These are representative sample records from Science.gov related to your search topic.
For comprehensive and current results, perform a real-time search at Science.gov.
1

Adverse reactions to orthodontic appliances in nickel-allergic patients.  

PubMed

Nickel allergy (NA) is common and causes more cases of allergic contact dermatitis (ACD) than all other metals combined. Many orthodontic appliances (ODAs) contain nickel but their clinical relevance in nickel-allergic patients is unclear. We aimed to characterize the relationship between NA and ODAs because the medical literature investigating this is controversial. A survey concerning adverse reactions to ODAs in patients with NA was distributed to members of the Wisconsin Society of Orthodontics. Forty-three surveys were analyzed. The surveyed group was experienced, representing a mean of 21.2 years in practice and averaging 242 appliances placed per year per orthodontist. Most new patients with orthodontia were 10-18 years old. Most wires used were nickel-titanium alloy. Although 76% of orthodontists inquired about NA at initial evaluation, 37% still placed nickel-containing ODAs in known nickel-allergic patients. Fifty percent placed a single intraoral appliance, observing for reactions. Three orthodontists applied ODAs to the skin similar to patch testing. Only 8 patients with reactions to ODAs were described in detail, 6 were female patients and 6 were aged 13-14 years. Intraoral and extraoral reactions were mild; diffuse urticaria was reported in one patient. Treatment included removing the appliances or changing to nonnickel alternatives with favorable outcomes. These cases, which included >33,000 patients, suggest a prevalence of 0.03%. Adverse reactions to ODAs in patients with NA have been observed but are uncommon. Using suitable alternatives, patients usually can be accommodated. PMID:17883919

Volkman, Kristen K; Inda, Michael J; Reichl, Peter G; Zacharisen, Michael C

2007-01-01

2

Adverse cutaneous drug reactions: Eight year assessment in hospitalized patients  

PubMed Central

Background: Adverse cutaneous drug reactions (ACDRs) are the most commonly reported adverse drug events. The causative drugs and clinical patterns of ACDRs are different in various populations. This study was conducted to identify the clinical patterns, causative drugs and reasons for drug administration in patients hospitalized due to ACDR. Materials and Methods: This retrospective study was carried out in a referral university hospital, Isfahan, Iran. The medical records of all patients who were hospitalized in the Dermatology Department due to ACDRs were reviewed covering an 8-year period between December 2006 and August 2013. Results: A total number of 282 patients with the mean age of 29.48 ± 21.18 years were hospitalized in this time period, of which 61% were females. The most common clinical patterns regarding the final diagnosis were Stevens-Johnson syndrome (SJS) (32%), exanthematous drug eruptions (24.5%) and toxic epidermal necrolysis (TEN) (11%). Anticonvulsants were the most frequently implicated drug group (51.8%) followed by antibiotics (33.7%) and analgesics and non-steroidal anti-inflammatory drugs (5.7%). The most common cause of drug administration was seizure (30%) and then upper respiratory tract infections (12%). The frequency distribution of clinical types of reactions was different between age groups (P < 0.001). The severe types (SJS, TEN, drug rash with eosinophilia and systemic symptoms and overlap syndrome) were more frequent in the patients aged ?50 years old (55.2%) compare to those aged ?50 years (28%) (P = 0.001). Conclusion: The main causative drugs of ACDRs were anticonvulsants and antibiotics. However, the sever types of reactions were more prevalent.

Mokhtari, Fatemeh; Nikyar, Zahra; Naeini, Bahareh Abtahi; Esfahani, Alireza Asemi; Rahmani, Siamak

2014-01-01

3

Patient reporting of adverse drug reactions: useful information for pain management?  

Microsoft Academic Search

Background. Patients’ perceptions of adverse effects caused by the medicines they are prescribed may influence how they use these medicines. Little is known about patients’ perceptions of the adverse effects of specific drugs in everyday use and whether these differ from those identified by clinical trials and standard post-marketing surveillance methods.Aim. To compare reports of perceived adverse drug reactions (ADRs)

Narumol Jarernsiripornkul; Janet Krska; R. Michael E Richards; Phillip A. G Capps

2003-01-01

4

Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran  

Microsoft Academic Search

Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran.BackgroundParenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use

Beckie Michael; Daniel W. Coyne; Steven Fishbane; Vaughn Folkert; Robert Lynn; Allen R. Nissenson; Rajiv Agarwal; Joseph W. Eschbach; Stephen Z. Fadem; J. Richard Trout; Jur Strobos; David G. Warnock

2002-01-01

5

Self-reported adverse reactions among patients initiating antiretroviral therapy in Brazil.  

PubMed

A cross-sectional analysis was carried out to describe adverse reactions to antiretroviral therapy (ART) reported by HIV-infected patients initiating treatment at two public health AIDS referral centers in Belo Horizonte, Brazil, 2001-2003 and to verify their association with selected variables. Adverse reactions were obtained through interview at the first follow-up visit (first month) after the antiretroviral prescription. Socio-demographic and behavioral variables related to ART were obtained from baseline and follow-up interviews and clinical variables from medical charts. Patients with four or more reactions were compared to those with less than four. Odds ratio with 95% confidence interval were estimated using logistic regression model for both univariate and multivariate analyses. At least one adverse reaction was reported by 92.2% of the participants while 56.2% reported four or more different reactions. Antiretroviral regimens including indinavir/ritonavir, irregular use of antiretrovirals and switch in regimens were independently associated with four or more adverse reactions (OR=7.92, 5.73 and 2.03, respectively). The initial period of ARV treatment is crucial and patients' perception of adverse reactions should be carefully taken into account. Strategies for monitoring and management of adverse reactions including the choice of regimens and the prevention of irregular ART should be developed in AIDS/HIV referral centers in Brazil to promote better adherence to antiretroviral therapy. PMID:17625721

Pádua, Cristiane A Menezes de; César, Cibele C; Bonolo, Palmira F; Acurcio, Francisco A; Guimarães, Mark Drew C

2007-02-01

6

Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients  

Microsoft Academic Search

Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients.BackgroundIron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of

Daniel W Coyne; Franklin N Adkinson; Allen R Nissenson; Steven Fishbane; Rajiv Agarwal; Joseph W Eschbach; Beckie Michael; Vaughn Folkert; Daniel Batlle; J Richard Trout; Naomi Dahl; Pamela Myirski; Jur Strobos; David G Warnock

2003-01-01

7

Zolpidem prescribing and adverse drug reactions in hospitalized general medicine patients at a veterans affairs hospital  

Microsoft Academic Search

Background: Zolpidem is prescribed for sleep disruption in hospitalized patients, but data on the incidence of adverse drug reactions (ADRs) are based largely on outpatient studies. Thus, the incidence of ADRs in hospitalized patients may be much higher.Objective: The goal of this study was to describe prescribing patterns of zolpidem for hospitalized medical patients aged ? 50 years, the incidence

Jane E Mahoney; Melissa J Webb; Shelly L Gray

2004-01-01

8

Adverse Reactions to intravenous N-Acetylcysteine in Chinese Patients with Paracetamol (Acetaminophen) Poisoning  

Microsoft Academic Search

The incidence of adverse reactions to intravenous N-acetylcysteine (NAC) was studied in 56 Chinese patients with paracetamol (acetaminophen) poisoning. Eight (14%) patients developed a skin rash (n= 7) or fever (n= 1) mostly during the initial high dose infusion of the antidote. In four subjects (three with toxic plasma paracetamol levels), the infusion was continued without a worsening of the

Thomas Y. K. Chan; Julian A. J. H. Critchley

1994-01-01

9

Adverse reactions and alleged allergy to local anesthetics: analysis of 331 patients.  

PubMed

The aim of this study was to determine the prevalence of true local anesthetic (LA) allergy among patients referred for suspected hypersensitivity and to describe the main characteristics of adverse drug reactions (ADR) induced by LA in our population. We retrospectively analyzed the medical files of patients referred to the Department of Dermatovenereology, University Hospital Center Rijeka, Rijeka, Croatia, for the investigation of LA hypersensitivity in the period between January 2000 and December 2012. A total of 331 patients underwent skin testing and, in cases of negative results, subcutaneous exposition to LA. In patients with suspected delayed reaction, patch test was performed. Altogether, 331 patients reported 419 independent ADR occurring during 346 procedures. Most commonly, patients reported having only one ADR, but 41 (12.4%) of them had two reactions, 14 (4.2%) had three, five (1.5%) had four and in one patient (0.3%) five ADR to LA were observed. The majority of reactions occurred during dental procedures when most commonly lidocaine and articaine were used. Local reactions were reported in 44 patients, whereas 490 general symptoms occurred during 375 independent ADR in 287 patients. The most common symptoms were cardiovascular system reactions in 89 patients (18.2%). Allergic reaction was detected in three patients (0.91%). One patient showed immediate-type reaction to bupivacaine and two patients had a delayed-type reaction to lidocaine. Adverse reactions to LA are common and are mostly due to their pharmacological properties and drug combinations or psychogenic origin. Allergic accidents to LA are rare. PMID:23682746

Batinac, Tanja; Sotošek Tokmadži?, Vlatka; Peharda, Vesna; Brajac, Ines

2013-07-01

10

Analysis of the direct cost of adverse drug reactions in hospitalised patients  

Microsoft Academic Search

The hospitalised patients in a cardiological hospital (Lille, France) over an 18-month period were subjected to a prospective high-intensity adverse drug reaction (ADR) monitoring in order to assess the additional financial resource utilisation associated with ADRs and analyse the distribution of excess of cost according to ADR nature and therapeutic classes. Over 18 months, among the 16,916 hospitalised patients, 371

R. Bordet; S. Gautier; H. Le Louet; B. Dupuis; J. Caron

2001-01-01

11

Incidence of adverse drug reactions induced by N-acetylcysteine in patients with acetaminophen overdose  

Microsoft Academic Search

Background: Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay. Objective: the aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose. Methods:

Saed H Zyoud; Rahmat Awang; Syed Azhar Syed Sulaiman; Waleed M Sweileh; Samah W Al-jabi

2010-01-01

12

Cutaneous adverse drug reaction profile in a tertiary care out patient setting in Eastern India  

PubMed Central

Background: Cutaneous adverse drug reactions (CADR) are the most frequent of all manifestations of drug sensitivity and manifest with varied and diverse morphology. Aims: To study the prevalence and clinical spectrum of CADR among patients attending outpatient department (OPD) in a tertiary care hospital. Materials and Methods: An observational study was undertaken over a 1-year period in dermatology OPD of a tertiary care teaching hospital in Eastern India. Patients presenting with suspected drug-related cutaneous lesions were included if drug identity could be ascertained. Clinical profiling was done. Drug history was recorded in a format specified in Indian National Pharmacovigilance Programme and causality assessment carried out as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria. Results: Commonest CADR in our study was morbilliform eruption (30.18%), followed by fixed drug eruption (24.52%), Stevens–Johnson syndrome (SJS)-Toxic epidermal necrolysis (TEN) and overlap of two (24.50%), exfoliative dermatitis (7.54%), urticaria (5.6%), phototoxic drug reaction (3.8%), pityriasis rosea-like eruptions (1.89%), and severe mucositis (1.80%). Drugs implicated were sulfonamides (17%), fixed-dose combinations of fluoroquinolones with nitroimidazoles (11.30%), analgesics (11.30%), antiepileptics (11.30%), beta-lactam antibiotics (9.40%), fluoroquinolones alone (7.50%), allopurinol (7.50%), and azithromycin (5.70%). Reaction latency varied from 1 to 43 days. Causality assessment was certain and probable for 18.9% and 41.5% of the reactions, respectively, and reactions were serious in 33.96% (95% confidence interval 21.21-46.71%). Conclusions: Cutaneous adverse drug reaction profile in this study is similar in many ways to studies conducted earlier in India. Incidence of life-threatening reactions like SJS-TEN was higher compared with studies conducted abroad. Reaction time and lesion patterns are helpful in identifying an offending drug in the setting of multiple drug therapy. PMID:23248414

Saha, Abanti; Das, Nilay Kanti; Hazra, Avijit; Gharami, Ramesh Chandra; Chowdhury, Satyendra Nath; Datta, Pijush Kanti

2012-01-01

13

379 Adverse Drug Reactions to Anti-asthmatics in Patients with Bronchial Asthma  

PubMed Central

Background The number of self-reported adverse drug reactions (ADRs) has been rapidly increased with the active pharmacovigilance activities in Korea. However, there has been few data on ADRs to anti-asthmatics in Korea. This study was conducted to investigate the clinical characteristics of ADRs to anti-asthmatics in adult patients with bronchial asthma. Methods ADRs to anti-asthmatics reported to Regional Pharmacovigilance Center of Inha University Hospital by 2 physicians were collected from January 2011 to April 2011. Causality assessment of adverse events was performed by using WHO-UMC criteria and Naranjo's probability scale. Clinical information was additionally collected from electronic medical records. Results Twenty five ADRs to anti-asthmatics were reported in 19 (male 5, female 14) out of 228 patients with asthma. The most common offending anti-asthmatics were inhaled glucocorticoids combined with inhaled long-acting beta agonist (LABA) (12 of 19 subjects, 63.2%), theobromine (10.5%), oral LABA (10.5%), doxofylline (5.3%), acetylcysteine (5.3%), and montelukast (5.3%). Severity of ADRs was mild in most patients (13 of 19, 68.5%), and no severe ADR was detected. By frequency, oral LABA was the commonest drug associated with ADRs (2 in 17 prescription, 11.8%). ADR frequency was not different according to asthma control status. But ADRs to simultaneously prescribed drugs were more frequently detected in patients with combined upper airway diseases (ADRs to antihistamines) or patients with combined infection (ADRs to anti-infective drugs, mucolytics, oral LABA, or to SABA), or older patients with asthma. Conclusions Although the severity is usually mild, ADRs are relatively common in patients with bronchial asthma. Physician should monitor ADRs to anti-asthmatics or related drugs in patients with asthma, especially in older patients or in patients with multiple drug treatment for combined conditions.

Kim, Cheol-Woo; Cho, Jae-Hwa; Jung, Eun-Hee; Lee, Hye-Kyung

2012-01-01

14

ISMP Adverse Drug Reactions  

PubMed Central

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration’s (FDA’s) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Shuster at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-947-7797; fax: 215-914-1492; e-mail: joel.shuster@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA’s MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner. PMID:24421415

2013-01-01

15

Impact of levofloxacin dose adjustments by dispensing pharmacists on adverse reactions and costs in the treatment of elderly patients.  

PubMed

Ensuring an appropriate dosage of renally eliminated drugs for patients with renal insufficiency is important for preventing adverse drug reactions. We investigated the effectiveness of interventions by pharmacists in a hospital pharmaceutical department. The comparative study was performed at Gifu Municipal Hospital in Japan from March to August 2011, and included an intervention (142 patients) and a control group (98 patients). Upon receiving a prescription of levofloxacin for patients aged > or = 75 years, pharmacists evaluated the patients' kidney function and adjusted the appropriate dosage at the time of dispensation. In the intervention and control groups, levofloxacin-induced adverse reactions developed in 6 of 142 (4.2%) and 13 of 98 (13.3%) patients, respectively (p < 0.05). The cost of reducing levofloxacin per patient was yen 191.1 and yen 0 in the intervention and control groups, respectively. The cost per patient for adverse reaction treatments and examinations was yen 15.5 and yen 290.0 in the intervention and control groups, respectively. The intergroup difference in the total cost per patient was yen 465.6. Dose adjustment of levofloxacin at the time of dispensation by the pharmacist for patients aged > or = 75 years resulted in a decrease in the incidence of adverse reactions and cost. These findings can be applied not only to hospitals, but also to community pharmacies, because the intervention, which is a manual system, is simply performed when pharmacists are dispensing drugs. PMID:24400446

Tachi, T; Teramachi, H; Asano, S; Tanaka, K; Fukuta, M; Osawa, T; Aoyama, S; Yasuda, M; Mizui, T; Goto, C; Tsuchiya, T

2013-12-01

16

Adverse Drug Reactions of Long-term Intravenous Antibiotics in Patients with Pyogenic Spondylitis  

PubMed Central

Objective The purpose of this study was to investigate the incidence, cause, and influence of the adverse drug reactions (ADRs) associated with long-term intravenous antibiotics in patients with pyogenic spondylitis (PS). Methods We retrospectively reviewed the medical records of 84 patients with PS who underwent intravenous antibiotic therapy in our hospital from January 2001 to December 2012. ADRs were categorized to drug eruption, acute renal failure (ARF), hematologic toxicity, toxic hepatitis, pseudomembranous colitis (PMC), drug fever, and neuronal toxicity. Incidence and onset time of each ADR after antibiotic therapy were analyzed with the incidence of ADRs according to types of antibiotics. Results ADRs occurred in 38 of the 84 patients (incidence: 45.2%). The use of antibiotics was longer in the patients with ADRs (62.7 days) than in the patients without ADRs (44.3 day). The incidence of drug eruption, ARF, hematologic toxicity, toxic hepatitis, PMC, drug fever, and neuronal toxicity were 22.6, 11.9, 11.9, 10.7, 7.1, 3.6%, and 1.2%, respectively. The duration of antibiotics administration was related to the occurrence of PMC (p=0.001). ADRs were more common in patients treated by glycopeptides including vacomycin and teicoplanin. Conclusion The incidence of ADRs due to long-term intravenous antibiotics was as high as 45.2% in patients with PS. Therefore, we speculate that the possibility of delayed ADRs should be considered after long-term use of the antibiotics. Furthermore, close observation is mandatory to identify and treat ADRs promptly, even though PS revealed the improvement after antibiotic therapy. PMID:25346755

Kim, Dong Hwan; Kim, Hwan Soo; Nam, Kyoung Hyup; Choi, Byung Kwan

2014-01-01

17

Development of an Adverse Drug Reaction Risk Assessment Score among Hospitalized Patients with Chronic Kidney Disease  

PubMed Central

Background Adverse drug reactions (ADRs) represent a major burden on the healthcare system. Chronic kidney disease (CKD) patients are particularly vulnerable to ADRs because they are usually on multiple drug regimens, have multiple comorbidities, and because of alteration in their pharmacokinetics and pharmacodynamic parameters. Therefore, one step towards reducing this burden is to identify patients who are at increased risk of an ADR. Objective To develop a method of identifying CKD patients who are at increased risk for experiencing ADRs during hospitalisation. Materials and Methods Factors associated with ADRs were identified by using demographic, clinical and laboratory variables of patients with CKD stages 3 to 5 (estimated glomerular filtration rate, 10–59 ml/min/1.73 m2) who were admitted between January 1, 2012, and December 31, 2012, to the renal unit of Dubai Hospital. An ADR risk score was developed by constructing a series of logistic regression models. The overall model performance for sequential models was evaluated using Akaike Information Criterion for goodness of fit. Odd ratios of the variables retained in the best model were used to compute the risk scores. Results Of 512 patients (mean [SD] age, 60 [16] years), 62 (12.1%) experienced an ADR during their hospitalisation. An ADR risk score included age 65 years or more, female sex, conservatively managed end-stage renal disease, vascular disease, serum level of C-reactive protein more than 10 mg/L, serum level of albumin less than 3.5 g/dL, and the use of 8 medications or more during hospitalization. The C statistic, which assesses the ability of the risk score to predict ADRs, was 0.838; 95% CI, 0.784–0.892). Conclusion A score using routinely available patient data can be used to identify CKD patients who are at increased risk of ADRs. PMID:24755778

Saheb Sharif-Askari, Fatemeh; Syed Sulaiman, Syed Azhar; Saheb Sharif-Askari, Narjes; Al Sayed Hussain, Ali

2014-01-01

18

Adverse Drug Reactions: A Retrospective Review of Hospitalized Patients at a State Psychiatric Hospital  

PubMed Central

Background: There is a paucity of information regarding adverse drug reactions (ADRs) in psychiatric patients. Information on common and preventable ADRs (pADRs) in psychiatric patients will allow for targeted improvement projects. Objective: To characterize reported ADRs and pharmacist interventions to prevent ADRs in an extended-care state psychiatric hospital. Methods: Four years of ADR reports were assessed for probability, reaction severity, pharmacological class of medication involved, preventability, change in therapy, and transfers to a medical facility. The pharmacist intervention database was queried for interventions classified as “prevention of ADR.” The interventions were assessed for type of medication and recommendation acceptance. Results: Medication classes responsible for ADRs included mood stabilizers (30%), typical antipsychotics (25%), atypical antipsychotics (25%), and antidepressants (8%). Nine percent resulted in transfer to a medical facility. Of all ADRs, 34.4% were pADRs; mood stabilizers (41%) and atypical antipsychotics (27%) were the most common pADRs. The most common causes of pADRs were supratherapeutic serum concentrations, drug-drug interactions, and history of reaction. There were 87 pharmacist interventions that were classified as “prevention of ADR,” and the acceptance rate of pharmacists’ recommendations was 96.5%. Mood stabilizers (20%), atypical antipsychotics (17%), and typical antipsychotics (11%) were commonly associated with prevented ADRs. Lithium accounted for 13.8% of prevented ADRs; these ADRs were most often due to a drug–drug interaction with a nonsteroidal anti-inflammatory drug. Conclusions: ADRs were most commonly associated with mood stabilizers and antipsychotics, and pADRs were common. There is an opportunity to provide education to medical staff on therapeutic drug monitoring and drug–drug interactions for these classes, particularly lithium. PMID:24474834

Iuppa, Courtney A.; Nelson, Leigh Anne; Elliott, Ellie; Sommi, Roger W.

2013-01-01

19

A clinical adverse drug reaction prediction model for patients with chagas disease treated with benznidazole.  

PubMed

Benznidazole (BZN) is the main trypanocidal drug used to treat Chagas disease, and the evidence supporting the benefits of BZN use during the chronic phase of the disease will favor its use in millions of individuals. However, more than 30% of patients treated with BZN may suffer adverse drug reactions (ADRs), and the development of tools to identify those patients at risk is highly desirable. In the present study, we aimed to identify predictive factors for ADRs in Chagas disease patients treated with BZN. Among 195 patients included in the study, 48.7% experienced ADRs and 31.3% had ADRs that caused BZN treatment discontinuation. Overall ADRs and ADRs that caused BZN treatment discontinuation were more common among women and in those who graduated from elementary school. Overall ADRs were also less frequent among black individuals. Based on logistic regression analysis, female sex (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.5 to 5.4), graduation from elementary school (OR, 2.0; 95% CI, 1.1 to 3.8), and white (OR, 5.0; 95% CI, 1.0 to 24.1) and mulatto (OR, 5.6; 95% CI, 1.1 to 28.7) races were considered to predict overall ADRs, and female sex (OR, 2.3; 95% CI, 1.2 to 4.3) was considered to predict ADRs that caused BZN treatment discontinuation. Graduation from elementary school also presented a tendency to predict ADRs that caused BZN treatment discontinuation (OR, 1.8; 95% CI, 0.9 to 3.6). The logistic regression (LR) models to predict ADRs to BZN described in this study may become important tools to minimize ADRs and improve patients' compliance and thus assist physicians treating patients with Chagas disease with BZN. PMID:25114135

Sperandio da Silva, Gilberto Marcelo; Mediano, Mauro Felippe Felix; Alvarenga Americano do Brasil, Pedro Emmanuel; da Costa Chambela, Mayara; da Silva, Joyce Almeida; de Sousa, Andrea Silvestre; Xavier, Sergio Salles; Rodrigues da Costa, Andrea; Magalhães Saraiva, Roberto; Hasslocher-Moreno, Alejandro Marcel

2014-11-01

20

The Patients' Adherence and Adverse Drug Reactions (ADRs) which are Caused by Helicobacter pylori Eradication Regimens  

PubMed Central

Background: Helicobacter pylori is a major cause of upper gastrointestinal disorders. The eradication of H. pylori has been recommended for the treatment of different gastrointestinal diseases. Notwithstanding, a combination therapy is needed for Helicobacter pylori eradication, but using these medications can be the cause, the incidence risk of patients’ adherence to treatment regimens reduction and probably increase risk of Adverse Drug Reactions (ADRS), so, it is seem that evaluation the out come of combination therapy is need more than the past. Aim: The aim of present study was to determine the patients’ adherence to the treatment and the ADRs with five eradiation regimens. Setting and Design: A cross sectional study was done in a well known referral clinic of gastrointestinal disorders in Tehran, Iran. Methods and Materials: Ninety patients were evaluated the study (18 in each of the five regimens). The adherence to the treatment and the ADRs of the patients were asked during the treatment, twice, by doing telephone assays. Statistical Analysis Used: The data were analyzed by using the SPSS, 17 software and the statistical significance was accepted for the P values of 0.05. Results: 81% of the patients had a good adherence and there was no significant difference between the types of regimens (triple or quadruple therapy) and the adherence to the treatment regimens by the patients (p=0.6). Also, we found that there was no significant relationship between the types of regimens and the sex (p=0.99), education level (p=0.99), accommodation (p=0.93), an existence of underlying disease (p=0.86) and the concurrent use other medications (p=0.93). But there was a significant relationship between the patients’ age and adherence to the treatment regimens (p=0.008). The most reported ADRs belonged to gastrointestinal (GI) disorders (an abnormal taste had the most prevalence (36.6%) among the GI disorders). There was no significant relationship between the regimen type and the GI ADRs, (p=0.48). Conclusion: The findings of this study showed that the patients’ adherence to the treatment regimens and the ADRs did not have a significant relationship with the various eradication regimens for H. pylori. It seems that the type of H. pylori eradication regimen may not be an important factor in the patients’ adherence to the treatment regimens and the ADRs. PMID:23634397

Abbasinazari, Mohammad; Sahraee, Zahra; Mirahmadi, Maryam

2013-01-01

21

Detecting Potential Adverse Reactions of Sulpiride in Schizophrenic Patients by Prescription Sequence Symmetry Analysis  

PubMed Central

Purpose Previous studies have demonstrated sulpiride to be significantly more effective than haloperidol, risperidone and olanzapine in schizophrenic treatment; however, only limited information is available on the potential risks associated with sulpiride treatment. This study attempts to provide information on the potential risks of sulpiride treatment of schizophrenia, especially with regard to unexpected adverse effects. Materials and Methods Patients with schizophrenia aged 18 and older, newly prescribed with a single antipsychotic medication from the National Health Insurance Research Database of Taiwan in the period from 2003 to 2010 were included. A within-subject comparison method, prescription sequence symmetry analysis (PSSA) was employed to efficiently identify potential causal relationships while controlling for potential selection bias. Results A total of 5,750 patients, with a mean age of 39, approximately half of whom were male, constituted the study cohort. The PSSA found that sulpiride was associated with EPS (adjusted SR, 1.73; 95% CI, 1.46–2.06) and hyperprolactinemia (12.04; 1.59–91.2). In comparison, EPS caused by haloperidol has a magnitude of 1.99 when analyzed with PSSA, and hyperprolactinemia caused by amisulpride has a magnitude of 8.05, respectively. Another finding was the unexpected increase in the use of stomatological corticosteroids, emollient laxatives, dermatological preparations of corticosteroids, quinolone antibacterials, and topical products for joint and muscular pain, after initiation of sulpiride treatment. Conclusions We found sulpiride to be associated with an increased risk of EPS and hyperprolactinemia, and the potential risk could be as high as that induced by haloperidol and amisulpride, respectively. Additionally, our study provides grounds for future investigations into the associations between sulpiride and the increased use of additional drugs for managing adverse effects, including stomatological, dermatological, and musculoskeletal or joint side effects, constipation, and pneumonia. PMID:24587038

Lai, Edward Chia-Cheng; Hsieh, Cheng-Yang; Kao Yang, Yea-Huei; Lin, Swu-Jane

2014-01-01

22

Adverse ocular reactions to drugs.  

PubMed Central

Drugs acting on various parts of the body may also affect the eye insidiously. Increased awareness of such drug toxicity by the prescribing doctor should encourage him to consider effects on the cornea, lens, retina, optic nerve and elsewhere when checking the patient's progress. The following review concerns adverse ocular effects of systemic drug administration. PMID:6356101

Spiteri, M. A.; James, D. G.

1983-01-01

23

Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients.  

PubMed

Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5?cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe. PMID:24672577

Steele, Megan L; Axtner, Jan; Happe, Antje; Kröz, Matthias; Matthes, Harald; Schad, Friedemann

2014-01-01

24

Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients  

PubMed Central

Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5?cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe. PMID:24672577

Steele, Megan L.; Happe, Antje; Kroz, Matthias; Matthes, Harald; Schad, Friedemann

2014-01-01

25

The Impact of Herbal Drug Use on Adverse Drug Reaction Profiles of Patients on Antiretroviral Therapy in Zimbabwe  

PubMed Central

Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%), Bidens pilosa (66.0%), Eucalyptus globulus (52.3%), Moringa oleifera (44.1%), Lippia javanica (36.3%), and Peltoforum africanum (34.3%). Two indigenous herbs, Musakavakadzi (OR = 0.25; 95% CI 0.076–0.828) and Peltoforum africanum (OR = 0.495; 95% CI 0.292–0.839) reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles. PMID:22506106

Mudzviti, Tinashe; Maponga, Charles C.; Khoza, Star; Ma, Qing; Morse, Gene D.

2012-01-01

26

The impact of herbal drug use on adverse drug reaction profiles of patients on antiretroviral therapy in zimbabwe.  

PubMed

Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%), Bidens pilosa (66.0%), Eucalyptus globulus (52.3%), Moringa oleifera (44.1%), Lippia javanica (36.3%), and Peltoforum africanum (34.3%). Two indigenous herbs, Musakavakadzi (OR = 0.25; 95% CI 0.076-0.828) and Peltoforum africanum (OR = 0.495; 95% CI 0.292-0.839) reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles. PMID:22506106

Mudzviti, Tinashe; Maponga, Charles C; Khoza, Star; Ma, Qing; Morse, Gene D

2012-01-01

27

Adverse Reactions of Prophylactic Intravenous Immunoglobulin; A 13Year Experience With 3004 Infusions in Iranian Patients With Primary Immunodefi ciency Diseases  

Microsoft Academic Search

? Abstract Intravenous immunoglobulin (IVIG) replacement therapy improves health-related quality of life in patients with a primary immunodefi ciency disease, although there have been reports of adverse reactions associated with its regular administration. The study population was composed of 99 patients with primary antibody defi ciencies. All the patients were diagnosed with a primary immunodefi ciency disease and received at

S Dashti-Khavidaki; A Aghamohammadi; F Farshadi; M Movahedi; N Parvaneh; N Pouladi; K Moazzami; T Cheraghi; S Saghafi; G Heydari; N Rezaei

2009-01-01

28

Serious Treatment Related Adverse Drug Reactions amongst Anti-Retroviral Na?ve MDR-TB Patients  

PubMed Central

Background Globally treatment outcomes for multidrug-resistant Mycobacterium tuberculosis (MDR-TB) remain poor and this is compounded by high drug toxicity. Little is known about the influence of adverse drug reactions (ADRs) on treatment outcomes in South Africa. Methods We evaluated the impact of severe ADRs among a prospective cohort of MDR-TB patients in South Africa (2000–2004). The HIV-infected study participants were anti-retroviral naïve. Results Of 2,079 patients enrolled, 1,390 (66.8%) were included in this analysis based on known HIV test results (39.1% HIV-infected). At least one severe ADR was reported in 83 (6.9%) patients with ototoxicity being the most frequent ADR experienced (38.9%). Conclusions We found that being HIV-infected but antiretroviral naïve did not increase occurrence of SADRs in patients on second-line anti-tuberculosis drugs. Early screening and proactive management of ADRs in this patient population is essential, especially given the rollout of decentralized care and the potential for overlapping toxicity of concomitant MDR-TB and HIV treatment. PMID:23573193

Van der Walt, Martha; Lancaster, Johanna; Odendaal, Ronel; Davis, Jeanne Garcia; Shean, Karen; Farley, Jason

2013-01-01

29

Advocating mandatory patient 'autonomy' in healthcare: adverse reactions and side effects.  

PubMed

Promoting patient autonomy has become a key imperative in health service encounters. We will examine the potential negative effects of over-promoting patient autonomy and consider the impact on patient access, their experience and the provision of equitable services by focusing on an extreme manifestation of this trend, i.e. calls for patient involvement in health care decision making to be mandatory. Advocates of mandatory autonomy hold that patients have a duty to themselves, to society and to the medical system to make decisions on their health care independently. Models of mandatory autonomy may be contrasted to those of optional autonomy that seek to ascertain patients' decisional preferences and to understand wider limitations on their freedom to choose. Where choice as decisional responsibility becomes mandatory it ceases to promote agency and where autonomous choice is understood as an individualistic practice it will contribute to the cultural dominance of Western values. Moreover, taking a view that principlist ethics needs to take account of the social and cultural contexts of individual lives, we argue that if mandatory autonomy were to be over-emphasised as part of an ongoing move towards patient choice in UK National Health Service (NHS), educated and affluent people would be more able to exercise choices at the expense of people who are experienced in asserting preferences and who have the resources to make use of choices. We will argue that the promotion of autonomy needs to be tempered by steps to enable less powerful social, cultural and economic groups to contribute to decision making and to support individuals who may feel abandoned by having decisional responsibility transferred to them. Until constraints on individual choice can be understood and addressed, we advocate the model of optional autonomy used in shared decision making and make recommendations for practice, policy, education and research. PMID:17975729

Davies, Myfanwy; Elwyn, Glyn

2008-12-01

30

Severe cutaneous adverse drug reactions  

PubMed Central

Severe cutaneous drug reactions are one of the commonest medical challenges presenting to an emergency room in any hospital. The manifestations range from maculopapular rash to severe systemic symptoms like renal failure and cardiovascular compromise. Toxic epidermal necrolysis, erythroderma, drug rash with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis and drug induced vasculitis are the common cutaneous drug reactions which can have severe morbidity and even mortality. Careful history taking of the lag period after drug intake and associated symptoms, along with detailed examination of the skin, mucosa and various systems, help in early diagnosis of these reactions. Early stoppage of the incriminating drug, specific therapy including corticosteroids, cyclosporine and intravenous immunoglobulin depending on the case along with supportive therapy and local measures help in salvaging most patients. An overview of these important cutaneous drug reactions along with their management is being reviewed in this article. PMID:24600147

Verma, Rajesh; Vasudevan, Biju; Pragasam, Vijendran

2013-01-01

31

Adverse Drug Reactions in Dental Practice  

PubMed Central

Adverse reactions may occur with any of the medications prescribed or administered in dental practice. Most of these reactions are somewhat predictable based on the pharmacodynamic properties of the drug. Others, such as allergic and pseudoallergic reactions, are less common and unrelated to normal drug action. This article will review the most common adverse reactions that are unrelated to drug allergy. PMID:24697823

Becker, Daniel E.

2014-01-01

32

Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR  

PubMed Central

Objectives Children are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs. Methods Intensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance. Results Incidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5–6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0–1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal. Conclusion Well premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety. PMID:23960842

Khan, Lateef M.; Al-Harthi, Sameer E.; Saadah, Omar I.

2012-01-01

33

Prediction of Adverse Drug Reactions Using Decision Tree Modeling  

Microsoft Academic Search

Drug safety is of great importance to public health. The detrimental effects of drugs not only limit their application but also cause suffering in individual patients and evoke distrust of pharmacotherapy. For the purpose of identifying drugs that could be suspected of causing adverse reactions, we present a structure–activity relationship analysis of adverse drug reactions (ADRs) in the central nervous

F Hammann; H Gutmann; N Vogt; C Helma; J Drewe

2010-01-01

34

Prediction of Adverse Drug Reactions Using Decision Tree Modeling  

Microsoft Academic Search

Drug safety is of great importance to public health. The detrimental effects of drugs not only limit their application but also cause suffering in individual patients and evoke distrust of pharmacotherapy. For the purpose of identifying drugs that could be suspected of causing adverse reactions, we present a structure-activity relationship analysis of adverse drug reactions (ADRs) in the central nervous

F. Hammann; H. Gutmann; N. Vogt; C. Helma; J. Drewe

2010-01-01

35

Safety of Celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and other non-steroidal anti- inflammatory drugs  

Microsoft Academic Search

Summary. Background:Acetaminophen (paracetamol-P) is a widely used analgesic-antipyretic drug with no anti- inflammatory effects and its rate of adverse hypersensitivity reactions is very low. On the contrary non-steroidal anti-inflammatory drugs (NSAIDs) are commonly involved in side effects. Celecoxib (CE) is a novel drug, with high selectivity and affinity for COX-2 enzyme. Objective: We evaluated the tolerability of CE in a

G. Liccardi; M. Cazzola; C. De Giglio; D. Manfredi; E. Piscitelli; M. D'Amato; G. D'Amato

36

Adverse drug reactions induced by valproic acid.  

PubMed

Valproic acid is a widely-used first-generation antiepileptic drug, prescribed predominantly in epilepsy and psychiatric disorders. VPA has good efficacy and pharmacoeconomic profiles, as well as a relatively favorable safety profile. However, adverse drug reactions have been reported in relation with valproic acid use, either as monotherapy or polytherapy with other antiepileptic drugs or antipsychotic drugs. This systematic review discusses valproic acid adverse drug reactions, in terms of hepatotoxicity, mitochondrial toxicity, hyperammonemic encephalopathy, hypersensitivity syndrome reactions, neurological toxicity, metabolic and endocrine adverse events, and teratogenicity. PMID:23792104

Nanau, Radu M; Neuman, Manuela G

2013-10-01

37

Immediate vesicular eruption caused by topical 23% lidocaine 7% tetracaine ointment in a patient scheduled for laser therapy: a new adverse drug reaction.  

PubMed

Topical anesthetic agents have increased in number, formulations, and applications because of their efficacy and generally mild side effect profile. To date, there have been no reports of immediate vesicular eruption as a result of topical application of lidocaine or tetracaine. Two cases and a brief review of the literature are presented. We report the cases of two patients who presented for ablative laser therapy. Immediately after application of 23% lidocaine and 7% tetracaine mixed in an ointment base, the patients developed a diffuse eruption of vesicles and bullae on a well-demarcated erythematous base. The patients' lesions resolved after <1?week with gentle skin care. One patient developed macules of postinflammatory hyperpigmentation which faded over 2?months. One patient chose to cancel his laser therapy because of concerns over reproducing this adverse reaction, while the second will proceed using a different topical anesthetic agent. While topical anesthetic agents should generally be considered safe, they are not without risks. These cases illustrate a previously unreported adverse event. Clinicians should be vigilant for this and other adverse drug reactions to commonly used topical anesthetics like lidocaine and tetracaine. PMID:22151940

Vij, Alok; Markus, Ramsey

2011-12-01

38

Idiosyncratic Adverse Drug Reactions: Current Concepts  

PubMed Central

Idiosyncratic drug reactions are a significant cause of morbidity and mortality for patients; they also markedly increase the uncertainty of drug development. The major targets are skin, liver, and bone marrow. Clinical characteristics suggest that IDRs are immune mediated, and there is substantive evidence that most, but not all, IDRs are caused by chemically reactive species. However, rigorous mechanistic studies are very difficult to perform, especially in the absence of valid animal models. Models to explain how drugs or reactive metabolites interact with the MHC/T-cell receptor complex include the hapten and P-I models, and most recently it was found that abacavir can interact reversibly with MHC to alter the endogenous peptides that are presented to T cells. The discovery of HLA molecules as important risk factors for some IDRs has also significantly contributed to our understanding of these adverse reactions, but it is not yet clear what fraction of IDRs have a strong HLA dependence. In addition, with the exception of abacavir, most patients who have the HLA that confers a higher IDR risk with a specific drug will not have an IDR when treated with that drug. Interindividual differences in T-cell receptors and other factors also presumably play a role in determining which patients will have an IDR. The immune response represents a delicate balance, and immune tolerance may be the dominant response to a drug that can cause IDRs. PMID:23476052

Naisbitt, Dean J.

2013-01-01

39

Benznidazole-Related Adverse Drug Reactions and Their Relationship to Serum Drug Concentrations in Patients with Chronic Chagas Disease  

PubMed Central

For treating Chagas disease (CD), a current worldwide health problem, only benznidazole and nifurtimox have been approved to be used. In both cases, unwanted drug-related adverse events (ADRs) are frequent when these drugs are used in adults in the chronic stage. The main objective of this study was to establish benznidazole ADRs and their relationship to serum concentrations in patients with chronic Trypanosoma cruzi infection in order to perform more accurate dosages to minimize ADRs. A total of 54 patients were recruited over 12 months. Of these 54 patients, 53 (98%) experienced at least one ADR during follow-up, and the overall average ADR incidence was 2.4 episodes/patient/month. Benznidazole treatment was discontinued in 11 patients, 7 among them due to severe adverse effects. The mean duration of treatment before withdrawal was 11 days. Benznidazole serum concentrations were recorded on days 15, 30, 45, and 60 of follow-up and evaluated according to clinical and epidemiological variables and ADR severity. No relationship was found between the benznidazole serum concentration and the ADRs. The mean (standard deviation) trough serum benznidazole concentrations (all below 20 mcg/ml) on days 15, 30, 45, and 60 were 6.4 (1.9), 6.1 (1.8), 6.2 (2.2), and 5.7 (1.7) ?g/ml, respectively. Benznidazole serum concentrations do not appear to be related to the appearance of serious ADRs. Further, well-controlled studies are necessary to establish the optimal regimen for benznidazole in adults with chronic CD. PMID:23114763

Guerrero, Laura; Posada, Elizabeth; Rodriguez, Elena; Soy, Dolors; Gascon, Joaquim

2013-01-01

40

Severe cutaneous adverse reactions: impact of immunology, genetics, and pharmacology.  

PubMed

Severe cutaneous adverse reactions, though rare, represent a mucocutaneous presentation of adverse drug responses associated with significant morbidity and mortality. Here, we review the recent literature highlighting the roles of selective immune responses, genetic factors, and drug metabolism in increasing susceptibility of a given patient to these rare and severe reactions. Further understanding of these factors and their relative contributions to a severe drug reaction may hold important implications for future patient-specific pharmacogenomic and immunologic profiling in an effort to personalize prescribing patterns by clinicians. Emerging concepts, such as the role of viral reactivation and the presence of overlapping clinical features in severe drug eruptions, are also discussed. PMID:25037255

Harp, Joanna L; Kinnebrew, Melissa A; Shinkai, Kanade

2014-03-01

41

[Cutaneous adverse reactions to tattoos and piercings].  

PubMed

Piercings and tattoos have become very popular in western society in recent decades, particularly among younger generations. Reports of medical complications associated with these decorative techniques have increased in parallel with the rise in their popularity. Due to their high frequency, adverse cutaneous reactions are particularly important among these potential complications. Tattoo-related complications include a number of cutaneous and systemic infections secondary to breach of the epidermal barrier, acute and delayed inflammatory reactions with different histopathological patterns, the appearance of benign and malignant tumors on tattooed areas of skin, and certain dermatoses triggered by isomorphic phenomena. Piercing-related complications are similar, though some, such as pyogenic skin infections, are much more common due to the delayed wound healing after piercing in certain sites. We must differentiate between complications that are independent of the site of piercing, and specific complications, which are closely related to the body area pierced. The rate of complications after performing piercings or tattoos depends on the experience of the artist, the hygiene techniques applied, and the postprocedural care by the customer. However, some of these complications are unpredictable and depend on factors intrinsic to the patient. In this article, we review the most common decorative techniques of body art, with particular focus on the potential cutaneous complications and their management. PMID:19775542

Mataix, J; Silvestre, J F

2009-10-01

42

Cutaneous Adverse Reactions to Tattoos and Piercings  

Microsoft Academic Search

Piercings and tattoos have become very popular in western society in recent decades, particularly among younger generations. Reports of medical complications associated with these decorative techniques have increased in parallel with the rise in their popularity. Due to their high frequency, adverse cutaneous reactions are particularly important among these potential complications. Tattoo-related complications include a number of cutaneous and systemic

J. Mataix; J. F. Silvestre

2009-01-01

43

Children and ADRs (Adverse Drug Reactions)  

Microsoft Academic Search

Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and\\/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions.

Ettore Napoleone

2010-01-01

44

The risk of cutaneous adverse reactions among patients with the HLA-A* 31:01 allele who are given carbamazepine, oxcarbazepine or eslicarbazepine: a perspective review.  

PubMed

Carbamazepine is a drug that is widely used for the treatment of epilepsy, trigeminal neuralgia and bipolar disorder. This drug is also known to cause cutaneous adverse drug reactions (cADRs) in up to 10% of patients. The recent progress in pharmacogenetics has revealed that human leukocyte antigen (HLA) genotypes are associated with a susceptibility to the cADRs caused by particular drugs. For carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis, very strong associations with HLA-B*15:02 have been found mainly in patients of Southeastern Asian origin. In some countries, prescreening HLA-B*15:02 allele has already been put to practical use as a biomarker to avoid the life-threatening adverse drug reactions. In this review, another risk factor for carbamazepine-induced cADRs is discussed, namely HLA-A*31:01. We compare the strength of the association between HLA-A*31:01 and carbamazepine-induced cADRs based on reports for various ethnic populations; discuss the difference between the HLA-A*31:01 and HLA-B*15:02 biomarkers and the usefulness of prescreening HLA-A*31:01 to detect patients at high risk for carbamazepine-induced cADRs; and refer to points that remain to be resolved. PMID:25114785

Kaniwa, Nahoko; Saito, Yoshiro

2013-12-01

45

Adverse drug reaction, patent blue V dye and anaesthesia  

PubMed Central

Background and Aim: Patent blue vital (PBV) dye is used for varied perioperative indications, and has a potential for causing life-threatening allergic reactions. In this retrospective case series study, at a tertiary level neurosciences centre, we analysed the nature, management and outcome of adverse drug reaction to the preoperative use of PBV for marking vertebral level prior to back surgeries. Methods: Patients were identified from the theatre and radiology database. Data were collected from the patients’ notes retrieved from the medical records division. Results: Eleven of 1247 (0.88%) patients experienced adverse reactions: 6 (0.48%) patients had minor grade I reactions (urticaria, blue hives, pruritis or generalised rash), 4 (0.32%) had grade II reactions (transient hypotension/bronchospasm/laryngospasm) and grade III reaction (hypotension requiring prolonged vasopressor support) was noted in 1 (0.08%) patient. No mortality was seen. The time of onset (range 10–45 min) frequently coincided with induction of anaesthesia or prone positioning of patient. Seven (63.6%) cases were cancelled or postponed (range 2–63 days). Treatment varied independent of the grade of reaction. Allergy workup (often incomplete) was done for 6 (54%) patients. Conclusion: An awareness of the time of onset and infrequency of life-threatening reactions to patent blue dye may result in better management, less postponement, more complete workup and referral of these events. PMID:23325942

Tripathy, Swagata; Nair, Priya V

2012-01-01

46

Pharmacogenomics and adverse drug reactions in children  

PubMed Central

Adverse drug reactions are a common and important complication of drug therapy in children. Over the past decade it has become increasingly apparent that genetically controlled variations in drug disposition and response are important determinants of adverse events for many important adverse events associated with drug therapy in children. While this research has been difficult to conduct over the past decade technical and ethical evolution has greatly facilitated the ability of investigators to conduct pharmacogenomic studies in children. Some of this research has already resulted in changes in public policy and clinical practice, for example in the case of codeine use by mothers and children. It is likely that the use of pharmacogenomics to enhance drug safety will first be realized among selected groups of children with high rates of drug use such as children with cancer, but it also likely that this research will be extended to other groups of children who have high rates of drug utilization and as well as providing insights into the mechanisms and pathophysiology of adverse drug reactions in children. PMID:24795743

Rieder, Michael J.; Carleton, Bruce

2014-01-01

47

Adverse Reactions to OsteoSet Bone Graft Substitute  

PubMed Central

Background: The purpose of this study was to identify factors that may be associated with the development of a sterile inflammatory reaction to OsteoSet (Wright Medical Technology) bone graft substitute. We report on a series of 58 consecutive cases of patients with benign bone lesions who developed an adverse reaction to Osteoset. All procedures were performed by a single orthopaedic oncology surgeon. Methods: Patients who exhibited an adverse reaction to OsteoSet and those who did not were analyzed for statistical differences with respect to age, sex, volume of graft material used, size of pellet, use of alcohol washes, mixing of OsteoSet with allograft, medications, drug allergies, and smoking history. Comparisons were made between the reaction group and the non-reaction group with respect to the these variables. Results: Eight definite (13.8%) and 3 probable (5.2%) reactions were identified. Symptoms developed an average of 38.9 days after the operation. There was no statistically significant difference (p>0.05) in the volume of Osteoset used, size of pellet, use of alcohol washes, mixing of OsteoSet with allograft, patient age, sex, drug allergies, or smoking history. Reported use of at least one medication was statistically significant between groups when probable reactions were included with the non-reaction group (p < 0.05), but not when probables were analyzed with the definite reaction group ( p < 0.10). A review of our patients' medication lists did not reveal any single or combination of medications likely to be responsible for this difference. Type and location of tumor also did not appear to differ significantly between the two groups. Conclusions: Although we report a 13.8%-19.0% incidence of adverse reaction to OsteoSet, we are unable to identify any statistically significant factors that might predict the development of a reaction. Fortunately, the reaction is essentially self limited and fairly benign requiring only anti-inflammatories and observation. PMID:12180608

Lee, Gregory H; Khoury, Joseph G; Bell, John-Erik; Buckwalter, Joseph A

2002-01-01

48

Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study  

PubMed Central

Background Patients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The impact of ADRs on treatment adherence, treatment outcomes and future treatment options is quiet considerable. Thus, the purpose of this study was to describe the common self-reported ADRs and their impact on antiretroviral treatment. Methods Cross-sectional study was conducted at antiretroviral therapy (ART) clinic of Gondar University Hospital. Semi-structured interview questionnaire was used to extract self-reported ADRs, socio-demographic, and psycho-social variables. Variables related to antiretroviral medication, laboratory values and treatment changes were obtained from medical charts. Chi-square and odds ratio with 95% confidence interval were used to determine the associations of dependent variables. Result A total of 384 participants were enrolled. At least one adverse drug reaction was reported by 345 (89.8%) study participants and the mean number of ADRs reported was 3.7 (±0.2). The most frequently reported ADRs were nausea (56.5%) and headache (54.9%). About 114 (31.0%) participants considered antiretroviral therapy to be unsuccessful if ADRs occurred and only 10 (2.6%) decided to skip doses as ADRs were encountered. Based on chart review, treatment was changed for 78 (20.3%) patients and from which 79% were due to documented ADRs (p = 0.00). Among them, CNS symptoms (27.4%) and anemia (16.1%) were responsible for the majority of changes. Around four percent of patients were non-adherent to ART. Non-adhered participants and those on treatment changes were not statistically associated with self-reported ADRs. Only unemployment status (AOR = 1.76 (1.15 - 2.70), p = 0.01) and ADR duration of less than one month (AOR = 1.95 (1.28-2.98), p = 0.001) were significantly associated with self-reported adverse effects of three or more in the multivariate analysis. Conclusion Self-reported ADRs to antiretroviral therapy are quite common. More of the reactions were of short lasting and their impact on adherence and treatment change were less likely. However, documented ADRs were the most prevalent reasons for ART switch. Moreover, the level of unemployment was a strong predictor of self-reported ADRs. PMID:24957052

2014-01-01

49

Revisiting cutaneous adverse reactions to pemetrexed  

PubMed Central

Pemetrexed (Alimta®) is a multitargeted antifolate drug approved as a single agent or in combination with cisplatin for the treatment of a small number of malignancies including advanced and metastatic non-squamous non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma. This review reports the recent peer-reviewed publications and original findings regarding cutaneous adverse reactions (CARs) to pemetrexed. Pemetrexed-related CARs are frequently reported under the unspecific term ‘skin rash’. However, more specific diseases were tentatively identified as alopecias, urticarial vasculitis, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, radiation recall dermatitis and pityriasis lichenoides. Most of the skin reactions occur shortly after pemetrexed administration. As with methotrexate-related CARs, the cell cycle arrest in the S phase may be regarded as a direct and major cause of the cytotoxic pathobiology. An adverse immune reaction is unlikely. In conclusion, pemetrexed is responsible for CARs exhibiting a variety of clinical presentations. Their origin is likely attributed to direct cytotoxicity following the cell cycle arrest in the S phase and cell necrosis. PMID:22866124

Pierard-Franchimont, Claudine; Quatresooz, Pascale; Reginster, Marie-Annick; Pierard, Gerald E.

