for the socioeconomic conditions of neighbourhoods. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

An independent review of NCCAM-funded studies of chiropractic.

PubMed

Ernst, Edzard; Posadzki, Paul

2011-05-01

To promote an independent and critical evaluation of 11 randomised clinical trials (RCTs) of chiropractic funded by the National Centre for Complementary and Alternative Medicine (NCCAM). Electronic searches were conducted to identify all relevant RCTs. Key data were extracted and the risk of bias of each study was determined. Ten RCTs were included, mostly related to chiropractic spinal manipulation for musculoskeletal problems. Their quality was frequently questionable. Several RCTs failed to report adverse effects and the majority was not described in sufficient detail to allow replication. The criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.

Modern pesticides and bobwhite populations

USGS Publications Warehouse

Stromborg, K.L.; Schitoskey, Frank=; Schitoskey, Elizabeth C.; Talent, Larry G.

1982-01-01

Bobwhite (Colinus virginianus) are frequently used as test animals for wildlife tests of pesticides. The organophosphate and carbamate pesticides that have replaced the organochlorines have many desirable properties, but they span a wide range of acute toxicities and some of them affe,ct survival, reproduction, food consumption, behavior, and nervous system enzymes in laboratory tests. Applying these laboratory findings to the field requires assumptions about the severity of exposure in the field. Direct field measurements show that birds may be exposed to significant amounts of these pesticides or even more toxic degradation products under some conditions. Adverse population effects may also result from depression of insect populations during the seasons when bobwhites rely on insects for food.

Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management

PubMed Central

St. Louis, Erik K; Rosenfeld, William E; Bramley, Thomas

2009-01-01

Antiepileptic drug (AED) monotherapy is the preferred initial management approach in epilepsy care, since most patients may be successfully managed with the first or second monotherapy utilized. This article reviews the rationale and evidence supporting preferential use of monotherapy when possible and guidelines for initiating and successfully employing AED monotherapy. Suggested approaches to consider when patients fail monotherapy include substituting a new AED monotherapy, initiating chronic maintenance AED polytherapy, or pursuit of non-pharmacologic treatments such as epilepsy surgery or vagus nerve stimulation. Reducing AED polytherapy to monotherapy frequently reduces the burden of adverse effects and may also improve seizure control. AED monotherapy remains the optimal approach for managing most patients with epilepsy. PMID:19949565

Management of substance use disorder in schizophrenia patients: current guidelines.

PubMed

Drake, Robert E

2007-10-01

Substance use disorder is the most frequent and clinically significant comorbidity among schizophrenia patients today. All schizophrenia patients should be assessed and monitored carefully regarding their substance use. Those with any regular use of alcohol or other drugs should be considered at risk for multiple adverse effects. As therapies for co-occurring substance use disorders have evolved over the past 20 years, medication management, psychosocial interventions, and rehabilitation models have increasingly emphasized the integration of mental health and substance abuse treatments, attention to group and residential interventions, matching interventions to stage of treatment, comprehensiveness, and long-term perspectives on recovery. Clinicians should understand the implications of each of these principles of care.

A gastrointestinal stromal tumour with pulmonary metastases mimicking unilateral gynaecomastia.

PubMed

Cimen, Sanem Guler; MacDonald, Frank; Cimen, Sertac; Molinari, Michele

2013-12-16

Gastrointestinal stromal tumours (GISTs) represent 1% of primary gastrointestinal cancers. These neoplasms most frequently metastasise to the liver and peritoneum and rarely to the lungs and bones. Treatment of unresectable GISTs involves systemic chemotherapy with tyrosine kinase inhibitors, imatinib and sunitinib being first-line and second-line drugs. We report the case of a 52-year-old man with GIST who developed a right-sided subareolar breast swelling and subsequently discovered to be an invasive metastatic pulmonary GIST. Given that gynaecomastia is a known adverse effect of imatinib and sunitinib, this case report illustrates the importance of including metastatic disease in the differential diagnosis of patients with GIST and with the new onset of soft tissue masses.

United States public policy and the elderly: the disproportionate risk to the well-being of women.

PubMed

Burkhauser, R V; Duncan, G J

1991-01-01

"Cross-sectional comparisons show that poverty among the aged in the United States has dropped dramatically over the last two decades. We use longitudinal data to identify economic events associated with unfavorable economic outcomes and to trace the influence of these events on women and men at different ages. We find that while social insurance programs appear to prevent severe financial hardship from the most frequent work-related events, they are far less effective in cushioning the economic impact of widowhood and divorce, especially for women. We suggest a number of policy changes that would provide some measure of social insurance against adverse family-related events." excerpt

Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care.

PubMed

Jamison, Robert N; Dorado, Kathleen; Mei, Anna; Edwards, Robert R; Martel, Marc O

2017-03-01

There is increasing concern among primary care practitioners about the use of opioids for chronic pain, including their adverse effects, but little attention has been given to how reports of side effects from prescription medication can contribute to outcomes among patients with chronic pain. The aim of this study was to investigate the impact of frequently reported side effects on mood, disability, and opioid misuse in patients with chronic pain prescribed opioids within primary care. Two hundred (N = 200) patients with chronic pain taking opioids for pain were recruited into the study. All patients completed baseline measures and a monthly side effects checklist once a month for 6 months. Patients were divided evenly based on a median split of the number of endorsed side effects over 6 months. The subjects repeated the baseline measures at the end of the study period. Over time, reports of medication side effects tended to decrease, but differences in frequency of reported side effects from baseline to follow-up (6-month time) were not significant, and the order of the frequency of the reported side effects remained similar. Patients who reported significant medication-related adverse effects reported significantly greater activity interference, negative affect, and catastrophizing compared with those with fewer side effects ( P < 0.01). In addition, those patients with pain who reported more side effects showed significantly higher scores on opioid misuse risk ( P < 0.001). This study demonstrates the important role of monitoring medication-related side effects among patients with chronic pain who are prescribed opioid medication for pain within primary care.

Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care

PubMed Central

Jamison, Robert N.; Dorado, Kathleen; Mei, Anna; Edwards, Robert R.; Martel, Marc O.

2017-01-01

Abstract Background: There is increasing concern among primary care practitioners about the use of opioids for chronic pain, including their adverse effects, but little attention has been given to how reports of side effects from prescription medication can contribute to outcomes among patients with chronic pain. The aim of this study was to investigate the impact of frequently reported side effects on mood, disability, and opioid misuse in patients with chronic pain prescribed opioids within primary care. Methods: Two hundred (N = 200) patients with chronic pain taking opioids for pain were recruited into the study. All patients completed baseline measures and a monthly side effects checklist once a month for 6 months. Patients were divided evenly based on a median split of the number of endorsed side effects over 6 months. The subjects repeated the baseline measures at the end of the study period. Results: Over time, reports of medication side effects tended to decrease, but differences in frequency of reported side effects from baseline to follow-up (6-month time) were not significant, and the order of the frequency of the reported side effects remained similar. Patients who reported significant medication-related adverse effects reported significantly greater activity interference, negative affect, and catastrophizing compared with those with fewer side effects (P < 0.01). In addition, those patients with pain who reported more side effects showed significantly higher scores on opioid misuse risk (P < 0.001). Discussion: This study demonstrates the important role of monitoring medication-related side effects among patients with chronic pain who are prescribed opioid medication for pain within primary care. PMID:29392205

Predicting long-term outcomes for children affected by HIV and AIDS: perspectives from the scientific study of children's development.

PubMed

Stein, Alan; Desmond, Christopher; Garbarino, James; Van IJzendoorn, Marinus H; Barbarin, Oscar; Black, Maureen M; Stein, Aryeh D; Hillis, Susan D; Kalichman, Seth C; Mercy, James A; Bakermans-Kranenburg, Marian J; Rapa, Elizabeth; Saul, Janet R; Dobrova-Krol, Natasha A; Richter, Linda M

2014-07-01

The immediate and short-term consequences of adult HIV for affected children are well documented. Little research has examined the long-term implications of childhood adversity stemming from caregiver HIV infection. Through overviews provided by experts in the field, together with an iterative process of consultation and refinement, we have extracted insights from the broader field of child development of relevance to predicting the long-term consequences to children affected by HIV and AIDS. We focus on what is known about the impact of adversities similar to those experienced by HIV-affected children, and for which there is longitudinal evidence. Cautioning that findings are not directly transferable across children or contexts, we examine findings from the study of parental death, divorce, poor parental mental health, institutionalization, undernutrition, and exposure to violence. Regardless of the type of adversity, the majority of children manifest resilience and do not experience any long-term negative consequences. However, a significant minority do and these children experience not one, but multiple problems, which frequently endure over time in the absence of support and opportunities for recovery. As a result, they are highly likely to suffer numerous and enduring impacts. These insights suggest a new strategic approach to interventions for children affected by HIV and AIDS, one that effectively combines a universal lattice of protection with intensive intervention targeted to selected children and families.

The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide.

PubMed

Eikelenboom-Schieveld, Selma J M; Lucire, Yolande; Fogleman, James C

2016-07-01

Adverse drug reactions and interactions are among the major causes of death in the United States. Antidepressants have been reported as causing suicide and homicide and share the class attribute of frequently producing akathisia, a state of severe restlessness associated with thoughts of death and violence. Medical examiners can now identify some pharmacogenetic interactions that cause drugs, deemed safe for most, to be lethal to others. Such deaths do not yet include medication-induced, akathisia-related suicides and homicides. An extrapyramidal side effect, akathisia is a manifestation of drug toxicity whose causes lie, inter alia, in drugs, doses, and co-prescribed medications that inhibit and compete for metabolizing enzymes, which may themselves be defective. In this paper, we report our investigation into adverse drug reactions/interactions in three persons who committed homicide, two also intending suicide, while on antidepressants prescribed for stressful life events. Their histories of medication use, adverse reactions and reasons for changes in medications are presented. DNA samples were screened for variants in the cytochrome P450 gene family; that produce drug metabolizing enzymes. All three cases exhibit genotype-based diminished metabolic capability that, in combination with their enzyme inhibiting/competing medications, decreased metabolism further and are the likely cause of these catastrophic events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

TVT versus TOT, 2-year prospective randomized study.

PubMed

Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

2013-06-01

To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

Lubiprostone: in constipation-predominant irritable bowel syndrome.

PubMed

Carter, Natalie J; Scott, Lesley J

2009-06-18

Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation. Oral lubiprostone was effective in the treatment of patients with constipation-predominant irritable bowel syndrome (IBS-C) in large (n = 193-583) phase II (dose-finding) and phase III randomized, double-blind, placebo-controlled, multicentre trials. The number of patients with IBS-C demonstrating an overall response to treatment (primary endpoint) in the two phase III trials was significantly greater in patients receiving lubiprostone 8 microg twice daily for 3 months than in those receiving placebo. In addition, a randomized, 4-week withdrawal period at the end of one of the phase III trials demonstrated that discontinuation of lubiprostone was not associated with rebound of IBS symptoms. Lubiprostone was generally well tolerated in clinical trials, with the majority of adverse events being of mild to moderate severity. In patients with IBS-C who received lubiprostone 8 microg twice daily, nausea was the most frequently occurring adverse event that was considered possibly or probably treatment related. No serious treatment-related adverse events were reported in a 36-week open-label extension to the phase III trials.

An Integrative data mining approach to identifying Adverse ...