2011-01-01

50

Multi-Indication Carbamazepine and the Risk of Severe Cutaneous Adverse Drug Reactions in Korean Elderly Patients: A Korean Health Insurance Data-Based Study  

PubMed Central

Objective To evaluate the risk of severe cutaneous adverse drug reactions (SCAR) after exposure to multi-indication antiepileptic drugs for in Korean elderly patients. Methods We used a nationwide database from the Korean Health Insurance Review and Assessment Service claims constructed for the monitoring of drug utilization among the entire Korean elderly population from January 2005 to June 2006. We identified cases of SCARs among inpatients aged ?65 years and those newly diagnosed with erythema multiforme according to the International Classification of Diseases, 10th revision code (L51). Each case was matched to four controls for gender, age, and the first hospitalization date as the index date. The use of carbamazepine, gabapentin, lamotrigine, topiramate, phenobarbital, phenytoin, and valproate during a 60-day period before the index date was compared. A conditional logistic regression analysis was performed to calculate the odds ratios (OR) and 95% confidence intervals (CI) of SCARs for antiepileptic drug. Results We identified 286 cases of SCAR and 1,144 matched controls. Among the 25 patients who were prescribed antiepileptic drugs within 60 days of the index date. There were 11 cases (3.8%) of severe ocular manifestations, and most elderly patients were first-time or short-term users of antiepileptic drugs. Among the 10 cases of carbamazepine use, only 2 cases were prescribed carbamazepine for seizure. All antiepileptic drugs were associated with an increased SCAR risk (adjusted OR?=?3.42, 95% CI: 1.75–6.63). The SCAR risk was highest in patients treated with carbamazepine (adjusted OR?=?10.39, 95% CI: 2.64–40.86, for multi-indication; adjusted OR?=?6.84, 95% CI: 1.55–30.10, for neuropathic pain). Conclusion Carbamazepine use was associated with a nearly 10-fold increase in severe cutaneous drug reactions in Korean elderly patients. This association was consistently high with SCAR patients who received carbamazepine for neuropathic pain. PMID:24391836

Kim, Ji Young; Lee, Joongyub; Ko, Young-Jin; Shin, Ju-Young; Jung, Sun-Young; Choi, Nam-Kyong; Park, Byung-Joo

2013-01-01

51

PATTERN OF ADVERSE DRUG REACTIONS EXPERIENCED BY TUBERCULOSIS PATIENTS IN A TERTIARY CARE TEACHING HOSPITAL IN WESTERN NEPAL  

Microsoft Academic Search

Tuberculosis is a common problem in developing countries including Nepal. Data regarding the safety profile of anti tubercular drugs is lacking in Nepal. The present study analyzed the pattern of ADRs caused by the antitubercular drugs. Inpatient files of all the TB patients who received treatment at the Manipal Teaching Hospital, Pokhara, Nepal during the period from 1st January 2001

KISHORE PV; SUBISH PALAIAN; PRADIP OJHA; SHANKAR PR

52

Smallpox vaccination and adverse reactions. Guidance for clinicians.  

PubMed

The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and persons aged < 18 years. In addition, history of Darier disease is a contraindication in a potential vaccinee and a contraindication if a household contact has active disease. In the event of a smallpox outbreak, outbreak-specific guidance will be disseminated by CDC regarding populations to be vaccinated and specific contraindications to vaccination. Vaccinia can be transmitted from a vaccinee's unhealed vaccination site to other persons by close contact and can lead to the same adverse events as in the vaccinee. To avoid transmission of vaccinia virus (found in the smallpox vaccine) from vaccinees to their close contacts, vaccinees should wash their hands with warm soapy water or hand rubs containing > or = 60% alcohol immediately after they touch their vaccination site or change their vaccination site bandages. Used bandages should be placed in sealed plastic bags and can be disposed of in household trash. Smallpox vaccine adverse reactions are diagnosed on the basis of clinical examination and history, and certain reactions can be managed by observation and supportive care. Adverse reactions that are usually self-limited include fever, headache, fatigue, myalgia, chills, local skin reactions, nonspecific rashes, erythema multiforme, lymphadenopathy, and pain at the vaccination site. Other reactions are most often diagnosed through a complete history and physical and might require additional therapies (e.g., VIG, a first-line therapy and cidofovir, a second-line therapy). Adverse reactions that might require further evaluation or therapy include inadvertent inoculation, generalized vaccinia (GV), eczema vaccinatum (EV), progressive vaccinia (PV), postvaccinial central nervous system disease, and fetal vaccinia. Inadvertent inoculation occurs when vaccinia virus is transferred from a vaccination site to a second location on the vaccinee or to a close contact. Usually, this condition is self-limited and no additional care is needed. Inoculations of the eye and eyelid require evaluation by an ophthalmologist and might require therapy with topical antiviral or

Cono, Joanne; Casey, Christine G; Bell, David M

2003-02-21

53

Adverse drug reactions in an elderly outpatient population.  

PubMed

The prevalence of adverse drug reactions (ADRs) in elderly outpatients was investigated, along with factors that might be associated with their occurrence. The medical records of elderly patients attending an interdisciplinary geriatric clinic and a general medical clinic during 1988 were audited to collect a variety of demographic and treatment data and to detect documentation of first-time ADRs. Subjects were classified as having had an ADR if a physician documented this or if a relevant symptom was noted in the record and a score of 1 or above was obtained on the Adverse Drug Reaction Probability Scale. The presence of potential drug interactions was also assessed. The sample size was 463 patients, of whom 332 attended the medical clinic and 131 attended the geriatric clinic. Potential drug interactions were identified in the records of 143 subjects (31%). There were 107 documented ADRs in 97 patients (21%). Of these patients, 86 were noted by the physicians as having had an ADR. Twelve patients were hospitalized as a direct result of an ADR. Significant risk factors for ADRs were attendance in the geriatric clinic, the use of potentially harmful drug combinations, and the use of drugs that require therapeutic monitoring. Patient age and the number of drugs had no association with ADRs. In the elderly population studied, patients with frailty arising from multiple pathologies were more likely to have ADRs than the more robust elderly, even when their therapeutic regimens were simplified. PMID:1570873

Schneider, J K; Mion, L C; Frengley, J D

1992-01-01

54

Acute adverse reactions to psychoactive drugs, drug usage, and psychopathology  

Microsoft Academic Search

Used a field survey method to examine the relationship between psychopathology and acute adverse reactions to psychoactive drugs. A paper-and-pencil measure of acute adverse reactions was developed and administered to 530 college students with drug-use experience. Acute adverse reactions were hypothesized to covary positively with regression, schizophrenia, and drug usage, and to covary negatively with adjustment and paranoia. These hypotheses

Murray P. Naditch

1974-01-01

55

Epidemiology Of Adverse Drug Reactions To Phenformin And Metformin  

Microsoft Academic Search

Adverse drug reactions (ADRs) to phenformin and metformin reported to the Swedish Adverse Drug Reaction Committee during 1965-77 were analysed in relation to sales and prescription data. The biguanides accounted for 0·6% of all reported adverse drug reactions but for 6% of the fatal cases (all phenformin). Sixty-four ADRs to phenformin and eight to metformin were classified as causal relation

Ulf Bergman; Gunnar Boman; Bengt-Erik Wiholm

1978-01-01

56

Parkinsonism caused by adverse drug reactions: a case series  

PubMed Central

Introduction Parkinsonism puts a high direct cost burden on both patient and caregiver. Several reports of drug-induced parkinsonism have been published, but to the best of our knowledge, there has not been any report of quinine or halothane inducing parkinsonism. Case presentation We describe two cases of parkinsonism possibly caused by adverse drug reaction to quinine in a 29-year-old black Nigerian woman and to halothane in a 36-year-old black Hausa (Nigerian) man who received it as general anaesthesia for appendicectomy in our teaching hospital. Conclusion These are two unusual cases of parkinsonism caused by adverse drug reactions to high-dose quinine and to halothane as general anaesthesia. We consider that these two cases are important in bringing this potential side-effect to the attention of both pharmacologists and primary care physicians as these are two of the most commonly used medications in our clinics. We conclude that parkinsonism should be included among the adverse drug reactions to high-dose quinine and halothane general anaesthetic. PMID:21410947

2011-01-01

57

Children and ADRs (Adverse Drug Reactions)  

PubMed Central

Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions. The lack of reliable data in the paediatric population is associated with specific problems including: limited availability of safety data due to the lack of clinical trials in the paediatric population; under- or over-dosing in some age groups due to the lack of pharmacokinetics data or dose-finding studies; maturation, growth and development of the paediatric population susceptible to drug-induced growth and development disorders as well as to delayed ADRs not findable in adults. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Spontaneous reporting of suspected ADRs become an important means to promote reasonable warning signs. Therefore some ADRs may be known in their qualitative aspect and quantitative aspect only after successful marketing and use in the population during a "normal" use. When the drug is used in clinical practice in large unselected populations, epidemiological post-marketing studies are useful as they find their major confirmation in recalling all the events that occur during monitoring, with estimates of incidence of ADRs that can not be obtained by spontaneous reports. In these studies a significant role can be played by the Family Pediatricians with the participation to active pharmacovigilance projects. PMID:20180963

2010-01-01

58

Adverse reactions to antituberculosis drugs in Manguinhos, Rio de Janeiro, Brazil  

PubMed Central

OBJECTIVES: This study aimed to characterize and estimate the frequency of adverse reactions to antituberculosis drugs in the population treated at the Centro de Saúde Escola Germano Sinval Faria, a primary health care clinic in Manguinhos, Rio de Janeiro City, and to explore the relationship between adverse drug reactions and some of the patients' demographic and health characteristics. METHODS: This descriptive study was conducted via patient record review of incident cases between 2004 and 2008. RESULTS: Of the 176 patients studied, 41.5% developed one or more adverse reactions to antituberculosis drugs, totaling 126 occurrences. The rate of adverse reactions to antituberculosis drugs was higher among women, patients aged 50 years or older, those with four or more comorbidities, and those who used five or more drugs. Of the total reactions, 71.4% were mild. The organ systems most affected were as follows: the gastrointestinal tract (29.4%), the skin and appendages (21.4%), and the central and peripheral nervous systems (14.3%). Of the patients who experienced adverse reactions to antituberculosis drugs, 65.8% received no drug treatment for their adverse reactions, and 4.1% had one of the antituberculosis drugs suspended because of adverse reactions. “Probable reactions” (75%) predominated over “possible reactions” (24%). In the study sample, 64.3% of the reactions occurred during the first two months of treatment, and most (92.6%) of the reactions were ascribed to the combination of rifampicin + isoniazid + pyrazinamide (Regimen I). A high dropout rate from tuberculosis treatment (24.4%) was also observed. CONCLUSION: This study suggests a high rate of adverse reactions to antituberculosis drugs. PMID:23644852

Damasceno, Glauciene Santana; Guaraldo, Lusiele; Engstrom, Elyne Montenegro; Filha, Mariza Miranda Theme; Santos, Reinaldo Souza-; Vasconcelos, Ana Gloria Godoi; Rozenfeld, Suely

2013-01-01

59

Quinolones: review of psychiatric and neurological adverse reactions.  

PubMed

Quinolones are a class of antibacterial agents for the treatment of several infectious diseases (e.g. urinary and respiratory tract infections). They are used worldwide due to their broad spectrum of activity, high bioavailability and good safety profile. The safety profile varies from quinolone to quinolone. The aim of this article was to review the neurological and psychiatric adverse drug reaction (ADR) profile of quinolones, using a literature search strategy designed to identify case reports and case series. A literature search using PubMed/MEDLINE (from inception to 31 October 2010) was performed to identify case reports and case series related to quinolone-associated neurological and psychiatric ADRs. The search was conducted in two phases: the first phase was the literature search and in the second phase relevant articles were identified through review of the references of the selected articles. Relevant articles were defined as articles referring to adverse events/reactions associated with the use of any quinolone. Abstracts referring to animal studies, clinical trials and observational studies were excluded. Identified case reports were analysed by age group, sex, active substances, dosage, concomitant medication, ambulatory or hospital-based event and seriousness, after Medical Dictionary for Regulatory Activities (MedDRA®) coding. From a total of 828 articles, 83 were identified as referring to nervous system and/or psychiatric disorders induced by quinolones. 145 individual case reports were extracted from the 83 articles. 40.7% of the individual case reports belonged to psychiatric disorders only, whereas 46.9% related to neurological disorders only. Eight (5.5%) individual case reports presented both neurological and psychiatric ADRs. Ciprofloxacin, ofloxacin and pefloxacin were the quinolones with more neurological and psychiatric ADRs reported in the literature. Ciprofloxacin has been extensively used worldwide, which may explain the higher number of reports, while for ofloxacin and pefloxacin, the number of reports may be over-representative. A total of 232 ADRs were identified from the selected articles, with 206 of these related to psychiatric and/or neurological ADRs. The other 26 were related to other body systems but were reported together with the reactions of interest. Mania, insomnia, acute psychosis and delirium were the most frequently reported psychiatric adverse events; grand mal convulsion, confusional state, convulsions and myoclonus were the most frequently reported neurological adverse events. Several aspects should be taken into account in the development of CNS adverse effects, such as the pharmacokinetics of quinolones, chemical structure and quinolone uptake in the brain. These events may affect not only susceptible patients but also 'healthy' patients. PMID:21585220

Tomé, Ana M; Filipe, Augusto

2011-06-01

60

Precautions and Adverse Reactions during Blood Transfusion  

MedlinePLUS

... as itching or a rash. Usually, acetaminophen Some Trade Names TYLENOL to reduce fever is the only ... need another transfusion may be given acetaminophen Some Trade Names TYLENOL before the next transfusion. Allergic reactions: ...

61

Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance  

PubMed Central

BACKGROUND—Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed.?METHODS—A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, consequences, and predictors.?RESULTS—Eighty three (14.4%) of the 578 admissions were drug related: 39 (6.7%) caused by adverse drug reactions and 44 (7.6%) caused by non-compliance with medication. One hundred ninety two (33.2%) patients had a history of non-compliance. Factors associated with an increased risk of admission because of an adverse drug reaction were patients with diabetes or neoplasms, and patients using numerous different medications. Factors associated with a higher risk of hospitalisation because of non-compliance were poor recall of the medication regimen, seeing numerous physicians, female sex, polypharmacy, drug costs, and switching over to non-conventional forms of treatment.?CONCLUSION—Many elderly admissions are drug related, with non-compliance accounting for a substantial fraction of these. Elderly people at high risk of suffering a drug related medical emergency are identified and suitable interventions may be planned by the healthcare policymakers to target them.???Keywords: adverse drug reactions; non-compliance; drug related medical emergencies; elderly PMID:11677279

Malhotra, S; Karan, R; Pandhi, P; Jain, S

2001-01-01

62

A case of two adverse reactions  

Microsoft Academic Search

Low molecular weight heparins are now widely prescribed in the treatment of thromboembolic disease and acute coronary syndromes. Anaphylaxis is a recognised but rare potentially life threatening side effect of heparin.Common clinical features of anaphylaxis are cardiovascular collapse, bronchospasm, cutaneous symptoms, angioedema, generalised oedema, or gastrointestinal symptoms. It is extremely rare, however, for patients to experience such dramatic and potentially

L-A Smith; M Harkness

2004-01-01

63

Tolerogenic role of Kupffer cells in immune-mediated adverse drug reactions  

Microsoft Academic Search

Immune-mediated adverse drug reactions (IADR) account for approximately 6–10% of all adverse drug reactions. Although IADR are often referred to as rare (afflicting 1\\/100 to 1\\/100,000 patients), their unpredictable and serious nature makes them a significant economic burden and safety concern to the health care community and the pharmaceutical industry. Current studies suggest that IADR are caused by immunogenic drug–protein

Cynthia Ju; Lance R. Pohl

2005-01-01

64

[Adverse cutaneous reactions induced by exposure to woods].  

PubMed

Various adverse cutaneous reactions may occur as a result of exposure to wood dust or solid woods. These include allergic contact dermatitis, irritant contact dermatitis and, more rarely, contact urticaria, photoallergic and phototoxic reactions. Also cases of erythema multiforme-like reactions have been reported. Contact dermatitis, both allergic and irritant, is most frequently provoked by exotic woods, e.g. wood of the Dalbergia spp., Machaerium scleroxylon or Tectona grandis. Cutaneous reactions are usually associated with manual or machine woodworking, in occupational setting or as a hobby. As a result of exposure to wood dust, airborne contact dermatitis is often diagnosed. Cases of allergic contact dermatitis due to solid woods of finished articles as jewelry or musical instruments have also been reported. The aim of the paper is to present various adverse skin reactions related to exposure to woods, their causal factors and sources of exposure, based on the review of literature. PMID:23650772

Chomiczewska-Skóra, Dorota

2013-01-01

65

Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.  

PubMed

CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal vaccinia; generalized vaccinia; accidental autoinoculation, nonocular; ocular vaccinia; progressive vaccinia; erythema multiforme major; postvaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox vaccine surveillance case definitions presented in the report can be used in future vaccination programs to ensure uniform reporting guidelines and case classification. PMID:16456528

Casey, Christine; Vellozzi, Claudia; Mootrey, Gina T; Chapman, Louisa E; McCauley, Mary; Roper, Martha H; Damon, Inger; Swerdlow, David L

2006-02-01

66

Clinical and economic burden of adverse drug reactions  

PubMed Central

Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs. Postmarketing drug safety monitoring through pharmacovigilance activities, including mining of spontaneous reporting and carrying out observational prospective cohort or retrospective database studies, allow longer follow-up periods of patients with a much wider range of characteristics, providing valuable means for ADR detection, quantification and where possible reduction, reducing healthcare costs in the process. Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs. The goal of this review is to explore the epidemiology and the costs of ADRs in routine care. PMID:24347988

Sultana, Janet; Cutroneo, Paola; Trifiro, Gianluca

2013-01-01

67

Contribution of patient and hospital characteristics to adverse patient incidents.  

PubMed Central

The 1974 medical malpractice "crisis" brought about extensive legislation and insurance regulation in the United States. Hospitals in many states are now required to support risk management programs that include investigation and systematic analyses of adverse patient incidents. However, no research supports the hypothesis that systematic analysis of adverse patient incidents can identify contributory factors. In this study, a simple prediction model was used to estimate relationships between adverse incidents and selected patient and environmental characteristics in a large hospital. While some of the incident-characteristic relationships were significant, none of the estimated equations yielded results that could be logically translated into policy recommendations for the hospital. These results point to the need for further research. The benefits that positive research results would have for patients, hospitals, an the bill-paying public are obvious. Additional negative results would suggest that many legislative bodies and regulatory agencies were presumptions in requiring hospitals to conduct analyses of incidents. PMID:7461973

Elnicki, R A; Schmitt, J P

1980-01-01

68

Patient perspectives of patient-provider communication after adverse events  

Microsoft Academic Search

Objective. To explore patient perceptions of patient-provider communication after an actual adverse medical event because prior patient error studies are rarely based on real situations. Design. We conducted four patient focus groups using a semi-structured guide. We analyzed transcripts using an editing approach to identify themes. Setting. Three sites in Colorado. Study participants. Participants were recruited from statewide post-injury program.

CHRISTINE W. DUCLOS; MARY EICHLER; LESLIE TAYLOR; JAVAN QUINTELA; DEBORAH S. MAIN; WILSON PACE; ELIZABETH W. STATON

2005-01-01

69

Dietary aspects of adverse reactions to foods in adults.  

PubMed Central

Dietary considerations play an important role in the diagnosis, treatment and management of immunologic and nonimmunologic reactions to foods. Food diaries and trial elimination diets may prove helpful in identifying the responsible foods. Elimination diets must be monitored carefully for nutritional adequacy and should be used no longer than absolutely necessary; in some instances appropriate vitamin and mineral supplementation may be necessary. Ideally the identification of foods that provoke symptoms should be confirmed by means of double-blind challenge testing. Avoidance of some problem foods is unlikely to cause nutritional problems, but the practical and nutritional implications of allergies to staple foods such as cow's milk, eggs and wheat are far greater. Nonimmunologic adverse reactions that may mimic food allergic reactions include gastrointestinal disorders, sensitivity to food additives and psychologically based adverse reactions. There may be some degree of tolerance in metabolic disorders, which makes dietary management easier. Sensitivity to food additives necessitates careful scrutiny of food labels. In psychologic adverse reactions to foods, several foods are often involved, which increases the risk of nutritional problems. PMID:3048623

Parker, S L; Sussman, G L; Krondl, M

1988-01-01

70

iADRs: towards online adverse drug reaction analysis.  

PubMed

Adverse Drug Reaction (ADR) is one of the most important issues in the assessment of drug safety. In fact, many adverse drug reactions are not discovered during limited pre-marketing clinical trials; instead, they are only observed after long term post-marketing surveillance of drug usage. In light of this, the detection of adverse drug reactions, as early as possible, is an important topic of research for the pharmaceutical industry. Recently, large numbers of adverse events and the development of data mining technology have motivated the development of statistical and data mining methods for the detection of ADRs. These stand-alone methods, with no integration into knowledge discovery systems, are tedious and inconvenient for users and the processes for exploration are time-consuming. This paper proposes an interactive system platform for the detection of ADRs. By integrating an ADR data warehouse and innovative data mining techniques, the proposed system not only supports OLAP style multidimensional analysis of ADRs, but also allows the interactive discovery of associations between drugs and symptoms, called a drug-ADR association rule, which can be further developed using other factors of interest to the user, such as demographic information. The experiments indicate that interesting and valuable drug-ADR association rules can be efficiently mined. PMID:23420567

Lin, Wen-Yang; Li, He-Yi; Du, Jhih-Wei; Feng, Wen-Yu; Lo, Chiao-Feng; Soo, Von-Wun

2012-12-01

71

Physician access to drug profiles to reduce adverse reactions  

NASA Astrophysics Data System (ADS)

Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.

Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.

1995-10-01

72

Molecular Mechanisms of Adverse Drug Reactions in Cardiac Tissue  

Microsoft Academic Search

The myocardium is the target of toxicity for a number of drugs. Based on pharmacological evidence, cellular targets for drugs\\u000a that produce adverse reactions can be categorized into a number of sites that include the cell membrane-bound receptors, the\\u000a second messenger system, ionic channels, ionic pumps, and intracellular organelles. Additionally, interference with the neuronal\\u000a input to the heart can also

Reza Tabrizchi

73

Improving adverse-drug-reaction reporting in ambulatory care clinics at a Veterans Affairs hospital  

Microsoft Academic Search

The detection of adverse drug reactions (ADRs) by a traditional passive reporting system and by a method involv- ing patient and provider interviews was studied. The study sample consisted of ran- domly selected outpatients seen by their primary care provider during scheduled appointments in January and February 2001 at a Veterans Affairs med- ical center. After ambulatory care clinic sessions,

MONICA B. ASPINALL; JEFF WHITTLE; SHERRIE L. ASPINALL; ROBERT L. MAHER; CHESTER B. GOOD

74

Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions.  

PubMed

Intravenous immunoglobulin (IVIG) is increasingly recommended for many diseases apart from primary immunodeficiency diseases (PID). Although effective and safe, adverse reactions may occur. We conducted a 2-year prospective observational study in 117 patients with PID who received regular IVIG replacement therapy at a median dose of 600mg/kg every 3 to 4weeks to examine IVIG's adverse effects; 1765 infusions were performed (mean=15/patient) in 75 males and 42 females (aged 3months to 77years) in 3 groups: ?9years (34.2%), 10-19years (26.5%), and ?20years (39.3%). Fifty patients had common variable immunodeficiency (CVID), 11 had X-linked agammaglobulinemia (XLA), and 55 had other immune system disorders. The drugs administered were Octagam® (49.1%), Tegeline® (17.3%), Imunoglobulin® (18.6%), Flebogama® (12.9%), Vigam® (1.2%), and Kiovig® (0.4%). Immediate infusion-related adverse reactions occurred in the cases of 38 out 1765 infusions (2.15%, IC95% 1.53%-2.94%), which were classified as mild (81.6%), moderate (10.5%), or severe (7.9%). Time until reaction ranged from 10 to 240min (mean=85.7, median=60). Reaction rates were similar across age groups. The most common reactions were malaise, headache, and abdominal pain. Reported severe events were tightness of the throat and seizure. All symptoms improved with temporary or complete IVIG interruption and symptomatic medications. Sixteen of 38 reactions to infusions occurred in the presence of an acute infection (p=0.09). Tegeline® represented a greater reaction risk factor than Octagam® (p<0.001). These results indicate that IVIG infusion can be considered a safe procedure. Low reaction incidence and few severe immediate infusion-related adverse reactions were observed. PMID:25257732

Bichuetti-Silva, Danielli C; Furlan, Fernanda P; Nobre, Fernanda A; Pereira, Camila T M; Gonçalves, Tessa R T; Gouveia-Pereira, Mariana; Rota, Rafael; Tavares, Lusinete; Mazzucchelli, Juliana T L; Costa-Carvalho, Beatriz T

2014-12-01

75

Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial  

Microsoft Academic Search

OBJECTIVE--To assess the frequency and type of side effects after influenza vaccination in elderly people. DESIGN--Randomised double blind placebo controlled study. SETTING--15 general practices in the southern Netherlands. SUBJECTS--1806 patients aged 60 or older, of whom 904 received influenza vaccine and 902 placebo. MAIN OUTCOME MEASURES--Adverse reactions reported on postal questionnaire completed four weeks after vaccination. RESULTS--210 (23%) patients given

T M Govaert; G J Dinant; K Aretz; N Masurel; M J Sprenger; J A Knottnerus

1993-01-01

76

Adverse reactions in the oral mucosa associated with anterior composite restorations.  

PubMed

This is a descriptive study of patients with symptomatic lichenoid-like reactions of the lips in contact with composite restorations (n = 12). Clinically, the lesions appeared as symptomatic single or multiple erythematous areas that included white papules. Candida was found by cultivation or histopathological examination in 7 of the lesions. Patch testing (n = 7) did not reveal any reactions to composite components, except for one patient who showed a delayed hypersensitivity reaction to formaldehyde. Replacement of existing dental materials parallel to antifungal treatment resulted in healing or significant improvement in 7 of 9 patients. This study shows that resin components can be associated with adverse reactions in the oral mucosa of the lips and that these reactions may be accompanied by an infection with Candida. PMID:8887075

Blomgren, J; Axéll, T; Sandahl, O; Jontell, M

1996-07-01

77

Case reports of suspected adverse drug reactions--systematic literature survey of follow-up  

Microsoft Academic Search

Objective To determine whether anecdotal reports of suspected adverse drug reactions are valuable early warning signals. Design Systematic literature survey Data sources We evaluated all case reports of adverse drug reactions published in 1997 in five medical journals. Reports were excluded if the adverse reaction had previously been described in earlier publications and was already listed in the product information

Yoon Kong Loke; Deirdre Price; Sheena Derry; Jeffrey K Aronson

2006-01-01

78

A CONTINUOUS GRASP TO DETERMINE THE RELATIONSHIP BETWEEN DRUGS AND ADVERSE REACTIONS  

E-print Network

A CONTINUOUS GRASP TO DETERMINE THE RELATIONSHIP BETWEEN DRUGS AND ADVERSE REACTIONS M. J. HIRSCH, C. N. MENESES, P. M. PARDALOS, M. A. RAGLE, AND M. G. C. RESENDE ABSTRACT. Adverse drug reactions drugs and adverse reac- tions that they cause. We formulate the drug-reaction relationship problem

Resende, Mauricio G. C.

79

Oral adverse reactions due to cinnamon-flavoured chewing gums consumption.  

PubMed

Cinnamon-flavoured products (toothpaste, chewing gum, food, candy and mouthwash) can cause oral adverse reactions; among these, the most common is contact stomatitis (cinnamon contact stomatitis, CCS). Signs and symptoms of contact allergic reactions affecting the oral mucosa can mimic other common oral disorders, making diagnosis difficult. As CCS may be more prevalent than believed and its clinical features can frequently determine misdiagnosis, we reviewed case reports and case series of oral adverse reactions due to cinnamon-containing chewing gums, emphasizing clinical aspects, diagnostic and management procedures. We also proposed an algorithm to perform a diagnosis of CCS as in the previous published literature the diagnostic approach was not based on a harmonized and shared evidence-based procedure. Moreover, as patients can refer to different specialists as dentists, dermatologists and allergists, a multidisciplinary approach is suggested. PMID:24004186

Calapai, G; Miroddi, M; Mannucci, C; Minciullo, Pl; Gangemi, S

2014-10-01

80

Nexavar®-related adverse reactions: Calabrian (Italy) experience for sorafenib exposition in 2012  

PubMed Central

Hepatocellular carcinoma (HCC) remains a major global health problem and Calabria in the south of Italy is not an exception. Sorafenib is the first and only Food and Drug Administration approved drug for the treatment of advanced HCC and it is currently under intensive monitoring by the Health Authorities in Italy Agenzia Italiana del Farmaco. This general report has been developed with the aim of briefly reviewing the data found in the reports of adverse reactions (ADRs) collected in Calabria in 2012 for sorafenib treated patients. Extrapolated data have highlighted some differences between the adverse drug reactions reported in patients younger or older than 70 years and other important differences with the current approved leaflet. Several limitations might be present in data analysis form spontaneous reporting, however, the relevance of reporting ADRs (dermatitis, asthenia, vomiting, etc.) for the early identification of drug related signals has to be underlined. PMID:24347990

Cilurzo, Felisa; Staltari, Orietta; Patanè, Marinella; Ammendola, Michele; Garaffo, Caterina; Di Paola, Eugenio Donato

2013-01-01

81

The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada  

Microsoft Academic Search

Background: Research into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We esti- mated the incidence of AEs among patients in Canadian acute care hospitals. Methods: We randomly selected 1 teaching, 1 large community and 2 small

G. Ross Baker; Peter G. Norton; Virginia Flintoft; Régis Blais; Adalsteinn Brown; Jafna Cox; Ed Etchells; William A. Ghali; Philip Hébert; Sumit R. Majumdar; Maeve O'Beirne; Luz Palacios-Derflingher; Robert J. Reid; Sam Sheps; Robyn Tamblyn

2004-01-01

82

Nurse-perceived Patient Adverse Events and Nursing Practice Environment  

PubMed Central

Objectives: To evaluate the occurrence of patient adverse events in Korean hospitals as perceived by nurses and examine the correlation between patient adverse events with the nurse practice environment at nurse and hospital level. Methods: In total, 3096 nurses working in 60 general inpatient hospital units were included. A two-level logistic regression analysis was performed. Results: At the hospital level, patient adverse events included patient falls (60.5%), nosocomial infections (51.7%), pressure sores (42.6%) and medication errors (33.3%). Among the hospital-level explanatory variables associated with the nursing practice environment, ‘physician- nurse relationship’ correlated with medication errors while ‘education for improving quality of care’ affected patient falls. Conclusions: The doctor-nurse relationship and access to education that can improve the quality of care at the hospital level may help decrease the occurrence of patient adverse events. PMID:25284199

Kang, Jeong-Hee; Kim, Chul-Woung; Lee, Sang-Yi

2014-01-01

83

Misuse of the Naranjo Adverse Drug Reaction Probability Scale in toxicology  

PubMed Central

Context When an adverse event occurs in an overdose patient, it may be difficult to determine whether the event was caused by the ingested drug or by medical therapy. Naranjo and colleagues developed a probability scale, the Naranjo Adverse Drug Reaction Probability Scale (Naranjo Scale), to assess the probability that a drug administered in therapeutic doses caused an adverse event thereby classifying the event as an adverse drug reaction (ADR). Although Naranjo et al. specifically excluded the application of this scale to adverse events in overdose patients, case reports demonstrate that authors continue to apply the Naranjo Scale to events in these patients. Objective The World Health Organization defines an ADR as occurring only when drugs are administered in therapeutic doses. Yet ADRs continue to be reported in overdose patients. We sought to examine the use of the Naranjo scale in case reports of overdose patients to assess the potential consequences of that application. Methods A Medline search via PubMed without language limits, through September 2012, using the search terms “Naranjo” and “overdose” or “poisoning” yielded 146 publications. Additional searches were performed to find articles with keywords of the Naranjo Scale development, current applications and validity of application in specific populations such as critically ill and overdose patients. Results From the 146 publications, we identified 17 case reports or series of overdose patients in which the Naranjo Scale was applied to a clinical complication to support a causal relationship between an administered drug and the clinical complication and thereby classify the clinical complication as an ADR. We also identified a recent publication in which the Naranjo Scale was applied to a new treatment modality (lipid emulsion) that is currently administered to overdose patients. Conclusion Adverse events that occur in overdose patients are excluded from the definition of ADR. Yet in case reports or series of overdose patients, the Naranjo Scale has been applied to assess the probability an event was caused by the ingested drug or therapeutic modality. This application of the Naranjo Scale is not scientifically valid and may lead to erroneous conclusions. There is no evidence to support the application of the Naranjo scale to any events that occur in overdose patients. PMID:23777343

Seger, Donna; BARKER, Kimberly; McNAUGHTON, Candace D.

2014-01-01

84

Late-onset inflammatory adverse reactions related to soft tissue filler injections.  

PubMed

An ever-increasing number of persons seek medical solutions to improve the appearance of their aging skin or for aesthetic and cosmetic indications in diverse pathological conditions, such as malformations, trauma, cancer, and orthopedic, urological, or ophthalmological conditions. Currently, physicians have many different types of dermal and subdermal fillers, such as non-permanent, permanent, reversible, or non-reversible materials. Despite the claims of manufacturers and different authors that fillers are non-toxic and non-immunogenic or that complications are very uncommon, unwanted side effects do occur with all compounds used. Implanted, injected, and blood-contact biomaterials trigger a wide variety of adverse reactions, including inflammation, thrombosis, and excessive fibrosis. Usually, these adverse reactions are associated with the accumulation of large numbers of mononuclear cells. The adverse reactions related to fillers comprise a broad range of manifestations, which may appear early or late and range from local to systemic. Clinicians should be aware of them since the patient often denies the antecedent of injection or is unaware of the material employed. Most of these adverse effects seem to have an immunological basis, the fillers acting more as adjuvants than as direct T-cell activators, on a background of genetic predisposition. Their treatment has not been the subject of well-designed studies; management of both acute and systemic reactions is often difficult, and requires anti-inflammatory and occasionally immunosuppressive therapy. The clinical, pathological, and therapeutic aspects of inflammatory and immune-mediated late-onset adverse reactions related to soft tissue filler injections are thoroughly reviewed herein. PMID:23361999

Alijotas-Reig, Jaume; Fernández-Figueras, Maria Teresa; Puig, Lluís

2013-08-01

85

[Adverse effects of local use of beta-blockaders in glaucoma. A literature review and a survey of reports to the adverse drug reaction authority 1986-95].  

PubMed

The review is based on a survey of studies on adverse reactions related to topical administration of beta-blockers for glaucoma. Locally applied beta-blocking agents are partially resorbed from the nasal mucosa. Concentrations which give rise to systemic effects occur invariably. Several reports exist of congestive heart failure, arrhythmias, severe respiratory symptoms, depression, hallucinations and confusion provoked by topical use of beta-blockers, especially timolol. It is impossible to estimate from the literature how often the various adverse effects occur. One has the impression, however, that adverse effects in the pulmonary and central nervous systems have not been fully considered. Between 1986 and 1995 the Norwegian Medicines Control Authority received reports on adverse reactions related to topical use of beta-blockers in 17 patients. Six of these patients had cardiovascular and four of them severe respiratory symptoms. The latter group also included three fatal cases. The adverse effects seem to occur most frequently in the elderly, and it has been suggested that timolol should not be used in elderly people. Adverse effects related to treatment with topical beta-blockers are probably underreported in Norway. PMID:9235677

Nygaard, H A; Høvding, G

1997-05-30

86

Adverse reactions to cosmetics and methods of testing.  

PubMed

Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and phototoxicity/photoirritation. The safety assessment of a cosmetic product clearly depends upon how it is used, since it determines the amount of substance which may be ingested, inhaled, or absorbed through the skin or mucous membranes. Concentration of ingredients used in the different products is also important. Various test procedures include in vivo animal models and in vitro models, such as open or closed patch test, in vivo skin irritation test, skin corrosivity potential tests (rat skin transcutaneous electrical resistance test, Episkin test), eye irritation tests (in vivo eye irritancy test and Draize eye irritancy test), mutagenicity/genotoxicity tests (in vitro bacterial reverse mutation test and in vitro mammalian cell chromosome aberration test), and phototoxicity/photoirritation test (3T3 neutral red uptake phototoxicity test). Finished cosmetic products are usually tested in small populations to confirm the skin and mucous membrane compatibility, and to assess their cosmetic acceptability. PMID:19172025

Nigam, P K

2009-01-01

87

Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events  

PubMed Central

Purpose: New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse event co-occurrences. Methods: We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value < 0.01) were identified and presented as well. Results: We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. Conclusions: We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences.

Roitmann, Eva; Eriksson, Robert; Brunak, S?ren

2014-01-01

88

Hepatic adverse drug reactions: a case\\/non-case study in Italy  

Microsoft Academic Search

Objective  Adverse drug reactions (ADRs) can involve all tissues and organs. Liver injuries are considered among the most serious and\\u000a are a cause for concern among physicians and patients. To assess the extent of drug-induced liver injuries in Italy we compared\\u000a the number of cases of hepatic ADRs with reports of all other drug-related reactions present in the same database.\\u000a \\u000a \\u000a \\u000a Methods  Spontaneous

Domenico Motola; Antonio Vargiu; Roberto Leone; Alfredo Cocci; Francesco Salvo; Barbara Ros; Ilaria Meneghelli; Mauro Venegoni; Paola Maria Cutroneo; Alberto Vaccheri; Gianpaolo Velo; Nicola Montanaro

2007-01-01

89

Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.  

PubMed

Disease-modifying antirheumatic drugs (DMARDs) and biological agents are critical in preventing the severe complications of rheumatoid arthritis (RA). However, the outcome of treatment with these drugs in RA patients is quite variable and unpredictable. Drug-metabolizing enzymes (dihydrofolate reductase, cytochrome P450enzymes, N-acetyltransferases, etc.), drug transporters (ATP-binding cassette transporters), and drug targets (tumor necrosis factor-? receptors) are coded for by variant alleles. These gene polymorphisms may influence the pharmacokinetics, pharmacodynamics, and side effects of medicines. The cause for differences in efficacy and adverse drug reactions may be genetic variation in drug metabolism among individuals. Polymorphisms in drug transporter genes may change the distribution and excretion of medicines, and the sensitivity of the targets to drugs is strongly influenced by genetic variations. In this article, we review the genetic polymorphisms that affect the efficacy of DMARDs or the occurrence of adverse drug reactions associated with DMARDs in RA. PMID:25144752

Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

2014-11-01

90

Postmarket Drug Surveillance Without Trial Costs: Discovery of Adverse Drug Reactions Through Large-Scale Analysis of Web Search Queries  

PubMed Central

Background Postmarket drug safety surveillance largely depends on spontaneous reports by patients and health care providers; hence, less common adverse drug reactions—especially those caused by long-term exposure, multidrug treatments, or those specific to special populations—often elude discovery. Objective Here we propose a low cost, fully automated method for continuous monitoring of adverse drug reactions in single drugs and in combinations thereof, and demonstrate the discovery of heretofore-unknown ones. Methods We used aggregated search data of large populations of Internet users to extract information related to drugs and adverse reactions to them, and correlated these data over time. We further extended our method to identify adverse reactions to combinations of drugs. Results We validated our method by showing high correlations of our findings with known adverse drug reactions (ADRs). However, although acute early-onset drug reactions are more likely to be reported to regulatory agencies, we show that less acute later-onset ones are better captured in Web search queries. Conclusions Our method is advantageous in identifying previously unknown adverse drug reactions. These ADRs should be considered as candidates for further scrutiny by medical regulatory authorities, for example, through phase 4 trials. PMID:23778053

Gabrilovich, Evgeniy

2013-01-01

91

Identification of risk factors for carbamazepine-induced serious mucocutaneous adverse reactions: A case-control study using data from spontaneous adverse drug reaction reports  

PubMed Central

Objectives: To identify risk factors other than genetic for severe carbamazepine-induced mucocutaneous reactions, that is, SJS, TEN, and exfoliative dermatitis (ED). Materials and Methods: We did a case-control study using data from the Swedish national database of spontaneously reported adverse drug reactions (ADRs). We selected all patients who had been reported from January 1, 1965 to March 31, 2010 as having experienced SJS (n = 78), TEN (n = 6), or ED (n = 8), and assessed as at least possibly related to carbamazepine. We also included diagnoses possibly representative of early signs of these serious conditions, that is, erythema multiforme (EM, n = 34) and scaly rash (n = 13). We compared data on demographics, drug treatment, and clinical features for these patients (cases, n = 139) with those from patients who had experienced any other type of ADR from carbamazepine during the same time period (controls, n = 887). Results: After adjustment for multiple comparisons, alcohol abuse was statistically significantly more common among cases than controls (34.5% vs 8.7%, odds ratio 5.5 [95% confidence interval 3.6-8.4], P = 3.14 × 10-14 ). The same was seen for SJS and EM individually. Conclusion: Alcohol abuse is a possible risk factor for serious carbamazepine-induced mucocutaneous reactions. PMID:24799813

Bertulyte, Ilma; Schwan, Sofie; Hallberg, Par

2014-01-01

92

Surveillance for fatal suspected adverse drug reactions in the UK  

PubMed Central

Aim: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. Results: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. Conclusions: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular. PMID:12456539

Clarkson, A; Choonara, I

2002-01-01

93

[Analyze causes of adverse reactions induced by traditional Chinese medicine injections from its quality standards].  

PubMed

Reviewing the literatures about adverse reactions induced by traditional Chinese medicine injections (TCMI) reported on CNKI from 1983 to 2013. Analyzing the causes of adverse reactions induced by TCMI from its quality standards. Provide ideas for improving security of TCMI and completing its quality standards. This review indicates that TCMI-induced adverse reactions have little relationship with the number of compositions, but have tight connection with chemical ingredients and solvents. Adverse reactions can be decreased by perfecting the quality standards of TCMI. PMID:25204194

Cui, Hong-Yu; Liang, Ai-Hu

2014-03-01

94

Medical adverse events in elderly hospitalized patients: A prospective study  

PubMed Central

OBJECTIVES: To determine the frequency of medical adverse events in elderly patients admitted to an acute care geriatric unit, the predictive factors of occurrence, and the correlation between adverse events and hospital mortality rates. METHODS: This prospective study included 171 admissions of patients aged 60 years and older in the acute care geriatric unit in a teaching hospital in Brazil between 2007 and 2008. The following variables were assessed at admission: the patient age, gender, number of prescription drugs, geriatric syndromes (e.g., immobility, postural instability, dementia, depression, delirium, and incontinence), comorbidities, functional status (evaluated with the Katz Index of Independence in Activities of Daily Living), and severity of illness (evaluated with the Simplified Acute Physiology Score II). The incidence of delirium, infection, mortality, and the prescription of potentially inappropriate medications (based on the Beers criteria) were assessed during hospitalization. An observer who was uninvolved in patient care reported the adverse events. RESULTS: The mean age of the sample was 78.12 years. A total of 187 medical adverse events occurred in 94 admissions (55%). The predictors of medical adverse events were undetermined. Compared with the patients with no adverse events, the patients with medical adverse events had a significantly longer hospital stay (21.41±15.08 days versus 10.91±7.21 days) and a higher mortality rate (39 deaths [41.5%] versus 17 deaths [22.1%]). Mortality was significantly predicted by the Simplified Acute Physiology Score II score (odds ratio [OR]?=?1.13, confidence interval [CI] 95%, 1.07 to 1.20), the Katz score (OR?=?1.47, CI 95%, 1.18 to 1.83), and medical adverse events (OR?=?3.59, CI 95%, 1.55 to 8.30). CONCLUSION: Medical adverse events should be monitored in every elderly hospitalized patient because there is no risk profile for susceptible patients, and the consequences of adverse events are serious, sometimes leading to longer hospital stays or even death. PMID:23184198

Szlejf, Claudia; Farfel, Jose Marcelo; Curiati, Jose Antonio; de Barros Couto Junior, Euro; Jacob-Filho, Wilson; Azevedo, Raymundo Soares

2012-01-01

95

Immunogenicity, efficacy and adverse events of adalimumab in RA patients  

Microsoft Academic Search

To assess the immunogenicity of adalimumab, a human anti-TNF-? mAb, we evaluated the formation of antibodies to adalimumab,\\u000a efficacy and adverse events among 15 patients with highly active rheumatoid arthritis. Four patients were treated with adalimumab\\u000a as monotherapy, and 11 patients with concomitant DMARDs. Disease activity was measured by DAS28. The antibodies were detected\\u000a by ELISA. Thirteen (87%) patients withdrew

Niko K. Bender; Christoph E. Heilig; Benjamin Dröll; Jessica Wohlgemuth; Franz-Paul Armbruster; Bernhard Heilig

2007-01-01

96

Adverse reactions to tick-borne encephalitis vaccine: FSME-Immun®  

Microsoft Academic Search

Summary  Vaccination against tick-borne encephalitis with FSME-Immun® vaccine was started in the Department of Infectious Diseases,\\u000a University Medical School of Bia?ystok, Poland, in 1992. No serious adverse reactions after vaccine administration were observed.\\u000a Post-vaccine side effects were reported in 242 (11.3%) persons after the first dose (n=2,135) and only in 14 patients (1.2%)\\u000a after the second one (n=1,183). These effects were

A. Grzeszczuk; E. Sokolewicz-Bobrowska; D. Prokopowicz

1998-01-01

97

Adverse reaction to sublingual Parietaria vaccine following an ultra-rush induction.  

PubMed

In the treatment of respiratory allergies Sublingual Immunotherapy (SLIT) represents a valid alternative to Subcutaneous Immunotherapy (SCIT) for its better safety profile. We describe a case of acute severe asthma following the first maintenance dose of SLIT in a boy allergic to Parietaria pollen. At the initiation of therapy, the patient was in healthy condition and his asthma appeared to be under control. An ultra-rush induction had given no reaction. Despite the good safety profile of SLIT, clinicians should be aware of the risk of adverse effects when prescribing SLIT for respiratory allergies. PMID:24853571

Scala, G; Ciccarelli, A; Calabrò, C

2014-05-01

98

Detect adverse drug reactions for drug Simvastatin Yihui Liu1,2  

E-print Network

Detect adverse drug reactions for drug Simvastatin Yihui Liu1,2 1 Institute of Intelligent Department of Computer Science, University of Nottingham, UK Abstract--Adverse drug reaction (ADR) is widely feature matrix and feature selection. The experiments are carried out on the drug Simvastatin. Major side

Aickelin, Uwe

99

Detect adverse drug reactions for drug Atorvastatin Yihui Liu1,2  

E-print Network

Detect adverse drug reactions for drug Atorvastatin Yihui Liu1,2 1 Institute of Intelligent Department of Computer Science, University of Nottingham, UK Abstract--Adverse drug reaction (ADR) is widely feature matrix and feature selection. The experiments are carried out on the drug Atorvastatin. Major side

Aickelin, Uwe

100

Detect adverse drug reactions for drug Pioglitazone Yihui Liu1,2  

E-print Network

Detect adverse drug reactions for drug Pioglitazone Yihui Liu1,2 1 Institute of Intelligent Department of Computer Science, University of Nottingham, UK Abstract--Adverse drug reaction (ADR) is widely feature matrix and feature selection. The experiments are carried out on the drug Pioglitazone. Major side

Aickelin, Uwe

101

Detect adverse drug reactions for drug Alendronate Yihui Liu1,2  

E-print Network

Detect adverse drug reactions for drug Alendronate Yihui Liu1,2 1 Institute of Intelligent Department of Computer Science, University of Nottingham, UK Abstract--Adverse drug reaction (ADR) is widely feature matrix and feature selection. The experiments are carried out on the drug Alendronate. Major side

Aickelin, Uwe

102

Adverse Reaction to Nicotine Gum in Malay Female Smoker: A Case Report  

ERIC Educational Resources Information Center

Nicotine replacement therapies (NRT) are prescribed in smoking cessation programmes to help smokers stop smoking. The ideal dosage of NRT should control cravings and withdrawal symptoms but avoid adverse reactions. This report describes a case of adverse reaction to nicotine gum in a female Malay smoker. Assays taken 2 h after the gum, showed that…

Noorzurani, Md Haris Robson; Bond, Alyson; Wolff, Kim

2008-01-01

103

Fatal neuropsychiatric adverse reactions to oseltamivir: Case series and overview of causal relationships  

Microsoft Academic Search

Background: Infection-associated encephalopathies such as Reye's syndrome have been one of the major public health problems in many countries. The not dissimilar neuropsychiatric adverse reactions, including deaths, observed with Tamiflu (oseltamivir phosphate: OP) have been another current problem especially in Japan. Methods: Among the cases with neuropsychiatric adverse reactions to Tamiflu on which I was consulted, those cases in which

Rokuro Hama

104

Pharmacogenomics of severe cutaneous adverse reactions and drug-induced liver injury.  

PubMed

Rare but severe adverse drug reactions (ADRs) are an important issue in drug development and in the proper usage of drugs during the post-approval phase. The ability to predict patient susceptibility to severe ADRs would prevent drug administration to high-risk patients. This would save lives and ensure the quality of life for these patients, but occurrence of idiosyncratic severe ADRs had been very difficult to predict for a long time. However, in this decade, genetic markers have been found for several ADRs, especially for severe cutaneous adverse reactions (SCARs) and drug-induced liver injury (DILI). In this review, we summarize recent progress in identifying genetic markers for SCARS and DILI, and discuss issues that remain unresolved. As for SCARs, associations of HLA-B*15:02 or HLA-A*31:01 and HLA-B*58:01 have been revealed for carbamazepine- and allopurinol-related Stevens-Johnson syndrome and toxic epidermal neclolysis, respectively. HLA-B*57:01 is strongly associated with abacavir-induced hypersensitivity syndrome. Several HLA alleles also demonstrate drug-specific associations with DILI, such as HLA-A*33:03 for ticlopidine, HLA-B*57:01 for flucloxacillin and HLA-DQA1*02:01 for lapatinib. Efforts should be continued to find other genetic markers to achieve high predictability for ADRs, with the goal being development of genetic tests for use in clinical settings. PMID:23635947

Kaniwa, Nahoko; Saito, Yoshiro

2013-06-01

105

A Pharmaceutical Intelligent Information System to detect allergies and Adverse Drugs Reactions based on internet of things  

Microsoft Academic Search

The incidence of serious and fatal Adverse Drugs Reaction (ADR) and harmful effects of pharmaceutical excipients in worldwide hospitals is extremely high. Some studies show a rate of ADR appearance about 6.5% in worldwide hospitals. The consequences of these cases lead to a rate of 80% of ADR incidences that require the patient admission, a medium bed stay of eight

Antonio J. Jara; Francisco J. Belchi; Alberto F. Alcolea; Jose Santa; Miguel A. Zamora-Izquierdo; Antonio Fernando Gómez-Skarmeta

2010-01-01

106

Pharmacogenetics of risperidone therapy in autism: association analysis of eight candidate genes with drug efficacy and adverse drug reactions  

Microsoft Academic Search

Little has been reported on the factors, genetic or other, that underlie the variability in individual response, particularly for autism. In this study we simultaneously explored the effects of multiple candidate genes on clinical improvement and occurrence of adverse drug reactions, in 45 autistic patients who received monotherapy with risperidone up to 1 year. Candidate genes involved in the pharmacokinetics

C T Correia; J P Almeida; P E Santos; A F Sequeira; C E Marques; T S Miguel; R L Abreu; G G Oliveira; A M Vicente

2010-01-01

107

Single-Dose Oral Tolerance Test with Alternative Compounds for the Management of Adverse Reactions to Drugs  

Microsoft Academic Search

Background: Adverse reactions to drugs are common in the clinical practice. Many outpatients are frequently referred to allergists in order to determine which drugs they can safely take in the future. Objective: We set up an oral single-dose tolerance test procedure to find out for each patient one or more alternative drugs that can be taken when needed. Methods: 452

Giovanni Passalacqua; Manlio Milanese; Marcello Mincarini; Giorgio Ciprandi; Laura Guerra; Antonio Scordamaglia; Giorgio Walter Canonica

2002-01-01

108

Adverse Drug Events in Cognitively Impaired Elderly Patients  

Microsoft Academic Search

Background\\/Aims: Adverse drug events (ADEs) are a frequent problem encountered in the elderly. The aim of this study was to elucidate the factors that influence ADEs in an elderly population with cognitive impairment. Methods: 242 patients were recruited from dementia clinics and assessed after 6 months for ADEs. The use of natural health products (NHPs) was also documented. Results: Backward

Hooman Ganjavi; Nathan Herrmann; Paula A. Rochon; Papita Sharma; Monica Lee; Daniel Cassel; Morris Freedman; Sandra E. Black; Krista L. Lanctôt

2007-01-01

109

Cutaneous adverse drug reaction type erythema multiforme major induced by eslicarbazepine  

PubMed Central

Severe skin reactions occur less frequently with eslicarbazepine (ESL) than with the other aromatic anticonvulsants. We report the first case of cutaneous adverse drug reaction (CADR) to ESL and co-sensitization between ESL and betalactams. A 41-year-old white woman developed focal epilepsy due to a meningioma that was removed. As post-operatory complication, she suffered meningitis as well as a maculo-papular erythema caused by the treatment with meropenem. Subsequently, ESL was started and gradually increased until 800 mg/day. Twenty-five days later, the patient developed an Erythema Multiforme Major (EMM). Strong positive immediate reaction was induced by prick test with carbamazepine (CBZ) and ESL at 0.01 and 0.1% within 15 and 30 minutes; however the delayed reading at 48 hours was negative. The patient was not carrier of the HLA alleles A3101 and B1502 associated with CBZ induced EMM. The hypersensitivity pathogenic mechanism of EMM is unclear and a delayed hypersensitivity process is speculated. However, the patch and intradermal tests in our patient did not show a delayed reaction but an immediate cutaneous one. A first allergic episode may elicit a massive nonspecific activation of the immune system, providing an enhanced expression of co-stimulatory molecules that decreases the level of tolerance to other drugs. When prescribing ESL, we suggest ruling out previous CADR, especially to CBZ and oxcarbazepine but also other chemically unrelated drugs such as beta-lactams.

Massot, Andreu; Gimenez-Arnau, Ana

2014-01-01

110

Implementing a pharmacovigilance program to evaluate cutaneous adverse drug reactions in an antiretroviral access program  

PubMed Central

Background Cutaneous adverse drug reactions (cADRs) can cause significant morbidity and distress in patients especially in the HIV infected population on antiretroviral therapy. Adverse Drug Reaction monitoring and ascertaining causality in resource limited settings still remains a challenge. This study was carried out to evaluate causality and measure incidence of cADRs in HIV infected patients on highly active antiretroviral therapy. The study was also designed to test a 3-step approach in the monitoring and evaluation of ADRs in resource limited settings. Methodology A retrospective patient medical records review was carried out at the Parirenyatwa Family Care Centre, (Harare, Zimbabwe). Cases of cADRs were reported to the Medicines Control Authority of Zimbabwe (Drug regulating body in Zimbabwe) for assessment and causality classification. Results Two hundred and twenty-one patient records were randomly selected and reviewed to determine if any diagnosis of cADRs was made by clinicians. Causality assessment revealed 13.1% of cADRs which were due to an offending agent in the antiretroviral therapy against an initial incidence of 17.6% which had been determined by the physicians. Conclusions cADRs had an incidence of 13.1% within the population under study due to non nucleoside reverse transcriptase inhibitors (NNRTIs). Most reactions were due to the NNRTIs which contributed 72.4 % of all cADRs. A panel of experts from the drug regulatory authority can be used as an implementation based mechanism in ascertaining causality objectively in settings where resources are constrained. PMID:23277506

Mudzviti, Tinashe; Sibanda, Marvelous; Gavi, Samuel; Maponga, Charles Chiedza; Morse, Gene D.

2012-01-01

111

Evaluation of the adverse reactions of antiretroviral drug regimens in a tertiary care hospital  

PubMed Central

Objectives: Antiretroviral toxicity is an increasingly important issue in the management of HIV-infected patients. The objective of our study was to evaluate the toxicity profile of currently used antiretroviral regimens and to compare these toxicities among males and females. Materials and Methods: A retrospective analysis with a one year follow-up was done at a tertiary care hospital by reviewing the record. Patients who were >18 years of age attending the hospital and were initiated an antiretroviral drug regimen were included in the analysis. Data regarding demographic details, medical history, details of human immunodeficiency virus (HIV) infection including most recent CD4 count, details of antiretroviral therapy (ART) collected from patient's records. Adverse drug reactions were recorded by reviewing patient records. Result: A total of 99 patients were included in study. Among them, 71 (71.7%) were males and 28(28.3%) were females. Common adverse effects observed included anemia (58.6%), pruritus(23.2%), skin rash(18.2%), hypertriglyceridemia(15.2%), and hepatitis (60.6%), peripheral neuropathy (14.1%). Prevalence of skin rash was more in females than males, the difference being statistically significant. Pruritus was also commonly seen in females than males though the difference observed in our study is statistically insignificant. Hypertriglyceridemia was more in males compared to females, the difference is statistically significant. Conclusion: The most common adverse effects associated with currently used ART regimens are anemia, hepatic toxicity, itching, skin rash, elevated triglycerides, and peripheral neuropathy. Gender differences were seen mainly with skin rash, which was significantly more in females. PMID:23716890

Rather, Zahoor A.; Chowta, Mukta N.; Raju, G. J. K. Prakash; Mubeen, Faheem

2013-01-01

112

The role of the clinical pharmacologist in the management of adverse drug reactions.  

PubMed

The classical definition of clinical pharmacology is the study or the knowledge of the effects of drugs in humans. The activities of a clinical pharmacologist can vary from country to country, usually ranging from involvement in clinical trials, especially fundamental pharmacodynamic studies, to studies of pharmacokinetics and drug metabolism, to pharmacogenetics. Most clinical pharmacologists outside industry are in hospitals or university hospitals and research centres. In addition to research, this implies teaching of clinical pharmacology, and interacting with other medical staff: in the field of research, giving advice on clinical trials methodology and often managing a therapeutic drug monitoring centre. Some clinical pharmacologists have clinical departments with beds or consulting offices. Can there be another role for the clinical pharmacologist that would increase his or her usefulness for the medical community? Adverse drug reactions (ADRs) are remarkably complex events, related to drug effects, patient characteristics (background diseases, genetics), and drug/disease interactions. Evaluation of ADRs requires understanding of drug mechanisms and interactions, and of disease diagnostics, especially in the discussion of alternative diagnoses. This implies expertise as a pharmacologist and a clinician. In addition, because not all adverse reactions or interactions are in the Summary of Product Characteristics, and because problems arise long before they report in the literature, it is necessary for the clinical pharmacologist to have knowledge of ongoing regulatory processes, in addition to having access to the published literature. Helping clinicians cope with individual patient problems will also improve the clinical pharmacologist's integration into the healthcare process. PMID:11219484

Moore, N

2001-01-01

113

Extrapyramidal adverse drug reactions associated with trimetazidine: a series of 21 cases.  

PubMed

Over the last few years, a number of cases of extrapyramidal disorders associated with trimetazidine (TMZ) use has been reported. Here, we report on a series of 21 cases. All but one of the patients (mean age 74) had been taking TMZ for several years. The indication for prescription of TMZ could not be identified in seven cases. The TMZ-associated adverse drug reactions were typical parkinsonism (akinesia and/or rigidity and/or rest tremor) in 17 cases, gait disorders in three cases (one with orthostatic tremor), and restless leg syndrome in one case. Discontinuation of TMZ led to complete disappearance of the symptoms in 16 cases and a significant reduction in the five other patients. TMZ has the same piperazine core as the dopamine antagonists flunarizine and cinnarizine (both of which have been reported to induce extrapyramidal symptoms). Hence, striatal D2 receptor blockade could result in the onset or the worsening of extrapyramidal disorders. Even though this adverse drug reaction is now listed in TMZ's Summary of Product Characteristics (because of the initial reports), the risk remains poorly known by clinicians. There is a need to raise awareness of this phenomenon and to reassess TMZ 's risk-benefit ration, especially in the elderly. PMID:22044594

Masmoudi, Kamel; Masson, Henri; Gras, Valérie; Andréjak, Michel

2012-04-01

114

Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?  

PubMed

In an effort to prevent potentially fatal adverse reactions to carbamazepine, the US Food and Drug Administration (FDA) issued an alert in 2007 containing pharmacogenomic information, which is still in effect today. The alert states that carbamazepine-induced skin reactions are significantly more common in patients with the human leukocyte antigen (HLA)-B*1502 allele and that these people are almost exclusively from 'broad areas of Asia, including South Asian Indians.' This study reviews the medical evidence relied upon by the FDA and finds that the alert does not accurately reflect the medical evidence relied upon in 2007 or evidence that has been generated over the last 5 years since the label was created. The FDA drug labeling should be modified to reflect current medical evidence. PMID:24752310

Payne, P W

2014-10-01

115

IVIG Adverse Reactions: Potential Role of Cytokines and Vasoactive Substances  

Microsoft Academic Search

Background and Objectives: A clinical study was conducted to determine the effect of IVIG infusion rates on adverse experiences (AE) and on serum levels of cytokines and vasoactive substances. Materials and Methods: Forty-two healthy volunteers were randomized into 3 groups with maximum IVIG infusion rates of 0.04, 0.06, and 0.08 ml/kg/min, and a final dose of 0.5 g IgG/kg body

A. Bagdasarian; S. Tonetta; W. Harel; R. Mamidi; Y. Uemura

1998-01-01

116

Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study  

PubMed Central

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3 n = 191, 90.5%, CTCAE grade 4/5 n = 20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2). Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms. PMID:22315630

Susskind, M.; Thurmann, P. A.; Luke, C.; Jeschke, E.; Tabali, M.; Matthes, H.; Ostermann, T.

2012-01-01

117

Research Article Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study  

E-print Network

Copyright © 2012 M. Süsskind et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3 n = 191, 90.5%, CTCAE grade 4/5 n = 20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1 % females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8 % of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2). Conclusion.

H. Matthes; T. Ostermann

118

Development and Validation of a Risk Model for Predicting Adverse Drug Reactions in Older People during Hospital Stay: Brighton Adverse Drug Reactions Risk (BADRI) Model  

PubMed Central

Background Older patients are at an increased risk of developing adverse drug reactions (ADR). Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR during hospital stay would enable healthcare staff to put measures in place to reduce the risk of such an event developing. The current study aimed to (1) develop and (2) validate an ADR risk prediction model. Methods We used a combination of univariate analysis and multivariate binary logistic regression to identify clinical risk factors for developing an ADR in a population of older people from a UK teaching hospital. The final ADR risk model was then validated in a European population (European dataset). Results Six-hundred-ninety patients (median age 85 years) were enrolled in the development stage of the study. Ninety-five reports of ADR were confirmed by independent review in these patients. Five clinical variables were identified through multivariate analysis and included in our final model; each variable was attributed a score of 1. Internal validation produced an AUROC of 0.74, a sensitivity of 80%, and specificity of 55%. During the external validation stage the AUROC was 0.73, with sensitivity and specificity values of 84% and 43% respectively. Conclusions We have developed and successfully validated a simple model to use ADR risk score in a population of patients with a median age of 85, i.e. the oldest old. The model is based on 5 clinical variables (?8 drugs, hyperlipidaemia, raised white cell count, use of anti-diabetic agents, length of stay ?12 days), some of which have not been previously reported. PMID:25356898

Tangiisuran, Balamurugan; Scutt, Greg; Stevenson, Jennifer; Wright, Juliet; Onder, G.; Petrovic, M.; van der Cammen, T. J.; Rajkumar, Chakravarthi; Davies, Graham

2014-01-01

119

A SNPshot of PubMed to associate genetic variants with drugs, diseases, and adverse reactions  

E-print Network

A SNPshot of PubMed to associate genetic variants with drugs, diseases, and adverse reactions Jörg, drug efficacy, and drug responses between individuals and sub-populations. Wrong dosages of drugs can lead to severe adverse drug reac- tions in individuals whose drug metabolism drastically differs from

Baral, Chitta

120

Automatic Detection Of Vaccine Adverse Reactions By Incorporating Historical Medical Conditions  

E-print Network

Automatic Detection Of Vaccine Adverse Reactions By Incorporating Historical Medical Conditions This paper extends the state of art by bringing the historical medical conditions into the vaccine adverse with certain vaccines. We propose a novel measure called dual-lift for this task. It is shown that the dual

Karypis, George

121

How to Discuss Errors and Adverse Events with Cancer Patients  

Microsoft Academic Search

Medical error has been increasingly recognized as a source of harm. The risk of harm can be even greater in cancer care with\\u000a its potentially life-limiting disease and toxic treatments. When errors and adverse events occur, patients have a right to\\u000a be informed and consistently report a desire to know about events in their care. Disclosure of errors is difficult

Iain E. Yardley; Sarah J. Yardley; Albert W. Wu

2010-01-01

122

Adverse drug reactions causing hospital admissions in childhood: a prospective, observational, single-centre study.  

PubMed

Adverse drug reactions (ADRs) are common problems in both paediatric and adult medicine. The aim of this study was to prospectively identify the ADRs causing hospital admission of children and identification of the risk factors and involved drugs. The study was performed at the University Hospital in Olomouc, Czech Republic. All patients aged 19 years or under admitted to hospital were included in the study, and all admissions for ADRs were prospectively screened for a period of 9 months. Suspected ADRs were subsequently evaluated in detail, and causality assessment was undertaken to determine whether each suspected reaction was possible, probable or definite. The assessment of ADR causality was performed using the Naranjo algorithm, the Liverpool ADR Causality Assessment Tool and the Edwards and Aronson causality assessment method. During the study period, 2903 admissions were identified; of these, there were 143 admissions of patients with an oncological disease. Sixty-four admissions (2.2%) were caused by an ADR. Anticancer chemotherapy accounted for 35% of the cases, followed by antibiotics (18%), immunosuppressants and vaccines (9% each). The use of different scoring systems does not lead to the differences in the numbers of ADR-diagnosed patient but may result in differences in the determination of the level of certainty. ADRs cause a substantial proportion of children's hospital admissions. The majority of the ADR-diagnosed patient affected the hematopoietic and gastrointestinal systems; the drugs most frequently involved were cytotoxic agents and antibiotics. The most important risk factors identified were female sex and oncological disease. PMID:24810357

Langerová, Petra; Vrtal, Ji?í; Urbánek, Karel

2014-12-01

123

Cutaneous adverse drug reactions during chemotherapy: consider non-antineoplastic drugs.  

PubMed

Cutaneous adverse drug reactions (CADR) during chemotherapy are not rare, but difficult to manage. Case 1, a 49-year-old man was treated with 5-fluorouracil, irinotecan, and oxaliplatin for a pancreatic tumour. He developed a generalized urticaria during his seventh course of chemotherapy. 2 months later, skin tests determined a granisetron allergy with an ondansetron cross-reaction. Substituting the anti-emetic allowed continuation of the chemotherapy. Case 2, a 44-year-old woman, having recurring breast cancer that was treated with doxorubicin, and docetaxel developed a maculo-papular rash (MPR) the day after the first chemotherapy treatment. 2 weeks later, skin tests determined a corticosteroid class A allergy. Using a class C corticosteroid, no other reaction occurred. Case 3, a 44-year-old woman, having breast cancer treated with 5-fluorouracil, cyclophosphamide, and epirubicin developed an MPR after the second chemotherapy treatment. 12 days later, skin tests showed a granisetron allergy. Using alizapride, chemotherapy was continued with no further reaction. CADR necessitate a thorough investigation, modified according to the patient's chemotherapy treatment chronology and precautions while testing the molecules. Tests are rarely carried out, however, these tests allow for continuation of effective chemotherapy once the responsible agent has been determined. The 3 cases reported underline the role of complementary treatment and the necessity to test those molecules. PMID:18503688

Bursztejn, A C; Tréchot, Ph; Cuny, J F; Schmutz, J L; Barbaud, A

2008-06-01

124

Natural Inhibitors of Cholinesterases: Implications for Adverse Drug Reactions  

PubMed Central

Purpose Acetylcholinesterase and butyrylcholinesterase are two closely related enzymes important in the metabolism of acetylcholine and anaesthetic drugs, including succinylcholine, mivacurium, and cocaine. The solanaceous glycoalkaloids (SGAs) are naturally occurring steroids in potatoes and related plants that inhibit both acetylcholinesterase and butyrylcholinesterase. There are many clinical examples of direct SGA toxicity due to cholinesterase inhibition. The aim of this study was to review the hypotheses that (1) SGAs may be the evolutionary driving force for atypical butyrylcholinesterase alleles and that (2) SGAs may adversely influence the actions of anaesthetic drugs that metabolized by acetylcholinesterase and butyrylcholinesterase. Source The information was obtained by Medline search and consultation with experts in the study of SGAs and cholinesterases. Principal findings The SGAs inhibit both acetylcholinesterase and butyrylcholinesterase in numerous in vitro and in vivo experiments. Although accurate assays of SGA levels are difficult, published data indicate human serum SGA concentrations at least ten-fold lower than required to inhibit acetylcholinesterase and butyrylcholinesterase in vitro. However, we review evidence that suggests the dietary ingestion of SGAs can initiate a cholinergic syndrome in humans. This syndrome occurs at SGA levels lower than those which interfere with anaesthetic drug catabolism. The world distribution of solanaceous plants parallels the distribution of atypical alleles of butyrylcholinesterase and may explain the genetic diversity of the butyrylcholinesterase gene. Conclusion Correlative evidence suggests that dietary SGAs may be the driving force for atypical butyrylcholinesterase alleles. In addition, SGAs may influence the metabolism of anaesthetic drugs and this hypothesis warrants experimental investigation. PMID:9161749

Krasowski, Matthew D.; McGehee, Daniel S.

2010-01-01

125

Days lost due to disability of diclofenac-induced adverse drug reactions  

PubMed Central

Disability Adjusted Life Years (DALY) is a widely used measure to quantify the burden of diseases or illness. DALYs for a disease is calculated as the sum of the Years of Life Lost (YLL) due to premature mortality in the population and the equivalent healthy Years Lost due to Disability (YLD). The only difference from the YLD and Days Lost due to Disability (DLD) calculation is that instead of considering the duration of Adverse Drug Reaction (ADR) in years, it is calculated in days. Objective DLD was measured for diclofenac tablets to prepare the ADR profile. Methods The study was done on the patients (18-65 years old) attending the community pharmacy at Kasaragod district, South India, with prescription of diclofenac tablets. Patients reported ADRs on their next visit to the pharmacy or they had called to the provided phone number and reported it. Disability Weight (DW) was calculated in an analogue scale from 0-1. Zero represent complete health and 1 represent death or equivalent condition. DW was multiplied with occurrence and duration of ADRs in days. Results About 943 patients received diclofenac tablets in 1000 prescriptions were successfully followed up for possible, probable and definite ADRs. A total of 561 reactions reported in 2010 for diclofenac tablet in the study population. There were 34 different types of ADRs under 12 physiological systems/organs. Most common reactions were on gastrointestinal (GI) system (48%), followed by skin (14%), Central Nervous System (10%), renal (7%), and cardiovascular (7%). Abdominal pain, cramps or flatulence was the highest occurring GI ADR (107), followed by 43 rashes, 42 nausea/vomiting, 37 indigestion, 34 peptic ulcers, 31 edema etc. DLD for peptic ulcer was considerably high (0.078) per 1000 of the study population on diclofenac. The most damaging ADR were peptic ulcer with or without perforation, followed by rash 0.036 DLD and edema 0.027 DLD. There was considerable DLD by acute renal failure (0.012) Steven-Johnson syndrome (0.013) even though few cases were reported. Conclusions Diclofenac has a complex adverse drug profile. Around 34 types of reactions were reported. Diclofenac was widely prescribed because of the experiential belief of comparative safety with other NSAIDs. The study shows the importance of pharmacovigilance even on the most prescribed medicine. Most disabling ADR for the study population was peptic ulcer with or without perforation. YLD or DLD are useful measures of calculating disability caused by ADRs. Future studies could focus on improving the usefulness & precision of DLD. PMID:24155815

Thomas, Dixon; Mathew, Molly; Raghavan, C. Vijaya; Mohanta, Guru P.; Reddy, Y. Padmanabha

126

Data Visualization Speeds Review of Potential Adverse Drug Events in Patients on Multiple Medications  

PubMed Central

Patients on multiple medications are at increased risk for adverse drug events. While physicians can reduce this risk by regularly reviewing the side-effect profiles of their patients’ medications, this process can be time-consuming. We created a decision support system designed to expedite reviewing potential adverse reactions through information visualization. The system includes a database containing 16,340 unique drug and side-effect pairs, representing 250 common medications. A numeric score is assigned to each pair reflecting the strength of association between drug and effect. Based on these scores, the system generates graphical adverse reaction maps for any user-selected combination of drugs. A study comparing speed and accuracy of retrieving side-effect data using this tool versus UpToDate® demonstrated a 60% reduction in time to complete a query (61 seconds vs. 155 seconds, p<0.0001) with no decrease in accuracy. These findings suggest that information visualization can significantly expedite review of potential adverse drug events. PMID:19995616

Duke, Jon D.; Li, Xiaochun; Grannis, Shaun J.

2010-01-01

127

Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms  

Microsoft Academic Search

Suspected adverse drug reactions first reported in 1963 in the “British Medical Journal,” the “Lancet,” the “Journal of the American Medical Association,” and the “New England Journal of Medicine” were reviewed 18 years later to assess their initial validity and subsequent verification. Of 52 first reports, five were deliberate investigations into potential or predictable reactions, and in each case causality

G R Venning

1982-01-01

128

Evaluation of Adverse Drug Reactions to Artemisinin- based Combination Therapy in a Nigeria University Community  

Microsoft Academic Search

Purpose: The study was carried out to evaluate the incidence of adverse reactions to antimalarial drugs among residents of a Nigeria university community with a focus on artemisinin-based combination therapy (ACT). Specifically, the profile of use, and the reporting culture of people with respect to experienced reactions were noted. Method: Questionnaires were administered to respondents at the university health centre

R Adisa; D Dike

129

Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil  

PubMed Central

Background Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service. Methods A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed. Results The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had moderate severity (58.9%), thus requiring intervention. Type A reactions were the most common (82.1%). At least one predisposing factor was present in 79.9% of the reports examined, and the most common predisposing factor was polypharmacy. Conclusions The results obtained will contribute to the development of strategies for the pharmacovigilance service at HGP and other hospitals throughout the country, which will improve the quality of ADR reporting and ensure safer drug use in Brazilian hospitals. PMID:23298396

2013-01-01

130

Patient-reported missed nursing care correlated with adverse events.  

PubMed

The aim of this study was to determine the extent and type of missed nursing care as reported by patients and the association with patient-reported adverse outcomes. A total of 729 inpatients on 20 units in 2 acute care hospitals were surveyed. The MISSCARE Survey-Patient was used to collect patient reports of missed care. Patients reported more missed nursing care in the domain of basic care (2.29 ± 1.06) than in communication (1.69 ± 0.71) and in time to respond (1.52 ± 0.64). The 5 most frequently reported elements of missed nursing care were the following: (a) mouth care (50.3%), (b) ambulation (41.3%), (c) getting out of bed into a chair (38.8%), (d) providing information about tests/procedures (27%), and (e) bathing (26.4%). Patients who reported skin breakdown/pressure ulcers, medication errors, new infections, IVs running dry, IVs infiltrating, and other problems during the current hospitalization reported significantly more overall missed nursing care. PMID:24006031

Kalisch, Beatrice J; Xie, Boqin; Dabney, Beverly Waller

2014-01-01

131

Adverse drug reactions in utero: perspectives on teratogens and strategies for the future.  

PubMed

Many think of an adverse drug reaction (ADR) as an adverse event caused by a medication intended for a given subject. However, as we learned from the thalidomide debacle 50 years ago, some of the most devastating ADRs affect not the subject who takes the medication but rather, in the case of pregnancy exposures, an innocent bystander--the fetus--and the ADRs include birth defects. PMID:21593753

Mitchell, A A

2011-06-01

132

Adverse effects of oral corticosteroids in relation to dose in patients with lung disease  

Microsoft Academic Search

BACKGROUNDThe adverse effects of oral corticosteroids are widely recognised but there are few quantitative data on which to base advice to patients. In a two part cross sectional study we compared adverse effects in patients with lung disease taking oral corticosteroids and control subjects and related the adverse effects to corticosteroid dose in the patient group.METHODSData on oral corticosteroid use,

L J Walsh; C A Wong; J Oborne; S Cooper; S A Lewis; M Pringle; R Hubbard; A E Tattersfield

2001-01-01

133

Adverse reactions following mass drug administration during the Programme to Eliminate Lymphatic Filariasis in Orissa State, India.  

PubMed

The frequency and severity of adverse reactions are the main reasons for low compliance of mass drug administration (MDA) under the Programme to Eliminate Lymphatic Filariasis (PELF). This paper reports the frequency and types of adverse reactions during two MDAs during January 2002 and September 2004 in the State of Orissa, India. Of the people who consumed the drugs, 15.5% in the 2002 MDA and 16.5% in the 2004 MDA reported one or more adverse reactions. This rate is higher (49.7%) in a group of individuals who were monitored for 6 days from the day of consumption of drugs during the 2002 MDA. However, many of these reactions were mild. No significant difference was found in the frequency of adverse reactions between MDA with diethylcarbamazine (DEC) alone and with DEC and albendazole. Significant gender differences were found in the 2004 MDA but no such differences were found in the 2002 MDA; however, the frequency of adverse reactions increased with age. Of all the adverse reactions, systemic adverse reactions typically associated with microfilarial death were more frequent. The frequency of adverse reactions was higher in microfilaraemics compared with amicrofilaraemic controls. The present study warrants developing an active adverse reaction surveillance system to minimise the impact of adverse reactions on MDA compliance. PMID:16288792

Babu, B V; Rath, K; Kerketta, A S; Swain, B K; Mishra, S; Kar, S K

2006-05-01

134

Alert systems for post-marketing surveillance of adverse drug reactions.  

PubMed

When monitoring spontaneous reports of adverse reactions to registered drugs, it is important to detect any change in the number of reported adverse reactions in the course of time. Sales adjusted adverse drug reaction rates are usually compared in order to be able to take drug exposure into account. Here we review the so-called arithmetic and some statistical procedures which could form the basis for an alert system. The advantages and disadvantages of each of these methods are discussed. The importance of data requirements and the problems which arise when using an alert system are pointed out and then clarified with the help of the example of diphtheria/tetanus vaccine. PMID:8134741

Praus, M; Schindel, F; Fescharek, R; Schwarz, S

1993-12-30

135

Influence of Adverse Drug Reactions on Treatment Success: Prospective Cohort Analysis of HIV-Infected Individuals Initiating First-Line Antiretroviral Therapy in India  

PubMed Central

Introduction Adverse drug reactions related to antiretroviral therapy (ART) remain a challenge in resource-limited settings, often causing significant morbidity and impaired adherence leading to treatment failure. This 2-year prospective study aimed to describe patterns and predictors of adverse reactions to first-line ART and assess the impact of these events on treatment success. Methods Between 2010–2013, 321 ART-naïve eligible adults were enrolled at two clinics in southern India. ART regimens included zidovudine or stavudine plus lamivudine, plus nevirapine or efavirenz. Pill count adherence, immunological and virological monitoring, and laboratory-based adverse drug reactions were measured prospectively and analyzed. Results Among 321 patients in the study, 289 (90.0%) patients experienced at least 1 adverse reaction, and 85 (26.5%) experienced at least 1 severe reaction. The incidence rate was 52 and 15 per 100 person-years for all reactions and severe reactions respectively. The cumulative incidence of zidovudine-induced anemia was 37.1% over 2 years. At 12 and 24 months, the proportion of patients with optimal adherence, undetectable viral load and CD4 counts >350 cells/mm3 were similar between patients who experienced or did not experience severe adverse drug reactions. Conclusions Our results highlight the high frequency of ART-related adverse drug reactions among individuals initiating first-line ART in India, underscoring the importance of detailed counseling and monitoring for maintaining ART durability. Severe drug-induced anemia needs to be addressed urgently with alternative first-line agents, and close laboratory surveillance. High treatment efficacy despite decreased drug safety seen here may be because patients have limited treatment options. Our results support the use of currently recommended safer first-line ART regimens that minimize the risk of severe life-threatening toxicities and provide for a better quality of life. Trial registration ISRTCN Registry: ISRCTN79261738. PMID:24614165

Shet, Anita; Antony, Jimmy; Arumugam, Karthika; Kumar Dodderi, Sunil; Rodrigues, Rashmi; DeCosta, Ayesha

2014-01-01

136

Adverse drug reactions to antiretroviral therapy during the early art period at a tertiary hospital in Ghana  

PubMed Central

Introduction Antiretroviral therapy (ART) has reduced HIV morbidity and mortality worldwide but has many adverse effects. These adverse drug reactions (ADRs) lead to discontinuations, disease progression or treatment failure. We explored the types and risk factors for ADRs in a cohort starting ART in a teaching hospital in Accra, Ghana where the main regimens used were a combination of nucleotide and non nucleotide reverse transcriptase inhibitors. Methods A Cross-sectional retrospective study was conducted reviewing data of 2042 patients initiated on HAART from 2003 to 2007. Univariate analysis was done for the dependent and independent variables. Stepwise logistic regression procedures were used to model the effect of gender on the development of ADRs controlling for other variables like age, marital status, weight at baseline and CD4 at baseline. Results The period prevalence of ADRs was 9.4%. The two most common adverse reactions were anaemia and diarrhoea. Female sex was a statistically significant independent predictor of an adverse drug reaction (AOR: 1.66, p = 0.01, CI: 1.16-2.36). CD4 counts 250 cells/mm3 or more was significantly associated with the occurrence of an ADR. The occurrence of anaemia in females was statistically significant compared to males. Conclusion Adverse drug reactions were less common than expected, anaemia was the commonest ADR. Female sex and high CD4 counts >250mm3 were predictors of ADRs whereas females were significantly more likely to develop anaemia than males. Recommendations were made for interventions to prevent and also mitigate the high levels of anaemia especially among women in the ART scale up. PMID:25368714

Lartey, Margaret; Asante-Quashie, Abena; Essel, Ama; Kenu, Ernest; Ganu, Vincent; Neequaye, Alfred

2014-01-01

137

[Analysis of drug safety information using large-scale adverse drug reactions database].  

PubMed

The worldwide situations of drug safety have changed dramatically. Drugs are used based on the evaluation of safety data collected in clinical practice worldwide. US Food Drug Administration collects spontaneous reports and requires manufacturers to report adverse drug reactions (ADRs) of US marketed drugs occurring worldwide. These worldwide data are available through the Adverse Event Reporting System (AERS) (about 4.1 million reports on about 3,073,340 patients, for 13 years: 1997.4th qr-2010.4th qr.). The current issues are how to analyze and utilize such large-scale safety data. Potential biases should always be kept in mind, because AERS is based on spontaneous reports. However, its huge volumes and exhaustiveness allow for sufficient scientific evaluation with the aid of current IT technology. Therefore, analysis of large-scale ADR database becomes a new research area not only from the medical science but also from the statistical viewpoint. In this report, I introduce some case studies in which we analyzed the AERS data on psychotropics including antipsychotics, antiepileptics, and antidepressants. Antipsychotics caused ADRs specific to each drug, and, in combination therapy, increased the incidences of diabetes mellitus, pancreatitis, and neuroleptic malignant syndrome; antiepileptics caused AEs (adverse events) including serious skin reactions such as Stevens-Johnson syndrome (SJS), congenital anomaly, and closed-angle glaucoma; and antidepressants caused AEs including serotonin syndrome, suicidal events, and congenital anomaly, and AEs occurring at a higher incidence for other indications, drugs often used in the elderly and AEs in combination therapy. We have analyzed ADRs associated with concomitant drug therapies using Bayesian approach. In the analysis we faced difficulties of overdispersion and we have to estimate a number of parameters, given a large number of target drugs as well as ADRs. In addition, ADR reports are not collected from uniform populations, we also have to consider the variations in the target populations. So, we use Bayesian statistics. Bayesian analysis has become feasible with advances in computer technologies and the Markov chain Monte Carlo (MCMC) methods. It allows us to analyze ADRs associated with concomitant drug therapies and estimate the ADR signals for each drug. Therefore, the analysis and evaluation of large-scale ADR database can provide important safety information in clinical practice and the studies on ADR database are the most important issues in ensuring the postmark safety of pharmaceutical products. PMID:22259840

Morikawa, Kaoru

2011-01-01

138

A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital  

PubMed Central

Adverse reactions are the recognized hazards of drug therapy and they can occur with any class of drugs and many studies revealed that the incidence is more in case of antibiotics. The main aim of this study was to detect and analyze Adverse Drug Reactions of antibiotics in inpatients of a tertiary care hospital. A prospective spontaneous reporting study by active and passive methods was carried out for a period of six months. A total of 49 ADRs were reported during the study period with male predominance (53.06%) and geriatric age group. More number of ADRs was from General Medicine and Pediatric departments in which the most affected organ systems were the GIT (38.77%) and the skin (30.61%). The antibiotic classes mostly accounted were cephalosporins (34.69%) followed by fluoroquinolones and others in which type A reactions were more compared to type B and 59.18% of them were predictable. The severity assessment revealed that most of them were moderate (63.26%) followed by mild and severe reactions. Of the reported reactions, 55.10% were definitely preventable and causality assessment was done which showed that 71.42% of the reactions were probable, possible (18.36%), definite (10.20%) and no reactions were unlikely. The study concluded that Adverse Drug Reactions to antibiotics are common and some of them resulted in increased healthcare cost due to the need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of Adverse Drug Reactions to antibiotics, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety. PMID:25161373

Shamna, M.; Dilip, C.; Ajmal, M.; Linu Mohan, P.; Shinu, C.; Jafer, C.P.; Mohammed, Yahiya

2013-01-01

139

Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine  

PubMed Central

Aims To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients. Methods Structured data regarding patient characteristics, ‘events’ (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by ‘event monitoring’ to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy. Results The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q1) and 9 (Q3) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8.6% of hospital days. Conclusions These data demonstrate the feasibility of the developed ‘event monitoring’ system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients. PMID:10671911

Fattinger, Karin; Roos, Malgorzata; Vergeres, Patrice; Holenstein, Clemens; Kind, Brigitt; Masche, Urspeter; Stocker, David N; Braunschweig, Suzanne; Kullak-Ublick, Gerd A; Galeazzi, Renato L; Follath, Ferenc; Gasser, Theo; Meier, Peter J

2000-01-01

140

Information about adverse drug reactions reported in children: a qualitative review of empirical studies  

PubMed Central

AIM To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS Medline and Embase databases were searched from origin and updated until February 2010. We included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring inpatients and outpatients. However, prevalence and incidence were much lower in the national databases. Types of reported ADRs, seriousness of ADRs and types of medicines differed substantially between studies due to differences in time periods and patient populations. Information about ADRs was mainly provided by health care professionals, although parents also contributed reports. CONCLUSIONS We found a higher incidence rate of ADRs in hospitalized children and outpatients than in national databases. There seems to be considerable potential for increasing the knowledge of ADRs by advocating the submission of reports to the spontaneous reporting systems. Our study underscores that ADRs in children constitute a significant public health problem. PMID:20840440

Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

2010-01-01

141

Relationships between thiopurine S-methyltransferase polymorphism and azathioprine-related adverse drug reactions in Chinese renal transplant recipients  

Microsoft Academic Search

Objective  To systematically investigate the relationships between thiopurine S-methyltransferase (TPMT) polymorphisms and azathioprine-related\\u000a adverse drug reactions in patients with kidney transplantation.\\u000a \\u000a \\u000a \\u000a Methods  Erythrocyte TPMT activity of 150 patients with kidney transplantation and AZA therapy was determined by HPLC. The frequency\\u000a of four common TPMT mutant alleles, TPMT*2, *3A, *3B, and *3C was determined by allele-specific PCR and PCR-restriction fragment length polymorphism (PCR-RFLP)

Hua-Wen Xin; Hui Xiong; Xiao-Chun Wu; Qing Li; Lei Xiong; Ai-Rong Yu

2009-01-01

142

Patient safety in hospitals: new insight form the Dutch adverse event study  

Microsoft Academic Search

The adverse event study is the first part of the Dutch national research program on patient safety. The main parts of the program are: (1a) a retrospective epidemiological study in 21 hospitals into the character, severity, extent and costs of adverse events during hospitalization and the resulting harm to patients, (1b) a retrospective epidemiological study of adverse events during day-care

C. Wagner; M. C. Bruyne; M. Zegers; L. Hoonhout; G. van der Wal

2007-01-01

143

Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria  

Microsoft Academic Search

BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR

Kazeem A Oshikoya; Jacob O Awobusuyi

2009-01-01

144

A Team Agent Approach to Postmarketing Surveillance of Adverse Drug Reactions  

Microsoft Academic Search

Current postmarketing surveillance methods largely rely on spontaneous reports which suffer from serious underreporting, latency, and inconsistent reporting. Thus they are not ideal for rapidly identifying rare adverse drug reactions (ADRs). We propose an active, multi-agent computer software system, where each agent is empowered with teamwork capabilities such as anticipating information needs, identifying relevant ADR information, and continuously monitoring and

Yanqing Ji; Hao Ying; Daniel C. Barth-Jones; John Yen; Shizhuo Zhu; Richard E. Miller; R. M. Massanari

2005-01-01

145

Prevalence of parentally perceived adverse reactions to food in young children.  

PubMed

A substantial number of parents perceive that their children have adverse reactions to food, but it is well documented that objective assessments agree with only one-quarter to one-half of parentally reported reactions. In order to prevent wrong diagnoses and curtail unnecessary or inadequate diets, primary health care providers need to deal with the parental perception of adverse reactions to food. A description of the prevalence and pattern of parentally perceived adverse reactions to food in children is needed to meet this challenge. The aim of the present study was to estimate the prevalence, incidence and cumulative incidences of parentally perceived adverse reactions to food in children younger than 2 years of age, and to study the duration of the reactions. A population-based cohort of 3623 children born in Norway was followed from birth until the age of two. At 6-month intervals, the parents completed questionnaires regarding the occurrence and type of any reaction to food. Information was available on the outcome measure at all age points for 77.4% of the families and these were used in the analyses; 3.8% of the cohort were entirely lost to follow-up. The cumulative incidence of adverse reactions to food was 35% by age two. Fruits, milk and vegetables accounted for nearly two-thirds of all reported reactions. Milk was the single food item most commonly incriminated, the cumulative incidence being 11.6%. The cumulative incidences of reported reactions to fruits and vegetables were 20.4% and 7.3%, respectively, with citrus fruits, strawberry and tomatoes as the most common food items in these groups. The cumulative incidences were less for food reactions associated with eggs (4.4%), fish (3%), nuts (2.1%) and cereals (1.4%). The duration of the reactions was short - approximately two-thirds of the reactions were not reported again 6 months later. However, the probability of remission depended on the food item concerned, the age at onset of reactions, and whether the reaction had been reported previously or not. Adverse reactions to food are reported by the parents of one-third of children in Norway before the age of two. The most striking feature of this study is the short duration of the food reactions, as approximately two-thirds of the reactions are not reported again 6 months later. Nevertheless, the high frequency of reactions attributable to milk is of concern. Milk is an important part of the Norwegian diet for children, and if removed from the diet its nutritional value is not easily replaced. Further studies are needed to assess the degree to which parents alter the diet of their children based upon perceived reactions to food. PMID:10478614

Eggesbø, M; Halvorsen, R; Tambs, K; Botten, G

1999-05-01

146

Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models  

PubMed Central

Adverse drug reaction (ADR) risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012) to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with practical design and good performance. Only then can implementation and impact be assessed with the aim of generating a model of high enough quality to be considered for use in clinical care to prioritize older people at high risk of suffering an ADR. PMID:25278750

Stevenson, Jennifer M; Williams, Josceline L; Burnham, Thomas G; Prevost, A Toby; Schiff, Rebekah; Erskine, S David; Davies, J Graham

2014-01-01

147

Hypersensitive reactions to local dental anesthetics and patient information: critical review of a drug leaflet  

PubMed Central

This paper discusses the case of a patient who experienced adverse reactions to a local anesthetic. It reviews symptoms of adverse reactions, possible causes, patient management, and alternative anesthesia modes. The second part of the paper discusses the product leaflet information and the associated legal issues. PMID:22915891

Simonet, Daniel

2011-01-01

148

Adverse Effects of Thalidomide Administration, in Patients with Myeloma Multiplex?  

PubMed Central

Introduction: Myeloma multiplex is defined by the presence of monoclonal plasma cell population in the bone marrow>10%,M protein in the serum and/or urine ,and clinical evidence of end organ damage like hypercalcemia ,renal failure, anemia, or bone lesions. In the most hematologic malignancies the role of induction treatment is to achieve complete remission (CR). Thalidomide became a new therapeutic approach but use of Thalidomide as a single agent or combination with steroids or chemotherapy is associated with several side effects like deep vein thrombosis (DVT), peripheral neuropathy (PN), constipation, somnolence, pyrexia, pain, fatigue osteonecrosis of jaw, and teratogenicity that is the most worrying adverse event. Risk of appearance of DVT increased if we use combination of Thalidomide plus Dexamethasone plus cytotoxic chemotherapy such Cyclophosphamide. >30% DVT usually occurs during the first months of treatment and is more frequent in newly diagnosed patients with a high tumor burden. The second side effect is peripheral neuropathy (PN) which occurs in 50% of patients with MM treated with Thalidomide plus Dexamethasone and chemotherapy. Patients and methods: Eighty patients of both sexes (43 males and 37 females) at the age of 31-81 (median range 58 years) with MM, were treated–one group with combinations of Thalidomide plus Dexamethasone plus Cyclophosphamide (CyThalDex) 4 cycle(>4months), and the other group with Thalidomide plus Dexamethasone plus Melphalan (MPT), (>4month) and third group with high dose of chemotherapy and continue with ThalDex (TD), the fourth group with CyThalDex, > than 5 cycles, and the fifth group with ThalDex (TD) only. Results: It is obvious while myelo-suppression is very rare, the incidence of nonhematologic side effects is high and dose dependent. Eight (or 10%) patients that developed DVT and CVI were initially treated with antiaggregation therapy of Aspirin 100mg per day, but those that already developed were treated with low dose of Heparin 40000 iE per day in ten days and continued with oral anticoagulans therapy. However, besides the given therapy in four (or 5 %) patients there was exitus letalis. PN was developed in twentyone patients (or 26.25%) from the total number of patients treated with Thalidomide, in ten patients the dosage of Thalidomide was decreased to 50mg per day, in one patient with Epi attacks it was interrupted and the other was with paresis n.occulomotorius and n.abducens. Conclusions: Patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism, but most patients who presenting DVT or some of thromboembolic events have had identifiable risk factors. The prolonged exposure to Thalidomide seems to induce resistance of MM reducing overall survival (OS). We must evaluate consolidation and maintenance therapies with Thalidomide, determinate which regimens provide a highness benefit with favorable side effect profiles in specific subgroups of patients. PMID:24944541

Svetlana Balkanov, Krstevska; Sotirova, Tatjana; Genadieva, Stavrik Sonja; Cevreska, Lidija; Stojanovik, Aleksandar; Balkanov, Trajan

2014-01-01

149

[Vigilance for veterinary medicinal products: reports of adverse reactions in the year 2011].  

PubMed

167 adverse reactions of Swissmedic-authorized veterinary medicinal products were reported during the year 2011 (2010: 160). Species and drug classes remain comparable with previous years: most of the reactions occurred following the use of antiparasitic products (39 %), antiinfectives (20 %) or non-steroidal antiinflammatory drugs (11 %) in companion animals (85 dogs and 27 cats) followed by cattle/calves (37). We received 15 cases of adverse reactions following reconverted use, 8 of them in treated cats. Additionally the Swiss Toxicological Information Centre in Zürich processed 84 enquiries and transmitted them to Swissmedic. One case of a successful new therapy to treat ivermectin poisoning in a pony is presented. Finally, the vaccinovigilance program received 60 declarations following the application of various vaccines, mainly to dogs or cats. PMID:23188763

Müntener, C R; Bruckner, L; Kupper, J; Althaus, F; Caduff-Janosa, P

2012-12-01

150

Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria  

PubMed Central

Aim: This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1–35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0–13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8–30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0–4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3–6.6), P = 0.0056] and 45–59years [OR = 1.9 (1.3–2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9–349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9–562.1), P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to zidovudine-based regimens. Peripheral neuropathy was also found to be associated with tenofovir-based regimen. This may require further studies and evaluation. PMID:23833736

Agu, Kenneth A.; Oparah, Azuka C.

2013-01-01

151

Few adverse reactions to metal on metal articulation in total hip arthroplasty in a review study on 358 consecutive cases with 1 to 5 years follow-up.  