EPA Pesticide Factsheets

The Adverse Outcome Pathway (AOP) framework is a tool for making biological connections and summarizing key information across different levels of biological organization to connect biological perturbations at the molecular level to adverse outcomes for an individual or population. Computational approaches to explore and determine these connections can accelerate the assembly of AOPs. By leveraging the wealth of publicly available data covering chemical effects on biological systems, computationally-predicted AOPs (cpAOPs) were assembled via data mining of high-throughput screening (HTS) in vitro data, in vivo data and other disease phenotype information. Frequent Itemset Mining (FIM) was used to find associations between the gene targets of ToxCast HTS assays and disease data from Comparative Toxicogenomics Database (CTD) by using the chemicals as the common aggregators between datasets. The method was also used to map gene expression data to disease data from CTD. A cpAOP network was defined by considering genes and diseases as nodes and FIM associations as edges. This network contained 18,283 gene to disease associations for the ToxCast data and 110,253 for CTD gene expression. Two case studies show the value of the cpAOP network by extracting subnetworks focused either on fatty liver disease or the Aryl Hydrocarbon Receptor (AHR). The subnetwork surrounding fatty liver disease included many genes known to play a role in this disease. When querying the cpAOP

[The concept of risk and its estimation].

PubMed

Zocchetti, C; Della Foglia, M; Colombi, A

1996-01-01

The concept of risk, in relation to human health, is a topic of primary interest for occupational health professionals. A new legislation recently established in Italy (626/94) according to European Community directives in the field of Preventive Medicine, called attention to this topic, and in particular to risk assessment and evaluation. Motivated by this context and by the impression that the concept of risk is frequently misunderstood, the present paper has two aims: the identification of the different meanings of the term "risk" in the new Italian legislation and the critical discussion of some commonly used definitions; and the proposal of a general definition, with the specification of a mathematical expression for quantitative risk estimation. The term risk (and risk estimation, assessment, or evaluation) has mainly referred to three different contexts: hazard identification, exposure assessment, and adverse health effects occurrence. Unfortunately, there are contexts in the legislation in which it is difficult to identify the true meaning of the term. This might cause equivocal interpretations and erroneous applications of the law because hazard evaluation, exposure assessment, and adverse health effects identification are completely different topics that require integrated but distinct approaches to risk management. As far as a quantitative definition of risk is of concern, we suggest an algorithm which connects the three basic risk elements (hazard, exposure, adverse health effects) by means of their probabilities of occurrence: the probability of being exposed (to a definite dose) given that a specific hazard is present (Pr(e[symbol: see text]p)), and the probability of occurrence of an adverse health effect as a consequence of that exposure (Pr(d[symbol: see text]e)). Using these quantitative components, risk can be defined as a sequence of measurable events that starts with hazard identification and terminates with disease occurrence; therefore, the following formal definition of risk is proposed: the probability of occurrence, in a given period of time, of an adverse health effect as a consequence of the existence of an hazard. In formula: R(d[symbol: see text]p) = Pr(e[symbol: see text]p) x Pr(d[symbol: see text]e). While Pr(e[symbol: see text]p) (exposure given hazard) must be evaluated in the situation under study, two alternatives exist for the estimation of the occurrence of adverse health effects (Pr(d[symbol: see text]e)): a "direct" estimation of the damage (Pr(d[symbol: see text]e) through formal epidemiologic studies conducted in the situation under observation; and an "indirect" estimation of Pr(d[symbol: see text]e) using information taken from the scientific literature (epidemiologic evaluations, dose-response relationships, extrapolations, ...). Both conditions are presented along with their respective advantages, disadvantages, and uncertainties. The usefulness of the proposed algorithm is discussed with respect to commonly used applications of risk assessment in occupational medicine; the relevance of time for risk estimation (both in the term of duration of observation, duration of exposure, and latency of effect) is briefly explained; and how the proposed algorithm takes into account (in terms of prevention and public health) both the etiologic relevance of the exposure and the consequences of exposure removal is highlighted. As a last comment, it is suggested that the diffuse application of good work practices (technical, behavioral, organizational, ...), or the exhaustive use of check lists, can be relevant in terms of improvement of prevention efficacy, but does not represent any quantitative procedure of risk assessment which, in any circumstance, must be considered the elective approach to adverse health effect prevention.

Adverse event reporting in Czech long-term care facilities.

PubMed

Hěib, Zdenřk; Vychytil, Pavel; Marx, David

2013-04-01

To describe adverse event reporting processes in long-term care facilities in the Czech Republic. Prospective cohort study involving a written questionnaire followed by in-person structured interviews with selected respondents. Long-term care facilities located in the Czech Republic. Staff of 111 long-term care facilities (87% of long-term care facilities in the Czech Republic). None. Sixty-three percent of long-term health-care facilities in the Czech Republic have adverse event-reporting processes already established, but these were frequently very immature programs sometimes consisting only of paper recording of incidents. Compared to questionnaire responses, in-person interview responses only partially tended to confirm the results of the written survey. Twenty-one facilities (33%) had at most 1 unconfirmed response, 31 facilities (49%) had 2 or 3 unconfirmed responses and the remaining 11 facilities (17%) had 4 or more unconfirmed responses. In-person interviews suggest that use of a written questionnaire to assess the adverse event-reporting process may have limited validity. Staff of the facilities we studied expressed an understanding of the importance of adverse event reporting and prevention, but interviews also suggested a lack of knowledge necessary for establishing a good institutional reporting system in long-term care.

Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study.