PubMed

The aim of the present study was to determine the frequency of adverse reaction to metal on metal total hip arthroplasty using a M2a-38 articulation and a Magnum articulation, (Biomet Warsaw, Indiana).All patients who had received a Metal on Metal bearing prosthesis, in two centres in Copenhagen, were asked to complete a questionnaire about groin pain. Patients with self-reported groin pain, 68/314, underwent a physical examination and had Co and Cr ion levels measured in full blood samples. Fifty patients also had a CT scan performed.The present study found one patient with bilateral arthroplasty, who had an adverse reaction on one side. In addition the study showed that females had higher values of Co and Cr, and that younger patient reported groin pain more often.The conclusion of this study is that the number of adverse reactions is low, despite the time of observation being relatively short, no high frequency of adverse reactions to this prosthesis is expected. PMID:22930667

Stürup, Jens; Dahl, Line B; Jensen, Karl-Erik; Larsen, Anne-Birgitte; Gebuhr, Peter

2012-01-01

152

Few Adverse Reactions to Metal on Metal Articulation in Total Hip Arthroplasty in a Review Study on 358 Consecutive Cases with 1 to 5 Years Follow-Up  

PubMed Central

The aim of the present study was to determine the frequency of adverse reaction to metal on metal total hip arthroplasty using a M2a-38 articulation and a Magnum articulation, (Biomet Warsaw, Indiana). All patients who had received a Metal on Metal bearing prosthesis, in two centres in Copenhagen, were asked to complete a questionnaire about groin pain. Patients with self-reported groin pain, 68/314, underwent a physical examination and had Co and Cr ion levels measured in full blood samples. Fifty patients also had a CT scan performed. The present study found one patient with bilateral arthroplasty, who had an adverse reaction on one side. In addition the study showed that females had higher values of Co and Cr, and that younger patient reported groin pain more often. The conclusion of this study is that the number of adverse reactions is low, despite the time of observation being relatively short, no high frequency of adverse reactions to this prosthesis is expected. PMID:22930667

Sturup, Jens; Dahl, Line B; Jensen, Karl-Erik; Larsen, Anne-Birgitte; Gebuhr, Peter

2012-01-01

153

Corrosion at the Head-Neck Taper as a Cause for Adverse Local Tissue Reactions After Total Hip Arthroplasty  

PubMed Central

Background: Corrosion at the modular head-neck junction of the femoral component in total hip arthroplasty has been identified as a potential concern, although symptomatic adverse local tissue reactions secondary to corrosion have rarely been described. Methods: We retrospectively reviewed the records of ten patients with a metal-on-polyethylene total hip prosthesis, from three different manufacturers, who underwent revision surgery for corrosion at the modular head-neck junction. Results: All patients presented with pain or swelling around the hip, and two patients presented with recurrent instability. Serum cobalt levels were elevated prior to the revision arthroplasty and were typically more elevated than were serum chromium levels. Surgical findings included large soft-tissue masses and surrounding tissue damage with visible corrosion at the femoral head-neck junction; the two patients who presented with instability had severe damage to the hip abductor musculature. Pathology specimens consistently demonstrated areas of tissue necrosis. The patients were treated with debridement and a femoral head and liner exchange, with use of a ceramic femoral head with a titanium sleeve in eight cases. The mean Harris hip score improved from 58.1 points preoperatively to 89.7 points at a mean of 13.0 months after the revision surgery (p = 0.01). Repeat serum cobalt levels, measured in six patients at a mean of 8.0 months following revision, decreased to a mean of 1.61 ng/mL, and chromium levels were similar to prerevision levels. One patient with moderate hip abductor muscle necrosis developed recurrent instability after revision and required a second revision arthroplasty. Conclusions: Adverse local tissue reactions can occur in patients with a metal-on-polyethylene bearing secondary to corrosion at the modular femoral head-neck taper, and their presentation is similar to the adverse local tissue reactions seen in patients with a metal-on-metal bearing. Elevated serum metal levels, particularly a differential elevation of serum cobalt levels with respect to chromium levels, can be helpful in establishing this diagnosis. Level of Evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence. PMID:23289127

John Cooper, H.; Della Valle, Craig J.; Berger, Richard A.; Tetreault, Matthew; Paprosky, Wayne G.; Sporer, Scott M.; Jacobs, Joshua J.

2012-01-01

154

Knowledge discovery of drug data on the example of adverse reaction prediction  

PubMed Central

Background Antibiotics are the widely prescribed drugs for children and most likely to be related with adverse reactions. Record on adverse reactions and allergies from antibiotics considerably affect the prescription choices. We consider this a biomedical decision-making problem and explore hidden knowledge in survey results on data extracted from a big data pool of health records of children, from the Health Center of Osijek, Eastern Croatia. Results We applied and evaluated a k-means algorithm to the dataset to generate some clusters which have similar features. Our results highlight that some type of antibiotics form different clusters, which insight is most helpful for the clinician to support better decision-making. Conclusions Medical professionals can investigate the clusters which our study revealed, thus gaining useful knowledge and insight into this data for their clinical studies. PMID:25079450

2014-01-01

155

Fluindione and drug reaction with eosinophilia and systemic symptoms: an unrecognised adverse effect?  

Microsoft Academic Search

Purpose  Fluindione is an oral vitamin K antagonist (indanedione derivative) exclusively marketed in France and Luxembourg, known to\\u000a have immuno-allergic adverse effects such as hepatitis, fever or interstitial nephritis. A few cases of drug reaction with\\u000a eosinophilia and systemic symptoms (DRESS) have been reported with fluindione. The aim of the present study was to investigate\\u000a fluindione-induced DRESS cases reported in France

Amélie Daveluy; Brigitte Milpied; Annick Barbaud; Bénédicte Lebrun-Vignes; Aurore Gouraud; Marie-Laure Laroche; Ecaterina Ciobanu; Bernard Bégaud; Nicholas Moore; Ghada Miremont-Salamé; Françoise Haramburu

156

Interplay of Factors Leading to Adverse Drug Reactions in the Liver, A Personal Viewpoint 1  

PubMed Central

Adverse drug reactions in liver involve formation of a reactive metabolic intermediary of the drug, binding of the intermediary to macromolecules in the cell, notably proteins in the plasma membrane, immunological response to these altered proteins and attack against hepatocytes bearing these altered proteins by immune mechanisms. At each step in this complex process many factors act to enhance or depress drug metabolism, metabolite disposition, macromolecular binding, neoantigen formation, and the cell mediated and humoral immune attack. The extent and direction of each step may be dose dependent but the complexity of the overall mechanism is so immense that predictability of hepatic drug reactions is unlikely in most instances. PMID:602258

Schaffner, Fenton

1977-01-01

157

Updating the French method for the causality assessment of adverse drug reactions.  

PubMed

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale. PMID:23773347

Arimone, Yannick; Bidault, Irène; Dutertre, Jean-Paul; Gérardin, Marie; Guy, Claire; Haramburu, Françoise; Hillaire-Buys, Dominique; Meglio, Carmine; Penfornis, Catherine; Théophile, Hélène; Valnet-Rabier, Marie-Blanche

2013-01-01

158

Adverse reactions to sunscreen agents: epidemiology, responsible irritants and allergens, clinical characteristics, and management.  

PubMed

Sunscreen is a key component in the preventive measures recommended by dermatologists and public health campaigns aimed at reducing sunburn, early skin aging, and skin cancer. To maximize compliance, adverse reactions to sunscreens should be minimized. Although inactive ingredients cause many of these reactions, it is important for dermatologists to be aware of reactions to active ultraviolet filters. There are approximately 120 chemicals that can function as ultraviolet (UV) filters. This review focuses on the 36 most common filters in commercial and historical use. Of these, 16 are approved for use by the US Food and Drug Administration. The benzophenones and dibenzoylmethanes are the most commonly implicated UV filters causing allergic and photoallergic contact dermatitis (PACD) reactions; benzophenone-3 is the leading allergen and photoallergen within this class. When clinically indicated, patch and photopatch testing should be performed to common UV filters. PMID:25384223

Heurung, Ashley R; Raju, Srihari I; Warshaw, Erin M

2014-01-01

159

[Adverse event in elderly patients in intensive care unit].  

PubMed

This study aims to identify the scientific production in Latin America about the safety of aged people in the ICU and adverse events dealt in the literature. It is a systematic revision, with indexed key words. The inclusion and exclusion criteria were respected. Twenty papers were selected for analysis. Most of them were carried out after the year 2000, in Brazil, by professional nurses and physicians, dealing mostly with adverse events connected to mistakes with medicines, accidental remove of probes and catheters, nosocomial infections, errors in the procedure techniques and occurrence of pressure sores. In the selected papers there were no mentions to adverse events related to behavior changes. The scientific production about the theme is still recent in Latin America, tending to increase. Its necessary to increase the focus to the aged population in these units, taking into account the possible risk to which they are exposed. PMID:23887794

Pedreira, Larissa Chaves; Brandão, Adriana Souza; Reis, Aline Macêdo

2013-01-01

160

IgG Anti-IgA Subclasses in Common Variable Immunodeficiency and Association with Severe Adverse Reactions to Intravenous Immunoglobulin Therapy  

Microsoft Academic Search

The current therapy for common variable immunodeficiency is based on the administration of intravenous immunoglobulin preparations which may cause severe adverse reactions. Some reports have associated these reactions with IgG anti-IgA antibodies, although this is not yet clear. We analyzed 20 sera from common variable immunodeficiency patients by an enzyme immunoassay to detect IgG anti-IgA and determine its subclass profile.

Maria Notomi Sato; Alberto Jos´e da Silva Duarte

2000-01-01

161

Localized chronic fibrosing vasculitis in a tattoo: a unique adverse tattoo reaction.  

PubMed

Decorative tattoos are associated with a variety of adverse cutaneous reactions. We describe a unique fibrosing vasculitic reaction to red tattoo ink. The histopathology was similar to that in localized chronic fibrosing vasculitis (LCFV), but sharply limited to sites of red tattoo ink injection and associated with florid verrucoid epidermal hyperplasia. LCFV has been described in a broad variety of slowly progressive disorders with a firm consistency such as erythema elevatum diutinum, plasma cell granuloma, granuloma faciale, and IgG4-associated sclerosing diseases. It has been hypothesized that LCFV is the result of maladaptive immune reaction with failure to clear the causative antigen. To the best of our knowledge, this is the first case of LCFV associated with tattoo. We speculate on the implications our case holds for the pathogenesis of LCFV. PMID:24736671

Deeken, Audrey; Jefferson, Julie; Hawkinson, Dana; Fraga, Garth R

2014-04-01

162

Adverse events during rotary-wing transport of mechanically ventilated patients: a retrospective cohort study  

PubMed Central

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

Seymour, Christopher W; Kahn, Jeremy M; Schwab, C William; Fuchs, Barry D

2008-01-01

163

Causality, Severity and Preventability Assessment of Adverse Cutaneous Drug Reaction: A Prospective Observational Study in a Tertiary Care Hospital  

PubMed Central

Introduction: The number of subjects involved in a clinical trial are limited, whose findings cannot be extrapolated to the entire population.Due to the emergence of newer molecules the pattern of Adverse Cutaneous Drug Reaction(ACDR) also changes frequently. The need for this study is for early diagnosis, to reduce the morbidity and mortality due to ACDR and to ensure safety of the patients. Material and Methods: Forty one subjects with the diagnosis of ACDR were included in the study for a period of 12 months(Jan 2009- Dec 2009). The informations such as patient demographic details, drug history, associated comorbid conditions and pattern of the skin reaction were noted. Assessment was done for causality, severity and preventability using separate valid scales. Results: The most common ACDR was fixed drug eruption (43.9%) and the most common causative drug for the same was surprisingly found to be paracetamol. Antimicrobials were the most common causative drug group and two significant associated risk factors were multiple drug intake and history of allergy. Among the total reactions 78% were of probable category and 59% were of moderate level severity reaction. Out of which 12% of the cases were definitely preventable. PMID:24551632

S., Padmavathi; K., Manimekalai; S., Ambujam

2013-01-01

164

Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study  

PubMed Central

Objectives To identify factors that predict repeat admission to hospital for adverse drug reactions (ADRs) in older adults. Design Population based retrospective cohort study. Setting All public and private hospitals in Western Australia. Participants 28?548 patients aged ?60 years with an admission for an ADR during 1980-2000 followed for three years using the Western Australian data linkage system. Results 5056 (17.7%) patients had a repeat admission for an ADR. Repeat ADRs were associated with sex (hazard ratio 1.08, 95% confidence interval 1.02 to 1.15, for men), first admission in 1995-9 (2.34, 2.00 to 2.73), length of hospital stay (1.11, 1.05 to 1.18, for stays ?14 days), and Charlson comorbidity index (1.71, 1.46 to 1.99, for score ?7); 60% of comorbidities were recorded and taken into account in analysis. In contrast, advancing age had no effect on repeat ADRs. Comorbid congestive cardiac failure (1.56, 1.43 to 1.71), peripheral vascular disease (1.27, 1.09 to 1.48), chronic pulmonary disease (1.61, 1.45 to 1.79), rheumatological disease (1.65, 1.41 to 1.92), mild liver disease (1.48, 1.05 to 2.07), moderate to severe liver disease (1.85, 1.18 to 2.92), moderate diabetes (1.18, 1.07 to 1.30), diabetes with chronic complications (1.91, 1.65 to 2.22), renal disease (1.93, 1.71 to 2.17), any malignancy including lymphoma and leukaemia (1.87, 1.68 to 2.09), and metastatic solid tumours (2.25, 1.92 to 2.64) were strong predictive factors. Comorbidities requiring continuing care predicted a reduced likelihood of repeat hospital admissions for ADRs (cerebrovascular disease 0.85, 0.73 to 0.98; dementia 0.62, 0.49 to 0.78; paraplegia 0.73, 0.59 to 0.89). Conclusions Comorbidity, but not advancing age, predicts repeat admission for ADRs in older adults, especially those with comorbidities often managed in the community. Awareness of these predictors can help clinicians to identify which older adults are at greater risk of admission for ADRs and, therefore, who might benefit from closer monitoring. PMID:19129307

2009-01-01

165

Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: key determinants  

PubMed Central

Objective To assess extent and determinants of past-month recognition of suspected adverse drug reactions (ADR) and past-year ADR reporting among healthcare professionals (HCPs) in Uganda. Setting Geographically diverse health facilities (public, private for-profit, private not-for-profit). Participants Of 2000 questionnaires distributed, 1345 were completed: return rate of 67%. Primary and secondary outcome measures Per cent HCPs who suspected ADR in the past month; reported ADR in the past year. Results Nurses were the majority (59%, 792/1345). Only half the respondents had heard about pharmacovigilance: 39% of nurses (295/763; 95% CI 35% to 42%), 70% otherwise (383/547; 95% CI 66% to 74%). One fifth (268/1289 or 21%; 95% CI 19% to 23%) had suspected an ADR in the previous 4?weeks, 111 of them were nurses; 15% (190/1296) had reported a suspected ADR in the past year, 103 of them were nurses. Past-month ADR suspicion was more likely by non-nurses (OR=1.7, 95% CI 1.16 to 2.40) and with medical research involvement (OR=1.5, 95% CI 1.05 to 2.15) but past-month receipt of patient ADR-complaint predominated (OR=19, 95% CI 14 to 28). Past-year ADR reporting was higher by hospital staff (OR=1.9, 95% CI 1.18 to 3.10), especially in medicine (OR=2.3, 95% CI 1.08 to 4.73); but lower from private for-profit health facilities (OR=0.5, 95% CI 0.28 to 0.77) and by older staff (OR=0.6, 95% CI 0.43 to 0.91); more likely by HCPs who had ever encountered a fatal ADR (OR=2.9, 95% CI 1.94 to 4.25), knew to whom to report (OR=1.7, 95% CI 1.18 to 2.46), or suggested how to improve ADR reporting (OR=1.6, 95% CI 1.04 to 2.49). Two attitudinal factors were important: diffidence and lethargy. Conclusions One in five HCPs suspected an ADR in the past-month and one in seven reported ADR in the previous year. Empowering patients could strengthen ADR detection and reporting in Africa. PMID:25421337

Kiguba, Ronald; Karamagi, Charles; Waako, Paul; Ndagije, Helen B; Bird, Sheila M

2014-01-01

166

Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports  

PubMed Central

Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health. PMID:24347986

Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M.; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

2013-01-01

167

ADVERSE REACTIONS TO FOOD IN A RANDOM SAMPLE OF pupn.s AND SCHOOL PERSONNELIN THE COUNTY OF UPPSALA, SWEDEN  

Microsoft Academic Search

Adverse reactions to specific food products are common in the population, but there are few epidemiological investigations on this topic. We have studied self-reponed food allergy and food intolerance in a random sample of school pupils (7-17y), and school personnel in mid­ Sweden. Infonnation on adverse reactions to food, allergies, and asthma was gathered by a self-administered questionnaire, mailed to

Dan NORBACK; Greta SMEDJE; Gunilla WIESLANDER

168

Impact of patient communication problems on the risk of preventable adverse events in acute care settings  

PubMed Central

Background Up to 50% of adverse events that occur in hospitals are preventable. Language barriers and disabilities that affect communication have been shown to decrease quality of care. We sought to assess whether communication problems are associated with an increased risk of preventable adverse events. Methods We randomly selected 20 general hospitals in the province of Quebec with at least 1500 annual admissions. Of the 145 672 admissions to the selected hospitals in 2000/01, we randomly selected and reviewed 2355 charts of patients aged 18 years or older. Reviewers abstracted patient characteristics, including communication problems, and details of hospital admission, and assessed the cause and preventability of identified adverse events. The primary outcome was adverse events. Results Of 217 adverse events, 63 (29%) were judged to be preventable, for an overall population rate of 2.7% (95% confidence interval [CI] 2.1%–3.4%). We found that patients with preventable adverse events were significantly more likely than those without such events to have a communication problem (odds ratio [OR] 3.00; 95% CI 1.43–6.27) or a psychiatric disorder (OR 2.35; 95% CI 1.09–5.05). Patients who were admitted urgently were significantly more likely than patients whose admissions were elective to experience an event (OR 1.64, 95% CI 1.07–2.52). Preventable adverse events were mainly due to drug errors (40%) or poor clinical management (32%). We found that patients with communication problems were more likely than patients without these problems to experience multiple preventable adverse events (46% v. 20%; p = 0.05). Interpretation Patients with communication problems appeared to be at highest risk for preventable adverse events. Interventions to reduce the risk for these patients need to be developed and evaluated. PMID:18519903

Bartlett, Gillian; Blais, Regis; Tamblyn, Robyn; Clermont, Richard J.; MacGibbon, Brenda

2008-01-01

169

Serious adverse drug reactions to pyrimethamine-sulphadoxine, pyrimethamine-dapsone and to amodiaquine in Britain.  

PubMed Central

All reports of adverse reactions with pyrimethamine-sulphadoxine (Fansidar), pyrimethamine-dapsone (Maloprim), and amodiaquine spontaneously reported through the UK national post-marketing system were reviewed. Retrospective reporting rates of serious reactions associated with these drugs were analysed using prescription data from the Department of Health, derived from the Prescription Pricing Authority, and relevant pharmaceutical companies. Whilst interpretation of these data requires caution, they allowed comparison with reporting rates from other studies. The reported rate for all serious reactions to pyrimethamine-sulphadoxine was 1:2100 prescriptions, and for cutaneous reactions was 1:4900 prescriptions, with a fatality rate of 1:11,100. The reported rate for serious reactions to pyrimethamine-dapsone was 1:9100 prescriptions, and for blood dyscrasias was 1:20,000 prescriptions, with a fatality rate of 1:75,000. The reported rate of blood dyscrasias associated with amodiaquine was 1:2100 users with a fatality rate of 1:31,000. Serious hepatic disorders occurred in 1:11 1000 pyrimethamine-sulphadoxine prescriptions, 1:75,200 pyrimethamine-dapsone prescriptions, and in 1:15,650 amodiaquine users. 35% of cases received these drugs needlessly as they were not exposed to drug resistant strains of Plasmodium falciparum. Since few serious reactions have been reported to chloroquine plus proguanil, these data support guidelines which restrict the use of reviewed drugs for those at greatest risk of infection. Dosage data indicated that fatalities had taken higher doses and continued prophylaxis after onset of symptoms. Two thirds of serious reactions to the compound antimalarials were reported in females. PMID:2138674

Phillips-Howard, P A; West, L J

1990-01-01

170

Broad range of adverse cutaneous eruptions in patients on TNF-alpha antagonists.  

PubMed

Biologic therapies targeting tumor necrosis factor (TNF)-alpha have become a mainstay in the management of a number of autoimmune diseases. We report a series of adverse skin eruptions in six patients (four females, two males, age: 21-58 years, mean: 39) receiving 4 months to 10 years (mean 3.1 years) of anti-TNF-alpha therapies (infliximab, n = 4; adalimumab, n = 1 or etanercept, n = 1). The following drug-associated diagnoses were made in eight skin biopsies performed at Massachusetts General Hospital between 3/2007 and 10/2010: pustular folliculitis, psoriasis, interface dermatitis, neutrophilic eccrine hidradenitis, Sweet's syndrome, lupus, vasculitis and palmoplantar pustulosis. The descriptions of neutrophilic eccrine hidradenitis-like and Sweet's-like hypersensitivity eruptions induced by anti-TNF-alpha therapies are the first such cases described in the literature. Each cutaneous eruption improved or resolved with switching to a different TNF-alpha inhibitor, discontinuation of the anti-TNF-alpha agent, and/or topical or systemic steroids. There was a clear chronologic relationship with, and clinical remission upon withdrawal or steroid suppression of the anti-TNF-alpha agents. The mechanism for such diverse cutaneous eruptions among this class of medications remains poorly understood. The cutaneous adverse reaction profile of TNF-alpha inhibitors is broad and should be considered in the histopathologic differential in this clinical setting. PMID:22515220

Hawryluk, Elena B; Linskey, Katy R; Duncan, Lyn M; Nazarian, Rosalynn M

2012-05-01

171

Gastrointestinal adverse effects of antiepileptic drugs in intractable epileptic patients  

Microsoft Academic Search

Gastrointestinal (GI) discomforts are among the most common side effects of antiepileptic drugs (AEDs) that might lead to discontinuation or irregular consumption of the drugs. This study was conducted to evaluate the frequency of GI side effects of different AEDs in intractable epileptic patients treated with single or multiple drugs. GI discomfort of 100 epileptic patients (aged 35–76 years) treated

Soodeh Razeghi Jahromi; Mansoureh Togha; Sohrab Hashemi Fesharaki; Masoumeh Najafi; Nahid Beladi Moghadam; Jalil Arab Kheradmand; Hadi Kazemi; Ali Gorji

2011-01-01

172

Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health Product and Prescription Drug Use in Community Pharmacies  

PubMed Central

Background Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use. Methodology/Principal Findings Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use. Conclusions/Significance Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms. PMID:23028841

Vohra, Sunita; Cvijovic, Kosta; Boon, Heather; Foster, Brian C.; Jaeger, Walter; LeGatt, Don; Cembrowski, George; Murty, Mano; Tsuyuki, Ross T.; Barnes, Joanne; Charrois, Theresa L.; Arnason, John T.; Necyk, Candace; Ware, Mark; Rosychuk, Rhonda J.

2012-01-01

173

Gastrointestinal adverse effects of antiepileptic drugs in intractable epileptic patients.  

PubMed

Gastrointestinal (GI) discomforts are among the most common side effects of antiepileptic drugs (AEDs) that might lead to discontinuation or irregular consumption of the drugs. This study was conducted to evaluate the frequency of GI side effects of different AEDs in intractable epileptic patients treated with single or multiple drugs. GI discomfort of 100 epileptic patients (aged 35-76 years) treated with one or multiple AEDs was assessed. Seventy six patients (76%) were treated with two or more AEDs, and 24 (24%) were on monotherapy. The most common prescribed drug for monotherapy was carbamazepine and the most frequent combination was phenytoin and carbamazepine. Patients were suffering from different GI side effects including heartburn (34.6%), nausea (33.7%), constipation (26%), vomiting (22.1%), diarrhea (21.2%) and dysphagia (19.2%). Nausea and vomiting were significantly higher in patients receiving monotherapy with carbamazepine and valproic acid, respectively. When phenytoin, gabapentine, or valproic acid was added to the other AEDs, the risk of the occurrence of diarrhea, dysphagia, or heartburn was significantly increased, respectively. Addition of gabapentine to the other AEDs in multiple drug therapy was accompanied with the highest frequency of GI complications. This study indicated that GI side effects, which can affect drug absorption and utilization, were common in intractable epileptic patients with long-term AEDs treatment. This may influence the efficacy of the therapy with AEDs and enhance the probability of further attacks. PMID:21236703

Jahromi, Soodeh Razeghi; Togha, Mansoureh; Fesharaki, Sohrab Hashemi; Najafi, Masoumeh; Moghadam, Nahid Beladi; Kheradmand, Jalil Arab; Kazemi, Hadi; Gorji, Ali

2011-05-01

174

Regional reporting of adverse drug reactions: a new computer-based network.  

PubMed

The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs) and adverse events (AE). Generally physicians, pharmaceutical manufacturers, and pharmacists use a paper-based form for sending spontaneous ADR and AE reports to the national drug regulatory authority. Besides underreporting, reporting lag-time and errors through data transformation are a major issue. In order to improve the current reporting situation we have set up a new computer-based, network-driven system for storing, transferring, and evaluating ADR reports. The system consists of three regional centres, one coordinating centre, and the central ADR database of the national drug regulatory authority. In the regional centres, clinical pharmacologists collect ADR data in local databases. There is a comfortable user-interface with an online help-function available. New reports are sent automatically to the Federal Agency using EUROSCAPE as a standardized electronic report form of the EU. The coordinating centre in Munich is responsible for overall performance and quality assurance. This model for a clinical health information network is of a high level of data security, is reliable and easily expandable through the use of standard tools, is fast and also inexpensive by using standard shareware products. PMID:15073886

Swoboda, W J; Göttler, M; Hasford, J

1999-04-01

175

Which adverse effects influence the dropout rate in selective serotonin reuptake inhibitor (SSRI) treatment? Results for 50,824 patients  

PubMed Central

Background: Nowadays, selective serotonin reuptake inhibitors (SSRIs) are the most frequently prescribed antidepressants due to their superior clinical efficacy, effectiveness, tolerability, and safety as compared to tricyclic antidepressants or monoamino oxidase inhibitors. However, despite these advantages SSRIs are still associated with a number of adverse drug reactions, especially in the early stages of treatment, which may lead to premature discontinuation of therapy in some cases. The aim of the present study was to assess the most common adverse drug reactions of SSRIs as well as their impact on dropout rate in a large study population. Patients and methods: Data for 50,824 patients treated for major depressive disorder with SSRIs for the first time was accessed via the Disease Analyzer database (IMS Health, Germany), providing information on SSRI adverse drug reactions and their influence on premature treatment discontinuation calculated by regression analysis. The presence of certain co-morbidities was also registered. Results: The mean age was 54.5 ± 19 years, two-thirds of the study population being female. The adverse effects mentioned most frequently were: “discomfort” of the digestive system (10%), sleep disorders (8.6%), and heart rhythm disorders (4%); however, these were of tolerable severity as they did not significantly influence the dropout rate. Contrary to that, somnolence and younger age (?50 years) in particular increased the chance of premature treatment discontinuation, while patients suffering from cardiovascular risk factors or osteoporosis tended to adhere to the therapy. Conclusions: Overall, there is high tolerability for early SSRI treatment, whereas the occurrence of somnolence leads to discontinuation. PMID:25332703

Kostev, Karel; Rex, Juliana; Eith, Thilo; Heilmaier, Christina

2014-01-01

176

Digging Up the Human Genome: Current Progress in Deciphering Adverse Drug Reactions  

PubMed Central

Adverse drug reactions (ADRs) are a major clinical problem. In addition to their clinical impact on human health, there is an enormous cost associated with ADRs in health care and pharmaceutical industry. Increasing studies revealed that genetic variants can determine the susceptibility of individuals to ADRs. The development of modern genomic technologies has led to a tremendous advancement of improving the drug safety and efficacy and minimizing the ADRs. This review will discuss the pharmacogenomic techniques used to unveil the determinants of ADRs and summarize the current progresses concerning the identification of biomarkers for ADRs, with a focus on genetic variants for genes encoding drug-metabolizing enzymes, drug-transporter proteins, and human leukocyte antigen (HLA). The knowledge gained from these cutting-edge findings will form the basis for better prediction and management for ADRs, ultimately making the medicine personalized. PMID:24734245

Chung, Wen-Hung

2014-01-01

177

Significant adverse reactions to long-acting gonadotropin-releasing hormone agonists for the treatment of central precocious puberty and early onset puberty  

PubMed Central

Purpose Long-acting gonadotropin-releasing hormone agonists (GnRHa) are commonly used to treat central precocious puberty (CPP) in Korea. Although rare, there have been reports on the characteristic of adverse reactions of GnRHa in CPP among the Korean population. This study was intended to report on our clinical experience regarding significant adverse reactions to long-acting GnRHa in CPP and early onset puberty and to evaluate the prevalence rate of serious side effects. Methods This retrospective study included children with CPP and early onset puberty, who were administered monthly with long-acting GnRHa (leuprolide acetate, triptorelin acetate) at the outpatient clinic of Department of Pediatrics, at Inha University Hospital, between January 2011 and December 2013. We analyzed the clinical characteristics of patients who experienced significant adverse reactions and evaluated the prevalence rate. Results Six serious side effects (0.9%) were observed among total of 621 CPP and early onset puberty children with GnRHa therapy. The number of sterile abscess formation was four in three patients (4 events of 621). Anaphylaxis occurred in only one patient, and unilateral slipped capital femoral epiphysis (SCFE) in another one patient. Anaphylaxis occurred after the 6th administration of the monthly depot triptorelin acetate. Unilateral SCFE developed in GnRHa therapy. Conclusion Sterile abscess formation occurred in 0.6% of CPP and early onset puberty patients from the administration of a monthly depot GnRHa therapy. The occurrences of anaphylaxis and SCFE are extremely rare, but can have serious implications on patients. Clinicians should be aware of these potential adverse effects related to GnRHa therapy in CPP.

Lee, Ji Woo; Kim, Hyung Jin; Choe, Yun Mee; Kang, Hee Suk; Kim, Soon Ki; Jun, Yong Hoon

2014-01-01

178

Effect of thyroid hormone status and concomitant medication on statin induced adverse effects in hyperlipidemic patients.  

PubMed

Statins are effective treatment for the prevention of cardiovascular diseases and used extensively worldwide. However, adverse effects induced by statins are the major barrier of maximalizing cardiovascular risk reduction. Hypothyroidism and administration of drugs metabolized on the same cytochrome P450 (CYPP450) pathways where statin biotransformation occurs represent a significant risk factor for statin induced adverse effects including myopathy. Simvastatin, atorvastatin and lovastatin are metabolized by CYP3A4, fluvastatin by CYP2C9, while rosuvastatin by CYP2C9 and 2C19. We investigated the levels of the free thyroid hormones and CYP metabolism of concomitant medication in 101 hyperlipidemic patients (age 61.3 +/- 9.9 ys) with statin induced adverse effects including myopathy (56 cases; 55.4%), hepatopathy (39 cases; 38.6%) and gastrointestinal adverse effects (24 cases; 23.8%). Abnormal thyroid hormone levels were found in 5 patients (4.95%); clinical hypothyroidism in 2 and hyperthyroidism in 3 cases. 11 patients had a positive history for hypothyroidism (10.9%). Myopathy occured in one patient with hypothyroidism and two patients with hyperthyroidism. There were no significant differences in the TSH, fT4 and fT3 levels between patients with statin induced myopathy and patients with other types of adverse effects. 78 patients (77.2%) were administered drugs metabolized by CYP isoforms also used by statins (3A4: 66 cases (65.3%); 2C9: 67 cases (66.3%); 2C19: 54 cases (53.5%)). Patients with myopathy took significantly more drugs metabolized by CYP3A4 compared to patients with other types of adverse effects (p < 0.05). More myopathy cases were found in patients on simvastatin treatment (52% vs. 38%, ns.), while significantly less patients with myopathy were on fluvastatin treatment (13% vs. 33%, p < 0.05) compared to patients with other types of statin induced adverse effects. Both abnormal thyroid hormone status and administration of drugs metabolized by CYP3A4, 2C9 and 2C19 are common in our patients with statin induced adverse effects. Normalizing the thyroid hormone status and optimizing of the concomitant medication may reduce the risk of statin induced adverse effects. PMID:24974574

Berta, E; Harangi, M; Zsíros, N; Nagy, E V; Paragh, G; Bodor, M

2014-06-01

179

Determinants of under-reporting of adverse drug reactions: a systematic review.  

PubMed

A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting. A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman's 'seven deadly sins') associated with reporting. Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies. While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors. PMID:19132802

Lopez-Gonzalez, Elena; Herdeiro, Maria T; Figueiras, Adolfo

2009-01-01

180

HLA-B*5801 allele as a genetic marker for severe cutaneous adverse reactions caused by allopurinol.  

PubMed

Allopurinol, a commonly prescribed medication for gout and hyperuricemia, is a frequent cause of severe cutaneous adverse reactions (SCAR), which include the drug hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The adverse events are unpredictable and carry significant morbidity and mortality. To identify genetic markers for allopurinol-SCAR, we carried out a case-control association study. We enrolled 51 patients with allopurinol-SCAR and 228 control individuals (135 allopurinol-tolerant subjects and 93 healthy subjects from the general population), and genotyped for 823 SNPs in genes related to drug metabolism and immune response. The initial screen revealed strong association between allopurinol-SCAR and SNPs in the MHC region, including BAT3 (encoding HLA-B associated transcript 3), MSH5 (mutS homolog 5), and MICB (MHC class I polypeptide-related sequence B) (P < 10(-7)). We then determined the alleles of HLA loci A, B, C, and DRB1. The HLA-B*5801 allele was present in all (100%) 51 patients with allopurinol-SCAR, but only in 20 (15%) of 135 tolerant patients [odds ratio 580.3 (95% confidence interval, 34.4-9780.9); corrected P value = 4.7 x 10(-24)] and in 19 (20%) of 93 of healthy subjects [393.51 (23.23-6665.26); corrected P value = 8.1 x 10(-18)]. HLA alleles A*3303, Cw*0302, and DRB1*0301 were in linkage disequilibrium and formed an extended haplotype with HLA-B*5801. Our results indicated that allopurinol-SCAR is strongly associated with a genetic predisposition in Han Chinese. In particular, HLA-B*5801 allele is an important genetic risk factor for this life-threatening condition. PMID:15743917

Hung, Shuen-Iu; Chung, Wen-Hung; Liou, Lieh-Bang; Chu, Chen-Chung; Lin, Marie; Huang, Hsien-Ping; Lin, Yen-Ling; Lan, Joung-Liang; Yang, Li-Cheng; Hong, Hong-Shang; Chen, Ming-Jing; Lai, Ping-Chin; Wu, Mai-Szu; Chu, Chia-Yu; Wang, Kuo-Hsien; Chen, Chien-Hsiun; Fann, Cathy S J; Wu, Jer-Yuarn; Chen, Yuan-Tsong

2005-03-15

181

Teaching dental students about patient communication following an adverse event: a pilot educational module.  

PubMed

Adverse events are an important but understudied area in dentistry. Most dentists will face the issue of an adverse event several times in their clinical careers. The authors implemented a six-hour pilot educational module at one dental school to improve fourth-year dental students' knowledge and confidence in communicating with patients about adverse events. Based on results from the twenty-nine students who completed both the pre- and posttests, the module significantly increased the students' knowledge of the key concepts involved in adverse events. However, the module did not improve the students' confidence that they would be able to implement these communication skills in clinical situations. Based on these results, this article discusses how future educational efforts can be modified to better prepare students for the communication challenges associated with adverse events. PMID:24789835

Raja, Sheela; Rajagopalan, Chelsea F; Patel, Janki; Van Kanegan, Kevin

2014-05-01

182

Early recognition of risk factors for adverse outcomes during hospitalization among Medicare patients: a prospective cohort study  

PubMed Central

Background There is a persistently high incidence of adverse events during hospitalization among Medicare beneficiaries. Attributes of vulnerability are prevalent, readily apparent, and therefore potentially useful for recognizing those at greatest risk for hospital adverse events who may benefit most from preventive measures. We sought to identify patient characteristics associated with adverse events that are present early in a hospital stay. Methods An interprofessional panel selected characteristics thought to confer risk of hospital adverse events and measurable within the setting of acute illness. A convenience sample of 214 Medicare beneficiaries admitted to a large, academic medical center were included in a quality improvement project to develop risk assessment protocols. The data were subsequently analyzed as a prospective cohort study to test the association of risk factors, assessed within 24 hours of hospital admission, with falls, hospital-acquired pressure ulcers (HAPU) and infections (HAI), adverse drug reactions (ADE) and 30-day readmissions. Results Mean age?=?75(±13.4) years. Risk factors with highest prevalence included >4 active comorbidities (73.8%), polypharmacy (51.7%), and anemia (48.1%). One or more adverse hospital outcomes occurred in 46 patients (21.5%); 56 patients (26.2%) were readmitted within 30 days. Cluster analysis described three adverse outcomes: 30-day readmission, and two groups of in-hospital outcomes. Distinct regression models were identified: Weight loss (OR?=?3.83; 95% CI?=?1.46, 10.08) and potentially inappropriate medications (OR?=?3.05; 95% CI?=?1.19, 7.83) were associated with falls, HAPU, procedural complications, or transfer to intensive care; cognitive impairment (OR?=?2.32; 95% CI?=?1.24, 4.37), anemia (OR?=?1.87; 95% CI?=?1.00, 3.51) and weight loss (OR?=?2.89; 95% CI?=?1.38, 6.07) were associated with HAI, ADE, or length of stay >7 days; hyponatremia (OR?=?3.49; 95% CI?=?1.30, 9.35), prior hospitalization within 30 days (OR?=?2.66; 95% CI?=?1.31, 5.43) and functional impairment (OR?=?2.05; 95% CI?=?1.02, 4.13) were associated with 30-day readmission. Conclusions Patient characteristics recognizable within 24 hours of admission can be used to identify increased risk for adverse events and 30-day readmission. PMID:23834816

2013-01-01

183

Health care costs for prostate cancer patients receiving androgen deprivation therapy: treatment and adverse events  

PubMed Central

Background Serious adverse events have been associated with androgen deprivation therapy (adt) for prostate cancer (pca), but few studies address the costs of those events. Methods All pca patients (ICD-9-CM 185) in Ontario who started 90 days or more of adt or had orchiectomy at the age of 66 or older during 1995–2005 (n = 26,809) were identified using the Ontario Cancer Registry and drug and hospital data. Diagnosis dates of adverse events—myocardial infarction, acute coronary syndrome, congestive heart failure, stroke, deep vein thrombosis or pulmonary embolism, any diabetes, and fracture or osteoporosis—before and after adt initiation were determined from administrative data. We excluded patients with the same diagnosis before and after adt, and we allocated each patient’s time from adt initiation to death or December 31, 2007, into health states: adt (no adverse event), adt-ae (specified single adverse event), Multiple (>1 event), and Final (?180 days before death). We used methods for Canadian health administrative data to estimate annual total health care costs during each state, and we examined monthly trends. Results Approximately 50% of 21,811 patients with no pre-adt adverse event developed 1 or more events after adt. The costliest adverse event state was stroke ($26,432/year). Multiple was the most frequent (n = 2,336) and the second most costly health state ($24,374/year). Costs were highest in the first month after diagnosis (from $1,714 for diabetes to $14,068 for myocardial infarction). Costs declined within 18 months, ranging from $784 per 30 days (diabetes) to $1,852 per 30 days (stroke). Adverse events increased the costs of adt by 100% to 265%. Conclusions The economic burden of adverse events is relevant to programs and policies from clinic to government, and that burden merits consideration in the risks and benefits of adt. PMID:24940106

Krahn, M.D.; Bremner, K.E.; Luo, J.; Alibhai, S.M.H.

2014-01-01

184

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

SciTech Connect

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, 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.

Keating, Christopher, E-mail: C.Keating@sheffield.ac.u [Department of Biomedical Sciences, University of Sheffield, Sheffield (United Kingdom); Martinez, Vicente; Ewart, Lorna [Department of Safety Pharmacology, Safety Assessment UK, AstraZeneca, Alderley Park (United Kingdom); Gibbons, Stephen; Grundy, Luke [Department of Biomedical Sciences, University of Sheffield, Sheffield (United Kingdom); Valentin, Jean-Pierre [Department of Safety Pharmacology, Safety Assessment UK, AstraZeneca, Alderley Park (United Kingdom); Grundy, David [Department of Biomedical Sciences, University of Sheffield, Sheffield (United Kingdom)

2010-06-15

185

Age-adapted morphine titration produces equivalent analgesia and adverse effects in younger and older patients  

E-print Network

in these patients is of importance because inadequate analgesia is likely to increase postoperative confusionAge-adapted morphine titration produces equivalent analgesia and adverse effects in younger Summary Background To determine efficacy and safety of postoperative titrated morphine in elderly patients

Paris-Sud XI, Université de

186

Predictive Factors of Herpes Zoster HIV-Infected Patients: Another Adverse Effect of Crack Cocaine  

E-print Network

Predictive Factors of Herpes Zoster HIV-Infected Patients: Another Adverse Effect of Crack Cocaine.001; and in patients previously reported to use crack cocaine AHR=5.9, (95%CI=1.4-25), P=0.02. Herpes zoster incidence inhibitors on herpes zoster incidence. The present study is the first to suggest that crack cocaine

Boyer, Edmond

187

Cumulative Adverse Financial Circumstances: Associations with Patient Health Status and Behaviors  

ERIC Educational Resources Information Center

This article examines associations between cumulative adverse financial circumstances and patient health in a sample of 1,506 urban emergency department (ED) patients. Study participants completed a previously validated Social Health Survey between May and October 2009. Five categories of economic deprivation were studied: food insecurity, housing…

Bisgaier, Joanna; Rhodes, Karin V.

2011-01-01

188

Adverse effects of hydroxyurea in beta-thalassemia intermedia patients: 10 years' experience.  

PubMed

The aim of this study was to evaluate the tolerance and adverse effects of hydroxyurea (HU) in thalassemia intermedia (TI) patients who had been treated by HU for a period of 10 years. One hundred forty-three TI patients, including 78 male and 65 female, median age 21 years old (range: 5-37 years old), who were treated by HU were investigated as a case study, and 106 TI, including 63 male and 43 female, median age 22 years old (range: 5-39 years old), who were not treated by any HU as a control group. Mean dose of HU treatment was 10.74 mg/kg/day (range: 8-12 mg/kg/day) and adverse effects of HU were recorded in 44 (30.7%) patients. Dermatologic side effects were most commonly seen, followed by neurological and gastrointestinal adverse effects. There were not any reports of hematologic toxicity or any signs of bone marrow suppression during HU treatment. Statistical analysis showed a positive correlation between advancing age and the presence of adverse effects during HU treatment (P < .001). But there were not any significant relations among gender, HU dose, and duration of HU treatment and the presence of adverse effects (P > .05). It was also observed that splenectomized patients more frequently experienced adverse effects of HU (P < .05). According to these results, it seems that most of adverse effects in low-dose HU therapy in patients with TI, at least in short and medium terms, are minor and can be tolerated without needs of discontinuation of treatment. PMID:20367264

Karimi, Mehran; Cohan, Nader; Mousavizadeh, Kazem; Moosavizadeh, Kazem; Falahi, Mohammad Javad; Haghpanah, Sezaneh

2010-04-01

189

Ten-year trends in hospital admissions for adverse drug reactions in England 1999-2009  

PubMed Central

Summary Objectives Adverse drug reactions (ADR) are an important cause of morbidity and mortality. We analysed trends in hospital admissions associated with ADRs in English hospitals between 1999 and 2008. Design Data from the Hospital Episode Statistics database were examined for all English hospital admissions (1999–2008) with a primary or secondary diagnosis of an ADR recorded. Setting All NHS (public) hospitals in England. Main outcome measures The number of admissions and in-hospital mortality rate with a primary (codes including ‘adverse drug reaction’, ‘drug-induced’, ‘due to drug’, ‘due to medicament’ or ‘drug allergy’) or secondary diagnosis of ADR (ICD-10 Y40-59) were obtained and analysed. Further analysis for the year 2008–2009 was performed with regard to age, gender, proportion aged >65 yrs and total bed-days. Results Between 1999 and 2008, there were 557,978 ADR-associated admissions, representing 0.9% of total hospital admissions. Over this period the annual number of ADRs increased by 76.8% (from 42,453 to 75,076), and in-hospital mortality rate increased by 10% (from 4.3% to 4.7%). In 2008, there were 6,830,067 emergency admissions of which 75,076 (1.1%) were drug-related. Systemic agents were most commonly implicated (19.2%), followed by analgesics (13.3%) and cardiovascular drugs (12.9%).There has been a near two-fold increase in nephropathy and cardiovascular consequences secondary to drugs and a 6.8% fall in mental and behavioural disorders due to drugs. Conclusions ADRs have a major impact on public health. Our data suggest the number of ADR admissions has increased at a greater rate than the increase in total hospital admissions; some of this may be due to improved diagnostic coding. However, in-hospital mortality due to ADR admissions also increased during the period. Our findings should prompt policymakers to implement further measures to reduce ADR incidence and their associated in-hospital mortality, and methods to improve the recording of ADRs. PMID:20513902

Wu, Tai-Yin; Jen, Min-Hua; Bottle, Alex; Molokhia, Mariam; Aylin, Paul; Bell, Derek; Majeed, Azeem

2010-01-01

190

Adverse reactions after large-scale treatment of onchocerciasis with ivermectin: combined results from eight community trials.  

PubMed Central

Eight community trials were carried out by the Onchocerciasis Control Programme in West Africa to determine the safety of the new microfilaricide ivermectin during large-scale treatment of onchocerciasis. The trial areas were located in eight different countries and varied greatly in endemicity level; a total of 50,929 persons were treated and monitored for 72 hours. Overall treatment coverage was 60% of the census population, the main reasons for non-treatment being the exclusion criteria. Of those treated, 9% reported with adverse reactions, 2.4% with moderate reactions, and 0.24% with severe reactions. Most reactions were reported during the first day of follow-up, the most frequent severe reaction being severe symptomatic postural hypotension (in 49 cases). Three cases of severe dyspnoea were life-threatening but their relationship with ivermectin treatment is uncertain. The incidence of adverse reactions was directly related to skin microfilarial load and was highest in the foci with the highest endemicity levels. Treatment resulted in 98% reductions in mean microfilarial loads at all endemicity levels. The benefit of treatment largely compensated for the discomfort due to adverse reactions, which were all transient and managed successfully. Ivermectin thus appears to be sufficiently safe for large-scale treatment but monitoring by resident nurses for at least 36 hours is recommended. PMID:2633886

De Sole, G.; Remme, J.; Awadzi, K.; Accorsi, S.; Alley, E. S.; Ba, O.; Dadzie, K. Y.; Giese, J.; Karam, M.; Keita, F. M.

1989-01-01

191

Adverse physiological events under anaesthesia and sedation: a pilot audit of electronic patient records.  

PubMed

Review of perioperative activity including adverse events, throughput and compliance with 'best practice', can theoretically be used to optimise healthcare delivery. Computer-based analysis of electronic patient records could provide a practical means to manage quality improvement. This pilot study examined the effectiveness of such a system in practice. All intraoperative patient notes and physiological data were collected over 17 months in a rural hospital using data from an electronic record-keeping system. Algorithms were developed to automatically identify potential adverse events based on physiological measures. Each computer-identified event was reviewed by a panel of three anaesthetists and assessed for validity, severity and probable cause. Two areas were identified to pilot quality improvement activities-sedation for colonoscopies and inhalational anaesthesia with desflurane. Specific 'in-house' guidelines were created for these procedures and feedback on the patterns of adverse events were provided to anaesthetic staff A total of 138 separate adverse events were identified for all operative cases over 17 months, with an overall adverse event incidence of 3.3%. The adverse event incidence during colonoscopy and laryngospasm/hypoxia during desflurane anaesthesia was 6.3% and 1.3% respectively. This decreased to 2.8% (P <0.005) and 0.13% (P <0.0001) respectively for the nine months following feedback and the introduction of guidelines. Anaesthesia information systems can be an effective quality improvement tool and may enhance existing tools such as incident reporting systems. PMID:18361014

Grant, C; Ludbrook, G; Hampson, E A; Semenov, R; Willis, R

2008-03-01

192

Interstitial lung disease caused by TS-1: a case of long-term drug retention as a fatal adverse reaction.  

PubMed

TS-1 is an oral anti-cancer agent for gastric cancer with a high response rate and low toxicity. We report a case of long-term drug retention of TS-1 causing interstitial lung disease (ILD) as a fatal adverse reaction. A 65-year-old woman underwent a total gastrectomy with pathologic confirmation of gastric adenocarcinoma. She received 6 cycles of TS-1 and low-dose cisplatin for post-operative adjuvant chemotherapy followed by single-agent maintenance therapy with TS-1. After 8 months, the patient complained of a productive cough with sputum and mild dyspnea. A pulmonary evaluation revealed diffuse ILD in the lung fields, bilaterally. In spite of discontinuing chemotherapy and the administration of corticosteroids, the pulmonary symptoms did not improve, and the patient died of pulmonary failure. TS-1-induced ILD can be caused by long-term drug retention that alters the lung parenchyma irreversibly, the outcome of which can be life-threatening. Pulmonary evaluation for early detection of disease is recommended. PMID:22200043

Park, Joong-Min; Hwang, In Gyu; Suh, Suk-Won; Chi, Kyong-Choun

2011-12-01

193

Adverse reactions associated with studying persons recently exposed to mass urban disaster.  

PubMed

This study assesses the psychological consequences of participation in a mental health study among people recently exposed to the September 11 attacks. Using cross-sectional telephone surveys, we interviewed random samples of English-speaking or Spanish-speaking adults living in New York City during the attacks 1 year after this event. Altogether, 2,368 people completed the surveys, including a random sample of 1,173 respondents who received mental health services after the attacks. Results indicated that 15% of New Yorkers found some of the survey questions stressful, whereas 28% of those who sought treatment found this to be the case. However, less than 2% reported being upset at survey completion, and among these persons, only four people consented to speak to the study's mental health consultant. Although the majority of those expressing adverse reactions had sought postdisaster treatment, even among these subjects, only 3% were still upset at survey completion, and 2% wanted more information about counseling services. In addition, more than 70% of participants expressed positive sentiments about survey participation. Predictive models indicated that respondents who met study criteria for posttraumatic stress disorder, depression, or anxiety were more likely to find questions stressful, with people having posttraumatic stress disorder or depression the most likely to be upset and to consent to psychiatric consultation at completion. We suggest that, with the proper safeguards, research with persons exposed to a resent mass urban disaster generally can be conducted safely and effectively. PMID:15387153

Boscarino, Joseph A; Figley, Charles R; Adams, Richard E; Galea, Sandro; Resnick, Heidi; Fleischman, Alan R; Bucuvalas, Michael; Gold, Joel

2004-08-01

194

Erythema multiforme-like eruption from a slimming drug preparation cutaneous adverse drug reaction.  

PubMed

We report a case of a 34-year-old woman presenting with an erythema multiforme (EM)-like eruption. Lesions developed after a 12-day treatment with a slimming drug preparation (food integrator with thermogenic activity) and a herbal remedy (pilosella tincture). Serological investigations excluded viral or bacterial infections. Patch testing with galenic preparations of both drugs demonstrated sensitization to the slimming drug preparation. According to literature reports and immune-chemical properties, those components that are likely to have triggered the skin eruption are clorazepate dipotassium and theobromine. Their interaction with other two constituents such as pseudoephedrine hydrochloride and dehydrocholic acid may have caused the adverse reaction by means of a summation effect. There are no reports specifically about EM caused by a slimming drug preparation and no studies have identified thermogenic pills as cause of EM/EM-like eruption. Weight-loss compounds in slimming preparations should be kept in mind as a possible cause of drug-induced EM-like eruption. PMID:23130230

Tognetti, Linda; Giorgini, Simonetta; Lotti, Torello

2011-07-01

195

The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety  

PubMed Central

The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety. PMID:24454289

Ekor, Martins

2014-01-01

196

Serious adverse incidents with the usage of low molecular weight heparins in patients with chronic kidney disease  

Microsoft Academic Search

Background: The aim of the study is to describe serious adverse events in patients with renal insufficiency administered low molecular weight heparins (LMWHs). Methods: Systematic case note review from July 2002 to March 2003, Hope Hospital, Salford, UK, was used. Results: Ten patients experienced an adverse incident on LMWH therapy. Five patients were on maintenance hemodialysis therapy, and 1 patient

Vasim Farooq; Janet Hegarty; Thangavelu Chandrasekar; Elizabeth H. Lamerton; Sandip Mitra; John B. Houghton; Philip A. Kalra; Stephen Waldek; Donal J. O’Donoghue; Grahame N. Wood

2004-01-01

197

A Multicenter Retrospective Analysis of Adverse Events in Korean Patients Using Bortezomib for Multiple Myeloma  

Microsoft Academic Search

The proteasome inhibitor bortezomib has demonstrated clinical activity in patients with multiple myeloma (MM). Adverse events,\\u000a including thrombocytopenia and peripheral neuropathy, have affected 30% to 60% of patients overall, and interrupted therapy\\u000a in 10% to 20%. No prior toxicity data are available for Asian patients who have used bortezomib for MM. We used National Cancer\\u000a Institute Common Terminology Criteria for

Soo-Mee Bang; Jae Hoon Lee; Sung-Soo Yoon; Chang-Ki Min; Chun-Choo Kim; Cheolwon Suh; Sang Kyun Sohn; Yoo-Hong Min; Je-Jung Lee; Chu-Myong Seong; Hwi-Joong Yoon; Kyung Sam Cho; Deog-Yeon Jo; Kyung Hee Lee; Na-Ri Lee; Chul Soo Kim

2006-01-01

198

The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study  

PubMed Central

Objectives: The present study was undertaken to provide the health professionals who were working at a tertiary care hospital, with a simple method to report Adverse Drug Reactions (ADRs) and to monitor, document and to evaluate them according to the set criteria. Method and materials: This study was conducted over a period of 15 months from 1st Jan’ 2008 to 31st March 2009 at Goa Medical College and Hospital (Goa, India). The evaluation of the data was done for various parameters, which included patient demographics and drug and reaction characteristics. An assessment was also done for the outcome, causality and the severity of the drug reactions. Results: A total of 265 ADRs were reported. Among the drugs, the ß-lactam antibiotics were implicated the maximum number of times (54, 20.37%), followed by fluoroquinolones (35, 13.20%), antiretrovirals (33, 12.45%) and antiepileptics (31, 11.69%). Females showed more ADRs (142, 54%) than males (123, 46%). The skin was involved in about 57.73% (153) of the ADRs, while the CNS and the vascular system were involved in 8.67% (23) and 8.30% (22) of the ADRs. Most of the ADRs were categorized as “Type II” (203, 77%) against “Type I” (62, 23%) by Rawlins and Thompson’s classification. The causality assessment was done by the Naranjo Algorithm and 62.26% (165) were seen to fall in the “probable category” as compared to 29.05% (77) in the “highly probable” one. Out of all the ADRs which were reported, 34.71% (148) were “severe”, in accordance with the Modified Hartwig and Siegel’s scale. Conclusion: The present work was a humble attempt to set up a well organized ADR reporting system at our government hospital. The systematic tracking and monitoring of ADRs can shed light on their extensiveness and their patterns of occurrence. PMID:23285441

Dang, Amit; Bhandare, P. N.

2012-01-01

199

Relation of motives for drug use and psychopathology in the development of acute adverse reactions to psychoactive drugs  

Microsoft Academic Search

The relation among motives for drug use, the degree of drug use, psychopathology, and acute adverse reactions to marihuana and LSD were examined using retrospective data on 483 male drug users (mean age 21.4 yrs). (A description of the measures used can be found in an earlier report by the author; . Three dimensions of motives were identified: (a) use

Murray P. Naditch

1975-01-01

200

A Distributed Adverse Drug Reaction Detection System Using Intelligent Agents with Fuzzy Recognition-Primed Decision Model  

E-print Network

about 100,000 deaths in the U.S. due to medical errors, of which about 7,000 were attributed to various, USA 4 Veterans Affairs Medical Center, Detroit, Michigan, USA #12;2 Abstract Discovering unknown model; Medical decision-making. #12;3 1. Introduction 1.1 Adverse Drug Reactions Every day numerous

201

A prognostic model for short term adverse events in normotensive patients with pulmonary embolism.  

PubMed

Risk stratification of patients with PE has gained interest in terms of the identification of patients in whom treatment on an outpatient base can be considered. Previous studies are of limited value due to their focus on adverse clinical events within several months after diagnosis of PE. We developed a prognostic model, based on easily accessible, clinical, and laboratory parameters, to predict adverse events during the first 10 days after the diagnosis of acute PE. We have analyzed the data of 210 outpatients with confirmed PE. Collected data included medical history, pulse rate, blood pressure, NT-proBNP, and D-dimer concentrations. The primary outcome was the occurrence of adverse clinical events in a 10 day follow-up period. Our final prognostic model to predict short-term adverse events consists of NT-proBNP levels, D-dimer concentrations, pulse rate, and the occurrence of active malignancy; the total score ranges from 0 to 37 points. Patients with a low score (no active malignancy, pulse rate <90 bpm, NT-proBNP <500 pg/ml, and D-dimer <3,000 ?g/l FEU) have a 10-day adverse event risk <1.5%. This risk increases to over 30% in patients with a maximum score, based on high pulse rate, D-dimer concentrations, and NT-proBNP levels. Our prognostic model, once prospectively validated in an independent sample of patients, can be used in the early risk stratification of PE to estimate the risk of adverse events and to differentiate between candidates for in- or out- hospital treatment. PMID:21630313

Agterof, Mariette J; Schutgens, Roger E G; Moumli, Noureddine; Eijkemans, M J C; van der Griend, René; Tromp, Ellen A M; Biesma, Douwe H

2011-08-01

202

Adverse reactions to suxamethonium and other muscle relaxants under general anesthesia  

SciTech Connect

The mechanisms of anaphylactic reactions to muscle relaxants under general anesthesia are not completely understood. Extending an earlier study, we report 41 cases of anaphylactic shock investigated by intradermal skin tests with muscle relaxants (suxamethonium, pancuronium, gallamine, nortoxiferine), in vitro leukocyte histamine release, and Prausnitz-Kuestner tests. Intradermal tests were significantly positive at concentrations ranging from 10 to 10(5) times less than those in controls. Reproducibility tested for suxamethonium at a 1-year interval in five patients was good. Histamine release induced by muscle relaxants in Tris-albumin-Ca++-Mg++ buffer showed positive results in 8/25 instances and was inhibited by antigen excess in seven cases. Addition of 50% deuterium oxide (D2O) caused significant increase of histamine release in positive cases and induced release in all five negative cases studied. Muscle relaxant-induced histamine release was inhibited by in vitro anti-IgE leukocyte desensitization. The mean maximal histamine release dropped from 58.2% +/- 9.7 to 5.8% +/- 2 (p less than 0.01). Similarly, leukocyte desensitization also inhibited histamine release induced by anti-IgE but not by formyl-L-methionyl-L-leucyl-L-phenylalanine or poly-L-arginine. Prausnitz-Kuestner tests were positive in five out of 21 cases studied and became negative after heat inactivation. These results confirm the usefulness of intradermal skin tests in diagnosis of patients' reaction to muscle relaxants and suggest an IgE-mediated rather than an idiosyncratic mechanism.

Vervloet, D.; Nizankowska, E.; Arnaud, A.; Senft, M.; Alazia, M.; Charpin, J.

1983-06-01

203

Individualized Risks of First Adverse Events in Patients With Fanconi Anemia  

Cancer.gov

Individualized Risks of First Adverse Events in Patients With Fanconi Anemia 1 Philip S. Rosenberg, PhD, 2Yi Huang, MS, 3Blanche P. Alter, MD, MPH From 1 Biostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute,

204

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011.  

PubMed

Background Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children. Objective To characterize paediatric ADRs reported for asthma medications licensed for paediatric use. Setting Spontaneous ADR reports located in the European ADR database, EudraVigilance. Method ADRs reported for asthma medications licensed for paediatric use from 2007 to 2011 were analysed. The included substances were beclometasone, budesonide, fenoterol, fluticasone, formoterol, mometasone, montelukast, salbutamol and terbutaline and the combinations of budesonide/formoterol, fenoterol/ipratropium and fluticasone/salmeterol. Main outcome measures Reported ADRs were categorized with respect to distribution on age, sex, type and seriousness of reported ADRs, medications and type of reporter. The unit of analysis was one ADR. Results We located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85 % of reported ADRs were serious including six fatal cases. In total, 57 % of ADRs were reported for boys. One quarter of all ADRs occurred in children up to 1 year of age. Physicians reported the majority of ADRs. Across medicines, the majority of reported ADRs were of the type "psychiatric disorders" (13 % of total ADRs), followed by "respiratory, thoracic and mediastinal disorders" (10 % of total ADRs) and "skin and subcutaneous disorders" (9 % of total ADRs). The largest number of ADRs was reported for budesonide (21 % of total ADRs), followed by salbutamol (20 % of total ADRs) and fluticasone (19 % of total ADRs). For salbutamol, the largest numbers of serious ADRs were "tachycardia", "accidental exposure/incorrect dose administered" and "respiratory failure". Conclusion Only a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious including fatal cases. PMID:25288145

Aagaard, Lise; Hansen, Ebba Holme

2014-12-01

205

Adverse Drug Reaction Monitoring of Antidepressants in the Psychiatry Outpatients Department of a Tertiary Care Teaching Hospital  

PubMed Central

Background and Introduction: Depression is a prevalent mental disorder and the 4th leading cause of disability in the world as per the World Health Organization (WHO). The adverse Drug Reactions (ADRs) to antidepressants are common and they can lead to a non compliance or even a discontinuation of the therapy. This study entitled us to monitor the ADR profile of the antidepressants in a tertiary care teaching hospital. Patients and Methods: A longitudinal, observational study was conducted in the Outpatients Department of Psychiatry in S.C.B. Medical College and Hospital l in collaboration with the I.M.S and SUM Hospital. A total of 160 cases were studied for ADRs by using a predesigned CDSCO form. The patients who were on TCAs, SSRIs and newer antidepressants (SNRIs/NDRIs) were assessed by doing physical examinations, neurological examinations and relevant lab tests. The causalities were assessed by the criteria of the WHO-UMC. The analysis of ADRs was done by using the Chi square test. Results: Among the 160 patients who took antidepressants, 26.87% reported ADRs, with at least one possible causality.None were labeled as certain, as a rechallenge was not performed.ADRs were mostly observed in polytherapy (14.37%) and with antidepressants like TCAs (58.84%). Conclusions: Agitation, anxiety and insomnia were the common ADRs which were associated with the use of antidepressants. This study offers a representative profile of the ADRs which can be expected in the Psychiatry Outpatients Department and due care must be taken to avoid these ADRs. PMID:23905119

Mishra, Swati; Swain, Trupti Rekha; Mohanty, Manjushree

2013-01-01

206

Thrombocytosis portends adverse prognostic significance in patients with stage II colorectal carcinoma  

PubMed Central

Thrombocytosis portends adverse prognostic significance in many types of cancers including ovarian and lung carcinoma. In this study, we determined the prevalence and prognostic significance of thrombocytosis (defined as platelet count in excess of 400 × 10 3/?l) in patients with colorectal cancer. We performed a retrospective analysis of 310 consecutive patients diagnosed at our Institution between 2004 and 2013. The patients (48.7% male and 51.3% female) had a mean age of 69.9 years (+/- 12.7 years) at diagnosis. Thrombocytosis was found in a total of 25 patients, with a higher incidence in those with stage III and IV disease (14.4% of patients). Although the mean platelet count increased with the depth of tumor invasion (pT), its values remained within normal limits in the whole patient cohort. No patient with stage I cancer (n=57) had elevated platelet count at diagnosis. By contrast, five of the 78 patients (6.4%) with stage II cancer showed thrombocytosis, and four of these patients showed early recurrence and/or metastatic disease, resulting in shortened survival (they died within one year after surgery). The incidence of thrombocytosis increased to 12.2% and 20.6%, respectively, in patients with stage III and IV disease. The overall survival rate of patients with thrombocytosis was lower than those without thrombocytosis in the stage II and III disease groups, but this difference disappeared in patients with stage IV cancer who did poorly regardless of their platelet count. We concluded that thrombocytosis at diagnosis indicates adverse clinical outcome in colorectal cancer patients with stage II or III disease. This observation is especially intriguing in stage II patients because the clinical management of these patients is controversial. If our data are confirmed in larger studies, stage II colon cancer patients with thrombocytosis may be considered for adjuvant chemotherapy.

Guo, Tianhua; Krzystanek, Marcin; Szallasi, Zoltan; Szallasi, Arpad

2014-01-01

207

Neurological adverse events in patients receiving anti-TNF therapy: a prospective imaging and electrophysiological study  

PubMed Central

Introduction The aim was to investigate the frequency of neurological adverse events in patients with rheumatoid arthritis (RA) and spondylarthropathies (SpA) treated with tumor necrosis factor (TNF) ? antagonists. Methods Seventy-seven patients eligible for anti-TNF? therapy were evaluated. There were 36 patients with RA, 41 with SpA [24 psoriatic arthritis (PsA) and 17 with ankylosing spondylitis (AS)]. All patients had a complete physical and neurological examination. Brain and cervical spine magnetic resonance imaging (MRI) and neurophysiological tests were performed in all patients before the initiation of anti-TNF? therapy and after a mean of 18 months or when clinical symptoms and signs indicated a neurological disease. Exclusion criteria included hypertension, diabetes mellitus, dyslipidemia, heart arrhythmias, atherothrombotic events, vitamin B12 and iron deficiency, head and neck trauma and neurological surgeries. Results Two patients did not receive anti-TNF? therapy because brain MRIs at baseline revealed lesions compatible with demyelinating diseases. Thus, 75 patients received anti-TNF? (38 infliximab, 19 adalimumab and 18 etanercept). Three patients developed neurological adverse events. A 35-year-old man with PsA after 8 months of infliximab therapy presented with paresis of the left facial nerve and brain MRI showed demyelinating lesions. Infliximab was discontinued and he was treated with pulses of corticosteroids recovering completely after two months. The second patient was a 45-year-old woman with RA who after 6 months of adalimumab therapy presented with optic neuritis. The third patient was a 50-year-old woman with AS, whom after 25 months of infliximab therapy, presented with tingling and numbness of the lower extremities and neurophysiological tests revealed peripheral neuropathy. In both patients anti-TNF were discontinued and they improved without treatment after 2 months. The rest of our patients showed no symptoms and MRIs showed no abnormalities. The estimated rate of neurological adverse events in patients treated with anti-TNF therapy is 4% (3/75). Conclusions Neurological adverse events after anti-TNF? therapy were observed in our patient. Brain MRI and neurophysiological tests are essential tools to discriminate neurological diseases. PMID:24938855

2014-01-01

208

Implant based differences in adverse local tissue reaction in failed total hip arthroplasties: a morphological and immunohistochemical study  

PubMed Central

Background Adverse local tissue reaction (ALTR) is characterized by periprosthetic soft tissue inflammation composed of a mixed inflammatory cell infiltrate, extensive soft tissue necrosis, and vascular changes. Multiple hip implant classes have been reported to result in ALTR, and clinical differences may represent variation in the soft tissue response at the cellular and tissue levels. The purpose of this study was to describe similarities and differences in periprosthetic tissue structure, organization, and cellular composition by conventional histology and immunohistochemistry in ALTR resulting from two common total hip arthroplasty (THA) implant classes. Methods Consecutive patients presenting with ALTR from two major hip implant classes (N?=?54 patients with Dual-Modular Neck implant; N?=?14 patients with Metal-on-Metal implant) were identified from our prospective Osteolysis Tissue Database and Repository. Clinical characteristics including age, sex, BMI, length of implantation, and serum metal ion levels were recorded. Retrieved synovial tissue morphology was graded using light microscopy and cellular composition was assessed using immunohistochemistry. Results Length of implantation was shorter in the DMN group versus MoM THA group (21.3 [8.4] months versus 43.6 [13.8] months respectively; p?reaction in both implants, with increased ratios of perivascular T-cell relative to B-cell markers in the DMN relative to the MoM group (p?=?0.032). Conclusion Our results demonstrate that both implant classes display common features of neo-synovial proliferation and necrosis with a CD4 and GATA-3 rich inflammatory infiltrate. Qualitative differences in corrosion product appearance, macrophage morphology, and lymphocyte distributions were seen between the two implant types. Our data suggests that ALTR represents a histological spectrum with implant-based features. PMID:25242891

2014-01-01

209

Safety of Etoricoxib in Patients With Reactions to NSAIDs  

Microsoft Academic Search

? Abstract Background: Adverse reactions to nonsteroidal anti-infl ammatory drugs (NSAIDs) are a frequently reported problem due to the fact that these molecules are often used for control of pain and infl ammation. Although the use of selective inhibitors of cyclooxygenase (COX) 2 helps to prevent some of these adverse reactions, they can have cardiac side effects when taken for

O Quercia; F Emiliani; FG Foschi; GF Stefanini

2008-01-01

210

ADVERSE DRUG REACTIONS TO ANTIBIOTICS OBSERVED IN TWO PULMONOLOGY DIVISIONS OF CATANZARO, ITALY: A SIX-YEAR RETROSPECTIVE STUDY  

Microsoft Academic Search

We retrospectively analysed adverse drug reactions (ADRs) associated with antibiotic therapy and reported over a 6-year period, from January 1995 to December 2000, in clinical notes of two Pulmonology Units of “Mater Domini” University Hospital and “Pugliese-Ciaccio” Hospital, both located in Catanzaro, Italy.Antibiotics were responsible for 92 (44.9%) out of 205 episodes of ADRs. In particular, 22 episodes (23.9%) were

L. GALLELLI; G. FERRERI; M. COLOSIMO; D. PIRRITANO; L. GUADAGNINO; G. PELAIA; R. MASELLI; G. B. DE SARRO

2002-01-01

211

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events  

Microsoft Academic Search

BACKGROUND: Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and\\/or ineffective for reviewing the data collected and improving the outcomes in patient safety. OBJECTIVE: To describe the

Ricardo Pietrobon; Raquel Lima; Anand Shah; Danny O Jacobs; Matthew Harker; Mariana McCready; Henrique Martins; William Richardson

2007-01-01

212

Association between hemoglobin variability, serum ferritin levels, and adverse events/mortality in maintenance hemodialysis patients.  

PubMed

In recent times, therapy for renal anemia has changed dramatically in that iron administration has increased and doses of erythropoiesis-stimulating agents (ESAs) have decreased. Here we used a prospective, observational, multicenter design and measured the serum ferritin and hemoglobin levels every 3 months for 2 years in 1086 patients on maintenance hemodialysis therapy. The associations of adverse events with fluctuations in ferritin and hemoglobin levels and ESA and iron doses were measured using a Cox proportional hazards model for time-dependent variables. The risks of cerebrovascular and cardiovascular disease (CCVD), infection, and hospitalization were higher among patients who failed to maintain a target-range hemoglobin level and who exhibited high-amplitude fluctuations in hemoglobin compared with patients who maintained a target-range hemoglobin level. Patients with a higher compared with a lower ferritin level had an elevated risk of CCVD and infectious disease. Moreover, the risk of death was significantly higher among patients with high-amplitude ferritin fluctuations compared with those with a low ferritin level. The risks of CCVD, infection, and hospitalization were significantly higher among patients who were treated with high weekly doses of intravenous iron compared with no intravenous iron. Thus, there is a high risk of death and/or adverse events in patients with hemoglobin levels outside the target range, in those with high-amplitude hemoglobin fluctuations, in those with consistently high serum ferritin levels, and in those with high-amplitude ferritin fluctuations. PMID:24759150

Kuragano, Takahiro; Matsumura, Osamu; Matsuda, Akihiko; Hara, Taiga; Kiyomoto, Hideyasu; Murata, Toshiaki; Kitamura, Kenichiro; Fujimoto, Shouichi; Hase, Hiroki; Joki, Nobuhiko; Fukatsu, Atushi; Inoue, Toru; Itakura, Ikuhiro; Nakanishi, Takeshi

2014-10-01

213

Adverse incidents and patient safety - improving the learning experience of junior doctors.  

PubMed

The need to ensure patient safety in the National Health Service (NHS) is a national priority. However, it has long been recognised that a culture of blame impedes learning from previous adverse incidents. It is important to feedback the outcomes of investigations into incidents to NHS staff, but junior doctors have little knowledge of learning points from investigations into adverse incidents. Learning from past mistakes would improve practice and the level of care provided by junior doctors. A forum for learning from mistakes could also provide an opportunity to review past incidents in an open and supportive environment. This could, in turn, start to change the current culture of blame in the NHS and contribute to higher standards of patient safety in the future. PMID:24532743

Baruch, Nina

2014-02-01

214

Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality of life in patients with multiple sclerosis: a cross-sectional study  

PubMed Central

Background Glatiramer acetate (GA) and interferon-beta (IFN-?) are disease-modifying therapies (DMTs) for multiple sclerosis that are administered through subcutaneous (SC) or intramuscular (IM) injections. Skin reactions associated with DMTs are common and may influence patient’s health-related quality of life (QoL). We aimed to determine the prevalence of cutaneous adverse events associated with long-term DMT use, and to assess the impact of cutaneous adverse events on QoL. Methods A cross-sectional study among patients with multiple sclerosis who had been treated with their first DMT for at least 2 years. Cutaneous events were assessed from photographs of injection-sites by dermatologists blinded for DMT. Generic and dermatology-specific health-related QoL were assessed using validated patient-reported questionnaires. Results A total of 229 patients were enrolled, of whom 156 (68%) had at least one skin reaction. The prevalence of cutaneous adverse events was higher for SC DMTs (75-82%) compared to IM DMT (41%) (P < 0.001). Erythema and lipoatrophy were the most common skin reactions, observed in 156 (68%) and 45 (20%) patients, respectively. Dermatology-specific, but not generic, QoL was significantly lower among patients with skin reactions compared to those without. Conclusions The prevalence of cutaneous adverse events was high in long-term DMT-treatment. Patients with cutaneous adverse events had a lower perceived dermatology-specific QoL. PMID:24131589

2013-01-01

215

Physicians' Reactions to Overweight Patients  

NSDL National Science Digital Library

This case study, by David M. Lane of Rice University, assesses the question, "Do physicians discriminate against overweight patients?" This study indicates that, at least in one respect, they do. Basic concepts are t-test, means, and boxplots. The experimental design, materials, descriptive statistics, inferential statistics, and raw data are given.

Lane, David M.

2009-02-26

216

Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes  

PubMed Central

Background In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood. Methods Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided. Results A total of 163 patients were enrolled for an average of 12 months (range = 1–28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms. Conclusions Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are complementary, each providing clinically meaningful information. Inclusion of both types of data in treatment trial results and drug labels appears to be warranted. PMID:19920223

Jia, Xiaoyu; Heller, Glenn; Barz, Allison; Sit, Laura; Fruscione, Michael; Appawu, Mark; Iasonos, Alexia; Atkinson, Thomas; Goldfarb, Shari; Culkin, Ann; Kris, Mark G.; Schrag, Deborah

2009-01-01

217

Anaphylaxis following intravenous ranitidine: A rare adverse reaction of a common drug  

PubMed Central

Ranitidine hydrochloride is a widely used drug that is generally well-tolerated. Anaphylaxis is rarely observed with ranitidine. We report a case who developed severe anaphylaxis following single dose of intravenous ranitidine. The article highlights the importance of recognition of this serious adverse event and re-emphasizes the need for cautious use of drugs, especially in those with known history of allergy. PMID:24741203

Chopra, Deepti; Arora, Pooja; Khan, Shamimullah; Dwivedi, Shridhar

2014-01-01

218

Effects of Polypharmacy on Adverse Drug Reactions among Geriatric Outpatients at a Tertiary Care Hospital in Karachi: A Prospective Cohort Study  

PubMed Central

Background Adverse drug reactions (ADRs) present a challenging and expensive public health problem. Polypharmacy is defined according to the WHO criteria as the, “concurrent use of five or more different prescription medication”. Elderly are more prone to adverse reactions due to comorbid conditions, longer lists of medications and sensitivity to drug effects. The aim of the study is to estimate the incidence and strength of association of ADRs due to polypharmacy among the geriatric cohort attending outpatient clinics at a tertiary care center. Methods A hospital based prospective cohort study was conducted at ambulatory care clinics of Aga Khan University Hospital April 2012 to March 2013. One thousand geriatrics patients (age ?65 years) visiting ambulatory clinics were identified. They were divided on the basis of exposure (polypharmacy vs. no polypharmacy). We followed them from the time of their enrollment (day zero) to six weeks, checking up on them once a week. Incidence was calculated and Cox Proportional Hazard Model estimates were used. Results The final analysis was performed on 1000 elderly patients. The occurrence of polypharmacy was 70% and the incidence of ADRs was 10.5% among the study cohort. The majority (30%) of patients were unable to read or write. The use of herbal medicine was reported by 3.2% of the patients and homeopathic by 3%. Our Cox adjusted model shows that polypharmacy was 2.3 times more associated with ADRs, con-current complementary and alternative medicine (CAM) was 7.4 times and those who cannot read and write were 1.5 times more associated with ADRs. Conclusion The incidence of ADRs due to poly pharmacy is alarmingly high. The factors associated with ADRs are modifiable. Policies are needed to design and strengthen the prescription pattern. PMID:25402452

Mujeeb, Rakshinda; Patel, Muhammad Junaid

2014-01-01

219

Systemic and Nonrenal Adverse Effects Occurring in Renal Transplant Patients Treated with mTOR Inhibitors  

PubMed Central

The mammalian target of rapamycin inhibitors (mTOR-I), sirolimus and everolimus, are immunosuppressive drugs largely used in renal transplantation. The main mechanism of action of these drugs is the inhibition of the mammalian target of rapamycin (mTOR), a regulatory protein kinase involved in lymphocyte proliferation. Additionally, the inhibition of the crosstalk among mTORC1, mTORC2, and PI3K confers the antineoplastic activities of these drugs. Because of their specific pharmacological characteristics and their relative lack of nephrotoxicity, these inhibitors are valid option to calcineurine inhibitors (CNIs) for maintenance immunosuppression in renal transplant recipients with chronic allograft nephropathy. However, as other immunosuppressive drugs, mTOR-I may induce the development of several adverse effects that need to be early recognized and treated to avoid severe illness in renal transplant patients. In particular, mTOR-I may induce systemic nonnephrological side effects including pulmonary toxicity, hematological disorders, dysmetabolism, lymphedema, stomatitis, cutaneous adverse effects, and fertility/gonadic toxicity. Although most of the adverse effects are dose related, it is extremely important for clinicians to early recognize them in order to reduce dosage or discontinue mTOR-I treatment avoiding the onset and development of severe clinical complications. PMID:24151517

Zaza, Gianluigi; Tomei, Paola; Ria, Paolo; Granata, Simona; Boschiero, Luigino; Lupo, Antonio

2013-01-01

220

Metabotropic Glutamate Receptor 5 Negative Modulation in Phase I Clinical Trial: Potential Impact of Circadian Rhythm on the Neuropsychiatric Adverse Reactions--Do Hallucinations Matter?  

PubMed Central

Metabotropic Glutamate Receptor 5 (mGluR5) negative allosteric modulators (NAMs) may play a role in some psychiatric disorders such as anxiety and depression. The pharmacokinetic profile and pharmacodynamics effects of mGluR5-NAMs have been previously reported. We performed a post hoc analysis of pharmacological and clinical data obtained from 18 young healthy female subjects who received a mGluR5-NAM in the context of a phase I drug-drug interaction study between a mGluR5 NAM and a monophasic oral contraceptive. mGluR5-NAM was administered in an escalating bidaily dose level design. There was no interaction between the OC and mGluR5-NAM. Higher morning mGluR5-NAM plasma concentrations were found compared to evening concentrations. Most of the observed clinically significant neuropsychiatric adverse reactions occurred nocturnally and included visual (pseudo) hallucinations, insomnia accompanied by secondary behavioural disorders, and cognitive dysfunction symptoms of sufficient severity to interfere with daily functioning. Circadian rhythm-related physiological variations in drug absorption and disposition may explain this pharmacokinetics-pharmacodynamics apparently disproportionate relationship. We suggest that clinical trials evaluating basic pharmacokinetic properties of psychiatric medications consider potential drug's chronopharmacokinetics. This may assist with dose optimization and minimize serious neuropsychiatric adverse reactions in the vulnerable psychiatric patient. PMID:24729909

Bruggeman, Richard; Balje-Volkers, Corine

2014-01-01

221

Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial  

PubMed Central

Background The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events. Methods Participants were recruited among patients, ages 18–65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n =?767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n =?249), 2) manual therapy excluding spinal manipulation (n =?258) and 3) manual therapy excluding stretching (n =?260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms. Results The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR =?2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR =?2.49 (95% CI: 1.77-3.52)) compared to men. Conclusion Adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men. Trial registration This trial was registered in a public registry (Current Controlled Trials) (ISRCTN92249294). PMID:24618345

2014-01-01

222

Clinical features associated with adverse events in patients with post-pericardiotomy syndrome following cardiac surgery.  

PubMed

Postpericardiotomy syndrome (PPS) may be associated with tamponade and pericardial constriction that may require procedural intervention. The aim of this study was to identify clinical features associated with adverse events requiring procedural intervention in patients with PPS. A total of 239 patients who developed PPS after cardiac surgery were monitored for 12 months. PPS was diagnosed if 2 of the 5 following findings were present: fever without infection, pleuritic pain, friction rub, pleural effusion, and pericardial effusion (<60 days after surgery). The primary end point was the development of pericardial effusion or pericardial constriction requiring procedural intervention. Among 239 patients with PPS, 75 (31%) required procedural intervention. In a univariate analysis, the odds of a procedural intervention were decreased with older age (odds ratio [OR] 0.98, 95% confidence interval [CI] 0.96 to 0.99) and with colchicine used in combination with anti-inflammatory agents (OR 0.45, 95% CI 0.26 to 0.79). However, the odds were increased in patients with preoperative heart failure (OR 1.84, 95% CI 1 to 3.39) and early postoperative constrictive physiology (OR 5.77, 95% CI 2.62 to 12.7). After multivariate adjustment, treatment with colchicine along with anti-inflammatory agents was associated with lower odds of requiring intervention (OR 0.43, 95% CI 0.95 to 0.99). Independent positive predictors of procedural intervention included age (OR 0.97, 95% CI 0.95 to 0.99), time to PPS (OR 0.97, 95% CI 0.95 to 0.99), and early postoperative constrictive physiology (OR 6.23, 95% CI 2.04 to 19.07). In conclusion, younger age, early-onset PPS, and postoperative constrictive physiology were associated with the need for procedural intervention in patients with PPS, whereas colchicine was associated with reduced odds of adverse events and procedural intervention. PMID:25306427

Alraies, M Chadi; Al Jaroudi, Wael; Shabrang, Cyrus; Yarmohammadi, Hirad; Klein, Allan L; Tamarappoo, Balaji K

2014-11-01

223

Managing adverse effects of glaucoma medications  

PubMed Central

Glaucoma is a chronic, progressive disease in which retinal ganglion cells disappear and subsequent, gradual reductions in the visual field ensues. Glaucoma eye drops have hypotensive effects and like all other medications are associated with adverse effects. Adverse reactions may either result from the main agent or from preservatives used in the drug vehicle. The preservative benzalkonium chloride, is one such compound that causes frequent adverse reactions such as superficial punctate keratitis, corneal erosion, conjunctival allergy, and conjunctival injection. Adverse reactions related to main hypotensive agents have been divided into those affecting the eye and those affecting the entire body. In particular, ?-blockers frequently cause systematic adverse reactions, including bradycardia, decrease in blood pressure, irregular pulse and asthma attacks. Prostaglandin analogs have distinctive local adverse reactions, including eyelash bristling/lengthening, eyelid pigmentation, iris pigmentation, and upper eyelid deepening. No systemic adverse reactions have been linked to prostaglandin analog eye drop usage. These adverse reactions may be minimized when they are detected early and prevented by reducing the number of different eye drops used (via fixed combination eye drops), reducing the number of times eye drops are administered, using benzalkonium chloride-free eye drops, using lower concentration eye drops, and providing proper drop instillation training. Additionally, a one-time topical medication can be given to patients to allow observation of any adverse reactions, thereafter the preparation of a topical medication with the fewest known adverse reactions can be prescribed. This does require precise patient monitoring and inquiries about patient symptoms following medication use. PMID:24872675

Inoue, Kenji

2014-01-01

224

Managing adverse effects of glaucoma medications.  

PubMed

Glaucoma is a chronic, progressive disease in which retinal ganglion cells disappear and subsequent, gradual reductions in the visual field ensues. Glaucoma eye drops have hypotensive effects and like all other medications are associated with adverse effects. Adverse reactions may either result from the main agent or from preservatives used in the drug vehicle. The preservative benzalkonium chloride, is one such compound that causes frequent adverse reactions such as superficial punctate keratitis, corneal erosion, conjunctival allergy, and conjunctival injection. Adverse reactions related to main hypotensive agents have been divided into those affecting the eye and those affecting the entire body. In particular, ?-blockers frequently cause systematic adverse reactions, including bradycardia, decrease in blood pressure, irregular pulse and asthma attacks. Prostaglandin analogs have distinctive local adverse reactions, including eyelash bristling/lengthening, eyelid pigmentation, iris pigmentation, and upper eyelid deepening. No systemic adverse reactions have been linked to prostaglandin analog eye drop usage. These adverse reactions may be minimized when they are detected early and prevented by reducing the number of different eye drops used (via fixed combination eye drops), reducing the number of times eye drops are administered, using benzalkonium chloride-free eye drops, using lower concentration eye drops, and providing proper drop instillation training. Additionally, a one-time topical medication can be given to patients to allow observation of any adverse reactions, thereafter the preparation of a topical medication with the fewest known adverse reactions can be prescribed. This does require precise patient monitoring and inquiries about patient symptoms following medication use. PMID:24872675

Inoue, Kenji

2014-01-01

225

Postoperative Adverse Outcomes in Intellectually Disabled Surgical Patients: A Nationwide Population-Based Study  

PubMed Central

Background Intellectually disabled patients have various comorbidities, but their risks of adverse surgical outcomes have not been examined. This study assesses pre-existing comorbidities, adjusted risks of postoperative major morbidities and mortality in intellectually disabled surgical patients. Methods A nationwide population-based study was conducted in patients who underwent inpatient major surgery in Taiwan between 2004 and 2007. Four controls for each patient were randomly selected from the National Health Insurance Research Database. Preoperative major comorbidities, postoperative major complications and 30-day in-hospital mortality were compared between patients with and without intellectual disability. Use of medical services also was analyzed. Adjusted odds ratios using multivariate logistic regression analyses with 95% confidence intervals were applied to verify intellectual disability's impact. Results Controls were compared with 3983 surgical patients with intellectual disability. Risks for postoperative major complications were increased in patients with intellectual disability, including acute renal failure (odds ratio 3.81, 95% confidence interval 2.28 to 6.37), pneumonia (odds ratio 2.01, 1.61 to 2.49), postoperative bleeding (odds ratio 1.35, 1.09 to 1.68) and septicemia (odds ratio 2.43, 1.85 to 3.21) without significant differences in overall mortality. Disability severity was positively correlated with postoperative septicemia risk. Medical service use was also significantly higher in surgical patients with intellectual disability. Conclusion Intellectual disability significantly increases the risk of overall major complications after major surgery. Our findings show a need for integrated and revised protocols for postoperative management to improve care for intellectually disabled surgical patients. PMID:22046425

Lin, Jui-An; Liao, Chien-Chang; Chang, Chuen-Chau; Chang, Hang; Chen, Ta-Liang

2011-01-01

226

CHADS2 Scores in the Prediction of Major Adverse Cardiovascular Events in Patients with Cushing's Syndrome  

PubMed Central

Vascular events are one of the major causes of death in case of Cushing's syndrome (CS). However, due to the relative low frequency of CS, it is hard to perform a risk assessment for these events. As represented congestive heart failure (C), hypertension (H), age (A), diabetes (D), and stroke (S), the CHADS2 score is now accepted to classify the risk of major adverse cardiovascular events (MACEs) in patients with atrial fibrillation. In this study, participants were enrolled from the National Health Research Institute Database (NHIRD) of Taiwan, and we reviewed 551 patients with their sequential clinically diagnosed CS data between 2002 and 2009 in relation to MACEs risk using CHADS2 score. Good correlation could be identified between the CS and CHADS2 score (AUC = 0.795). Our results show that patients with CS show significantly higher risk of vascular events and the CHADS2 score could be applied for MACEs evaluation. Adequate lifestyle modifications and aggressive cardiovascular risks treatment are suggested for CS patients with higher CHADS2 score. PMID:25101124

Chuang, Mei-Hua; Chuang, Tzyy-Ling; Huang, Kung-Yung; Lyu, Shaw-Ruey; Huang, Chih-Yuan; Lee, Ching-Chih

2014-01-01

227

[Anaphylactic reaction after soya intake in a patient with birch pollen allergy].  

PubMed

Patients with birch pollen allergy may suffer from severe anaphylactic reactions after ingestion of foodstuffs containing soya. The reason for this is similarities in protein structure between a major birch pollen allergen (bet v 1) and Gly m 4, a pollen-related protein in soya. A 65-year-old patient allergic to birch pollen developed an adverse systemic reaction after consumption of a soya-containing drink. The diagnosis could be confirmed by in vitro and skin testing methods. Patients who suffer from birch pollen allergy should strictly avoid the intake of soya-containing foodstuffs. PMID:21959773

El-Hifnawi, D; Neudert, M; Hardt, A; Hauswald, B; Zahnert, T

2012-02-01

228

Adverse drug reactions in adult medical inpatients in a South African hospital serving a community with a high HIV/AIDS prevalence: prospective observational study  

PubMed Central

Aims To describe the frequency, nature and preventability of community-acquired and hospital-acquired adverse drug reactions (ADRs) in a South African hospital serving a community with a high prevalence of human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome. Methods A 3-month prospective observational study of 665 adults admitted to two medical wards. Results Forty-one (6.3%) patients were admitted as a result of an ADR and 41 (6.3%) developed an ADR in hospital. Many of the ADRs (46.2%) were considered preventable, although less likely to be preventable in HIV-infected patients than in those with negative or unknown HIV status (community-acquired ADRs 2/24 vs. 35/42; P < 0.0001; hospital-acquired ADRs 3/25 vs. 14/26; P = 0.003). Patients admitted with ADRs were older than patients not admitted with an ADR (median 53 vs. 42 years, P = 0.003), but 60% of community-acquired ADRs at hospital admission were in patients <60 years old. Among patients <60 years old, those HIV infected were more likely to be admitted with an ADR [odds ratio (OR) 2.32, 95% confidence interval (CI) 1.17, 4.61; P = 0.017]. Among HIV-infected patients, those receiving antiretroviral therapy (ART) were more likely to be admitted with an ADR than those not receiving ART (OR 10.34, 95% CI 4.50, 23.77; P < 0.0001). No ART-related ADRs were fatal. Antibiotics and drugs used for opportunistic infections were implicated in two-thirds of hospital-acquired ADRs. Conclusions ADRs are an important, often preventable cause of hospitalizations and inpatient morbidity in South Africa, particularly among the elderly and HIV-infected. Although ART-related injury contributed to hospital admissions, many HIV-related admissions were among patients not receiving ART, and many ADRs were associated with medicines used for managing opportunistic infections. What is already known about this subject Studies conducted primarily in developed countries have shown that adverse drug reactions (ADRs) are a significant cause of hospital admission, prolong hospital stay and consequently increase the cost of disease management in patients.Cardiovascular medicines, hypoglycaemic agents, nonsteroidal anti-inflammatory drugs and antibiotics are the most frequently implicated medicines in these studies.A large proportion of these ADRs have been shown to be preventable through improved drug prescribing, administration and monitoring for adverse effects. What this paper adds This is the first Sub-Saharan African study in the HIV/AIDS era that describes the contribution of ADRs to patient morbidity, hospitalisation and mortality.Cardiovascular medicines and antiretroviral therapy contributed the most to community-acquired ADRs at the time of hospital admission while medicines used for opportunistic infections (such as antifungals, antibiotics and antituberculosis medicines were most frequently implicated in hospital acquired ADRs.ADRs in HIV-infected patients were less likely to be preventable. PMID:18070223

Mehta, Ushma; Durrheim, David N; Blockman, Marc; Kredo, Tamara; Gounden, Ronald; Barnes, Karen I

2008-01-01

229

Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia  

PubMed Central

Objective: The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system. Methods: An anonymous, self-administered questionnaire (15 items) was designed. The questionnaire was subjected to face validity and content validity. The reliability coefficient was found to be 0.71. This study recruited proportionately large convenience sample of the general public in Penang. Interviews using a structured questionnaire were conducted over a week period in August 2009. The recommended sample size was calculated to be 368. Results: Three hundred thirty-four responses were received. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179). When asked about the sources of their medication majority of them reported medical doctor (85.6%), whereas small number (34.7%) reported community pharmacists as sources of medications. Three-quarter of the respondents (77.2%) get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%). More than half of the respondents (65.6%, n = 219) reported unawareness about the existence of ADR center set up by the Ministry of Health. Conclusion: Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases. PMID:24082699

Elkalmi, Ramadan; Hassali, Mohamed Azmi; Al-lela, Omar Qutaiba; Jawad Awadh, Ammar Ihsan; Al-Shami, Abdul Kareem; Jamshed, Shazia Qasim

2013-01-01

230

Adverse ophthalmic reaction in poppers users: case series of 'poppers maculopathy'  

PubMed Central

Background Poppers are a recreational substance of abuse belonging to the alkyl nitrite family of compounds. In the United Kingdom, where they are legal to purchase but illegal to sell for human consumption, 10% of the general population have tried them. They are considered low risk to physical and mental health. Two recent case series from France demonstrated foveal pathology in individuals associated with poppers use. Method A case series of seven patients presenting to four hospitals in the United Kingdom with visual impairment and maculopathy associated with inhalation of poppers. Results All patients experienced visual symptoms associated with poppers use. The majority had impaired visual acuity, central scotomata, distortion, or phosphenes. Clinical signs on fundoscopy ranged from normal foveal appearance to yellow, dome-shaped lesions at the foveola. Spectral domain optical coherence tomography (SD-OCT) showed varying degrees of disruption of the presumed inner segment/outer segment (IS/OS) junction. Discussion Although poppers have been in use for several decades, in 2007, following legislative changes, there was a change in the most commonly used compound from isobutyl nitrite to isopropyl nitrite. There were no reports of ‘poppers maculopathy' before this. Poppers maculopathy may be missed if patients are not directly questioned about their use. The disruption or loss of the presumed IS/OS junction on SD-OCT are a characteristic feature. Further study of maculopathy in poppers users is now needed. Raising public awareness of the ocular risks associated with their use may be necessary. PMID:23079752

Davies, A J; Kelly, S P; Naylor, S G; Bhatt, P R; Mathews, J P; Sahni, J; Haslett, R; McKibbin, M

2012-01-01

231

Exploring Off-Targets and Off-Systems for Adverse Drug Reactions via Chemical-Protein Interactome -- Clozapine-Induced Agranulocytosis as a Case Study  

PubMed Central

In the era of personalized medical practice, understanding the genetic basis of patient-specific adverse drug reaction (ADR) is a major challenge. Clozapine provides effective treatments for schizophrenia but its usage is limited because of life-threatening agranulocytosis. A recent high impact study showed the necessity of moving clozapine to a first line drug, thus identifying the biomarkers for drug-induced agranulocytosis has become important. Here we report a methodology termed as antithesis chemical-protein interactome (CPI), which utilizes the docking method to mimic the differences in the drug-protein interactions across a panel of human proteins. Using this method, we identified HSPA1A, a known susceptibility gene for CIA, to be the off-target of clozapine. Furthermore, the mRNA expression of HSPA1A-related genes (off-target associated systems) was also found to be differentially expressed in clozapine treated leukemia cell line. Apart from identifying the CIA causal genes we identified several novel candidate genes which could be responsible for agranulocytosis. Proteins related to reactive oxygen clearance system, such as oxidoreductases and glutathione metabolite enzymes, were significantly enriched in the antithesis CPI. This methodology conducted a multi-dimensional analysis of drugs' perturbation to the biological system, investigating both the off-targets and the associated off-systems to explore the molecular basis of an adverse event or the new uses for old drugs. PMID:21483481

Chen, Jian; Jegga, Anil G.; Luo, Heng; Shi, Leming; Wan, Chunling; Guo, Xizhi; Qin, Shengying; He, Guang; Feng, Guoyin; He, Lin

2011-01-01

232

Exploring off-targets and off-systems for adverse drug reactions via chemical-protein interactome--clozapine-induced agranulocytosis as a case study.  

PubMed

In the era of personalized medical practice, understanding the genetic basis of patient-specific adverse drug reaction (ADR) is a major challenge. Clozapine provides effective treatments for schizophrenia but its usage is limited because of life-threatening agranulocytosis. A recent high impact study showed the necessity of moving clozapine to a first line drug, thus identifying the biomarkers for drug-induced agranulocytosis has become important. Here we report a methodology termed as antithesis chemical-protein interactome (CPI), which utilizes the docking method to mimic the differences in the drug-protein interactions across a panel of human proteins. Using this method, we identified HSPA1A, a known susceptibility gene for CIA, to be the off-target of clozapine. Furthermore, the mRNA expression of HSPA1A-related genes (off-target associated systems) was also found to be differentially expressed in clozapine treated leukemia cell line. Apart from identifying the CIA causal genes we identified several novel candidate genes which could be responsible for agranulocytosis. Proteins related to reactive oxygen clearance system, such as oxidoreductases and glutathione metabolite enzymes, were significantly enriched in the antithesis CPI. This methodology conducted a multi-dimensional analysis of drugs' perturbation to the biological system, investigating both the off-targets and the associated off-systems to explore the molecular basis of an adverse event or the new uses for old drugs. PMID:21483481

Yang, Lun; Wang, Kejian; Chen, Jian; Jegga, Anil G; Luo, Heng; Shi, Leming; Wan, Chunling; Guo, Xizhi; Qin, Shengying; He, Guang; Feng, Guoyin; He, Lin

2011-03-01

233

Use of an Interactive, Telephone-based Self-management Support Program to Identify Adverse Events Among Ambulatory Diabetes Patients  

Microsoft Academic Search

BACKGROUND  There is growing interest in the use of interactive telephone technology to support chronic disease management. We used the\\u000a implementation of an automated telephone self-management support program for diabetes patients as an opportunity to monitor\\u000a patient safety.\\u000a \\u000a \\u000a \\u000a METHODS  We identified adverse and potential adverse events among a diverse group of diabetes patients who participated in an automated\\u000a telephone health-IT self-management program

Urmimala Sarkar; Margaret A. Handley; Reena Gupta; Audrey Tang; Elizabeth Murphy; Hilary K. Seligman; Kaveh G. Shojania; Dean Schillinger

2008-01-01

234

Prevalence and Predictors of Adverse Events in Older Surgical Patients: Impact of the Present on Admission Indicator  

ERIC Educational Resources Information Center

Purpose of the Study: To examine the effects of the present on admission (POA) indicator on the prevalence of and factors associated with postsurgical adverse events in older patients. Design and Methods: This is a secondary data analysis of 82,898 surgical patients aged 65 years or older in 252 acute care hospitals in California in 2004. Four…

Kim, Hongsoo; Capezuti, Elizabeth; Kovner, Christine; Zhao, Zhonglin; Boockvar, Kenneth

2010-01-01

235

Adverse reaction to metal debris after ReCap-M2A-Magnum large-diameter-head metal-on-metal total hip arthroplasty  

PubMed Central

Background and purpose The clinical findings of adverse reaction to metal debris (ARMD) following large-diameter-head metal-on-metal total hip arthroplasty (LDH MoM THA) may include periarticular fluid collections, soft tissue masses, and gluteal muscle necrosis. The ReCap-M2a-Magnum LDH MoM THA was the most commonly used hip device at our institution from 2005 to 2012. We assessed the prevalence of and risk factors for ARMD with this device. Methods 74 patients (80 hips) had a ReCap-M2a-Magnum LDH MoM THA during the period August 2005 to December 2006. These patients were studied with hip MRI, serum chromium and cobalt ion measurements, the Oxford hip score questionnaire, and by clinical examination. The prevalence of ARMD was recorded and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.0 (5.5–6.7) years. Results A revision operation due to ARMD was needed by 3 of 74 patients (3 of 80 hips). 8 additional patients (8 hips) had definite ARMD, but revision was not performed. 29 patients (32 hips) were considered to have a probable or possible ARMD. Altogether, 43 of 80 hips had a definite, probable, or possible ARMD and 34 patients (37 hips) were considered not to have ARMD. In 46 of 78 hips, MRI revealed a soft tissue mass or a collection of fluid (of any size). The symptoms clicking in the hip, local hip swelling, and a feeling of subluxation were associated with ARMD. Interpretation ARMD is common after ReCap-M2a-Magnum total hip arthroplasty, and we discourage the use of this device. Asymptomatic patients with a small fluid collection on MRI may not need instant revision surgery but must be followed up closely. PMID:24171688

2013-01-01

236

Adverse drug reaction and concepts of drug safety in Ayurveda: An overview.  