PubMed

Jang, Soobin; Kim, Kyeong Han; Sun, Seung-Ho; Go, Ho-Yeon; Lee, Eun-Kyung; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

2017-01-01

Background. This survey aimed to investigate the characteristics of users and nonusers of herbal medicine and the adverse events experienced due to herbal medicines in South Korea. Methods. The questionnaire consisted of safety, using experience, using type, usage and nonusage reason, purchase location, and adverse events of herbal medicine. The survey was administered by online. Results. Of the total 1,134 respondents, 726 (64.0%) considered herbal medicine safe, and 693 (61.1%) answered that they have taken herbal medicines within the past year. Most common place to purchase them was "TKM hospital or clinic" (63.6%), and most participants (72.2%) took a decoction from a TKM institution. The biggest reason for taking them was for "health improvement" (57.3%), and the reasons for not using them was "medication not necessary" (63.7%). Among those who took herbal medicines, 46 experienced adverse events, and the most frequently reported symptoms were digestive disorders (52.2%). Of the 46 participants who experienced adverse events, 20 (43.5%) were treated by TKM doctors. Conclusions. This study suggests that regulation of herbal medicines is needed in order to resolve problems related to the safety of herbal medicines.

Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study

PubMed Central

Kim, Kyeong Han; Lee, Eun-Kyung; Shin, Yong-Cheol

2017-01-01

Background. This survey aimed to investigate the characteristics of users and nonusers of herbal medicine and the adverse events experienced due to herbal medicines in South Korea. Methods. The questionnaire consisted of safety, using experience, using type, usage and nonusage reason, purchase location, and adverse events of herbal medicine. The survey was administered by online. Results. Of the total 1,134 respondents, 726 (64.0%) considered herbal medicine safe, and 693 (61.1%) answered that they have taken herbal medicines within the past year. Most common place to purchase them was “TKM hospital or clinic” (63.6%), and most participants (72.2%) took a decoction from a TKM institution. The biggest reason for taking them was for “health improvement” (57.3%), and the reasons for not using them was “medication not necessary” (63.7%). Among those who took herbal medicines, 46 experienced adverse events, and the most frequently reported symptoms were digestive disorders (52.2%). Of the 46 participants who experienced adverse events, 20 (43.5%) were treated by TKM doctors. Conclusions. This study suggests that regulation of herbal medicines is needed in order to resolve problems related to the safety of herbal medicines. PMID:28491107

Outcome of cataract surgery at one year in Kenya, the Philippines and Bangladesh.

PubMed

Lindfield, R; Kuper, H; Polack, S; Eusebio, C; Mathenge, W; Wadud, Z; Rashid, A M; Foster, A

2009-07-01

To assess the change in vision following cataract surgery in Kenya, Bangladesh and the Philippines and to identify causes and predictors of poor outcome. Cases were identified through surveys, outreach and clinics. They underwent preoperative visual acuity measurement and ophthalmic examination. Cases were re-examined 8-15 months after cataract surgery. Information on age, gender, poverty and literacy was collected at baseline. 452 eyes of 346 people underwent surgery. 124 (27%) eyes had an adverse outcome. In Kenya and the Philippines, the main cause of adverse outcome was refractive error (37% and 49% respectively of all adverse outcomes) then comorbid ocular disease (26% and 27%). In Bangladesh, this was comorbid disease (58%) then surgical complications (21%). There was no significant association between adverse outcome and gender, age, literacy, poverty or preoperative visual acuity. Adverse outcomes following cataract surgery were frequent in the three countries. Main causes were refractive error and preoperative comorbidities. Many patients are not attaining the outcomes available with modern surgery. Focus should be on correcting refractive error, through operative techniques or postoperative refraction, and on a system for assessing comorbidities and communicating risk to patients. These are only achievable with a commitment to ongoing surgical audit.

Adverse reactions of Methylphenidate in children with attention deficit-hyperactivity disorder: Report from a referral center

PubMed Central

Khajehpiri, Zahra; Mahmoudi-Gharaei, Javad; Faghihi, Toktam; Karimzadeh, Iman; Khalili, Hossein; Mohammadi, Mostafa

2014-01-01

Objective: The aim of the current study was to determine various aspects of methylphenidate adverse reactions in children with attention deficit-hyperactivity disorder (ADHD) in Iran. Methods: During the 6 months period, all children under methylphenidate treatment alone or along with other agents attending a university-affiliated psychology clinic were screened regarding all subjective and objective adverse drug reactions (ADRs) of methylphenidate. Causality and seriousness of detected ADRs were assessed by relevant World Health Organization definitions. The Schumock and Thornton questionnaire was used to determine preventability of ADRs. Findings: Seventy-one patients including 25 girls and 46 boys with ADHD under methylphenidate treatment were enrolled within the study period. All (100%) ADHD children under methylphenidate treatment developed at least one ADR. Anorexia (74.3%), irritability (57.1%), and insomnia (47.2%) were the most frequent methylphenidate-related adverse reactions. Except for one, all other detected ADRs were determined to be mild. In addition, no ADR was considered to be preventable and serious. Conclusion: Our data suggested that although methylphenidate related adverse reactions were common in children with ADHD, but they were mainly mild and nonserious. PMID:25535621

Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.

PubMed

Hornik, Christoph P; Herring, Amy H; Benjamin, Daniel K; Capparelli, Edmund V; Kearns, Gregory L; van den Anker, John; Cohen-Wolkowiez, Michael; Clark, Reese H; Smith, P Brian

2013-07-01

Carbapenems are commonly used in hospitalized infants despite a lack of complete safety data and associations with seizures in older children. We compared the incidence of adverse events in hospitalized infants receiving meropenem versus imipenem/cilastatin. We conducted a retrospective cohort study of 5566 infants treated with meropenem or imipenem/cilastatin in neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2010. Multivariable conditional logistic regression was performed to evaluate the association between carbapenem therapy and adverse events, controlling for infant factors and severity of illness. Adverse events were more common with use of meropenem compared with imipenem/cilastatin (62.8/1000 infant days versus 40.7/1000 infant days, P < 0.001). There was no difference in seizures with meropenem versus imipenem/cilastatin (adjusted odds ratio 0.96; 95% confidence interval: 0.68, 1.32). The incidence of death, as well as the combined outcome of death or seizure, was lower with meropenem use-odds ratio 0.68 (0.50, 0.88) and odds ratio 0.77 (0.62, 0.95), respectively. In this cohort of infants, meropenem was associated with more frequent but less severe adverse events when compared with imipenem/cilastatin.