PubMed

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of 'Vyapad', 'Viruddha', 'Ahita', 'herb-herb interaction', 'idiosyncrasy', 'Prakritiviruddha' etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept "Drug which is not appropriate to be used as medicine"(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

2013-12-01

237

Real-World Efficiency of Pharmacogenetic Screening for Carbamazepine-Induced Severe Cutaneous Adverse Reactions  

PubMed Central

Objectives We evaluated the cost and efficiency of routine HLA-B*15?02 screening to prevent carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis (CBZ-SJS/TEN) in Hong Kong. Methods Data were extracted from patients who commenced CBZ as the first-ever AED treatment or tested for HLA-B*15?02 allele in three years before policy implementation (pre-policy: 16 September 2005 to 15 September 2008) and three years after (post-policy: 16 September 2008 to 15 September 2011). Using published unit costs, we estimated the cost of screening by comparing the costs to prevent and treat CBZ-SJS/TEN. We compared the number of person-tests needed and the cost to prevent resultant death with cancer screening programs. Results The number of screening tests needed to prevent one case of CBZ-SJS/TEN was 442, and to prevent one resultant death was 1,474 to 8,840. The screening cost was $332 per person, of which 42% was attributed to an additional consultation to review result and prescribe appropriate medication. HLA-B*15?02 screening expended $146,749 to prevent a case of CBZ-SJS/TEN, and $489,386– $2,934,986 to prevent a resultant death. The corresponding numbers of tests and costs for mammography and Pap smear to prevent death due to breast and cervical cancers were 7,150 and 7,000, and $614,900 and $273,000, respectively. Comparing to the SJS/TEN treatment cost, HLA-B*15?02 screening would become cost saving if a point-of-care test of less than $37 was available. Conclusions HLA-B*15?02 screening is as efficient as mammography and Pap smear in preventing death. Development of point-of-care testing will vastly improve efficiency. PMID:24806465

Chen, Zhibin; Liew, Danny; Kwan, Patrick

2014-01-01

238

Exposing physicians to reduced residency work hours did not adversely affect patient outcomes after residency.  

PubMed

In 2003, work hours for physicians-in-training (residents) were capped by regulation at eighty hours per week, leading to the hotly debated but unexplored issue of whether physicians today are less well trained as a result of these work-hour reforms. Using a unique database of nearly all hospitalizations in Florida during 2000-09 that were linked to detailed information on the medical training history of the physician of record for each hospitalization, we studied whether hospital mortality and patients' length-of-stay varied according to the number of years a physician was exposed to the 2003 duty-hour regulations during his or her residency. We examined this database of practicing Florida physicians, using a difference-in-differences analysis that compared trends in outcomes of junior physicians (those with one-year post-residency experience) pre- and post-2003 to a control group of senior physicians (those with ten or more years of post-residency experience) who were not exposed to these reforms during their residency. We found that the duty-hour reforms did not adversely affect hospital mortality and length-of-stay of patients cared for by new attending physicians who were partly or fully exposed to reduced duty hours during their own residency. However, assessment of the impact of the duty-hour reforms on other clinical outcomes is needed. PMID:25288430

Jena, Anupam B; Schoemaker, Lena; Bhattacharya, Jay

2014-10-01

239

Development of a combined system for identification and classification of adverse drug reactions: Alerts Based on ADR Causality and Severity (ABACUS)  

PubMed Central

Currently, adverse drug reaction (ADR) causality and severity are assessed using different systems but there is no standard method to combine the results. In this work, a combined ADR causality and severity assessment system, including an online version, was developed. Logical rules were defined to translate the score obtained from the system into three alert zones: green, amber, and red. The alert zones are useful for triaging ADR cases as they help define the seriousness of the ADR and the urgency of the responses required. This new scoring system may be useful for clinicians, investigators, and regulators seeking information on the likelihood of a drug causing an adverse reaction, and whether an adverse reaction is sufficiently dangerous for the drug to be withheld or undergo further investigation. PMID:20962137

Koh, Yvonne; Yap, Chun Wei

2010-01-01

240

ToxAlerts: A Web Server of Structural Alerts for Toxic Chemicals and Compounds with Potential Adverse Reactions  

PubMed Central

The article presents a Web-based platform for collecting and storing toxicological structural alerts from literature and for virtual screening of chemical libraries to flag potentially toxic chemicals and compounds that can cause adverse side effects. An alert is uniquely identified by a SMARTS template, a toxicological endpoint, and a publication where the alert was described. Additionally, the system allows storing complementary information such as name, comments, and mechanism of action, as well as other data. Most importantly, the platform can be easily used for fast virtual screening of large chemical datasets, focused libraries, or newly designed compounds against the toxicological alerts, providing a detailed profile of the chemicals grouped by structural alerts and endpoints. Such a facility can be used for decision making regarding whether a compound should be tested experimentally, validated with available QSAR models, or eliminated from consideration altogether. The alert-based screening can also be helpful for an easier interpretation of more complex QSAR models. The system is publicly accessible and tightly integrated with the Online Chemical Modeling Environment (OCHEM, http://ochem.eu). The system is open and expandable: any registered OCHEM user can introduce new alerts, browse, edit alerts introduced by other users, and virtually screen his/her data sets against all or selected alerts. The user sets being passed through the structural alerts can be used at OCHEM for other typical tasks: exporting in a wide variety of formats, development of QSAR models, additional filtering by other criteria, etc. The database already contains almost 600 structural alerts for such endpoints as mutagenicity, carcinogenicity, skin sensitization, compounds that undergo metabolic activation, and compounds that form reactive metabolites and, thus, can cause adverse reactions. The ToxAlerts platform is accessible on the Web at http://ochem.eu/alerts, and it is constantly growing. PMID:22876798

2012-01-01

241

CD34 expression predicts an adverse outcome in patients with NPM1-positive acute myeloid leukemia.  

PubMed

Patients with acute myeloid leukemia (AML) harboring an NPM1 mutation exhibit a heterogeneous clinical outcome. Recent studies have shown that the absence of FLT3 internal tandem duplication (FLT3-ITD) mutation confers a favorable prognosis in NPM1-positive AML. However, the prognostic impact of immunophenotypes in this subgroup remains unclear. In this study, FLT3 mutation status and immunophenotypic profile of 85 NPM1-positive patients with de novo AML were retrospectively analyzed and correlated with their clinical features and survival outcomes. Univariate analysis detected 5 markers with prognostic relevance: older age (?60 years), high white blood cell (WBC) count (>30 × 10(9)/L), FLT3-ITD, CD7, and CD34 expression. Multivariate analysis showed that high WBC count was the only independent predictor of a lower complete remission rate (P = .019). Older age (P = .035), high WBC count (P = .008), FLT3-ITD (P = .012), and CD34 expression (P = .006) were independent predictors of a shorter event-free survival (EFS). High WBC count (P = .014), FLT3-ITD (P = .005), and CD34 expression (P = .047) were independent predictors of a shorter overall survival (OS). Furthermore, based on FLT3-ITD status in NPM1 mutation-positive patients, we showed that both high WBC and CD34 expression conferred a poor EFS (P = .010 and P = .016, respectively) and OS (P = .032 and P = .001, respectively) in the FLT3-ITD-negative group, whereas high WBC predicted a poor EFS (P = .016) and OS (P = .027) in the FLT3-ITD-positive group. Our results confirm the prognostic value of assessing FLT3-ITD mutations in NPM1-positive AML and identify the adverse prognostic impact of high WBC and CD34 expression in this subgroup of AML. PMID:23701943

Dang, Harry; Chen, Yan; Kamel-Reid, Suzanne; Brandwein, Joseph; Chang, Hong

2013-10-01

242

Principal long-term adverse effects of imatinib in patients with chronic myeloid leukemia in chronic phase  

PubMed Central

Imatinib mesylate (IM), an original Abl tyrosine kinase inhibitor, entered the clinics in 1998 for the treatment of patients with chronic myeloid leukemia (CML). The drug is universally considered the treatment of choice for most, if not all, patients with CML. Importantly, lessons learned from patients with CML have been applied successfully for the treatment of patients with other disorders where IM has since been found to be active by virtue of its ability to target other kinases, such as c-kit in patients with gastrointestinal stromal tumors. IM is associated with mild to moderate toxicity, mostly reversible by dose reduction or discontinuation of the drug. Most adverse effects occur within the first 2 years of starting therapy; however, late effects, many being unique, are now being recognized. In this report, we assess the toxicity associated with IM, with an emphasis on the long-term adverse effects. PMID:21209726

Mughal, Tariq I; Schrieber, Andrew

2010-01-01

243

A Structure-Based Approach for Mapping Adverse Drug Reactions to the Perturbation of Underlying Biological Pathways  

PubMed Central

Adverse drug reactions (ADR), also known as side-effects, are complex undesired physiologic phenomena observed secondary to the administration of pharmaceuticals. Several phenomena underlie the emergence of each ADR; however, a dominant factor is the drug's ability to modulate one or more biological pathways. Understanding the biological processes behind the occurrence of ADRs would lead to the development of safer and more effective drugs. At present, no method exists to discover these ADR-pathway associations. In this paper we introduce a computational framework for identifying a subset of these associations based on the assumption that drugs capable of modulating the same pathway may induce similar ADRs. Our model exploits multiple information resources. First, we utilize a publicly available dataset pairing drugs with their observed ADRs. Second, we identify putative protein targets for each drug using the protein structure database and in-silico virtual docking. Third, we label each protein target with its known involvement in one or more biological pathways. Finally, the relationships among these information sources are mined using multiple stages of logistic-regression while controlling for over-fitting and multiple-hypothesis testing. As proof-of-concept, we examined a dataset of 506 ADRs, 730 drugs, and 830 human protein targets. Our method yielded 185 ADR-pathway associations of which 45 were selected to undergo a manual literature review. We found 32 associations to be supported by the scientific literature. PMID:20808786

Wallach, Izhar; Jaitly, Navdeep; Lilien, Ryan

2010-01-01

244

Brine chemistry and control of adverse chemical reactions with natural gas production. Annual report, January-December 1986  

SciTech Connect

Monitoring brine chemistry to determine the extent of potential adverse reactions has been simplified by the development of a field-brine test kit and a series of nomographs. Results of the kit analyses serve as input to the nomographs, which provide a graphic means of determining the scaling tendency (Saturation Index value) of a brine. Brines that do not tend to form scale may be corrosive. Saturation Index values were correlated with various processes using data from geopressured wells in the Gulf Coast area. Control of scale in surface equipment with chemical inhibitors has been successful. Numerous laboratory simulations of inhibitor squeeze operations were completed using core material with calcite present and absent. The corresponding wells were squeezed with phosphorous-containing inhibitors, and the flowback of brine was monitored for phosphorous concentrations vs time. A new procedure to measure the concentration of phosphorous-containing inhibitors down to 0.05 mg/l was developed and applied to brines from the Gladys McCall No. 1 DOE Design well. Methods to optimize inhibitor squeezes and scale and corrosion control are presently being investigated. The goal of the work is to understand the mechanisms responsible for scale and corrosion and to develop appropriate control measures.

O'Day, P.; Salimi, M.H.; Greenberg, J.; Sethuraman, G.; Tomson, M.B.

1987-01-01

245

[Venous thromboembolism and combined oral contraceptives. Reported adverse reactions indicate at least similar risk with the most recent contraceptive pills].  

PubMed

Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such as venous thromboembolism (VTE), are seldom disclosed until a COC has been on the market for some time. Two new COCs, Yasmin and Cilest have recently been launched in several European countries with expectations of being safer than older COCs. Utilising data from spontaneous reporting of ADRs to the Medical Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest was estimated and compared with VTE incidence for a second (Follimin) and a third generation (Desolett) COC. The reported VTE incidence for Yasmin and Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000 users per year, respectively. The differences were, however, not statistically significant. We conclude that the risk of VTE associated with the most recent COCs is at least similar to that of older COCs. PMID:14560670

Kieler, Helle; Persson, Ingemar; Odlind, Viveca

2003-09-25

246

Translational potential of a mouse in vitro bioassay in predicting gastrointestinal adverse drug reactions in Phase I clinical trials  

PubMed Central

Background Motility-related gastrointestinal (GI) adverse drug reactions (GADRs) such as diarrhea and constipation are a common and deleterious feature associated with drug development. Novel biomarkers of GI function are therefore required to aid decision making on the GI liability of compounds in development. Methods Fifteen compounds associated with or without clinical GADRs were used to assess the ability of an in vitro colonic motility bioassay to predict motility-related GADRs. Compounds were examined in a blinded fashion for their effects on mouse colonic peristaltic motor complexes in vitro. For each compound concentration-response relationships were determined and the results compared to clinical data. Compounds were also assessed using GI transit measurements obtained using an in vivo rat charcoal meal model. Key Results Within a clinically relevant dosing range, the in vitro assay identified five true and three false positives, four true and three false negatives, which gave a predictive capacity of 60%. The in vivo assay detected four true and four false positives, four false and three true negatives, giving rise to a predictive capacity for this model of 47%. Conclusions & Inferences Overall these results imply that both assays are poor predictors of GADRs. Further analysis would benefit from a larger compound set, but the data show a clear need for improved models for use in safety pharmacology assessment of GI motility. PMID:24813024

Keating, C; Ewart, L; Grundy, L; Valentin, JP; Grundy, D

2014-01-01

247

Dysregulated Mineral Metabolism in Patients with Acute Kidney Injury and Risk of Adverse Outcomes  

PubMed Central

Objective Numerous studies have evaluated the prevalence and importance of vitamin D deficiency among patients with chronic kidney disease and end-stage renal disease, however, little is known about vitamin D levels in acute kidney injury (AKI). We evaluated the association between vitamin D metabolites and clinical outcomes among patients with AKI. Design Prospective cohort study. Patients 30 participants with AKI and 30 controls from general hospital wards and intensive care units at a tertiary care hospital. Measurements Plasma levels of 25-hydroxyvitamin D [25(OH)D], 1,25-dihydroxyvitamin D [1,25(OH)2D], 24R,25-dihydroxyvitamin D3, vitamin D binding protein (VDBP), and fibroblast growth factor 23 (FGF23) were measured within 24 hours of AKI onset and 5 days later. Bioavailable 25(OH)D and 1,25(OH)2D levels, defined as the sum of free- and albumin-bound 25(OH)D and 1,25(OH)2D, were estimated using equations. Results Compared to controls, participants with AKI had lower levels of 1,25(OH)2D [17 (10-22) versus 25 (15-35) pg/ml, p=0.01], lower levels of VDBP [23 (15-31) versus 29 (25-36) mg/dl, p=0.003], and similar levels of bioavailable 25(OH)D and 1,25(OH)2D at enrollment. Levels of bioavailable 25(OH)D were inversely associated with severity of sepsis in the overall sample (p<0.001). Among participants with AKI, bioavailable 25(OH)D, but not other vitamin D metabolites, was significantly associated with mortality after adjusting for age and serum creatinine (adjusted odds ratio per 1 SD ln [bioavailable 25(OH)D]=0.16, 95% confidence interval=0.03 to 0.85). Conclusions Bioavailable 25(OH)D could have a role as a biomarker or mediator of adverse outcomes among patients with established AKI. PMID:23414198

Leaf, David E.; Waikar, Sushrut S.; Wolf, Myles; Cremers, Serge; Bhan, Ishir; Stern, Leonard

2013-01-01

248

Does Mental Illness Stigma Contribute to Adolescent Standardized Patients' Discomfort With Simulations of Mental Illness and Adverse Psychosocial Experiences?  

ERIC Educational Resources Information Center

Objective: Adolescent mental illness stigma-related factors may contribute to adolescent standardized patients' (ASP) discomfort with simulations of psychiatric conditions/adverse psychosocial experiences. Paradoxically, however, ASP involvement may provide a stigma-reduction strategy. This article reports an investigation of this hypothetical…

Hanson, Mark D.; Johnson, Samantha; Niec, Anne; Pietrantonio, Anna Marie; High, Bradley; MacMillan, Harriet; Eva, Kevin W.

2008-01-01

249

A fuzzy recognition-primed decision model-based causal association mining algorithm for detecting adverse drug reactions in postmarketing surveillance  

Microsoft Academic Search

The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (<;;10% reporting rate), latency, and inconsistent reporting. We propose a new interestingness measure, causal-leverage, to signal potential adverse drug reactions (ADRs) from electronic health databases which are readily available in most modern hospitals. This measure is based on

Yanqing Ji; Hao Ying; Peter Dews; Margo S. Farber; A. Mansour; J. Tran; R. Michael Massanari

2010-01-01

250

The Scars of Childhood Adversity: Minor Stress Sensitivity and Depressive Symptoms in Remitted Recurrently Depressed Adult Patients  

PubMed Central

Background Childhood adversity may lead to depressive relapse through its long-lasting influence on stress sensitivity. In line with the stress sensitization hypothesis, minor (daily) stress is associated with depressive relapse. Therefore, we examine the impact of childhood adversity on daily stress and its predictive value on prospectively assessed depressive symptoms in recurrently depressed patients. Method Daily stress was assessed in recurrently depressed adult patients, enrolled into two randomized trials while remitted. The reported intensity and frequency of dependent and independent daily stress was assessed at baseline. Independent stress is externally generated, for example an accident happening to a friend, while dependent stress is internally generated, for example getting into a fight with a neighbor. Hierarchical regression analyses were performed with childhood adversity, independent and dependent daily stress as predictor variables of prospectively measured depressive symptoms after three months of follow-up (n?=?138). Results We found that childhood adversity was not significantly associated with a higher frequency and intensity of daily stress. The intensity of both independent and dependent daily stress was predictive of depressive symptom levels at follow-up (unadjusted models respectively: B?=?0.47, t?=?2.05, p?=?0.041, 95% CI?=?0.02–0.92; B?=?0.29, t?=?2.20, p?=?0.028, 95% CI?=?0.03–0.55). No associations were found between childhood adversity and depressive symptoms at follow-up. Conclusion No evidence was found supporting stress sensitization due to the experience of childhood adversity in this recurrently depressed but remitted patient group. Nevertheless, our research indicates that daily stress might be a target for preventive treatment. Trial Registration Trial A: Nederlands Trial Register NTR1907 Trial B: Nederlands Trial Register NTR2503 PMID:25393812

Burger, Huibert; Elgersma, Hermien; Riper, Heleen; Cuijpers, Pim; Dekker, Jack; Smit, Filip; Bockting, Claudi

2014-01-01

251

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events  

PubMed Central

Background Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. Objective To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. Software architecture DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Results Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. Discussion This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. Conclusion The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License. PMID:17472749

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-01-01

252

Drugs causing adverse events in patients aged 45 or older: a randomised survey of Australian general practice patients  

PubMed Central

Objective To determine prevalence of adverse drug events (ADEs) in patients aged 45?years or older presenting to Australian general practitioners (GPs) and identify drug groups related to ADEs, their severity and manifestation. Design Substudy of the Bettering the Evaluation and Care of Health continuous survey of Australian GP clinical activity in which randomly selected GPs collected survey data from patients. Data are reported with 95% CIs. Setting General practice in Australia. Main outcome measures Prevalence in the preceding 6?months, type, implicated drugs, severity (including hospitalisation) and manifestation of ADEs. Participants From three survey samples, January–October 2007, and two samples, January–March 2010, responses were received from 482 GPs about 7561 patients aged 45?years or older. Results Of a final sample of 7518 patients (after duplicate patients removed), 871 (11.6%) reported ADEs in the previous 6?months. The type of ADE was recognised side effect (75.8%, 95% CI 72.0 to 79.7), drug sensitivity (9.9%, 95% CI 7.2 to 12.7) and drug allergy (7.4%, 95% CI 4.7 to 10.1). Drug interaction (1.0%, 95% CI 0.1 to 1.8), overdose (0.8%, 95% CI 0.0 to 1.5) and contraindications (0.2%, 95% CI 0.0 to 0.6) were very infrequent. A severity rating was provided for 846 patients. Almost half (45.9%, 95% CI 42.0 to 49.7) were rated as ‘mild’ events, 42.2% (95% CI 38.8 to 45.6) ‘moderate’, 11.8% (95% CI 9.5 to 14.1) severe and 5.4% (95% CI 3.8 to 7.0) had been hospitalised as a result of the most recent ADE. Thirteen commonly prescribed drug groups accounted for 58% of all ADEs, opioids being the group most often implicated. Conclusion ADEs in patients aged 45 or older are frequent and are associated with significant morbidity. Most of ADEs result from commonly prescribed drugs at therapeutic dosage. The list of causative agents bears little relationship to published lists of ‘inappropriate medications’. PMID:24114371

Miller, Graeme C; Valenti, Lisa; Britt, Helena; Bayram, Clare

2013-01-01

253

Tamoxifen-associated skin reactions in breast cancer patients: from case report to literature review.  

PubMed

The purpose of this study was to firstly present the maiden case of tamoxifen-induced acute cutaneous lupus erythematosus (ACLE), and secondly, to broaden the discussion into a systematic review of the various tamoxifen-related skin changes documented in patients with breast cancer. We searched PubMed, Cochrane, Embase, CancerLit, Scopus, Web of Science, and Google Scholar databases using keywords to identify reported cases of tamoxifen-related cutaneous adverse events. Outcomes captured included type of cutaneous reaction, time to adverse event, pathologic mechanism, and possible treatment. From 17 clinical studies identified, over ten distinct types of adverse reactions of the skin were itemized. The character of these cutaneous events ranged from the relatively common hot flashes to the rare, but potentially life-threatening, Steven Johnson syndrome. Overall, tamoxifen is generally a well-tolerated hormone therapy with decades of supporting safety data. Based on current medical literature, we present the first case of tamoxifen-induced ACLE. Our clinical experience of managing this case revealed that despite its broad use and the frequency of associated skin reactions, there is a lack of concise information detailing the cutaneous adverse events associated with tamoxifen. The absence of summarized information concerning tamoxifen-related skin changes prompted us to perform a review herein. PMID:25292419

Andrew, Peter; Valiani, Sabira; MacIsaac, Jennifer; Mithoowani, Hamid; Verma, Shailendra

2014-11-01

254

Delayed Adverse Reaction to Contrast-enhanced CT: A Prospective Single-Center Study Comparison to Control Group without Enhancement 1  

PubMed Central

Purpose: To prospectively assess the incidence of delayed adverse reactions (DARs) in patients undergoing contrast material–enhanced computed tomography (CT) with the low osmolar nonionic contrast agent iohexol and compare with the incidence of DARs in patients undergoing unenhanced CT as control subjects. Materials and Methods: Institutional review board approval and informed written consent for this prospective study were obtained. The study was HIPAA compliant. Patients undergoing CT for routine indications were enrolled from a random next-available scheduling template by an on-site clinical trials monitor. All subjects received a questionnaire asking them to indicate any DAR occurring later than 1 hour after their examination. Sixteen manifestations were listed and included rash, skin redness, skin swelling, nausea, vomiting, and dizziness, among others. To ensure maximal surveillance, a clinical trials coordinator initiated direct telephone contact for further assessment. Patients suspected of having moderately severe cutaneous reactions were invited to return for a complete dermatologic clinical assessment including skin biopsy, if indicated. Statistical analysis was performed by using a two-sided Wilcoxon-Mann-Whitney test, a logistic regression utilizing a ?2 test to adjust for sex and age, and a two-sided Fisher exact test. Results: A total of 539 patients (258 receiving iohexol and 281 not receiving contrast material) were enrolled. DARs were observed in 37 (14.3%) of 258 subjects receiving iohexol and in seven (2.5%) of 281 subjects in the control group (P < .0001, ?2 test) after adjusting for sex and age. Specific manifestations of DARs that were significantly more frequent at contrast-enhanced CT were skin rash (P = .0311), skin redness (P = .0055), skin swelling (P = .0117), and headache (P = .0246). DARs involving the skin included generalized rashes of the face, neck, chest, back, and extremities and were often associated with swelling, erythema, and pruritus. Conclusion: This study substantiates a frequent occurrence of DARs at contrast-enhanced CT compared with that in control subjects. Continued growth in the use of contrast-enhanced CT suggests a need for greater awareness and attention to prevention and management. © RSNA, 2010 Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10091848/-/DC1 PMID:20406882

Bagheri, Sepideh; Katzberg, Richard W.; Fung, Maxwell A.; Li, Chin-Shang

2010-01-01

255

Hypersensitivity Reaction Associated with Abacavir Therapy in an Indian HIV Patient - A Case Report  

PubMed Central

The most important and unique adverse effect of abacavir (ABC) is fatal hypersensitivity reaction (HSR). The objective of this report is to describe a case of ABC induced HSR that occurred in an Indian HIV patient during treatment. Although this adverse effect is not uncommon, it is perhaps underreported or has never been reported so far in an Indian case scenario. A 44-year-old known case of HIV-1 was admitted in view of his worsening condition and very low CD4 cell counts 3 cells/?L. He was on anti-retroviral therapy since three years but not regular. On the basis of treatment failure, non-compliance and progressive low CD4 counts, the anti HIV regime was switched over to abacavir 600 mg+ atazanavir/ ritonavir 300mg/100mg Two weeks after ABC therapy he presented with maculopapular rash, headache and signs of hepatic damage (serum AST, ALP and ALT increased to 3-4 fold) suggestive of hypersensitivity reaction. As we know discontinuation of the drug is the ultimate litmus test to confirm diagnosis of drug induced adverse reaction. We did confirm ABC induced HSR by de-challenge wherein, rash disappeared within 2-3 days and LFT came back to normal within 5 days. However, no rechallenge was done. HSR was more in favour of ABC because atazanavir failed to produce any similar reaction after re-challenge. PMID:25386460

Janardhanan, Manju; Vidyasagar, Sudha; Kumari K, Meena; Holla, Sadhana N

2014-01-01

256

Disclosure and adverse effects of complementary and alternative medicine used by hospitalized patients in the North East of England  

PubMed Central

Objective This study aimed to investigate the prevalence, disclosure and adverse effects of complementary and alternative medicine (CAM) use in hospitalised patients, and to explore the associations between patients' perceived side-effects and relevant factors. Methods Patients who were admitted to a district general hospital and met the eligibility criteria were interviewed using a semi-structured questionnaire. Their medications and pertinent details were verified from the medical notes. All quantitative and qualitative data were collated and analysed. A chi-squared test was performed to test the associations of the perceived CAM side-effects with the significance level determined at ?=0.05. Results A total of 240 in-patients completed the study. They were mostly white British (98.8%). The prevalence of CAM use within two years was 74.6% and one month 37.9%. Only 19 of 91 patients (20.9%) using CAM within one month disclosed their current CAM applications. Nearly half of patients (45.8%) who used CAM within two years experienced various CAM side-effects that tended to resolve after discontinuation. Slightly more than half (57.6%) perceived CAM side-effects and their perceptions were significantly associated with gender (P=0.048) and consideration for future CAM use (P=0.033). Potential interactions between herbal remedies/dietary supplements and prescribed drugs, such as garlic with lisinopril or aspirin, were assessed in 82 patients (45.8%). Conclusions Most in-patients used CAM and experienced some adverse effects. The disclosure of CAM use and its adverse outcomes should be encouraged by healthcare professionals. PMID:24155828

Bello, Nusirat; Winit-Watjana, Win; Baqir, Wasim; Mcgarry, Kenneth

257

Adverse effects of human immunoglobulin therapy.  

PubMed

Human immunoglobulin (IG) is used for IgG replacement therapy in primary and secondary immunodeficiency, for prevention and treatment of certain infections, and as an immunomodulatory agent for autoimmune and inflammatory disorders. IG has a wide spectrum of antibodies to microbial and human antigens. Several high-titered IGs are also available enriched in antibodies to specific viruses or bacterial toxins. IG can be given intravenously (IGIV), intramuscularly (IGIM) or by subcutaneous infusions (SCIG). Local adverse reactions such as persistent pain, bruising, swelling and erythema are rare with IGIV infusions but common (75%) with SCIG infusions. By contrast, adverse systemic reactions are rare with SCIG infusions but common with IGIV infusions, occurring as often as 20% to 50% of patients and 5% to 15% of all IGIV infusions. Systemic adverse reactions can be immediate (60% of reactions) occurring within 6 hours of an infusion, delayed (40% of reactions) occurring 6 hours-1 week after an infusion, and late (less than 1% of reactions), occurring weeks and months after an infusion. Immediate systemic reactions such as head and body aches, chills and fever are usually mild and readily treatable. Immediate anaphylactic and anaphylactoid reactions are uncommon. The most common delayed systemic reaction is persistent headache. Less common but more serious delayed reactions include aseptic meningitis, renal failure, thromboembolism, and hemolytic reactions. Late reactions are uncommon but often severe, and include lung disease, enteritis, dermatologic disorders and infectious diseases. The types, incidence, causes, prevention, and management of these reactions are discussed. PMID:23835249

Stiehm, E Richard

2013-07-01

258

Adverse childhood experiences and prescription drug use in a cohort study of adult HMO patients  

Microsoft Academic Search

BACKGROUND: Prescription drugs account for approximately 11% of national health expenditures. Prior research on adverse childhood experiences (ACEs), which include common forms of child maltreatment and related traumatic stressors, has linked them to numerous health problems. However, data about the relationship of these experiences to prescription drug use are scarce. METHOD: We used the ACE Score (an integer count of

Robert F Anda; David W Brown; Vincent J Felitti; Shanta R Dube; Wayne H Giles

2008-01-01

259

Determining Adverse Events in Patients with Neck Pain Receiving Orthopaedic Manual Physiotherapy: A Pilot and Feasibility Study  

PubMed Central

ABSTRACT Purpose: To pilot and determine the feasibility of estimating adverse events in patients with neck pain treated with cervical manipulation/mobilization by Canadian orthopaedic manual physiotherapists (OMPTs) using an online data-collection system to provide estimates for a future larger multi-centre international study. Methods: In a prospective multi-site two-group cohort study, participants received usual care and either (a) combined manipulation and mobilization or (b) mobilization only. Study feasibility objectives and criteria for success were set a priori. Data were analyzed using descriptive statistics. Results: A total of 20 patients were recruited from 6 of 16 participating centres, 17 to the mobilization group and 3 to the combined group. Barriers to data collection included low recruitment, difficulties in using the online data-collection system, and clinicians' and patients' being too busy to participate. Missing data for the primary outcome averaged 28.5%. A total of 69 symptom occurrences were reported during the treatment phase, all benign and transient. Most began within 0–12 hours after treatment (66/69, 95.6%) and lasted for 0–2 days (56/69, 81.2%). Kappa estimates of agreement between therapists and patients on reporting of adverse symptoms across visits 1–5 was substantial (?=0.68; 95% CI, 0.52–0.84; p<0.01). Conclusions: This pilot study demonstrates substantial challenges in conducting a large multi-centre trial. Brief, benign, and transient adverse events were common; no substantial adverse events were observed. PMID:24403696

Macdermid, Joy C.; Santaguida, P. Lina; Thabane, Lehana

2013-01-01

260

Black psychiatric patients' reactions to the cultural mistrust inventory.  

PubMed Central

This pilot study examined African-American psychiatric patients' reactions to the Cultural Mistrust Inventory, a measure of blacks' mistrust of white society. Twenty-two black psychiatric patients were screened for the Culturally-Sensitive Diagnostic Interview Research Project. All patients were debriefed after the screening interview including queries about their reactions to the experience, whether they would be willing to participate in the next interview, and their reasons for participating or not. Patients' responses were recorded verbatim and were categorized in terms of their valence (positive, neutral, or negative) and affectivity (yes or no) by independent raters. Agreement between raters in terms of the valence of patients' reactions was very good, but it was poor to fair in terms of affectivity ratings. The majority of these black patients' responses were positive and nonaffective. Administration of the Cultural Mistrust Inventory to black psychiatric patients does not cause negative emotional reactions. PMID:9884498

Whaley, A. L.

1998-01-01

261

Neuroticism and Reactions to Social Comparison Information Among Cancer Patients  

Microsoft Academic Search

In an experimental study neuroticism was examined as a moderator of breast cancer patients' affective reactions to social comparison information about a fellow patient. Fifty-seven women with breast cancer completed Eysenck's Personality Questionnaire and received social comparison information about a fellow patient who was either doing better (upward condi- tion) or worse (downward condition) than themselves. As expected, patients showed

Karen Van der Zee; Bram Buunk; Robbert Sanderman

262

Patient versus professional based psychosocial risk factor screening for adverse pregnancy outcomes.  

PubMed

To identify Psychopathology, Psychosocial problems and substance use (PPS) as predictors of adverse pregnancy outcomes, two screen-and-advice instruments were developed: Mind2Care (M2C, self-report) and Rotterdam Reproductive Risk Reduction (R4U, professional's checklist). To decide on the best clinical approach of these risks, the performance of both instruments was compared. Observational study of 164 pregnant women who booked at two midwifery practices in Rotterdam. Women were consecutively screened with M2C and R4U. For referral to tailored care based on specific PPS risks, inter-test agreement of single risks was performed in terms of overall accuracy and positive accuracy (risk present according to both instruments). With univariate regression analysis we explored determinants of poor agreement (<90 %). For triage based on risk accumulation and for detecting women-at-risk for adverse birth outcomes, M2C and R4U sum scores were compared. Overall accuracy of single risks was high (mean 93 %). Positive accuracy was lower (mean 46 %) with poorest accuracy for current psychiatric symptoms. Educational level and ethnicity partly explained poor accuracy (p < 0.05). Overall low PPS prevalence decreased the statistical power. For triage, M2C and R4U sum scores were interchangeable from sum scores of five or more (difference <1 %). The probability of adverse birth outcomes similarly increased with risk accumulation for both instruments, identifying 55-75 % of women-at-risk. The self-report M2C and the professional's R4U checklist seem interchangeable for triage of women-at-risk for PPS or adverse birth outcomes. However, the instruments seem to provide complementary information if used as a guidance to tailored risk-specific care. PMID:24585399

Quispel, Chantal; van Veen, Mieke J; Zuijderhoudt, Christianne; Steegers, Eric A P; Hoogendijk, Witte J G; Birnie, Erwin; Bonsel, Gouke J; Lambregtse-van den Berg, Mijke P

2014-11-01

263

Drug-Associated Adverse Events and Their Relationship with Outcomes in Patients Receiving Treatment for Extensively Drug-Resistant Tuberculosis in South Africa  

PubMed Central

Background Treatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce. Methods Case records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0?=?none; grade 1–2?=?mild to moderate; and grade 3–5?=?severe (drug stopped, life-threatening or death)]. Findings 161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ?50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3–5) vs. grade 0–2 AEs [2/27(7%) vs. 24/88(27%); p?=?0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient). Conclusion Drug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB. PMID:23667572

Shean, Karen; Streicher, Elizabeth; Pieterson, Elize; Symons, Greg; van Zyl Smit, Richard; Theron, Grant; Lehloenya, Rannakoe; Padanilam, Xavier; Wilcox, Paul; Victor, Tommie C.; van Helden, Paul; Groubusch, Martin; Warren, Robin; Badri, Motasim; Dheda, Keertan

2013-01-01

264

Medication Monitoring in a Nurse-Led Respiratory Outpatient Clinic: Pragmatic Randomised Trial of the West Wales Adverse Drug Reaction Profile  

PubMed Central

Objective To assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR) Profile for Respiratory Medicine. Design Single-site parallel-arm pragmatic trial using stratified randomisation. Setting Nurse-led respiratory outpatient clinic in general hospital in South Wales. Participants 54 patients with chronic respiratory disease receiving bronchodilators, corticosteroids or leukotriene receptor antagonists. Intervention Following initial observation of usual nursing care, we allocated participants at random to receive at follow up: either the West Wales ADR Profile for Respiratory Medicine in addition to usual care (‘intervention arm’ with 26 participants); or usual care alone (‘control arm’ with 28 participants). Main Outcome Measures Problems reported and actions taken. Results We followed up all randomised participants, and analysed data in accordance with treatment allocated. The increase in numbers of problems per participant identified at follow up was significantly higher in the intervention arm, where the median increase was 20.5 [inter-quartile range (IQR) 13–26], while that in the control arm was ?1 [?3 to +2] [Mann-Whitney U test: z?=?6.28, p<0.001]. The increase in numbers of actions per participant taken at follow up was also significantly higher in the intervention arm, where the median increase was 2.5 [1]–[4] while that in the control arm was 0 [?1.75 to +1] [Mann-Whitney U test: z?=?4.40, p<0.001]. Conclusion When added to usual nursing care, the West Wales ADR Profile identified more problems and prompted more nursing actions. Our ADR Profile warrants further investigation as a strategy to optimise medication management. Trial Registration Controlled-trials.com ISRCTN10386209 PMID:24798210

Gabe, Marie E.; Murphy, Fiona; Davies, Gwyneth A.; Russell, Ian T.; Jordan, Susan

2014-01-01

265

Atrial overdrive pacing and incidence of heart failure-related adverse events in permanently paced patients  

Microsoft Academic Search

Background  Atrial overdrive pacing algorithms may be effective in preventing or suppressing atrial fibrillation (AF). However, the maintenance\\u000a of a heart rate incessantly faster than spontaneous could induce left ventricular (LV) dysfunction and promote heart failure\\u000a (HF) on the long term.\\u000a \\u000a \\u000a \\u000a Objective  This post hoc analysis examined the effects of a new overdrive algorithm on the incidence of HF-related adverse events in

Andreas Schuchert; Mark Carlson; John Ip; John Messenger; Scott Beau; Steven Kalbfleisch; Pierre Gervais; Douglas A. Cameron; Aurelio Duran; Jesus Val-Mejias; Judith Mackall; Michael Gold

2007-01-01

266

Comparison of reversal and adverse effects of sugammadex and combination of — Anticholinergic-Anticholinesterase agents in pediatric patients  

PubMed Central

Background: We aimed to compare clinical effects of sugammadex versus combination of anticholinergic-anticholinesterase agents for reversing of nondepolarizing neuromuscular block in pediatric patients. Materials and Methods: A total of 60 pediatric patients whom should be performed general anesthesia in the supine position were enrolled to this randomized double-blinded clinical trial. Fentanyl 1 ?g/kg, propofol 2 mg/kg, rocuronium 0.6 mg/kg were used in induction and sevofluran, 50% O2-50% N2O in maintenance of anesthesia. Neuromuscular conductions were assessed by train of four (TOF)-Watch SX (Organon, Schering-Plough, Ireland) acceleromyograph. Patients were intubated at the moment of TOF 0. At the end of the operation emergence of T2 point was replied by 2 mg/kg sugammadex administration in group 1 and 0.06 mg/kg neostigmine +0.02 mg/kg atropine in group 2. At the moment of T0.9 inhalation, gases were ceased, and patients were extubated. Hemodynamic alterations, access to T0.9, extubation time, recovery parameters, drug consumptions and adverse effects were recorded. Results: Train of four scores showed a lesser increase in group 2 than group 1 from 15th s to 30th min during post reverse period (from 6.9 ± 6.4 to 91.7 ± 7.2 in group 2 vs. from 35.4 ± 21.4 to 99.5 ± 1.0 in group 1) (p < 0.0004). Group 1 patients exhibited much more complete muscle strength rates than group 2 (P < 0.001). T0.9 and extubation times were significantly longer in group 2 than group 1 (P < 0.001). Comparison of adverse effects yielded no difference. Conclusion: Sugammadex can be considered as a safe agent in order to reverse neuromuscular block in pediatric patients.

Özgün, Çi?dem; Çakan, Türkay; Baltac?, Bülent; Ba?ar, Hülya

2014-01-01

267

Hormonal regulation of energy-protein homeostasis in hemodialysis patients: an anorexigenic profile that may predispose to adverse cardiovascular outcomes  

PubMed Central

To assess whether endocrine dysfunction may cause derangement in energy homeostasis in patients undergoing hemodialysis (HD), we profiled hormones, during a 3-day period, from the adipose tissue and the gut and the nervous system around the circadian clock in 10 otherwise healthy HD patients and 8 normal controls. The protocol included a 40-h fast. We also measured energy-protein intake and output and assessed appetite and body composition. We found many hormonal abnormalities in HD patients: 1) leptin levels were elevated, due, in part, to increased production, and nocturnal surge in response to daytime feeding, exaggerated. 2) Peptide YY (PYY), an anorexigenic gut hormone, was markedly elevated and displayed an augmented response to feeding. 3) Acylated ghrelin, an orexigenic gut hormone, was lower and did not exhibit the premeal spike as observed in the controls. 4) neuropeptide Y (NPY), a potent orexigenic peptide, was markedly elevated and did not display any circadian variation. 5) Norepinephrine, marginally elevated, did not exhibit the normal nocturnal dip. By contrast, ?-melanocyte-stimulating hormone and glucagon-like peptide-1 were not different between the two groups. Despite these hormonal abnormalities, HD patients maintained a good appetite and had normal body lean and fat mass, and there was no evidence of increased energy expenditure or protein catabolism. We explain the hormonal abnormalities as well as the absence of anorexia on suppression of parasympathetic activity (vagus nerve dysfunction), a phenomenon well documented in dialysis patients. Unexpectedly, we noted that the combination of high leptin, PYY, and NPY with suppressed ghrelin may increase arterial blood pressure, impair vasodilatation, and induce cardiac hypertrophy, and thus could predispose to adverse cardiovascular events that are the major causes of morbidity and mortality in the HD population. This is the first report attempting to link hormonal abnormalities associated with energy homeostasis to adverse cardiovascular outcome in the HD patients. PMID:20959536

Suneja, Manish; Murry, Daryl J.; Stokes, John B.

2011-01-01

268

Do family practitioners in Lithuania inform their patients about adverse effects of common medications?  

Microsoft Academic Search

Objectives:(1) To investigate the extent to which family physicians (GPs) in Lithuania inform their patients about possible side-effects when a common treatment is proposed. (2) To examine the relation between physicians’ estimation of the severity and frequency of these side-effects and their willingness to inform patients. (3) To identify the reasons for informing or not informing the patients.Methods:A questionnaire, presenting

I Liseckiene; Z Liubarskiene; R Jacobsen; L Valius; M Norup

2008-01-01

269

Overweight and obesity adversely affect outcomes of assisted reproductive technologies in polycystic ovary syndrome patients  

PubMed Central

Overweight and obesity may have negative impact on IVF/ICSI treatment outcomes. However, it is not clear whether overweight and obesity have impact on IVF/ICSI outcomes in PCOS patients. The aim of this study was to examine the effect of overweight and obesity on IVF/ICSI treatment outcomes in PCOS patients treated with GnRH agonist long protocol. This retrospective study was conducted in a reproductive medicine center from January 2009 to June 2013. IVF/ICSI characteristics and outcomes were analyzed in 688 PCOS patients according to their BMI. A total of 409 normal weight patients (group A, 18.5 kg/m2 ? BMI <24 kg/m2) and 279 overweight and obese patients (group B, BMI ?24 kg/m2) were included into this study. Patient age, basal FSH, basal LH and peak E2 concentration were comparable in the two groups. Compared with patients in group A, patients in group B had similar number of retrieved oocytes, 2PN, and high quality embryos. However, overweight and obese women needed more ampoules of gonadotrophin and longer days of stimulation. In addition, the implantation rate (38.3% vs. 35.6%; P=0.000) was also higher in normal weight patients. Overweight and obese women seemed to have lower clinical pregnancy rate (56.9% vs. 53.4%; P>0.05), but the difference was not statistically significant. In conclusion, overweight and obesity is associated with unfavorable IVF/ICSI outcomes in PCOS patients treated with GnRH agonist long protocol. PMID:24260609

Bu, Zhiqin; Dai, Wei; Guo, Yihong; Su, Yingchun; Zhai, Jun; Sun, Yingpu

2013-01-01

270

Intermedin as a prognostic factor for major adverse cardiovascular events in patients with ST-segment elevation acute myocardial infarction.  

PubMed

Intermedin functions systemically as a potent vasodilator and its plasma levels have been shown to be elevated in patients with acute myocardial infarction. This study aimed to evaluate the prognostic value of plasma intermedin level in the patients with ST-segment elevation acute myocardial infarction. Plasma intermedin concentrations of 128 patients and 128 healthy controls were determined using a radioimmunoassay. Patients were followed up for 6 months for major adverse cardiovascular events (MACE) consisting of cardiovascular mortality, reinfarction, hospitalization for decompensated heart failure, and lift-threatening arrhythmia. The association of plasma intermedin levels with MACE was investigated by univariate and multivariate analyses. Plasma intermedin levels were significantly higher in patients than in healthy subjects. Elevated plasma level of intermedin was identified as an independent predictor of MACE. Receiver operating characteristic curve analysis showed that plasma intermedin levels had high predictive value for MACE. Moreover, its predictive value was similar to Global Registry of Acute Coronary Events scores' based on area under curve. Meantime, it obviously improved Global Registry of Acute Coronary Events scores' predictive value in a combined logistic-regression model. In multivariate Cox's proportional hazard analysis, plasma intermedin level emerged as an independent predictor of MACE-free survival. Thus, our results suggest that high plasma intermedin level is associated with poor outcomes of patients and may be a useful prognostic biomarker in ST-segment elevation acute myocardial infarction. PMID:24969626

Tang, Bei; Zhong, Ze; Shen, Hong-Wei; Wu, Hui-Ping; Xiang, Peng; Hu, Bin

2014-08-01

271

Patent Foramen Ovale Is an Important Predictor of Adverse Outcome in Patients With Major Pulmonary Embolism  

Microsoft Academic Search

Background—Right-to-left shunt through a patent foramen ovale is frequently diagnosed by contrast echocardiography and can be particularly prominent in the presence of elevated pressures in the right side of the heart. Its prognostic significance in patients with pulmonary thromboembolism, however, is unknown. Methods and Results—The present prospective study included 139 consecutive patients with major pulmonary embolism diagnosed on the basis

Stavros Konstantinides; Annette Geibel; Wolfgang Kasper; Manfred Olschewski; Liane Blumel; Hanjorg Just

272

Minimizing Cardiovascular Adverse Effects of Atypical Antipsychotic Drugs in Patients with Schizophrenia  

PubMed Central

The use of atypical antipsychotic agents has rapidly increased in the United States and worldwide in the last decade. Nonetheless, many health care practitioners do not appreciate the significance of the cardiovascular side effects that may be associated with their use and the means to minimize them. Thus, atypical antipsychotic medications can cause cardiovascular side effects such as arrhythmias and deviations in blood pressure. In rare cases, they may also cause congestive heart failure, myocarditis, and sudden death. Patients with schizophrenia have a higher risk of cardiovascular mortality than healthy individuals, possibly because of excessive smoking, the underlying disorder itself, or a combination of both factors. Increased awareness of these potential complications can allow pharmacists and physicians to better manage and monitor high risk patients. Accurate assessments are very important to avoid medications from being given to patients inappropriately. Additionally, monitoring patients regularly via blood draws and checking blood pressure, heart rate, and electrocardiogram can help catch any clinical problems and prevent further complications. Finally, patient and family-member education, which pharmacists in particular can play key roles in, is central for the management and prevention of side effects, which is known to reflect positively on morbidity and mortality in these patients. PMID:24649390

Khasawneh, Fadi T.; Shankar, Gollapudi S.

2014-01-01

273

Minimizing cardiovascular adverse effects of atypical antipsychotic drugs in patients with schizophrenia.  

PubMed

The use of atypical antipsychotic agents has rapidly increased in the United States and worldwide in the last decade. Nonetheless, many health care practitioners do not appreciate the significance of the cardiovascular side effects that may be associated with their use and the means to minimize them. Thus, atypical antipsychotic medications can cause cardiovascular side effects such as arrhythmias and deviations in blood pressure. In rare cases, they may also cause congestive heart failure, myocarditis, and sudden death. Patients with schizophrenia have a higher risk of cardiovascular mortality than healthy individuals, possibly because of excessive smoking, the underlying disorder itself, or a combination of both factors. Increased awareness of these potential complications can allow pharmacists and physicians to better manage and monitor high risk patients. Accurate assessments are very important to avoid medications from being given to patients inappropriately. Additionally, monitoring patients regularly via blood draws and checking blood pressure, heart rate, and electrocardiogram can help catch any clinical problems and prevent further complications. Finally, patient and family-member education, which pharmacists in particular can play key roles in, is central for the management and prevention of side effects, which is known to reflect positively on morbidity and mortality in these patients. PMID:24649390

Khasawneh, Fadi T; Shankar, Gollapudi S

2014-01-01

274

Cost of prescribed NSAID-related gastrointestinal adverse events in elderly patients  

PubMed Central

Aims It is well established that nonsteroidal anti-inflammatory drugs (NSAIDs) have gastrointestinal (GI) side-effects. However, the cost of health care resources spent on preventing and managing these side-effects is not clear. The objective of this study was to estimate the direct cost of NSAID-related GI events in an elderly population. Methods From the Régie de l'assurance-maladie du Québec (RAMQ) database, we obtained medical, pharmaceutical and demographic records of a 10% random sample (n = 49 033) of seniors who, between January 1, 1993 and December 31, 1997, had a dispensed prescription of a NSAID. Patients who did not have any GI events during the year prior to their first dispensed prescription were included in the cohort. All patients were followed-up for 2 years. The daily direct Canadian dollar costs of GI events that were incurred by these patients while they were on NSAID therapy were compared with those of GI events that were incurred by these same patients while they were not on NSAID therapy. The difference in these daily costs was attributed to NSAIDs. Results A total of 12 082 new NSAID users were included in the study. Two hundred and seventeen (1.8%) were hospitalized for GI-related problems; of these, 130 (60%) had their GI hospitalization as their first GI event; 3257 (27.0%) used gastroprotective agents (GPAs), and 857 (26.3%) took GPAs without any apparent prior GI symptoms; 801 (6.6%) had GI diagnostic tests; and 661 (5.5%) died. The average direct costs of GI side-effects per patient-day on NSAIDs were 3.5 times higher than those of a patient-day not on NSAIDs. The direct cost of GI side-effects per patient-day on NSAIDs was $1.34, of which more than 70% ($0.94) was attributed to GI events resulting from NSAID treatment. Conclusions Approximately one Canadian dollar was added to patient costs for every day he/she was on NSAID therapy. Safer therapies and appropriate patient risk management may potentially reduce NSAID-related health care resource use. PMID:11488776

Rahme, Elham; Joseph, Lawrence; Kong, Sheldon X; Watson, Douglas J; LeLorier, Jacques

2001-01-01

275

Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain.  

PubMed

The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain. This prospective observational study included patients who received acupuncture for chronic low back pain or chronic neck pain. After treatment all patients documented adverse events associated with acupuncture (defined as adverse effects) and provided details e.g. on treatment. Cost data was provided by the health insurance companies. We used a societal perspective including direct health care costs related to the acupuncture and the indirect costs caused through lost workdays. From 73,406 patients, 5440 patients (7.4% [95% CI 7.2%; 7.6%] reported experiencing at least one adverse effect and 1422 patients (1.9% [1.8%; 2.0%]) required treatment. The subsequent treatments reported were either self-treatment (1.2% [1.09%; 1.25%]), treatment with medication and/or by a physician (0.6% [0.57%; 0.68%]), or treatment in a hospital (0.03% [0.02%; 0.04%]). Patients reporting adverse effects that required treatment had higher costs compared to patients without adverse effects (at 3months €1265 [1179; 1351] vs. €1140 [1128; 1153] and at 12months € 3534 [3256; 3812] vs. € 3249 [3209; 3289]. The difference was caused through the expense of visiting physicians and higher indirect costs (difference at 3months: €125 [38; 211], p=0.005 and at 12months: €285 [4; 566], p=0.047). Adverse effects from acupuncture occur in about 7% of patients and were mainly treated by themselves. When these effects needed treatment by a health professional additional expenses were the consequence. PMID:20609604

Witt, Claudia M; Pach, Daniel; Reinhold, Thomas; Wruck, Katja; Brinkhaus, Benno; Mank, Sigrid; Willich, Stefan N

2011-02-01

276

Factors predicting adverse short-term outcomes in patients with acute cholangitis undergoing ERCP: A single center experience  

PubMed Central

AIM: To identify potential factors that can predict adverse short-term outcomes in patients with acute cholangitis undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Retrospective analysis of consecutive patients admitted to our center for acute cholangitis and underwent ERCP from 2001 to 2012. Involvement of two or more organ systems was termed as organ failure (OF). Cardiovascular failure was defined based on a systolic blood pressure of < 90 mmHg despite fluid replacement and/or requiring vasopressor treatment; respiratory failure if the Pa02/Fi02 ratio was < 300 mmHg and/or required mechanical ventilation; coagulopathy if the platelet count was < 80; and renal insufficiency if serum creatinine was > 1.9 mg/dL. Variables associated with short term adverse clinical outcomes defined as persistent OF and/or 30-d mortality was determined. RESULTS: A total of 172 patients (median age 62 years, 56.4% female) were included. The median door to ERCP time was 17 h. Bile duct stones were the most common etiology (n = 67, 39.2%). In multivariate analysis, factors that were independently associated with persistent OF and/or 30-d mortality included American Society of Anesthesiology (ASA) physical classification score > 3 (OR = 7.70; 95%CI: 2.73-24.40), presence of systemic inflammatory response syndrome (OR = 3.67; 95%CI: 1.34-10.3) and door to ERCP time greater than 72 h (OR = 3.36; 95%CI: 1.12-10.20). Door to ERCP time greater than 72 h was also associated with 70% increase in the mean length of stay (P < 0.001). Every one point increase in the ASA physical classification and every 1 mg/dL increase in the pre-ERCP bilirubin level was associated with a 34% and 2% increase in the mean length of hospital stay, respectively. Transfer status did not impact clinical outcomes. CONCLUSION: Higher ASA physical classification and delays in ERCP are associated with adverse clinical outcomes and prolonged length of hospital stay in patients with acute cholangitis undergoing ERCP. PMID:24634711

Navaneethan, Udayakumar; Gutierrez, Norma G; Jegadeesan, Ramprasad; Venkatesh, Preethi GK; Sanaka, Madhusudhan R; Vargo, John J; Parsi, Mansour A

2014-01-01

277

Exercise capacity as an independent risk factor for adverse cardiovascular outcomes among nondiabetic and diabetic patients  

PubMed Central

Introduction To investigate if decreased exercise capacity is an independent risk factor for major adverse cardiovascular events (MACE) in diabetics and nondiabetics. Material and methods The association of decreased exercise capacity (EC) during a treadmill exercise sestamibi stress test with MACE was investigated in 490 nondiabetics and 404 diabetics. Mean follow-up was 53 months. Results Nondiabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (34% vs. 19%, p = 0.0002), 2- or 3-vessel obstructive coronary artery disease (CAD) (31% vs. 13%, p = 0.016), myocardial infarction (MI) (17% vs. 7%, p = 0.0005), stroke (8% vs. 2%, p = 0.002), death (11% vs. 3%, p = 0.0002), and MI or stroke or death at follow-up (32% vs. 11%, p < 0.001) compared to nondiabetics with a predicted EC ? 85%. Diabetics with a predicted EC < 85% had a higher prevalence of myocardial ischemia (48% vs. 32%, p = 0.0009), 2- or 3-vessel obstructive CAD (54% vs. 28%, p = 0.001), MI (32% vs. 14%, p < 0.001), stroke (22% vs. 6%, p < 0.001), death (17% vs. 9%, p = 0.031), and MI or stroke or death at follow-up (65% vs. 27%, p < 0.001). Stepwise Cox regression analysis showed decreased EC was an independent and significant risk factor for MACE among nondiabetics (hazard ratio 3.3, p < 0.0001) and diabetics (hazard ratio 2.7, p < 0.0001). Conclusions Diabetics and nondiabetics with decreased EC were at increased risk for MACE with nondiabetics and decreased EC at similar risk as diabetics with normal EC. PMID:24701210

Pierre-Louis, Bredy; Guddati, Achuta K.; Khyzar Hayat Syed, Muhammed; Gorospe, Vanessa E.; Manguerra, Mark; Bagchi, Chaitali; Ahn, Chul

2014-01-01

278

Adverse experiences in childhood influence brain responses to emotional stimuli in adult psychiatric patients  

Microsoft Academic Search

Previous results suggest that early life stress (ELS) may be related to altered cortical responses to emotional stimuli. In a previous study, we found suppressed cortical responses to emotional pictures in psychiatric patients with high-ELS. The present study explored the stability of this effect across time and stimulation conditions. In addition, the relationship between ELS and current life stress was

Katharina Matz; Markus Junghöfer; Thomas Elbert; Katja Weber; Christian Wienbruch; Brigitte Rockstroh

2010-01-01

279

Matrix Metalloproteinase 7 Is Associated with Symptomatic Lesions and Adverse Events in Patients with Carotid Atherosclerosis  

PubMed Central

Background Atherosclerosis is a major cause of cerebrovascular disease. Matrix metalloproteinases (MMPs) play an important role in matrix degradation within the atherosclerotic lesion leading to plaque destabilization and ischemic stroke. We hypothesized that MMP-7 could be involved in this process. Methods Plasma levels of MMP-7 were measured in 182 consecutive patients with moderate (50–69%) or severe (?70%) internal carotid artery stenosis, and in 23 healthy controls. The mRNA levels of MMP-7 were measured in atherosclerotic carotid plaques with different symptomatology, and based on its localization to macrophages, the in vitro regulation of MMP-7 in primary monocytes was examined. Results Our major findings were (i) Patients with carotid atherosclerosis had markedly increased plasma levels of MMP-7 compared to healthy controls, with particularly high levels in patients with recent symptoms (i.e., within the last 2 months). (ii) A similar pattern was found within carotid plaques with markedly higher mRNA levels of MMP-7 than in non-atherosclerotic vessels. Particularly high protein levels of MMP-7 levels were found in those with the most recent symptoms. (iii) Immunhistochemistry showed that MMP-7 was localized to macrophages, and in vitro studies in primary monocytes showed that the inflammatory cytokine tumor necrosis factor-? in combination with hypoxia and oxidized LDL markedly increased MMP-7 expression. (iv) During the follow-up of patients with carotid atherosclerosis, high plasma levels of MMP-7 were independently associated with total mortality. Conclusion Our findings suggest that MMP-7 could contribute to plaque instability in carotid atherosclerosis, potentially involving macrophage-related mechanisms. PMID:24400123

Abbas, Azhar; Aukrust, Pal; Russell, David; Krohg-S?rensen, Kirsten; Almas, Trine; Bundgaard, Dorte; Bjerkeli, Vigdis; Sagen, Ellen Lund; Michelsen, Annika E.; Dahl, Tuva B.; Holm, Sverre; Ueland, Thor

2014-01-01

280

Alcoholism and other socio-demographic risk factors for adverse TB-drug reactions and unsuccessful tuberculosis treatment - data from ten years' observation at the Regional Centre of Pulmonology, Bydgoszcz, Poland  

PubMed Central

Background Tuberculosis (TB) is one of the most dangerous infectious diseases and has one of the highest mortality rates. For decades a strong association has been evident between certain socio-economic factors and TB adverse events and failure of treatment, yet there is a limited quantity of literature available on this subject, especially in the Polish literature. Material/Methods We examined epidemiological data from 2025 TB patients treated at the Regional Centre of Pulmonology in Bydgoszcz, Poland between 2001 and 2010. This article focuses on the association between all forms of unsuccessful TB treatment outcomes or adverse drug reaction (ADR) and socio-demographic characteristics, condition on admission, and other biological, clinical, social, and healthcare access factors. Results The rate of TB-ADR during hospitalization was 38.9%. Multivariate logistic regression analysis showed that age (P<0.001) and alcohol abuse (P=0.007) were independently associated with the occurrence of TB-ADR. The rate of unsuccessful TB treatment was 10.5%. After adjusting for confounding variables, age (P<0.001), alcohol abuse (P=0.002), and education (P=0.01) were significantly associated with unsuccessful treatment. Smoking did not have any significant influence on occurrence of either TB-ADR during hospitalization or unsuccessful treatment. Conclusions Among our TB patients treated between 2001 and 2010, alcohol abuse significantly worsened the treatment outcome. This information will be crucial in developing strategies targeted at this demographic group. PMID:24643127

Przybylski, Grzegorz; Dabrowska, Anita; Trzcinska, Hanna

2014-01-01

281

OBESITY ADVERSELY IMPACTS DISEASE SPECIFIC OUTCOMES IN PATIENTS WITH UPPER TRACT UROTHELIAL CARCINOMA  

PubMed Central

Introduction and Objective Increased body mass index (BMI) is associated with worse outcomes for several different malignancies. The relationship between BMI and urothelial carcinoma is poorly understood. We investigated the association between BMI and oncological outcomes in upper tract urothelial carcinoma (UTUC). Methods We retrospectively studied 520 patients treated with radical nephroureterectomy (RNU) for UTUC without neoadjuvant chemotherapy. Univariable Cox regression analyses were performed to evaluate recurrence-free (RFS) and cancer-specific survival (CSS) estimates. We created a multivariable model based on preoperative and postoperative characteristics. BMI was treated as a continuous and a categorical variable defined as normal weight (<25 kg/m2), overweight (25–29.9 kg/m2) or obese (?30 kg/m2). Results The median patient BMI was 27.9 kg/m2 (IQR: 6.7). Median follow-up was 38 months (IQR: 54). Patients with a higher BMI were more likely to have infiltrative architecture (p<0.001) and lymphovascular invasion (p=0.012). BMI was not associated with age, smoking history, pathologic stage, tumor grade, concomitant CIS, tumor necrosis, and the selection of a laparoscopic or open procedure. In the preoperative multivariable model a BMI of 25–29 kg/m2 (HR 2.25, 95% CI: 1.3–3.8, p=0.003) and BMI ? 30 kg/m2 (HR 3.72, 95% CI: 2.2–6.3, <0.001) were both associated with disease recurrence. A BMI ?30kg/m2 (HR 4.24, CI: 2.4–7.5, p<0.001) was associated with cancer specific death. In the postoperative model, tumor stage (p<0.001), positive lymph nodes (HR 2.52, 95% CI: 1.59–4.0, p<0.001), BMI 25–29 kg/m2 (HR 2.18, 95% CI: 1.27–3.73, p=0.005) and BMI ?30 kg/m2 (HR 3.52, 95% CI: 2.08–5.95, p<0.001) were associated with disease recurrence. Tumor stage (p<0.001), positive lymph nodes (HR 3.1, 95% CI: 1.84–5.21, p<0.001), and a BMI?30 kg/m2 (HR 4.13, 95% CI: 2.32–7.36, p<0.001) were associated with cancer-specific death. Conclusions Higher BMI is associated with worse cancer-specific outcomes in patients treated with RNU for UTUC. Improving cancer specific survival by also focusing on patient modifiable factors such as BMI could have significant individual and public health implications in UTUC patients. Future studies should be encouraged to evaluate the molecular mechanisms of tumorigenesis and progression associated with metabolic changes in obesity. PMID:21571333

Ehdaie, Behfar; Chromecki, Thomas F.; Lee, Richard K.; Lotan, Yair; Margulis, Vitaly; Karakiewicz, Pierre I.; Novara, Giacomo; Raman, Jay D.; Ng, Casey; Lowrance, William T.; Scherr, Douglas S.; Shariat, Shahrokh F.

2014-01-01

282

Amelioration of sexual adverse effects in the early breast cancer patient  

Microsoft Academic Search

Background  As the number of breast cancer survivors increases, the long term consequences of breast cancer treatment are gaining attention.\\u000a Sexual dysfunction is a common complaint amongst breast cancer survivors, and there are few evidence based recommendations\\u000a and even fewer well designed clinical trials to establish what treatments are safe or effective in this patient population.\\u000a \\u000a \\u000a \\u000a \\u000a Design  We conducted a PubMed search

Michelle E. Melisko; Mindy Goldman; Hope S. Rugo

2010-01-01

283

Case report: adverse granulomatous reaction (Granuloma formation) and pseudomonas superinfection after lip augmentation by the new filler DermaLive®  

Microsoft Academic Search

In recent years, there has been a huge increase of injectable filler materials on the aesthetic market to correct wrinkles,\\u000a aging lines, or volume deficits in the face. Despite their nontoxicity and low immunologic reactivity, they can induce a foreign\\u000a body reaction and formation of inflammatory nodules or granulomas. We report a case of severe complications with granuloma\\u000a formation and

Birgit Weyand; Henrik Menke

2008-01-01

284

Preclinical evidence of potential craniofacial adverse effect of zoledronic acid in pediatric patients with bone malignancies.  

PubMed

High doses of zoledronic acid (ZOL), one of the most potent inhibitors of bone resorption, are currently evaluated in phase III clinical trials in Europe for the treatment of malignant pediatric primary bone tumors. The impact of such an intensive treatment on the craniofacial skeleton growth is a critical question in the context of patients with actively growing skeleton; in particular, in light of our previous studies evidencing that endochondral bone formation was transiently disturbed by high doses of ZOL. Two protocols adapted from pediatric treatments were developed for newborn mice (a total of 5 or 10 injections of ZOL 50?g/kg every two days). Their impact on skull bones and teeth growth was analyzed by X-rays, microCT and histology up to 3months after the last injection. ZOL administrations induced a transient delay of skull bone growth and an irreversible delay in incisor, first molar eruption and root elongation. Other teeth were affected, but most were erupted by 3months. Root histogenesis was severely impacted for all molars and massive odontogenic tumor-like structures were observed in all mandibular incisors. High doses of ZOL irreversibly disturbed teeth eruption and elongation, and delayed skull bone formation. These preclinical observations are essential for the follow-up of onco-pediatric patients treated with ZOL. PMID:25193159

Lézot, Frédéric; Chesneau, Julie; Battaglia, Séverine; Brion, Régis; Castaneda, Beatriz; Farges, Jean-Christophe; Heymann, Dominique; Rédini, Françoise

2014-11-01

285

TGFB1 Single Nucleotide Polymorphisms Are Associated With Adverse Quality of Life in Prostate Cancer Patients Treated With Radiotherapy  

SciTech Connect

Purpose: To investigate whether the presence of single nucleotide polymorphisms (SNPs) located within TGFB1 might be predictive for the development of adverse quality-of-life outcomes in prostate cancer patients treated with radiotherapy. Methods and Materials: A total of 141 prostate cancer patients treated with radiotherapy were screened for SNPs in TGFB1 using DNA sequencing. Three quality-of-life outcomes were investigated: (1) prospective decline in erectile function, (2) urinary quality of life, and (3) rectal bleeding. Median follow-up was 51.3 months (range, 12-138 months; SD, 24.4 months). Results: Those patients who possessed either the T/T genotype at position -509, the C/C genotype at position 869 (pro/pro, codon 10) or the G/C genotype at position 915 (arg/pro, codon 25) were significantly associated with the development of a decline in erectile function compared with those who did not have these genotypes: 56% (9 of 16) vs. 24% (11 of 45) (p = 0.02). In addition, patients with the -509 T/T genotype had a significantly increased risk of developing late rectal bleeding compared with those who had either the C/T or C/C genotype at this position: 55% (6 of 11) vs. 26% (34 of 130) (p = 0.05). Conclusions: Possession of certain TGFB1 genotypes is associated with the development of both erectile dysfunction and late rectal bleeding in patients treated with radiotherapy for prostate cancer. Therefore, identification of patients harboring these genotypes may represent a means to predict which men are most likely to suffer from poor quality-of-life outcomes after radiotherapy for prostate cancer.

Peters, Christopher A. [Department of Radiation Oncology, Mount Sinai School of Medicine, New York, NY (United States)], E-mail: christopher.peters@mountsinai.org; Stock, Richard G.; Cesaretti, Jamie A.; Atencio, David P.; Peters, Sheila B.A.; Burri, Ryan J. [Department of Radiation Oncology, Mount Sinai School of Medicine, New York, NY (United States); Stone, Nelson N. [Department of Radiation Oncology, Mount Sinai School of Medicine, New York, NY (United States); Department of Urology, Mount Sinai School of Medicine, New York, NY (United States); Ostrer, Harry [Human Genetics Program, Department of Pediatrics, New York University School of Medicine, New York, NY (United States); Rosenstein, Barry S. [Department of Radiation Oncology, Mount Sinai School of Medicine, New York, NY (United States); Department of Dermatology, Mount Sinai School of Medicine, New York, NY (United States); Department of Community and Preventive Medicine, Mount Sinai School of Medicine, New York, NY (United States); Department of Radiation Oncology, New York University School of Medicine, New York, NY (United States)

2008-03-01

286

Discharging patients earlier from Winnipeg hospitals: does it adversely affect quality of care?  

PubMed Central

OBJECTIVE: To determine whether decreasing lengths of stay over time for selected diagnostic categories were associated with increased hospital readmission rates and mean number of physician visits after discharge. DESIGN: Retrospective descriptive study. SETTING: The seven large (125 beds or more) acute care hospitals in Winnipeg. PATIENTS: Manitoba residents admitted to any one of the seven hospitals because acute myocardial infarction (AMI), bronchitis or asthma, transurethral prostatectomy (TURP) and uterine or adnexal procedures for nonmalignant disease during the fiscal years 1989-90 to 1992-93. Patients from out of province, those who died in hospital, those with excessively long stays (more than 60 days) and those who were transferred to or from another institution were excluded. OUTCOME MEASURES: Length of hospital stay, and rate of readmission within 30 days after discharge for all four categories and mean number of physician visits within 30 days after discharge for two categories (AMI and bronchitis or asthma. RESULTS: The length of stay decreased significantly over the 4 years for all of the four categories, the smallest change being observed for patients with AMI (11.1%) and the largest for those with bronchitis or asthma (22.0%). The readmission rates for AMI, bronchitis or asthma, and TURP showed no consistent change over the 4 years. The readmission rate for uterine or adnexal procedures increased significantly between the first and second year (chi 2 = 4.28, p = 0.04) but then remained constant over the next 3 years. The mean number of physician visits increased slightly for AMI in the first year (1.92 to 2.01) and then remained virtually the same. It decreased slightly for bronchitis or asthma over the 4 years. There was no significant correlation between length of stay and readmission rates for individual hospitals in 1992-93 in any of the four categories. Also, no correlation was observed between length of stay and mean number of physician visits for individual hospitals in 1992-93 in the categories AMI and bronchitis or asthma. CONCLUSIONS: Improving hospital efficiency by shortening length of stay does not appear to result in increased rates of readmission or numbers of physician visits within 30 days after discharge from hospital. Research is needed to identify optimal lengths of stay and expected readmission rates. PMID:7664228

Harrison, M L; Graff, L A; Roos, N P; Brownell, M D

1995-01-01

287

[Histamine-related reactions in patients with byssinosis].  

PubMed

The purpose of the study was to analyze the mechanism of histamine action in histamine-dependent reactions of neutrophils and lymphocytes in patients with byssinosis and chronic asthmatic bronchitis under cotton and flax dust effect. The appraisal of histamine content in blood serum, receptor/histamine distribution of lymphocyte and neutrophil subpopulations (rosette-forming double and triple reactions), determination of histamine modeling effect on lymphocyte-neutrophil cooperation in the inhibition reaction of leukocyte migration revealed that under cotton dust effect neutrophils and the complement system were involved into the histamine liberation process in byssinosis patients, lymphocytes were most likely not involved into the process. Flax dust-affected histamine reactions were not so distinct: lymphocyte and neutrophil reactivity in byssinosis patients did not exceed the standards. Patients with chronic asthmatic bronchitis had high blood concentration of histamine and experienced some changes in cells' migration characteristics. It was assumed that primarily nonimmune mechanisms of histamine liberation and activation of the complement system were involved into byssinosis pathological process in patients exposed to cotton and flax dust effect. In patients with chronic asthmatic bronchitis there occurred all 3 activation mechanisms of biologically active substances, i.e., allergic and nonantigenic ways of histamine liberation and activation of the complement system. PMID:2473011

Grishina, T I; A?zina, N L; Babok, A L; Alekseeva, O G

1989-01-01

288

Assessing the role of the biomaterial Aquavene in patient reactions to Landmark midline catheters.  

PubMed

Landmark midline catheters (Menlo Care, Inc., Palo Alto, CA) provide peripheral venous access for the infusion of medications or fluids. They are constructed of an inner layer of polyurethane and an outer layer of the biomaterial Aquavene, a blend of polyurethane and polyethylene oxide to which butylated hyroxyanisole (BHA), butylated hydroxytoluene (BHT), and triallyl-s-triazine trione (TTT) are added. Once inside the vein, the Aquavene material becomes hydrated and the catheter swells resulting in minimal trauma to the vein. It is well recognized that some patients experience reactions to catheterization. Recent reports of hypersensitivity-like reactions in some patients catheterized with Landmark catheters have prompted the manufacturer to reexamine biocompatibility data and clinical data to assess whether Aquavene was the source of the patient responses. None of the biocompatibility studies provided by Menlo Care in support of U.S. registration and marketing of Aquavene-based catheters demonstrated any tendency for Aquavene or material extracted from Aquavene to invoke an immunological or toxicological response. Examination of potential catheter residuals revealed that significant amounts of BHA and BHT were unlikely to be released from the catheters during expected use. The amounts of polyethylene oxide and TTT expected to be released during the first few minutes after catheter insertion (when most of the patient reactions were reported) are almost 92,500 and 270,000 times lower, respectively, than nontoxic animal exposures. These analyses do not support chemically mediated toxicity as an explanation for the adverse events experienced by some patients. A review of the postmarket surveillance data on Aquavene-based catheters revealed that the reported events were not consistent with a hypersensitivity (immunogenic) response to the biomaterial. The rare reported adverse events tend to occur quickly, most often after flushing of the catheter, and resolve quickly, even when the catheter remains in place. Determining the frequency and severity of adverse events reported in association with the use of Landmark catheters will ultimately require a controlled prospective study, preferably one with a concurrent control group using alternative products. PMID:9056501

Silverstein, B; Witkin, K M; Frankos, V H; Terr, A I

1997-02-01

289

The association between a prolonged stay in the emergency department and adverse events in older patients admitted to hospital: a retrospective cohort study  

Microsoft Academic Search

ObjectivePatient safety studies have identified older adults as a high-risk group for adverse events (AEs). As frequent users of the emergency department (ED), they are vulnerable to the negative consequences of ED crowding. The study objective was to determine whether a prolonged ED stay is associated with an increased risk for the occurrence of AEs for older patients admitted to

S Ackroyd-Stolarz; J Read Guernsey; N J MacKinnon; G Kovacs

2011-01-01

290

Frequency of Adverse Clinical Events in the 12 Months Following Successful Intracoronary Stent Placement in Patients Treated With Aspirin and Ticlopidine (Without Warfarin)  

Microsoft Academic Search

Little is known about the frequency of adverse events in the year following stent placement in patients treated with aspirin and ticlopidine, without warfarin. We analyzed the first such 234 consecutive patients treated at our hospital between October 1994 and December 1995. Their mean age was 62 ± 12 years; 40% had had a prior myocardial infarction, 22% had undergone

Peter B Berger; Malcolm R Bell; Diane E Grill; Steve Melby; David R Holmes

1998-01-01

291

Predictive value of high-sensitivity troponin I and D-dimer assays for adverse outcome in patients with acute pulmonary embolism  

PubMed Central

High-sensitivity troponin (hs-cTn) assays enable the troponin cutoff value to be lowered, resulting in an increase of sensitivity at the cost of specificity. In the present study, the risk of a short-term adverse outcome was assessed in patients with acute pulmonary embolism (PE) using high-sensitivity troponin I (hs-cTnI). We used a cutoff value of 0.1 ng/ml in accordance with current guidelines for unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI), although the detection limit of the troponin assay is lower. In addition, the risk of an adverse outcome in patients with acute PE was investigated with respect to initial D-dimer serum concentrations. In 65 patients with confirmed acute PE, hs-cTnI and D-dimer values were measured. Adverse clinical outcome was defined as cardiogenic shock, cardiopulmonary resuscitation, mechanical ventilation, vasopressor therapy, thrombolysis, catheter intervention or mortality within 60 days of PE. Patients with acute PE and serum hs-cTnI values >0.1 ng/ml showed significantly higher D-dimer concentrations (P= 0.0467) and a 5-fold increased risk of an adverse clinical outcome [odds ratio (OR), 4.9; 95% confidence interval (CI), 1.28–18.66; P=0.0235] compared with patients with acute PE and hs-cTnI values <0.1 ng/ml. In patients with acute PE suffering from adverse clinical outcome, D-dimer concentrations were significantly elevated compared with those in patients with acute PE without adverse clinical outcome (P=0.02). In patients with acute PE, a hs-cTnI cutoff value of 0.1 ng/ml, which is identical to the recommended cutoff value of NSTEMI, may identify patients with a 5-fold increased risk of a short-term adverse outcome. D-dimer values are significantly higher in PE patients with elevated hs-cTnI values as well as in patients with an adverse outcome. PMID:23403884

WALTER, THOMAS; APFALTRER, PAUL; WEILBACHER, FRANK; MEYER, MATHIAS; SCHOENBERG, STEFAN O.; FINK, CHRISTIAN; GRUETTNER, JOACHIM

2013-01-01

292

Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above  

PubMed Central

Introduction Evidence of patients’ experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. Methods and analysis The 45 and Up Study is a cohort of 265?000 adults aged 45?years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20?000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients’ experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients’ experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Ethics and dissemination Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. PMID:25311039

Walton, Merrilyn; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

2014-01-01

293

A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection  

PubMed Central

Background Depot antipsychotic injections are an important tool for the management of patients with schizophrenia who have difficulty with adherence to oral medication. However, pain and discomfort at the injection site can be a potential impediment to the use of these long-acting formulations. We report here the results of a pooled analysis of injection site-related adverse events (AEs) collected during treatment with the olanzapine long-acting injection (olanzapine LAI). Methods Unsolicited injection site-related AEs were pooled from 7 olanzapine LAI clinical trials conducted in patients between March 2001 and December 2010. All patients had a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder and were between the ages of 18 and 75. Doses ranged from 45 to 405 mg olanzapine LAI, and injection intervals were 2, 3, or 4 weeks. Events were evaluated for severity, timing, possible risk factors, and outcome. A criterion of p?patients received at least 1 olanzapine LAI injection. Of these, 92 patients (5.3%) reported at least 1 injection site-related AE, with “pain” being the most common type (2.9%). Most events were mild (81.4%) and the median duration was 3 days. Four patients (0.2%) discontinued due to injection site-related AEs. Dose volume and body mass index did not appear to affect the probability of injection site-related AEs. However, patients who experienced a post-injection delirium/sedation syndrome event (n?=?37) were more likely to have or have had an injection site-related AE at some time during the study. Incidence of injection site-related AEs appeared to decrease over time. In 94.2% of the injection site-related AEs, no specific treatment or concomitant medication was reported; in 9 cases, patients received pharmacologic treatment for reaction, mass, abscess, rash, or pain. Conclusions Injection site-related AEs with olanzapine LAI were generally mild. The incidence and nature of these injection site-related AEs were generally similar to those occurring during treatment with other injectable antipsychotics. Trial registration ClinicalTrials.gov ID; URL: NCT00094640, NCT00088478, NCT00088491, NCT00088465, and NCT00320489. PMID:24423017

2014-01-01

294

Adverse neurologic reactions after both doses of pandemic H1N1 influenza vaccine with optic neuritis and demyelination.  

PubMed

When a neurologic condition develops after vaccination of a patient, the causal relationship is difficult to determine. We report an unusual case in which neurologic signs occurred in a previously healthy child after both doses of H1N1 2009 influenza vaccine, culminating in bilateral optic neuritis and disseminated encephalomyelitis. A causal association is more likely with repeated injury following influenza vaccination. PMID:20686434

Lapphra, Keswadee; Huh, Linda; Scheifele, David W

2011-01-01

295

IgE Reactivity to Profilin in Pollen-Sensitized Subjects with Adverse Reactions to Banana and Pineapple  

Microsoft Academic Search

Background: The so-called ‘latex-fruit syndrome’ is a well-documented phenomenon in cross-reactive allergies. By contrast, there is a lack of information about allergy to exotic fruits in patients with a predominant pollen sensitization. Since the ubiquitous protein profilin has been identified as an allergen in natural rubber latex as well as in pollen-related foods, the aim of this study was to

J. Reindl; H. P. Rihs; S. Scheurer; A. Wangorsch; D. Haustein; S. Vieths

2002-01-01

296

Using Systems Biology-based Analysis Approaches to Identify Mechanistically Significant Adverse Drug Reactions: Pulmonary Complications from Combined Use of Anti-TNF? Agents and Corticosteroids  

PubMed Central

Anti-TNF drugs are frequently associated with serious Adverse Events (AEs), which necessitates an improved understanding of individual factors that determine efficacy and safety of anti-TNF agents. We mined the US FDA’s Adverse Event Reporting System (AERS) for anti-TNF-associated AEs to identify and stratify patient subgroups and drug combinations that exhibit specifically correlated complications. We demonstrate the existence of patient subgroup and anti-TNF agent-specific associations for relative risks of developing known and novel AEs including infections, edema, and organ damage associated processes. Concomitant use of anti-TNFs with corticosteroids significantly increased risk of AEs (p < 0.001) including pulmonary fibrosis and pulmonary edema. Using these tightly correlated phenotypes, we mined mouse phenotype data to identify the molecular basis of these AEs. Multiple pathways and networks that regulate injury response, fluid regulation, and wound healing were implicated suggesting modification of anti-TNF-based therapeutic strategies to minimize corticosteroid-based combinatorial risk of severe AEs. PMID:24303326

Sarangdhar, Mayur; Kushwaha, Akash; Dahlquist, Jeanine; Jegga, Anil; Aronow, Bruce

2013-01-01

297

Endocrine-related adverse events following ipilimumab in patients with advanced melanoma: a comprehensive retrospective review from a single institution.  

PubMed

Novel immune checkpoint blockade with ipilimumab, an antibody blocking the cytotoxic T-lymphocyte antigen 4 (CTLA4), is revolutionizing cancer therapy. However, ipilimumab induces symptomatic, sometimes severe, endocrine immune-related adverse events (irAEs) that are inconsistently recognized and reported. The objective of this review was to comprehensively characterize the incidence, presentation, and management of endocrinopathies following ipilimumab therapy in a single center that is highly specialized in immune checkpoint blockade. We carried out a retrospective analysis of endocrine irAEs in melanoma patients receiving ipilimumab therapy in clinical trials between 2007 and 2013. A total of 256 patients were included in this analysis. We reviewed pituitary-, thyroid-, and adrenal-related hormone test results, as well as radiographic studies and the clinical histories of patients, to identify and characterize cases of hypophysitis, hypothyroidism, thyroiditis, and adrenal dysfunction. Following ipilimumab therapy, the overall incidence of hypophysitis was 8% and that of hypothyroidism/thyroiditis 6%. Primary adrenal dysfunction was rare. Therapy with a combination of ipilimumab and nivolumab, an anti-programmed cell death 1 (PDCD1, also called PD1) receptor antibody, was associated with a 22% incidence of either thyroiditis or hypothyroidism and a 9% incidence of hypophysitis. Symptomatic relief, in particular, for hypophysitis, was achieved in all patients with hormone replacement, although endogenous hormone secretion rarely recovered. In summary, we observed that CTLA4 blockade alone, and in particular in combination with PD1 blockade, is associated with an increased risk of symptomatic, sometimes severe, hypophysitis as well as thyroid dysfunction. Prompt initiation with hormone replacement reverses symptoms. Evaluation and reporting of endocrine irAEs in clinical trials should be done using standardized diagnostic criteria and terminology. PMID:24610577

Ryder, Mabel; Callahan, Margaret; Postow, Michael A; Wolchok, Jedd; Fagin, James A

2014-04-01

298

Adverse effects profile of sulfhydryl compounds in man.  

PubMed

Many of the adverse reactions produced by penicillamine and other compounds with an active sulfhydryl group form a distinctive pattern when viewed as a class. Alterations in taste perception, mucocutaneous lesions, proteinuria due to immune-complex membranous glomerulopathy, and pemphigus are adverse reactions that have been encountered with all of the compounds discussed herein. Hematologic reactions such as neutropenia and thrombocytopenia occur rarely and with variable frequency. The angiotension converting enzyme inhibitor captopril has an active sulfhydryl group. When it was first given in high doses to patients with severe hypertension, adverse effects similar in pattern to those just outlined were reported. With reduced doses and more careful patient selection, the more serious reactions are no longer found, but disturbances of taste perception, rash, and oral mucosal ulcers are still encountered. PMID:2937293

Jaffe, I A

1986-03-01

299

Adverse Events in the Long-Term Follow-Up of Patients Treated With Samarium Sm 153 Lexidronam for Osseous Metastases  

SciTech Connect

Purpose: To investigate adverse events after samarium Sm 153 lexidronam and the effect of pre- and post-samarium Sm 153 lexidronam external beam radiation therapy (EBRT) and/or chemotherapy on myelosuppression in patients who received samarium Sm 153 lexidronam for osseous metastases. Methods and Materials: We performed a single-institution retrospective review of 139 patients treated with samarium Sm 153 lexidronam between November 1997 and February 2008. New-onset adverse events after samarium Sm 153 lexidronam were reported. The effect of samarium Sm 153 lexidronam on platelet and peripheral white blood cell counts and the duration of myelosuppression after samarium Sm 153 lexidronam plus EBRT and/or chemotherapy were calculated. Differences in the prevalence of adverse events among patients with varying treatment histories were evaluated with the Pearson chi-square test. Results: Hematologic follow-up was available for 103 patients. Chemotherapy and/or EBRT had no effect on the magnitude or duration of myelosuppression. The most common nonhematologic adverse events were acute lower extremity edema (n = 27) and acute and transient neuropathy (n = 29). Patients treated with chemotherapy after samarium Sm 153 lexidronam had a higher prevalence of lower extremity edema (9 of 18 [50%]) than those who were not treated with chemotherapy after samarium Sm 153 lexidronam (18 of 85 [21.2%]) (p = 0.01, chi-square test). No adverse events were correlated with EBRT. Conclusions: Our observation of new-onset, acute and transient edema and neuropathy after samarium Sm 153 lexidronam and of a relationship between edema and post-samarium Sm 153 lexidronam chemotherapy suggests the need for re-examination of patients in past series or for a prospective investigation with nonhematologic adverse events as a primary endpoint.

Paravati, Anthony J., E-mail: Anthony.J.Paravati@dartmouth.edu [Dartmouth Medical School, Hanover, NH (United States); Russo, Andrea L. [Dartmouth Medical School, Hanover, NH (United States); Aitken, Candice [Dartmouth Medical School, Hanover, NH (United States); Department of Medicine, Section of Radiation Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, NH (Lebanon)

2011-10-01

300

Cost of illness of patient-reported adverse drug events: a population-based cross-sectional survey  

PubMed Central

Objectives To estimate the cost of illness (COI) of individuals with self-reported adverse drug events (ADEs) from a societal perspective and to compare these estimates with the COI for individuals without ADE. Furthermore, to estimate the direct costs resulting from two ADE categories, adverse drug reactions (ADRs) and subtherapeutic effects of medication therapy (STE). Design Cross-sectional study. Setting The adult Swedish general population. Participants The survey was distributed to a random sample of 14?000 Swedish residents aged 18?years and older, of which 7099 responded, 1377 reported at least one ADE and 943 reported an ADR or STE. Main outcome measures Societal COI, including direct and indirect costs, for individuals with at least one self-reported ADE, and the direct costs for prescription drugs and healthcare use resulting from self-reported ADRs and STEs were estimated during 30?days using a bottom-up approach. Results The economic burden for individuals with ADEs were (95% CI) 442.7 to 599.8 international dollars (Int$), of which direct costs were Int$ 279.6 to 420.0 (67.1%) and indirect costs were Int$ 143.0 to 199.8 (32.9%). The average COI was higher among those reporting ADEs compared with other respondents (COI: Int$ 442.7 to 599.8 versus Int$ 185.8 to 231.2). The COI of respondents reporting at least one ADR or STE was Int$ 468.9 to 652.9. Direct costs resulting from ADRs or STEs were Int$ 15.0 to 48.4. The reported resource use occurred both in hospitals and outside in primary care. Conclusions Self-reported ADRs and STEs cause resource use both in hospitals and in primary care. Moreover, ADEs seem to be associated with high overall COI from a societal perspective when comparing respondents with and without ADEs. There is a need to further examine this relationship and to study the indirect costs resulting from ADEs. PMID:23794552

Gyllensten, Hanna; Rehnberg, Clas; Jonsson, Anna K; Petzold, Max; Carlsten, Anders; Andersson Sundell, Karolina

2013-01-01

301

Are Ambient Ultrafine, Accumulation Mode, and Fine Particles Associated with Adverse Cardiac Responses in Patients Undergoing Cardiac Rehabilitation?  

PubMed Central

Background: Mechanisms underlying previously reported air pollution and cardiovascular (CV) morbidity associations remain poorly understood. Objectives: We examined associations between markers of pathways thought to underlie these air pollution and CV associations and ambient particle concentrations in postinfarction patients. Methods: We studied 76 patients, from June 2006 to November 2009, who participated in a 10-week cardiac rehabilitation program following a recent (within 3 months) myocardial infarction or unstable angina. Ambient ultrafine particle (UFP; 10–100 nm), accumulation mode particle (AMP; 100–500 nm), and fine particle concentrations (PM2.5; ? 2.5 ?m in aerodynamic diameter) were monitored continuously. Continuous Holter electrocardiogram (ECG) recordings were made before and during supervised, graded, twice weekly, exercise sessions. A venous blood sample was collected and blood pressure was measured before sessions. Results: Using mixed effects models, we observed adverse changes in rMSSD [square root of the mean of the sum of the squared differences between adjacent normal-to-normal (NN) intervals], SDNN (standard deviation of all NN beat intervals), TpTe (time from peak to end of T-wave), heart rate turbulence, systolic and diastolic blood pressures, C-reactive protein, and fibrinogen associated with interquartile range increases in UFP, AMP, and PM2.5 at 1 or more lag times within the previous 5 days. Exposures were not associated with MeanNN, heart-rate–corrected QT interval duration (QTc), deceleration capacity, and white blood cell count was not associated with UFP, AMP, and PM2.5 at any lag time. Conclusions: In cardiac rehabilitation patients, particles were associated with subclinical decreases in parasympathetic modulation, prolongation of late repolarization duration, increased blood pressure, and systemic inflammation. It is possible that such changes could increase the risk of CV events in this susceptible population. PMID:22542955

Zareba, Wojciech; Beckett, William; Hopke, Philip K; Oakes, David; Frampton, Mark W; Bisognano, John; Chalupa, David; Bausch, Jan; O'Shea, Karen; Wang, Yungang; Utell, Mark J

2012-01-01

302

First Indian Study Evaluating Role of Biochemical Investigations and Diagnostic Tools in Detection of Adverse Drug Reactions  

PubMed Central

Aim of Study: To evaluate the role of biochemical investigations (BI) and diagnostic tools (DT) in ADR detection. Materials and Methods: An observational prospective cross-sectional study was done using suspected ADR data collection form. Results: A total of 2381 ADR related events were recorded in two years. Total number/percentage of biochemical abnormalities (BA) related ADR detection rate was 14.57% and of DT was 1.091% in contrast to 84.33% recorded with clinical presentation. Maximum cases were inward patients (87.13%), 67.02% were recorded by active surveillance. ADR detection rate at one point & detection on follow up was 56.31% Vs 46.38%. ADR detection rate of ECG, endoscopy, X-ray were 0.57%, 0.22%, 0.22% and of CT scan, MRI, DEXA scan, USG and biopsy was 0.04% each. Maximum ADRs were severe/serious, latent and Type-A in nature. Anemia (4.6%), followed by liver dysfunction (2.8%), renal dysfunction, electrolyte imbalance, hyperglycemia (1.1% each), abnormal coagulation profile (1%), decrease platelet count (0.8%), hypoglycemia (0.7%) were the most common BAs. Anti retroviral drugs (ART), tirofiban and methotrexate accounted for anemia, ART and anti tubercular drugs for liver & renal dysfunction, insulin for hypoglycemia, tirofiban, paclitaxel, capecipabine and ifosfamide for thrombocytopenia, hematuria by enoxaparin & dyslipidemia with ART were common ADRs. Conclusion: BI and DT can play very important role in ADR detection. PMID:25386459

Khajuria, Vijay; Raina, Kapila; Mahajan, Vivek; Sharma, Aman; Gillani, Zahid

2014-01-01

303

Influence of gender on the risk of death and adverse events in patients with acute myocardial infarction undergoing pharmacoinvasive strategy.  

PubMed

Pharmacoinvasive treatment is an acceptable alternative for patients with ST-segment elevation myocardial infarction (STEMI) in developing countries. The present study evaluated the influence of gender on the risks of death and major adverse cardiovascular events (MACE) in this population. Seven municipal emergency rooms and the Emergency Mobile Healthcare Service in São Paulo treated STEMI patients with tenecteplase. The patients were subsequently transferred to a tertiary teaching hospital for early (<24 h) coronary angiography. A total of 469 patients were evaluated [329 men (70.1 %)]. Compared to men, women had more advanced age (60.2 ± 12.3 vs. 56.5 ± 11 years; p = 0.002); lower body mass index (BMI; 25.85 ± 5.07 vs. 27.04 ± 4.26 kg/m(2); p = 0.009); higher rates of hypertension (70.7 vs. 59.3 %, p = 0.02); higher incidence of hypothyroidism (20.0 vs. 5.5 %; p < 0.001), chronic renal failure (10.0 vs. 8.8 %; p = 0.68), peripheral vascular disease (PVD; 19.3 vs. 4.3 %; p = 0.03), and previous history of stroke (6.4 vs. 1.3 %; p = 0.13); and higher thrombolysis in myocardial infarction risk scores (40.0 vs. 23.7 %; p < 0.001). The overall in-hospital mortality and MACE rates for women versus men were 9.3 versus 4.9 % (p = 0.07) and 12.9 versus 7.9 % (p = 0.09), respectively. By multivariate analysis, diabetes (OR 4.15; 95 % CI 1.86-9.25; p = 0.001), previous stroke (OR 4.81; 95 % CI 1.49-15.52; p = 0.009), and hypothyroidism (OR 3.75; 95 % CI 1.44-9.81; p = 0.007), were independent predictors of mortality, whereas diabetes (OR 2.05; 95 % CI 1.03-4.06; p = 0.04), PVD (OR 2.38; 95 % CI 0.88-6.43; p = 0.08), were predictors of MACE. In STEMI patients undergoing pharmacoinvasive strategy, mortality and MACE rates were twice as high in women; however, this was due to a higher prevalence of risk factors and not gender itself. PMID:24671733

Lanaro, Eduardo; Caixeta, Adriano; Soares, Juliana A; Alves, Cláudia Maria Rodrigues; Barbosa, Adriano Henrique Pereira; Souza, José Augusto Marcondes; Sousa, José Marconi Almeida; Amaral, Amaury; Ferreira, Guilherme M; Moreno, Antônio Célio; Júnior, Iran Gonçalves; Stefanini, Edson; Carvalho, Antônio Carlos

2014-11-01

304

Treatment-, patient-, and disease-related factors and the emergence of adverse events with tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia.  

PubMed

Four breakpoint cluster region (BCR)-ABL1 tyrosine kinase inhibitors (TKIs) are currently available for the treatment of chronic myeloid leukemia (CML): imatinib, nilotinib, dasatinib, and bosutinib. Choosing the most appropriate TKI requires clinicians to consider a host of patient-, disease-, and treatment-related factors, not the least of which include the safety profiles of the agents. This review discusses the potential impact of treatment-, patient-, and disease-related characteristics on the emergence of adverse events during TKI therapy, with a focus on the underlying mechanisms believed to be responsible for a number of important adverse events associated with these agents and what implications they may have for treatment choice, particularly in the setting of first-line treatment. A literature search of the PubMed database was conducted to identify articles that described the molecular mechanisms of BCR-ABL1-mediated leukemic transformation, the efficacy and safety of imatinib, nilotinib, dasatinib, and bosutinib in patients with CML, the kinase-binding spectrum of each TKI, and evidence suggesting a link between the TKI-binding profile and adverse events. The pattern of adverse events associated with each agent is important when selecting treatment with a TKI. Clinical studies suggest that imatinib, nilotinib, dasatinib, and bosutinib have differing safety profiles, which are in part attributable to the specificity and selectivity of each agent. Although much basic research must be conducted to further illuminate the mechanisms responsible for TKI-related adverse events, on- and off-target effects are believed to be at least partly responsible for cardiovascular toxicity, myelosuppression, fluid retention, gastrointestinal toxicity, and dermatologic toxicity. Increased understanding of the factors that affect TKI-associated adverse events and long-term safety data will enable a more informed approach to the selection of therapy best suited to the individual needs of patients with CML. PMID:23553655

Irvine, Elizabeth; Williams, Casey

2013-08-01

305

Adverse drug reactions associated with the use of NSAIDs: a case/noncase analysis of spontaneous reports from the French pharmacovigilance database 2002-2006.  