Pulmonary exposure to cellulose nanocrystals caused deleterious effects to reproductive system in male mice

PubMed Central

Farcas, Mariana T.; Kisin, Elena R.; Menas, Autumn L.; Gutkin, Dmitriy W.; Star, Alexander; Reiner, Richard S.; Yanamala, Naveena; Savolainen, Kai; Shvedova, Anna A.

2016-01-01

Over the past several years there has been an increased number of applications of cellulosic materials in many sectors, including the food industry, cosmetics, and pharmaceuticals. However, to date, there are few studies investigating the potential adverse effects of cellulose nanocrystals (CNC). The objective of this study was to determine long-term outcomes on the male reproductive system of mice upon repeated pharyngeal aspiration exposure to CNC. To achieve this, cauda epididymal sperm samples were analyzed for sperm concentration, motility, morphological abnormalities, and DNA damage. Testicular and epididymal oxidative damage was evaluated, as well as histopathology examination of testes. In addition, changes in levels of testosterone in testes and serum and of luteinizing hormone (LH) in serum were determined. Three months after the last administration, CNC exposure significantly altered sperm concentration, motility, cell morphology, and sperm DNA integrity. These parameters correlated with elevated proinflammatory cytokines levels and myeloperoxidase (MPO) activity in testes, as well as oxidative stress in both testes and epididymis. Exposure to CNC also produced damage to testicular structure, as evidenced by presence of interstitial edema, frequent dystrophic seminiferous tubules with arrested spermatogenesis and degenerating spermatocytes, and imbalance in levels of testosterone and LH. Taken together, these results demonstrate that pulmonary exposure to CNC induces sustained adverse effects in spermatocytes/spermatozoa, suggesting male reproductive toxicity. PMID:27558875

Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy with cataplexy.

PubMed

Lavault, Sophie; Dauvilliers, Yves; Drouot, Xavier; Leu-Semenescu, Smaranda; Golmard, Jean-Louis; Lecendreux, Michel; Franco, Patricia; Arnulf, Isabelle

2011-06-01

The benefit/risk ratio of modafinil was recently re-evaluated by the European Medicines Agency and was shown to be negative for idiopathic hypersomnia (IH) because of insufficient data. To evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs. narcolepsy/cataplexy. The benefit (Epworth sleepiness score, ESS; visual analog scale, patient and clinician opinions) and risks (habituation, adverse effects) of modafinil were studied in a consecutive clinical cohort of 104 IH patients (59 with long sleep time) and 126 patients with narcolepsy/cataplexy. Modafinil was the first line treatment in 96-99% of patients. It produced a similar ESS change in IH patients and in narcolepsy patients (-2.6±5.1 vs. -3±5.1) and a similar benefit as estimated by the patients (6.9±2.7 vs. 6.5±2.5 on a visual analog scale) and clinicians. The ESS change was lower in IH patients with long sleep time than in those without. Sudden loss of efficacy and habituation were rare in both groups. Patients with IH reported similar but more frequent adverse effects with modafinil than narcolepsy patients: nervousness (14%), palpitations (13%), and headache (11%). Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy. Copyright © 2011 Elsevier B.V. All rights reserved.

Bullying by peers in childhood and effects on psychopathology, suicidality, and criminality in adulthood.

PubMed

Klomek, Anat Brunstein; Sourander, Andre; Elonheimo, Henrik

2015-10-01

Bullying is shown to be associated with adverse outcomes in cross-sectional studies, but only a few studies have prospectively examined the effects of childhood bullying on adult outcomes. Our Series paper focuses on prospective longitudinal studies that used large, population-based, community samples analysed through quantitative methods and published between 1960 and 2015. We describe the results of childhood bullying in adulthood in three of the most burdensome areas: psychopathology, suicidality, and criminality. We note that the different groups involved (ie, victims, bullies, and bully-victims) are at risk of difficulties later in life, but their risk profiles differ and the contributions are probably not independent. Controlling for confounders reduces the risk and sometimes eliminates it. Victims are at a high risk of internalising disorders. Bullies seem to be at risk of later externalising disorders and criminality, mainly violent crime and illicit drug misuse. Bully-victims seem to be at risk of internalising disorders, externalising disorders, and criminality, but not all studies examined bully-victims as a separate group. Boys and girls differ in their long-term outcomes. A dose effect exists in which frequent bullying involvement in childhood is most strongly associated with adult adversities. Future studies need to control for additional factors (including genetic, psychosocial, and environmental) to account for the mechanisms behind the reported longitudinal associations. Copyright © 2015 Elsevier Ltd. All rights reserved.

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

PubMed

Tamminga, Cindy; Kavanaugh, Michael; Fedders, Charlotte; Maiolatesi, Santina; Abraham, Neethu; Bonhoeffer, Jan; Heininger, Ulrich; Vasquez, Carlos S; Moorthy, Vasee S; Epstein, Judith E; Richie, Thomas L

2013-08-02

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting. The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events. Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17% of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26% (32/124) of publications failed to report data on serious adverse events. The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability. The search strategy missed studies published in languages other than English and excluded studies reporting on vaccine trials for diseases besides malaria, TB and HIV. Copyright © 2013 Elsevier Ltd. All rights reserved.

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy.

PubMed

Wood, R A; Sicherer, S H; Burks, A W; Grishin, A; Henning, A K; Lindblad, R; Stablein, D; Sampson, H A

2013-06-01

Immunotherapy for peanut allergy may be limited by the risk of adverse reactions. To investigate the safety and immunologic effects of a vaccine containing modified peanut proteins. This was a phase 1 trial of EMP-123, a rectally administered suspension of recombinant Ara h 1, Ara h 2, and Ara h 3, modified by amino acid substitutions at major IgE-binding epitopes, encapsulated in heat/phenol-killed E. coli. Five healthy adults were treated with 4 weekly escalating doses after which 10 peanut-allergic adults received weekly dose escalations over 10 weeks from 10 mcg to 3063 mcg, followed by three biweekly doses of 3063 mcg. There were no significant adverse effects in the healthy volunteers. Of the 10 peanut-allergic subjects [4 with intermittent asthma, median peanut IgE 33.3 kUA /l (7.2-120.2), and median peanut skin prick test wheal 11.3 mm (6.5-18)]; four experienced no symptoms; one had mild rectal symptoms; and the remaining five experienced adverse reactions preventing completion of dosing. Two were categorized as mild, but the remaining three were more severe, including one moderate reaction and two anaphylactic reactions. Baseline peanut IgE was significantly higher in the five reactive subjects (median 82.4 vs 17.2 kUA /l, P = 0.032), as was baseline anti-Ara h 2 IgE (43.3 versus 8.3, P = 0.036). Peanut skin test titration and basophil activation (at a single dilution) were significantly reduced after treatment, but no significant changes were detected for total IgE, peanut IgE, or peanut IgG4. Rectal administration of EMP-123 resulted in frequent adverse reactions, including severe allergic reactions in 20%. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Behavioral toxicology, risk assessment, and chlorinated hydrocarbons.

PubMed Central

Evangelista de Duffard, A M; Duffard, R

1996-01-01

Behavioral end points are being used with greater frequency in neurotoxicology to detect and characterize the adverse effects of chemicals on the nervous system. Behavioral measures are particularly important for neurotoxicity risk assessment since many known neurotoxicants do not result in neuropathology. The chlorinated hydrocarbon class consists of a wide variety of chemicals including polychlorinated biphenyls, clioquinol, trichloroethylene, hexachlorophene, organochlorine insecticides (DDT, dicofol, chlordecone,dieldrin, and lindane), and phenoxyherbicides. Each of these chemicals has effects on motor, sensory, or cognitive function that are detectable using functional measures such as behavior. Furthermore, there is evidence that if exposure occurs during critical periods of development, many of the chlorinated hydrocarbons are developmental neurotoxicants. Developmental neurotoxicity is frequently expressed as alterations in motor function or cognitive abilities or changes in the ontogeny of sensorimotor reflexes. Neurotoxicity risk assessment should include assessments of the full range of possible neurotoxicological effects, including both structural and functional indicators of neurotoxicity. PMID:9182042

Nephrotoxic effects of designer drugs: synthetic is not better!

PubMed

Luciano, Randy L; Perazella, Mark A

2014-06-01

Designer drugs are synthetic, psychoactive substances with similar structures and activity to existing scheduled drugs or controlled chemical compounds. The use of these drugs is not generally considered illegal and they cannot be detected using standard toxicology tests--essentially they are considered to be 'legal highs'. Over the past several years, increasing numbers of designer drugs have become available. These drugs are classified as amphetamine derivatives, phenylpiperazine derivatives, synthetic cathinones, synthetic cannabinoids, phencyclidine derivatives and synthetic opioids. Although euphoria is the desired effect, neuropsychiatric and cardiac manifestations are frequently observed in individuals using these drugs at high doses or using drugs that are contaminated with other substances. Some designer drugs are also associated with adverse renal effects, including acute kidney injury from pigment nephropathy, acute tubular necrosis, obstructive nephropathy and hyponatraemia. The misuse of these drugs should be recognized and clinicians made aware of the potential for acute nephrotoxicity as the health burden of these compounds increases.

Polychlorinated biphenyls (PCBs) and dichlorodiphenyl dichloroethene (DDE) in human milk: effects on growth, morbidity, and duration of lactation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rogan, W.J.; Gladen, B.C.; McKinney, J.D.

1987-10-01

The authors followed 858 children from birth to one year of age to determine whether the presence of polychlorinated biphenyls (PCBs) and dichlorodiphenyl dichloroethene (DDE) in breast milk affected their growth or health. Neither chemical showed an adverse effect on weight or frequency of physician visits for various illnesses, although differences were seen between breast-fed and bottle-fed children, with bottle-fed children being heavier and having more frequent gastroenteritis and otitis media. Children of mothers with higher levels of DDE were breast-fed for markedly shorter times, but adjustments for possible confounders and biases did not change the findings. In absence ofmore » any apparent effect on the health of the children, they speculate that DDE may be interfering with the mother's ability to lactate, possibly because of its estrogenic properties.« less

Novel Treatment Using Low-Dose Naltrexone for Lichen Planopilaris.

PubMed

Strazzulla, Lauren C; Avila, Lorena; Lo Sicco, Kristen; Shapiro, Jerry

2017-11-01

Lichen planopilaris (LPP) is a variant of lichen planus that affects the scalp causing scarring hair loss. Patients also frequently experience symptoms of scalp itch, pain, and burning. To date, there are no long-term remittive nor curative therapies available. Low-dose naltrexone has anti-inflammatory properties and has recently been described in the context of treating autoimmune conditions. This retrospective medical record review describes four LPP patients treated with low-dose (3 milligrams per day) naltrexone. This medication provided benefit in these four patients including reduction in symptoms of pruritus, clinical evidence of inflammation of the scalp, and disease progression. All patients tolerated naltrexone without adverse effects. This is the first case series demonstrating the beneficial effects of low-dose naltrexone for patients with LPP. This medication was well-tolerated by the patients and is cost-effective.

J Drugs Dermatol. 2017;16(11):1140-1142.

Orlistat. No hurry....

PubMed Central

1999-01-01

Treatments for obesity are disappointing. None has yet shown an effect on morbidity and mortality. Nondrug treatments are poorly assessed. Stable long-term weight loss necessitates long-term management. Orlistat (Xenical, Hoffman-La Roche), a gastrointestinal lipase inhibitor, is indicated, in combination with a low-calorie diet, for management of obesity. The assessment file is bulky and methodologically sound, at least in terms of the weight loss end point. During medium-term trials (12 to 24 months), orlistat administered at a dose of 120 mg three times daily and combined with dietary intervention had a moderate positive effect on body weight (-3.5 kg on average). No longer-term trials have been done. It is unknown whether this drug affects morbidity and mortality linked to obesity. In clinical trials, patients treated with orlistat had an increased frequency of breast cancer. This potential risk is currently being assessed in a specific trial. Gastrointestinal adverse effects are frequent. Treatment is costly. PMID:10540693

[Recommendations on therapy for chronic constipation--working group for functional diagnosis and psychosomatics of the austrian society of gastroenterology and hepatology].

PubMed

Vogelsang, H; Pfeiffer, J; Moser, G

2011-02-01

Constipation is one of the most frequent gastroenterological problems, especially among elderly people. Chronic constipation is now defined by the new Rome III criteria. Life style counselling is usually only effective in early stages of disease and for mild types. In patients with constipation one should actively screen for possible causative, medically adverse events. Recently new effective opioid antagonists were introduced to act against constipation in patients on long-term opioid therapy. If these actions fail, medical therapy with polyethylene glycol or lactulose should be favoured in the long-term treatment. Psychodiagnostic queries concerning fear should be included in the diagnostic procedures. Biofeedback is an effective therapy in these cases and especially with pelvic floor dyssynergia. Surgical interventions are rarely indicated or successful with the exception of chronic outlet obstruction with severe anatomic changes. © Georg Thieme Verlag KG Stuttgart · New York.

Topiramate-induced paresthesia is more frequently reported by migraine than epileptic patients.

PubMed

Sedighi, Behnaz; Shafiei, Kaveh; Azizpour, Iman

2016-04-01

Topiramate is an approved and effective drug in migraine prophylaxis. Paresthesia is the most commonly reported side effect. The primary objective of this study was to compare the frequency of topiramate-induced paresthesia in migraine headache to epileptic patients. Patients with migraine without aura and epilepsy were enrolled in this observational study. All cases were interviewed by telephone about their history of paresthesia. Confounding factors were controlled through logistic regression. The odds ratio of developing topiramate-induced paresthesia in migraine compared to epilepsy patients was 3.4. Three factors were independent contributors to developing topiramate-induced paresthesia: female sex (odds ratio 2.1), topiramate dosage (odds ratio 0.3) and duration of therapy. Our findings indicate an independent association between migraine and development of paresthesia. Migraineurs were more likely than epileptic patients to report paresthesia as topiramate adverse effects. Female sex, treatment duration and topiramate dosage contribute significantly to subsequent development of paresthesia.

The Relationship between Frequently Used Glucose-Lowering Agents and Gut Microbiota in Type 2 Diabetes Mellitus.

PubMed

Lv, You; Zhao, Xue; Guo, Weiying; Gao, Ying; Yang, Shuo; Li, Zhuo; Wang, Guixia

2018-01-01

Metabolic diseases, especially diabetes mellitus, have become global health issues. The etiology of diabetes mellitus can be attributed to genetic and/or environmental factors. Current evidence suggests the association of gut microbiota with metabolic diseases. However, the effects of glucose-lowering agents on gut microbiota are poorly understood. Several studies revealed that these agents affect the composition and diversity of gut microbiota and consequently improve glucose metabolism and energy balance. Possible underlying mechanisms include affecting gene expression, lowering levels of inflammatory cytokines, and regulating the production of short-chain fatty acids. In addition, gut microbiota may alleviate adverse effects caused by glucose-lowering agents, and this can be especially beneficial in diabetic patients who experience severe gastrointestinal side effects and have to discontinue these agents. In conclusion, gut microbiota may provide a novel viewpoint for the treatment of patients with diabetes mellitus.

Treatment Participation among Children with Conduct Problems and the Role of Telephone Reminders

ERIC Educational Resources Information Center

Watt, Bruce D.; Hoyland, Margaret; Best, Denisse; Dadds, Mark R.

2007-01-01

Children with antisocial, aggressive and disruptive behaviour problems are among the most frequent referrals to mental health services. These young people and their families present with a range of adverse contextual factors and can prove challenging to engage. We examined the characteristics of children with conduct problems, treatment…

Emotional and Behavioural Problems in Children and Adolescents with Congenital Heart Disease

ERIC Educational Resources Information Center

Johnson, Beena; Francis, Johnson

2005-01-01

Major physical illnesses usually have an impact on the psychological well-being of any individual. An illness of early onset, with necessity of frequent diagnostic and therapeutic interventions can adversely affect the emotional balance and behavioural adaptation of children and adolescents. This is applicable for congenital heart disease,…

Group Cognitive Behavior Therapy for Children with High-Functioning Autism Spectrum Disorders and Anxiety: A Randomized Trial

ERIC Educational Resources Information Center

Reaven, Judy; Blakeley-Smith, Audrey; Culhane-Shelburne, Kathy; Hepburn, Susan

2012-01-01

Background: Children with high-functioning autism spectrum disorders (ASD) are at high risk for developing significant anxiety. Anxiety can adversely impact functioning across school, home and community environments. Cognitive behavioral therapies (CBT) are frequently used with success for children with anxiety symptoms. Modified CBT interventions…

Improving Social and Academic Outcomes for All Learners through the Use of Teacher Praise

ERIC Educational Resources Information Center

Marchant, Michelle; Anderson, Darlene H.

2012-01-01

Students who frequently engage in problem behavior tend to disrupt teacher instruction and impede others' learning, and they can seriously limit their own opportunities for academic and social success. The view that negative student-teacher interaction adversely impacts classroom climate is well documented. A positive and engaging classroom…

Intrathecal treatment in cancer patients unresponsive to multiple trials of systemic opioids.

PubMed

Mercadante, Sebastiano; Intravaia, Giuseppe; Villari, Patrizia; Ferrera, Patrizia; Riina, Salvatore; David, Fabrizio; Mangione, Salvatore

2007-01-01

The aim of this study was to evaluate the clinical response to a combination of intrathecal morphine and levobupivacaine in advanced cancer patients who were highly opioid-tolerant, being previously treated with multiple opioid trials unsuccessfully. Initial intrathecal morphine dose was calculated from the previous opioid consumption using a morphine oral-intrathecal ratio of 100:1. Then, doses of both drugs were modified during the treatment according to the clinical needs and balanced with adverse effects. Fifty-five patients were assessed during admission, before starting the intrathecal treatment, during the titration phase, and followed up to death, by frequent phone contacts or visits, as available. Pain and symptom intensities were recorded before starting the intrathecal treatment (T0), at time of hospital discharge (T dis), and then at 1 month (T1), 3 months (T3), 6 months (T6) intervals, and the last observation, at least 1 week before death (T death). Fifty-five patients were selected for starting an intrathecal treatment. Thirty-two patients were males. The mean age was 60 years (95% CI 57-63), and 65.4% of patients were under 65 years. The most frequent indication was the presence of adverse effects and poor pain control. Complete data with adequate follow-up until death were available in 45 patients. Statistical differences in pain intensity were found at the different time intervals examined until death. Statistical decreases in the intensity of drowsiness and confusion were found until 1 month after starting intrathecal therapy. Statistical differences were found in daily intrathecal morphine doses, with a 3-fold increase at time of hospital discharge. Subsequently, further increases in doses were not significant. Conversely, systemic opioids, expressed as oral morphine equivalents, significantly decreased at all the intervals examined until death. Early complications included mild bleeding in 2 patients, without consequences, headache in 4 patients, bladder catheterization in 6 patients, reoperation for bleeding or changes of catheter position in 4 patients, unrelated death in 1 patient, and stroke in another 1. Late complications included local infection in 2 patients, and discontinuation of intrathecal therapy due to spinal compression. In patients who had received multiple trial of opioids and routes of administration, the intrathecal treatment started with an oral-intrathecal morphine conversion ratio of 100:1, and local anesthetics at the most convenient clinical doses provided a long-term improvement of analgesia, with a decrease in adverse effects and opioid consumption until death.

The broadening application of chemodenervation in X-linked dystonia-parkinsonism (Part II): an open-label experience with botulinum toxin-A (Dysport®) injections for oromandibular, lingual, and truncal-axial dystonias.

PubMed

Rosales, Raymond L; Ng, Arlene R; Santos, Mary Mildred Delgado-Delos; Fernandez, Hubert H

2011-01-01

While the majority of chemodenervation clinics worldwide typically use botulinum toxins for the treatment of common conditions such as blepharopsams, cervical dystonia, limb dystonia, and spasticity, the unusually high concentration of X-linked dystonia-parkinsonism (XDP) has allowed us to collect and describe our experience in the use of botulinum toxin type A (BoNT-A) on rarer dystonic patterns. BoNT-A (Dysport®) was injected in a total 109 dystonias of XDP. Our cohort included: 50 cases in the oromandibular area (jaw opening: 32 cases, jaw closing: 12 cases, and jaw deviation: 6 cases); 35 cases in the lingual area (tongue protrusion: 27 cases and tongue curling: 8 cases); and, 24 cases in the truncal-axial area (flexor: 12 cases, extensor: 7 cases, and lateral-extensor: 5 cases). Interestingly, pain, often a nonprominent symptom of dystonias, was frequently reported in 40/50 XDP cases with oromandibular dystonia and 18/24 XDP cases with truncal-axial dystonia. All BoNT-A procedures were performed under electromyography guidance. A "high potency, low dilution" BoNT-A protocol was applied for oromandibular, lingual, cranial, cervical, and distal limb dystonias; whereas for dystonias of the abdominal, paraspinal, and proximal limb muscles, a "low potency, high dilution" BoNT-A injection protocol was applied. Outcomes measures included: the global dystonia rating scale (DRS) and pain visual analog scale (VAS) reduction at week 4; duration of BoNT-A effects; and, side effect profile. The median DRS score after 4 weeks was 3 ("substantial improvement") for oromandibular and lingual dystonias and 2 ("moderate improvement") for truncal-axial dystonias. Pain reduction was significantly reduced (75%-80% in oromandibular; 30%-80% in truncal-axial dystonias). The median duration of BoNT-A effect was 16 weeks for oromandibular, 12 weeks for lingual, and 11 weeks for truncal-axial dystonias. Compared to a generally safe and well-tolerated BoNT-A injections for truncal-axial dystonias, the oromandibular-lingual dystonias had the following frequency of adverse events: oromandibular--19% in jaw opening and 17% in jaw closing dystonias; lingual--19% in tongue protrusion and 13% in tongue curling dystonias. The most frequent adverse events were mouth dryness and dysphagia. Thus, BoNT-A injection working protocols may be adopted in XDP dystonia that adheres to cost minimization (e.g., lower dose end per selected muscle), while achieving some benefit, and potentially reduce the adverse event profile.

[Drug-induced extrapyramidal disorders].

PubMed

Horga, J F; Navarro, M; Peiró, V; Hernández, M

1995-01-01

We analyze 402 drug-adverse events consisting of movement disorders or aggravation of parkinsonisms, submitted to Sistema Español de Farmacovigilancia until 1994. Our aim is to know patient characteristics and the drugs related with these submissions. Most of them (64) belong to calcium-entry blocker group (31%) and benzamides (27%). Case age intervals more frequent were 11-30 and 60-80 years-old and the events affect predominantly females. The percentage of serious adverse events were near 80%. We think that drug-related parkinsonisms have high prevalence rate and that the role of calcium-entry blockers in these events should be considered at the moment to prescribe groups.