PubMed

To evaluate the safety profile of eight oral nonsteroidal anti-inflammatory drugs (NSAIDs) available in France, using data reported through the French pharmacovigilance system. Data (from 2002 to 2006) were analysed for aceclofenac, diclofenac, ketoprofen, meloxicam, naproxen, nimesulide, piroxicam and tenoxicam, focusing on the reported rates of serious adverse drug reactions (ADRs) in the following system organ classes: gastrointestinal, hepatic, cutaneous, renal and cardiovascular. A total of 42 389 serious ADR reports were identified, and 38 506 were included in a case/noncase analysis. Ketoprofen was associated with the highest cumulative reported rate of serious ADRs (0.78 cases per million defined daily doses), followed by diclofenac (0.58), nimesulide (0.52), naproxen (0.50), piroxicam (0.47), tenoxicam (0.42), meloxicam (0.41) and aceclofenac (0.30). The most frequently reported serious ADRs were cutaneous, followed by gastrointestinal, hepatic, renal and rarely, cardiovascular events. In the case/noncase analysis, ketoprofen, piroxicam and naproxen were associated with the highest risk of serious gastrointestinal ADRs (odds ratios [ORs] of 6.87, 6.54 and 5.07, respectively). Nimesulide and aceclofenac were associated with the highest risk of liver ADRs (adjusted ORs of 4.53 and 3.67, respectively), as was meloxicam for cutaneous ADRs (adjusted OR of 3.15) and tenoxicam for renal ADRs (adjusted OR of 3.17). The most frequent serious ADRs reported with the selected oral NSAIDs are cutaneous, followed by gastrointestinal, hepatic and renal events. The highest risks for serious gastrointestinal, hepatic, cutaneous and renal adverse events were linked, respectively, with ketoprofen, nimesulide, meloxicam and tenoxicam compared with the other NSAIDs. PMID:21929527

Lapeyre-Mestre, Maryse; Grolleau, Sabrina; Montastruc, Jean-Louis

2013-04-01

306

Survival and risk of adverse events in older patients receiving postoperative adjuvant chemotherapy for resected stages II-IIIA lung cancer: observational cohort study  

Microsoft Academic Search

Objective To compare the survival and risk of serious adverse events in older patients with stages II-IIIA non-small cell lung cancer treated with or without postoperative platinum based chemotherapy.Design Observational cohort study.Setting Cases of lung cancer in Surveillance Epidemiology and End Results registry linked to Medicare files, 1992-2005, and follow-up data to December 2007.Participants 3324 patients aged more than 65

Juan P Wisnivesky; Cardinale B Smith; Stuart Packer; Gary M Strauss; Linda Lurslurchachai; Alex Federman; Ethan A Halm

2011-01-01

307

Thiopurine Methyltransferase (TPMT) Activity and Adverse Effects of Azathioprine in Inflammatory Bowel Disease: Long-Term Follow-Up Study of 394 Patients  

Microsoft Academic Search

AIM:To prospectively evaluate whether a relationship between thiopurine methyltransferase (TPMT) activity and incidence of adverse effects (especially myelotoxicity) exists, in a long-term follow-up study of a large group of patients with inflammatory bowel disease treated with azathioprine.METHODS:TPMT activity in red blood cells (RBC) was measured by a radiochemical method in 394 consecutive patients with Crohn's disease (238) or ulcerative colitis

Javier P. Gisbert; Pilar Niño; Luis Rodrigo; Carlos Cara; Luis G. Guijarro

2006-01-01

308

Medications and Drug Allergic Reactions  

MedlinePLUS

... detaches like in a patient who has suffered burns, is another type of severe cutaneous adverse reaction. ... you may develop a cough or facial and tongue swelling. Some people are sensitive to aspirin, ibuprofen ...

309

Interplay between Genetic and Clinical Variables Affecting Platelet Reactivity and Cardiac Adverse Events in Patients Undergoing Percutaneous Coronary Intervention  

PubMed Central

Several clinical and genetic variables are associated with influencing high on treatment platelet reactivity (HTPR). The aim of the study was to propose a path model explaining a concurrent impact among variables influencing HTPR and ischemic events. In this prospective cohort study polymorphisms of CYP2C19*2, CYP2C19*17, ABCB1, PON1 alleles and platelet function assessed by Multiple Electrode Aggregometry were assessed in 416 patients undergoing percutaneous coronary intervention treated with clopidogrel and aspirin. The rates of major adverse cardiac events (MACE) were recorded during a 12-month follow up. The path model was calculated by a structural equation modelling. Paths from two clinical characteristics (diabetes mellitus and acute coronary syndrome (ACS)) and two genetic variants (CYP2C19*2 and CYP2C19*17) independently predicted HTPR (path coefficients: 0.11 0.10, 0.17, and -0.10, respectively; p<0.05 for all). By use of those four variables a novel score for prediction of HTPR was built: in a factor-weighted model the risk for HTPR was calculated with an OR of 3.8 (95%CI: 3.1–6.8, p<0.001) for a score level of ?1 compared with a score of <1. While MACE was independently predicted by HTPR and age in the multivariate model (path coefficient: 0.14 and 0.13, respectively; p<0.05), the coexistence of HTPR and age ?75 years emerged as the strongest predictor of MACE. Our study suggests a pathway, which might explain indirect and direct impact of variables on clinical outcome: ACS, diabetes mellitus, CYP2C19*2 and CYP2C19*17 genetic variants independently predicted HTPR. In turn, age ?75 years and HTPR were the strongest predictors of MACE. PMID:25051347

Siller-Matula, Jolanta M.; Lang, Irene M.; Neunteufl, Thomas; Kozinski, Marek; Maurer, Gerald; Linkowska, Katarzyna; Grzybowski, Tomasz; Kubica, Jacek; Jilma, Bernd

2014-01-01

310

Identifying Adverse Drug Events by Relational Learning University of WisconsinMadison  

E-print Network

Identifying Adverse Drug Events by Relational Learning David Page University of Wisconsin�Madison V- sight agencies are all strongly interested in identify- ing adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken

Natarajan, Sriraam

311

Management of hematologic adverse events in patients with relapsed and/or refractory multiple myeloma treated with single-agent carfilzomib.  

PubMed

Hematologic adverse events (AEs) are commonly encountered in patients with multiple myeloma (MM) owing to the nature of the disease and the adverse effects related to myeloma treatment. Immunomodulatory drugs (eg, thalidomide, lenalidomide, and pomalidomide) and the proteasome inhibitor bortezomib have all been associated with increased rates of anemia, neutropenia, and thrombocytopenia, as well as greater incidences of infection caused by associated immunosuppression. The proteasome inhibitor carfilzomib was recently approved in the United States for the treatment of patients with relapsed and refractory MM. This article reviews the hematologic safety profile of carfilzomib in patients with relapsed/refractory MM, as assessed in a cross-trial safety analysis of four phase II studies, and makes recommendations for the appropriate management of hematologic AEs. PMID:25184231

Nooka, Ajay K

2013-12-01

312

Adverse events from diagnostic and therapeutic joint injections: a literature review  

Microsoft Academic Search

This review article classifies the various adverse reactions arising from intra-articular injections by severity, diagnostic\\u000a category, and whether they are due to corticosteroid, local anesthetic or viscosupplementation injections. Life-threatening\\u000a and serious adverse events from intra-articular injections are rare and range from local complications to systemic afflictions.\\u000a Measures to reduce the likelihood of an adverse event occurring are outlined and patients

Cynthia Peterson; Juerg Hodler

2011-01-01

313

Pneumothorax as adverse event in patients with lung metastases of soft tissue sarcoma treated with pazopanib: a single reference centre case series  

PubMed Central

Background Recently, the phase III PALETTE study introduced pazopanib (Votrient®) as treatment for adult patients with locally advanced or metastatic non-liposarcoma soft tissue sarcoma after prior treatment with doxorubicin and/or ifosfamide. Pneumothorax was reported as adverse event in 8 of 246 treated patients (3.3%) in that study. This case series presents the incidence and clinic of this complication in the Leiden University Medical Centre. Cases Forty-three patients were treated with pazopanib of which six patients (14.0%) developed a pneumothorax. These six patients were treated for malignant peripheral nerve sheath tumour, angiosarcoma, synovial sarcoma, fibromyxomatoid sarcoma, pleomorphic sarcoma and endometrial stromal sarcoma. All six patients had subpleural pulmonary or pleural metastases at the start of pazopanib and the pneumothorax developed during or shortly after treatment with pazopanib and was difficult to treat. Discussion The incidence reported by us is higher than the incidence in the PALETTE study. Trials with pazopanib in renal cell carcinoma, urothelial carcinoma and cervix carcinoma did not report pneumothorax as an adverse event, suggesting pneumothorax as a specific adverse event in soft tissue sarcoma patients treated with pazopanib. This may be related to the fact that there is often pleural metastatic involvement and cystic degeneration due to pazopanib treatment may add to the risk. Conclusion The risk of an, often difficult to treat, pneumothorax during pazopanib therapy should be discussed with the patient before initiation of treatment for a pulmonary metastasized sarcoma and physicians should be alert to the occurrence of such an event. PMID:25302110

2014-01-01

314

Fludarabine plus alemtuzumab (FA) front-line treatment in young patients with chronic lymphocytic leukemia (CLL) and an adverse biologic profile.  

PubMed

In 45, ? 60 years old patients with CLL and an adverse biologic profile, a front-line treatment with Fludarabine and Campath (Alemtuzumab(®)) was given. The overall response rate was 75.5%, the complete response rate (CR) 24.4% with the lowest CR rates, 16.7% and 8.3%, in 11q and 17p deleted cases. The 3-year progression-free survival (PFS) and overall survival were 42.5% and 79.9%, respectively. PFS was significantly influenced by CLL duration, beta2-microglobulin, and improved by post-remissional stem cell transplantation. Front-line fludarabine and alemtuzumab showed a manageable safety profile and evidence of a benefit in a small series of CLL patients with adverse biologic features. PMID:24314589

Mauro, Francesca R; Molica, Stefano; Laurenti, Luca; Cortelezzi, Agostino; Carella, Angelo M; Zaja, Francesco; Chiarenza, Annalisa; Angrilli, Francesco; Nobile, Francesco; Marasca, Roberto; Musolino, Caterina; Brugiatelli, Maura; Piciocchi, Alfonso; Vignetti, Marco; Fazi, Paola; Gentile, Giuseppe; De Propris, Maria S; Della Starza, Irene; Marinelli, Marilisa; Chiaretti, Sabina; Del Giudice, Ilaria; Nanni, Mauro; Albano, Francesco; Cuneo, Antonio; Guarini, Anna; Foà, Robin

2014-02-01

315

Aspirin effect on the incidence of major adverse cardiovascular events in patients with diabetes mellitus: a systematic review and meta-analysis  

Microsoft Academic Search

Background  Aspirin has been recommended for the prevention of major adverse cardiovascular events (MACE, composite of non-fatal myocardial\\u000a infarction, non-fatal stroke, and cardiovascular death) in diabetic patients without previous cardiovascular disease. However,\\u000a recent meta-analyses have prompted re-evaluation of this practice. The study objective was to evaluate the relative and absolute\\u000a benefits and harms of aspirin for the prevention of incident MACE

Sonia Butalia; Alexander A Leung; William A Ghali; Doreen M Rabi

2011-01-01

316

Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade  

PubMed Central

Background The prescribing of psychotropic medicines for the paediatric population is rapidly increasing. In attempts to curb the use of psychotropic medicine in the paediatric population, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise ADRs reported for psychotropic medicines in the Danish paediatric population over a decade. Findings All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age and gender of the child, suspected medicine and type of reported ADR. A total of 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious. Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents, especially for antidepressants and psychostimulants. Approximately 60% of ADRs were reported for boys. Forty percent of all ADRs were from the category 'nervous and psychiatric disorders'. All but one ADR reported for children below two years were serious and two of these were fatal. A number of serious ADRs reported in children from birth up to 2 years of age were presumably caused by mothers' use of psychotropic medicines during pregnancy. Conclusion The high number of serious ADRs reported for psychotropic medicines in the paediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women. PMID:20573185

2010-01-01

317

Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital  

PubMed Central

Background: Lack of knowledge of pharmacovigilance (PhV) and adverse event (AE) reporting culture among the healthcare providers have been identified as major factors for under reporting of AE in developing countries. Hence, this study was planned to assess and compare the knowledge, attitude, and practices (KAP) of resident doctors and nurses about PhV and AE reporting. Material and Methods: This cross-sectional, questionnaire-based study was conducted to compare KAP of 100 doctors and 100 nurses on PhV and AE reporting. Results: All the respondents felt that AE reporting is necessary and two-thirds were aware of the existing PhV Program of India. Significantly, higher proportion of doctors had correct understanding regarding PhV (P<0.05) and knew what should be reported (P<0.05) but nurses (75%) knew better about where to report (P<0.001). Significantly (P<0.001), more doctors (98%) felt that the patients are benefited by reporting AE. Nurses (96%) felt the need for information on drugs causing AE and their management strategy (P<0.001). Around 60% of all the respondents were in favor of mandatory PhV and feedback on the submitted AE. Doctors (67%) (P<0.05) had a practice of inquiring patients for any untoward outcome of therapy. Higher proportion (P<0.05) of nurses (55%) mentioned that observed AE are recorded in patient's case record, but random screening of 1000 patients’ record did not reveal it. Nurses mentioned that they never reported any AE (P<0.05) and witnessed discussions on ADRs during the ward rounds (P<0.001). All the respondents preferred phone as the convenient method for reporting AE followed by drop box kept in the ward/OPD and felt the need of frequent workshops and continuing medical education. Conclusion: Resident doctors and nurses had good knowledge and awareness on AE reporting and PhV but their practices need to be improved. PMID:23248397

Rehan, H. S.; Sah, Ravinder Kumar; Chopra, Deepti

2012-01-01

318

Treatment of the adverse effects of contrast media.  

PubMed

Although low-osmolar contrast media are relatively safe, a moderate non-life-threatening reaction requiring some treatment does occur in 0.2-0.4% of patients. A severe life-threatening reaction can be expected in 0.04% of patients. Prompt recognition and treatment are invaluable in blunting the adverse response of a patient to radiographic contrast material and may prevent the reaction from becoming severe or even life-threatening. Radiologists and their staff should review treatment protocols regularly so that each can play his/her role efficiently. Knowledge, training, and preparation are crucial for guaranteeing appropriate and effective therapy in the event of an adverse contrast-related event. On the basis of a review of the literature, we suggest a treatment protocol. PMID:9571931

Thomsen, H S; Bush, W H

1998-05-01

319

Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).  

PubMed

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. PMID:25265940

Basch, Ethan; Reeve, Bryce B; Mitchell, Sandra A; Clauser, Steven B; Minasian, Lori M; Dueck, Amylou C; Mendoza, Tito R; Hay, Jennifer; Atkinson, Thomas M; Abernethy, Amy P; Bruner, Deborah W; Cleeland, Charles S; Sloan, Jeff A; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St Germain, Diane; O'Mara, Ann M; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B; Schrag, Deborah

2014-09-01

320

In-hospital daily insulin dose predicts long-term adverse outcome in patients with diabetes with ST-elevation myocardial infarction treated with successful primary percutaneous angioplasty  

PubMed Central

Introduction Early initiation of reperfusion therapy including primary percutaneous coronary revascularization (PPCI) has been recognized as a crucial factor determining clinical outcomes in the acute phase of myocardial infarction. In unstable patients with type 2 diabetes mellitus (T2D) the clear benefit from PPCI was proven. We aim to evaluate the prognostic value of factors describing glycometabolic state on admission in patients with T2D undergoing PPCI in acute ST-elevation myocardial infarction (STEMI). Material and methods Prospective analysis of clinical and laboratory variables (mean daily short acting exogenous insulin dose (DID), admission blood glucose, glycated hemoglobin (HbA1c), microalbuminuria) was performed in 112 consecutive patients with T2D with STEMI who underwent PPCI. Women comprised 58% of the group. Results Insulin dosing was targeted to obtain a mean daily glucose level < 7.8 mmol/l. During 12-month follow-up 33 (29.5%) major adverse cardiac events (major adverse cardiac events (MACE) consisting of death, reinfarction, and repeated target vessel revascularization) were reported. Microalbuminuria was present in 68 (60.5%) patients. The mean HbA1c level was 7.9%. In the multivariate logistic regression model only DID > 44 IU remained an independent risk factor for MACE (p = 0.02, OR = 5.2). Conclusions In patients with diabetes with STEMI treated with PPCI, simple measurement of DID during hospitalization can add valuable prognostic information about the future risk of MACE.

Peruga, Jan Z.; Kasprzak, Jaroslaw D.; Bendinger, Tomasz; Plewka, Michal; Drozdz, Jaroslaw; Drzewoski, Jozef; Krzeminska-Pakula, Maria

2014-01-01

321

Reversible Ototoxicity: A Rare Adverse Reaction of Liposomal Amphotericin-B Used for the Treatment of Antimony-Resistant Visceral Leishmaniasis in an Elderly Male  

PubMed Central

Amphotericin-B, a broad spectrum antifungal agent, has been known to cause adverse effects such as nephrotoxicity and infusion-related side effects such as fever, chills, rigor, and arthralgias. However, ototoxicity as an adverse effect of Amphotericin-B has not yet been reported in medical literature. We here report a case of a reversible form of ototoxicity induced by liposomal Amphotericin-B (L-AmB). PMID:25093006

Das, PC; Kandel, Ramesh; Sikka, Kapil; Dey, AB

2014-01-01

322

Adverse Clinical and Economic Outcomes Attributable to Methicillin Resistance among Patients with Staphylococcus aureus Surgical Site Infection  

Microsoft Academic Search

Data for 479 patients were analyzed to assess the impact of methicillin resistance on the outcomes of patients with Staphylococcus aureus surgical site infections (SSIs). Patients infected with methicillin-resistant S. aureus (MRSA) had a greater 90-day mortality rate than did patients infected with methicillin-susceptible S. aureus (MSSA; adjusted odds ratio, 3.4; 95% confidence interval, 1.5-7.2). Patients infected with MRSA had

John J. Engemann; Yehuda Carmeli; Sara E. Cosgrove; Vance G. Fowler; Melissa Z. Bronstein; Sharon L. Trivette; Jane P. Briggs; Daniel J. Sexton; Keith S. Kaye

2003-01-01

323

Adverse drug reaction prediction using scores produced by large-scale drug-protein target docking on high-performance computing machines.  

PubMed

Late-stage or post-market identification of adverse drug reactions (ADRs) is a significant public health issue and a source of major economic liability for drug development. Thus, reliable in silico screening of drug candidates for possible ADRs would be advantageous. In this work, we introduce a computational approach that predicts ADRs by combining the results of molecular docking and leverages known ADR information from DrugBank and SIDER. We employed a recently parallelized version of AutoDock Vina (VinaLC) to dock 906 small molecule drugs to a virtual panel of 409 DrugBank protein targets. L1-regularized logistic regression models were trained on the resulting docking scores of a 560 compound subset from the initial 906 compounds to predict 85 side effects, grouped into 10 ADR phenotype groups. Only 21% (87 out of 409) of the drug-protein binding features involve known targets of the drug subset, providing a significant probe of off-target effects. As a control, associations of this drug subset with the 555 annotated targets of these compounds, as reported in DrugBank, were used as features to train a separate group of models. The Vina off-target models and the DrugBank on-target models yielded comparable median area-under-the-receiver-operating-characteristic-curves (AUCs) during 10-fold cross-validation (0.60-0.69 and 0.61-0.74, respectively). Evidence was found in the PubMed literature to support several putative ADR-protein associations identified by our analysis. Among them, several associations between neoplasm-related ADRs and known tumor suppressor and tumor invasiveness marker proteins were found. A dual role for interstitial collagenase in both neoplasms and aneurysm formation was also identified. These associations all involve off-target proteins and could not have been found using available drug/on-target interaction data. This study illustrates a path forward to comprehensive ADR virtual screening that can potentially scale with increasing number of CPUs to tens of thousands of protein targets and millions of potential drug candidates. PMID:25191698

LaBute, Montiago X; Zhang, Xiaohua; Lenderman, Jason; Bennion, Brian J; Wong, Sergio E; Lightstone, Felice C

2014-01-01

324

[Developing and standardizing experimental protocols using human iPS-derived cells to predict adverse drug reactions in pre-clinical safety studies].  

PubMed

In this study, we have standardized experimental protocols to evaluate the possibility of using cells differentiated from human induced pluripotent stem cells (hiPSCs) in the pre-clinical studies for the drug approval processes. Cells differentiated from hiPSC, especially cardiomyocytes, neurons and hepatocytes, are expected to be used as new pharmacological and toxicological assay tools. Current preclinical test methods have limitations for predicting clinical adverse drug reactions. This is because of the so-called 'problem of species difference'. Drug-induced arrhythmia, cognitive impairment and hepatotoxicity which can't be predicted in pre-clinical studies are major causes of the high rate attrition of new-drug candidates in clinical studies and of withdrawal of products from the market. The development of new pre-clinical test methods using cells differentiated from hiPSCs would resolve these problems, in addition to solving the issue of "the replacement, refinement and reduction (3Rs)" of animal experiments. From 2010 to 2011, we surveyed companies belonging to the Japan Pharmaceutical Manufacturers Association (JPMA) and academic researchers about the usage of differentiated cells in their laboratories. We found that studies were performed using differentiated cells from different cell lines of hiPSC with laboratory-specific differentiation methods. The cells were cultured in various conditions and their activities were measured using different methods. This resulted in a variety of pharmacological responses of the cells. It is therefore impossible to compare reproducibility and ensure reliability of experiments using these cells. To utilize the cells in the drug approval processes, we need robust, standardized test methods to accurately reproduce these methods in all laboratories. We will then be able to compare and analyze the obtained results. Based on the survey, the Ministry of Health, Labor and Welfare funded our study. In our study, we standardize pharmacological methods among several laboratories, including our laboratory, to develop robust tests, using the same lot of cells, the same culture conditions, reference compounds, experimental protocols, and analysis methodology. In conclusion, to standardize robust test methods, we need a consistent supply of high-quality differentiated cells. Further, indexes to quantify the quality of the differentiated cells will be needed for their effective usage in the pre-clinical safety studies. PMID:24340667

Sekino, Yuko; Sato, Kaoru; Kanda, Yasunari; Ishida, Seiichi

2013-01-01

325

Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions  

PubMed Central

Background Adverse drug reactions (ADRs) are an important cause of harm in children. Current data are incomplete due to methodological differences between studies: only half of all studies provide drug data, incidence rates vary (0.6% to 16.8%) and very few studies provide data on causality, severity and risk factors of pediatric ADRs. We aimed to determine the incidence of ADRs in hospitalized children, to characterize these ADRs in terms of type, drug etiology, causality and severity and to identify risk factors. Methods We undertook a year-long, prospective observational cohort study of admissions to a single UK pediatric medical and surgical secondary and tertiary referral center (Alder Hey, Liverpool, UK). Children between 0 and 16 years 11 months old and admitted for more than 48 hours were included. Observed outcomes were occurrence of ADR and time to first ADR for the risk factor analysis. Results A total of 5,118 children (6,601 admissions) were included, 17.7% of whom experienced at least one ADR. Opiate analgesics and drugs used in general anesthesia (GA) accounted for more than 50% of all drugs implicated in ADRs. Of these ADRs, 0.9% caused permanent harm or required admission to a higher level of care. Children who underwent GA were at more than six times the risk of developing an ADR than children without a GA (hazard ratio (HR) 6.40; 95% confidence interval (CI) 5.30 to 7.70). Other factors increasing the risk of an ADR were increasing age (HR 1.06 for each year; 95% CI 1.04 to 1.07), increasing number of drugs (HR 1.25 for each additional drug; 95% CI 1.22 to 1.28) and oncological treatment (HR 1.90; 95% CI 1.40 to 2.60). Conclusions ADRs are common in hospitalized children and children who had undergone a GA had more than six times the risk of developing an ADR. GA agents and opiate analgesics are a significant cause of ADRs and have been underrepresented in previous studies. This is a concern in view of the increasing number of pediatric short-stay surgeries. PMID:24228998

2013-01-01

326

Epidermal growth factor receptor (EGFR) is an independent adverse prognostic factor in esophageal adenocarcinoma patients treated with cisplatin-based neoadjuvant chemotherapy  

PubMed Central

Neoadjuvant platin-based therapy is accepted as a standard therapy for advanced esophageal adenocarcinoma (EAC). Patients who respond have a better survival prognosis, but still a significant number of responder patients die from tumor recurrence. Molecular markers for prognosis in neoadjuvantly treated EAC patients have not been identified yet. We investigated the epidermal growth factor receptor (EGFR) in prognosis and chemotherapy resistance in these patients. Two EAC patient cohorts, either treated by neoadjuvant cisplatin-based chemotherapy followed by surgery (n=86) or by surgical resection (n=46) were analyzed for EGFR protein expression and gene copy number. Data were correlated with clinical and histopathological response, disease-free and overall survival. In case of EGFR overexpression, the prognosis for neoadjuvant chemotherapy responders was poor as in non-responders. Responders had a significantly better disease-free survival than non-responders only if EGFR expression level (p=0.0152) or copy number (p=0.0050) was low. Comparing neoadjuvantly treated patients and primary resection patients, tumors of non-responder patients more frequently exhibited EGFR overexpression, providing evidence that EGFR is a factor for indicating chemotherapy resistance. EGFR overexpression and gene copy number are independent adverse prognostic factors for neoadjuvant chemotherapy-treated EAC patients, particularly for responders. Furthermore, EGFR overexpression is involved in resistance to cisplatin-based neoadjuvant chemotherapy. PMID:25216514

Aichler, Michaela; Motschmann, Martin; Jutting, Uta; Luber, Birgit; Becker, Karen; Ott, Katja; Lordick, Florian; Langer, Rupert; Feith, Marcus; Siewert, Jorg Rudiger; Walch, Axel

2014-01-01

327

Adverse Effects of Bisphosphonates  

Microsoft Academic Search

Use of bisphosphonates has been growing steadily in the last decade. This follows the introduction of simpler dosing regimes,\\u000a the availability of lower-priced generics, and concerns about the safety of hormone-replacement therapy. Bisphosphonates have\\u000a a relatively good safety record and are tolerated by the majority of patients, but serious adverse events have been recorded\\u000a in some cases. Only the most

Bo Abrahamsen

2010-01-01

328

Efficacy and adverse events of high-frequency oscillatory ventilation in adult patients with acute respiratory distress syndrome: a meta-analysis  

PubMed Central

Introduction Theoretically, high-frequency oscillatory ventilation (HFOV) achieves all goals of a lung-protective ventilatory mode and seems ideal for the treatment of adult patients with acute respiratory distress syndrome (ARDS). However, its effects on mortality and adverse clinical outcomes remain uncertain given the paucity of high-quality studies in this area. This meta-analysis was performed to evaluate the efficacy and adverse events of HFOV in adults with ARDS. Methods We searched PubMed, EMBASE and Cochrane Central Register of Controlled Trials through February 2014 to retrieve randomized controlled trials of HFOV in adult ARDS patients. Two independent reviewers extracted data on study methods, clinical and physiological outcomes and adverse events. The primary outcome was 30-day or hospital mortality. Risk of bias was evaluated with the Cochrane Collaboration’s tool. Mortality, oxygenation and adverse effects of HFOV were compared to those of conventional mechanical ventilation. A random-effects model was applied for meta-analysis. Results A total of five trials randomly assigning 1,580 patients met inclusion criteria. Pooled data showed that HFOV significantly improved oxygenation on day one of therapy (four studies; 24% higher; 95% confidence interval (CI) 11 to 40%; P <0.01). However, HFOV did not reduce mortality risk (five studies; risk ratio (RR) 1.04; 95% CI 0.83 to 1.31; P?=?0.71) and two early terminated studies suggested a harmful effect of HFOV in ARDS (two studies; RR 1.33; 95% CI 1.09 to 1.62; P <0.01). Safety profiles showed that HFOV was associated with a trend toward increased risk of barotrauma (five studies; RR 1.19; 95% CI 0.83 to 1.72; P?=?0.34) and unfavorable hemodynamics (five studies; RR 1.16; 95% CI 0.97 to 1.39; P?=?0.12). Conclusions HFOV improved oxygenation in adult patients with ARDS; however, it did not confer a survival benefit and might cause harm in the era of lung-protective ventilation strategy. The evidence suggests that HFOV should not be a routine practice in ARDS and further studies specifically selecting patients for this ventilator mode should be pursued. PMID:24886674

2014-01-01

329

Pain Flare Is a Common Adverse Event in Steroid-Naïve Patients After Spine Stereotactic Body Radiation Therapy: A Prospective Clinical Trial  

SciTech Connect

Purpose: To determine the incidence of pain flare after spine stereotactic body radiation therapy (SBRT) in steroid-naïve patients and identify predictive factors. Methods and Materials: Forty-one patients were treated with spine SBRT between February 2010 and April 2012. All patients had their pain assessed at baseline, during, and for 10 days after SBRT using the Brief Pain Inventory. All pain medications were recorded daily and narcotics converted to an oral morphine equivalent dose. Pain flare was defined as a 2-point increase in worst pain score as compared with baseline with no decrease in analgesic intake, a 25% increase in analgesic intake as compared with baseline with no decrease in worst pain score, or if corticosteroids were initiated at any point during or after SBRT because of pain. Results: The median age and Karnofsky performance status were 57.5 years (range, 27-80 years) and 80 (range, 50-100), respectively. Eighteen patients were treated with 20-24 Gy in a single fraction, whereas 23 patients were treated with 24-35 Gy in 2-5 fractions. Pain flare was observed in 68.3% of patients (28 of 41), most commonly on day 1 after SBRT (29%, 8 of 28). Multivariate analysis identified a higher Karnofsky performance status (P=.02) and cervical (P=.049) or lumbar (P=.02) locations as significant predictors of pain flare. In those rescued with dexamethasone, a significant decrease in pain scores over time was subsequently observed (P<.0001). Conclusions: Pain flare is a common adverse event after spine SBRT and occurs most commonly the day after treatment completion. Patients should be appropriately consented for this adverse event.

Chiang, Andrew [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada) [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada); Zeng, Liang; Zhang, Liying; Lochray, Fiona; Korol, Renee; Loblaw, Andrew; Chow, Edward [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada)] [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Sahgal, Arjun, E-mail: arjun.sahgal@sunnybrook.ca [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada) [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada)

2013-07-15

330

Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil*  

PubMed Central

BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multi-drug therapy. PMID:23739719

Maia, Marina Valente; Cunha, Maria da Graça Souza; Cunha, Carolina Souza

2013-01-01

331

Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib  

PubMed Central

Carfilzomib, a selective proteasome inhibitor approved in the USA in 2012, is a single agent for relapsed and refractory multiple myeloma. Carfilzomib is administered as a 2–10-minute infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle at a starting dose of 20 mg/m2 for cycle 1 and a target dose of 27 mg/m2 thereafter. In the pivotal Phase II study (PX-171-003-A1), carfilzomib 20/27 mg/m2 provided durable responses in a heavily pretreated population with relapsed and refractory multiple myeloma (n=266), with an overall response rate of 22.9% and a median duration of response of 7.8 months. In an integrated safety analysis of four Phase II studies, common adverse events (32.7%–55.5%) included fatigue, anemia, nausea, thrombocytopenia, dyspnea, and diarrhea. Grade 3/4 adverse events were generally hematologic and included thrombocytopenia (23.4%), anemia (22.4%), and lymphopenia (18.1%). Serious adverse events included pneumonia (9.9%), acute renal failure (4.2%), pyrexia (3.4%), and congestive heart failure (3.4%). New or worsening peripheral neuropathy was infrequent (13.9% overall, 1.3% grade 3, no grade 4). This review discusses findings of the integrated safety analysis and provides practical experience from a single institution in managing treatment-related and disease-related adverse events. Individualized treatment with proactive management of side effects and complications allows patients with advanced multiple myeloma to remain on carfilzomib for extended periods. PMID:24855395

Harvey, R Donald

2014-01-01

332

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products?-?part 1: Achillea millefolium-Curcuma longa.  

PubMed

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 1: Achillea millefolium L.-Curcuma longa L. PMID:24621152

Calapai, Gioacchino; Miroddi, Marco; Minciullo, Paola L; Caputi, Achille P; Gangemi, Sebastiano; Schmidt, Richard J

2014-07-01

333

Predictors of Adverse Outcome in Cancer Patients with Candidemia 1 1 Supported by a grant from Pfizer Pharmaceuticals, Inc  

Microsoft Academic Search

BACKGROUND: Many factors, including severity of illness, neutropenia, intravenous catheter management, and drug therapy may affect the outcome of candidemia in cancer patients.METHODS: The records of all patients at M. D. Anderson Cancer Center who developed one or more positive blood cultures for Candida spp between January 1, 1988, and December 31, 1992, were retrospectively reviewed. Four hundred ninety-one episodes

Elias J Anaissie; John H Rex; Ömrün Uzun; Shahe Vartivarian

1998-01-01

334

Autoimmune reactions in patients with silicone breast implants.  

PubMed

Silicone breast implants have been surgical routine for over 30 years. An association between silicone augmentation and immune related diseases has been reported in approximately 100 cases. In a retrospective single center study we investigated 36 non-selected women with silicone breast implants and 36 sex- and age-matched controls. Autoimmune reactions were evaluated by measuring antinuclear antibodies (ANA), rheumatoid factor (RF) and thyroid gland antibodies (TMS), along with angiotensin-converting enzyme (ACE), C-reactive protein (CRP) and other immunological and laboratory parameters. In the controls only 3 (8%) women had an elevated ANA titer and 1 demonstrated thyroid autoantibodies (microsomal), giving a total of 4 (11%) women with detectable autoantibodies. By contrast, 12 (33%) of the 36 women with silicone augmentation had raised ANA titers (> or = 1 : 80), a significantly higher percentage than in the control group (p < 0.02). Of the 12 women, 1 showed antismooth muscle antibodies (ASMA; titer 1 : 40) and 2 of the patients displayed antineutrophilic cytoplasm antibodies (ANCA; 1 : 320 and 1 : 40, respectively), one of the latter also being positive for rheumatoid factor. 2 further women demonstrated thyroid autoantibodies (microsomal), giving a total of 14 (39%) women in whom significant autoantibodies were detectable. Clinical symptoms (musculoskeletal) were present in 1 patient. Most of the observed autoantibodies were organ-unspecific, with a predominance of elevated ANA titers of the heterogeneous type and not related to a distinct clinical entity. However, none of the investigated women with silicone breast implants showed clinical symptoms or signs of connective tissue disease according to ARA criteria. PMID:9017890

Zazgornik, J; Piza, H; Kaiser, W; Bettelheim, P; Steiner, G; Smolen, J; Biesenbach, G; Maschek, W

1996-12-27

335

Late-Onset Immune-Mediated Adverse Effects after Poly-L-Lactic Acid Injection in Non-HIV Patients: Clinical Findings and Long-Term Follow-Up  

Microsoft Academic Search

Background: It has been thought that poly-L-lactic acid (PLLA) injections do not have inflammatory side effects. Recent evidence shows that local\\/regional\\/systemic delayed adverse effects may appear with its use. Objective: To evaluate the clinical complaints, treatment response and long-term follow-up of non-HIV patients with delayed immune-mediated adverse effects related to PLLA injections. Methods: Prospective, case series study of 10 patients

Jaume Alijotas-Reig; Victor Garcia-Gimenez; Miquel Vilardell-Tarres

2009-01-01

336

The Relationship Between Childhood Adversity and Dysphoric Inner States Among Borderline Patients Followed Prospectively for 10 Years.  

PubMed

Childhood experiences of abuse and neglect were assessed in relation to dysphoric states among patients with borderline personality disorder (BPD) over a 10-year course of prospective follow-up. The Revised Childhood Experiences Questionnaire was administered at baseline to 290 patients meeting DIB-R and DSM-III-R criteria for BPD. The Dysphoric Affect Scale-a 50-item self-report measure of affective and cognitive states thought to be common among and specific to borderline patients-was administered at fives waves of prospective follow-up. Significant predictors of dysphoric states included emotional abuse, verbal abuse, physical abuse, sexual abuse, emotional withdrawal, inconsistent treatment, denial of patient's feelings, lack of a real relationship, placing patient in parental role, and failure to protect patient. This suggests that abusive and neglectful childhood experiences are significant risk factors for severe affective and cognitive difficulties reported by borderline patients and that sexual abuse is neither necessary nor sufficient for the development of these troubling inner states. PMID:23445475

Reed, Lawrence Ian; Fitzmaurice, Garrett; Zanarini, Mary C

2013-02-27

337

Association Between Statin Medications and Mortality, Major Adverse Cardiovascular Event, and Amputation-Free Survival Rates in Patients with Critical Limb Ischemia  

PubMed Central

Objectives To determine the associations between statin use and major adverse cardiovascular and cerebrovascular events (MACCE) and amputation-free survival in critical limb ischemia (CLI) patients. Background CLI is an advanced form of peripheral arterial disease (PAD) associated with nonhealing arterial ulcers and high rates of MACCE and major amputation. While statin medications are recommended for secondary prevention in PAD, their effectiveness in CLI is uncertain. Methods We reviewed 380 CLI patients who underwent diagnostic angiography or therapeutic endovascular intervention from 2006–2012. Propensity scores and inverse probability of treatment weighting were used to adjust for baseline differences between patients taking and not taking statins. Results 246 (65%) patients were prescribed statins. The mean serum low-density lipoprotein (LDL) level was lower in patients prescribed statins (75±28 vs. 96±40 mg/dL, P<0.001). Patients prescribed statins had more baseline comorbidities including diabetes, coronary artery disease, and hypertension, as well as more extensive lower extremity disease (all P <0.05). After propensity weighting, statin therapy was associated with lower one-year rates of MACCE (stroke, myocardial infarction, or death; hazard ratio [HR] 0.53, 95% CI 0.28–0.99), mortality (HR 0.49, 95% CI 0.24–0.97), and major amputation or death (HR 0.53, 95% CI 0.35–0.98). Statin use was also associated with improved lesion patency among patients undergoing infrapopliteal angioplasty. Patients with LDL levels above 130mg/dL had increased hazards of MACCE and mortality compared to patients with lower levels of LDL. Conclusions Statins are associated with lower mortality and MACCE and increased amputation-free survival in CLI patients. PMID:24315911

Westin, Gregory G.; Armstrong, Ehrin J.; Bang, Heejung; Yeo, Khung-Keong; Anderson, David; Dawson, David L.; Pevec, William C.; Amsterdam, Ezra A.; Laird, John R.

2014-01-01

338

Beneficial and adverse psychotropic effects of antiepileptic drugs in patients with epilepsy: a summary of prevalence, underlying mechanisms and data limitations.  

PubMed

Antiepileptic drugs (AEDs) can have both beneficial and adverse psychotropic effects. They act on neurotransmitter systems, neuronal ion permeability and other targets, although the exact mechanisms are not generally fully elucidated. A systematic review of the literature reveals evidence for both positive and negative effects on depression, anxiety, aggression, psychosis and sleep in patients with epilepsy. Topiramate, vigabatrin, levetiracetam, tiagabine and zonisamide have been associated primarily with adverse psychotropic effects, whilst gabapentin, pregabalin, lacosamide and lamotrigine, in particular, have demonstrated a more beneficial psychotropic profile, especially with regard to affective symptoms. This review, however, identifies specific methodological issues with studies that have reported on the psychotropic effects of AEDs, suggesting that some of the findings might be inconclusive or unreliable because of confounding factors, particularly the presence of psychiatric history. More rigorous double-blind, randomized, placebo-controlled trials on larger numbers of patients with epilepsy, with clear inclusion/exclusion criteria, that are specifically designed to investigate psychotropic changes are more likely to produce results that inform clinical practice and direct future research. PMID:22393904

Piedad, John; Rickards, Hugh; Besag, Frank M C; Cavanna, Andrea E

2012-04-01

339

Adverse events analysis as an educational tool to improve patient safety culture in primary care: A randomized trial  

Microsoft Academic Search

Background  Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries\\u000a generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions\\u000a and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with\\u000a training becoming a priority

Clara González-Formoso; María Victoria Martín-Miguel; Ma José Fernández-Domínguez; Antonio Rial; Fernando Isidro Lago-Deibe; Luis Ramil-Hermida; Margarita Pérez-García; Ana Clavería

2011-01-01

340

Moderate altitude is not associated with adverse postoperative outcomes for patients undergoing bidirectional cavopulmonary anastomosis and Fontan operation: A comparative study among Denver, Edmonton, and Toronto  

PubMed Central

Objective Outcomes of patients with single ventricle physiology undergoing cavopulmonary palliations depend on pulmonary vascular resistance (PVR) and have been suggested to be adversely affected by living at elevated altitude. We compared the pulmonary hemodynamic data in correlation with postoperative outcomes at the 3 centers of Denver, Edmonton, and Toronto at altitudes of 1604, 668, and 103 meters, respectively. Methods Hemodynamic data at pre-bidirectional cavopulmonary anastomosis (BCPA) and pre-Fontan catheterization between 1995 and 2007 were collected. Death from cardiac failure or heart transplantation in the same period was used to define palliation failure. Results There was no significant correlation between altitude (ranged from 1 to 2572 meters) and PVR, pulmonary artery pressure (PAP) or transpulmonary gradient (TPG) at pre-BCPA and pre-Fontan catheterization. BCPA failure occurred in 11 (9.2%) patients in Denver, 3 (2.9%) in Edmonton, and 34 (11.9%) in Toronto. Fontan failure occurred in 3 (6.1%) patients in Denver, 5 (7.2%) in Edmonton, and 11 (7.0%) in Toronto. There was no significant difference in BCPA and Fontan failure among the 3 centers. BCPA failure positively correlated with PVR and the presence of a right ventricle as the systemic ventricle. Fontan failure positively correlated with PAP and TPG. Conclusions Moderate altitude is not associated with an increased PVR or adverse outcomes in patients with a functional single ventricle undergoing BCPA and the Fontan operation. The risk factors for palliation failure are higher PVR, PAP, and TPG and a systemic right ventricle, but not altitude. Our study reemphasizes the importance of cardiac catheterization assessments of pulmonary hemodynamics before BCPA and Fontan operations. PMID:23353110

Zhou, Zhi; Malhotra, Sunil P.; Yu, Xiaoyang; Rutledge, Jennifer; Rebeyka, Ivan M.; Ross, David B.; Rausch, Christopher; Gu, Hong; McCrindle, Brian; Lacour-Gayet, Francois; Ivy, Dunbar; Li, Jia

2013-01-01

341

Severe photosensitivity reaction induced by topical diclofenac  

PubMed Central

Albeit uncommon, photosensitivity reaction induced by diclofenac can be an unfortunate adverse reaction complicating its use as a topical analgesic. We here present a case of a patient who suffered such a reaction as a result of exposure to diclofenac, employed as a topical analgesic for low backache. The lesions healed with conservative management without extensive scarring or other complications. PMID:24014923

Akat, Pramod B.

2013-01-01

342

Chronic Kidney Disease Is an Independent Predictor of Adverse Clinical Outcomes in Patients with Recent Small Subcortical Infarcts  

PubMed Central

Background Chronic kidney disease (CKD) is associated with cerebral small vessel diseases (SVD) and predicts stroke, cardiovascular events and mortality. However, its association with recent small subcortical infarcts (RSSI), a novel subtype of cerebral SVD, has not yet been established in stroke patients. The aim of this longitudinal study was to clarify whether CKD can predict clinical outcome in patients with RSSI. Methods We enrolled patients with first-ever RSSI (formerly categorized as acute lacunar stroke). CKD was defined as an estimated glomerular filtration rate of <60 ml/min/1.73 m2 on admission. The patients were divided into two groups according to the presence or absence of CKD. The endpoints were recurrent stroke, cardiovascular events or all-cause mortality. The patients were followed up at 3, 6 and 12 months after stroke onset and yearly thereafter. Event-free survival analysis was undertaken using Kaplan-Meier plots and the log-rank test. Cox's proportional-hazards analysis was conducted regarding age, sex and the presence of any cerebral SVD. Results A total of 152 patients (66% males; mean age: 67.6 years) were consecutively enrolled, and 44 (29%) had CKD. During the follow-up period (median: 3 years; interquartile range: 1-4), 27 patients (18%) reached endpoints. The numbers of patients per endpoint were as follows: all-cause mortality 14, ischemic stroke 9, hemorrhagic stroke 2 and aortic dissection 2. Patients with CKD were significantly older (77 vs. 64 years; p < 0.001), had higher serum creatinine (0.96 vs. 0.65 mg/dl; p < 0.001), higher brain natriuretic peptide (51.1 vs. 18.5 pg/ml; p < 0.001) and a higher National Institutes of Health Stroke Scale score on admission (3 vs. 2; p < 0.001), and were less likely to have modified Rankin Scale scores of 0-2 after stroke onset (52 vs. 77%; p = 0.003). Patients with white matter hyperintensity [odds ratio (OR) 3.0; 95% confidence interval (CI): 1.5-6.2; p = 0.003] and those with microbleeds (OR 2.5; 95% CI: 1.2-5.1; p = 0.015) had more pronounced CKD than the remaining patients. A Kaplan-Meier curve analysis showed that patients with CKD had a less favorable outcome than those without CKD (p < 0.001). The multivariate Cox proportional-hazards analysis revealed that CKD was associated with recurrent stroke, cardiovascular events or all-cause mortality (hazard ratio 2.22; 95% CI: 1.12-4.25; p = 0.02). Conclusions CKD was found to be independently associated with recurrent stroke, cardiovascular events or all-cause mortality in patients with RSSI.

Saji, Naoki; Sato, Takahiro; Sakuta, Kenichi; Aoki, Junya; Kobayashi, Kazuto; Matsumoto, Noriko; Uemura, Junichi; Shibazaki, Kensaku; Kimura, Kazumi

2014-01-01

343

Impact of Hyperglycemia on Survival and Infection-Related Adverse Events in Patients with Metastatic Colorectal Cancer Who Were Receiving Palliative Chemotherapy  

PubMed Central

Purpose Non-metastatic colorectal cancer patients with diabetes have poor overall survival than those without diabetes. However, the effect of hyperglycemia on survival after diagnosis of metastatic colorectal cancer (CRC) has not been assessed. Therefore, we assessed the impact of hyperglycemia on the survival and infection-related adverse events (AEs) in patients with metastatic CRC. Materials and Methods We reviewed the records of 206 patients with newly diagnosed metastatic CRC who were treated with palliative chemotherapy from March 2000 to December 2012 at Chungbuk National University Hospital. The mean glucose level of each patient was calculated using all available glucose results. Results The mean glucose levels ranged between 76.8 and 303.5 mg/dL, and patients were categorized into quartiles in accordance to their mean glucose level: group 1 (< 106.7 mg/dL), group 2 (106.7-117.2 mg/dL), group 3 (117.3-142.6 mg/dL), and group 4 (> 142.6 mg/dL). The median overall survival for patients in groups 1, 2, 3, and 4 were 22.6, 20.1, 18.9, and 17.9 months, respectively; however, this difference was not statistically significant (p=0.643). Compared with patients in group 1, those in groups 2, 3, and 4 were at a higher risk of infection-related AEs, according to a multivariate analysis (p=0.002). Conclusion Hyperglycemia was not associated with shorter survival; however, it was associated with infection-related AEs in patients with newly diagnosed metastatic CRC receiving palliative chemotherapy. PMID:25038764

Hong, Yong Joo; Han, Hye-Suk; Jeong, Yusook; Jeong, Jiwon; Lim, Sung-Nam; Choi, Hyung Jin; Jeon, Hyun-Jung; Oh, Tae-Keun; Lee, Sang-Jeon; Lee, Ki Hyeong

2014-01-01

344

Quantifying Risk of Adverse Clinical Events With One Set of Vital Signs Among Primary Care Patients with Hypertension  

Microsoft Academic Search

BACKGROUND Hypertension is often uncontrolled. One reason might be physi- cians' reticence to modify therapy in response to single offi ce measurements of vital signs. METHODS Using electronic records from an inner-city primary care practice, we extracted information about vital signs, diagnoses, test results, and drug therapy available on the fi rst primary care visit in 1993 for patients with

William M Tierney; Margaret Brunt; Joseph Kesterson; Xiao-Hua Zhou; Gil L'Italien; Pablo Lapuerta

345

Oral adverse effects of head and neck radiotherapy: literature review and suggestion of a clinical oral care guideline for irradiated patients  

PubMed Central

Radiotherapy, alone or associated with surgery or chemotherapy, produces a significant increase in cure rates for many malignancies of the head and neck region. However, high doses of radiation in large areas, including the oral mucosa, may result in several undesired reactions that manifest during or after the completion of therapy. The multidisciplinary management is the best alternative to minimize or even prevent such reactions, and the dentist has a fundamental role in this context. This paper reviews the literature related to the main oral sequelae from head and neck radiotherapy and establishes clinical oral management protocol for these irradiated patients. PMID:21986648

TOLENTINO, Elen de Souza; CENTURION, Bruna Stuchi; FERREIRA, Lucia Helena Caetano; de SOUZA, Andreia Pereira; DAMANTE, Jose Humberto; RUBIRA-BULLEN, Izabel Regina Fischer

2011-01-01

346

Oral adverse effects of head and neck radiotherapy: literature review and suggestion of a clinical oral care guideline for irradiated patients.  

PubMed

Radiotherapy, alone or associated with surgery or chemotherapy, produces a significant increase in cure rates for many malignancies of the head and neck region. However, high doses of radiation in large areas, including the oral mucosa, may result in several undesired reactions that manifest during or after the completion of therapy. The multidisciplinary management is the best alternative to minimize or even prevent such reactions, and the dentist has a fundamental role in this context. This paper reviews the literature related to the main oral sequelae from head and neck radiotherapy and establishes clinical oral management protocol for these irradiated patients. PMID:21986648

Tolentino, Elen de Souza; Centurion, Bruna Stuchi; Ferreira, Lúcia Helena Caetano; Souza, Andréia Pereira de; Damante, José Humberto; Rubira-Bullen, Izabel Regina Fischer

2011-10-01

347

Adverse psychological effects of ECT  

Microsoft Academic Search

Although it is known that a proportion of people find ECT distressing to receive, these adverse psychological reactions are little understood. Twenty people who reported having found ECT upsetting were interviewed about their experiences in detail. A variety of them es emerged, including feelings of fear, shame and hum iliation, worthlessness and helplessness, and a sense of having been abused

LUCY JOHNSTONE

1999-01-01

348

Cyclooxygenase2 predicts adverse effects of tamoxifen: a possible mechanism of role for nuclear HER2 in breast cancer patients  

Microsoft Academic Search

Cyclooxygenase-2 (COX-2) is associated with breast tumour progression. Clinical and molecular studies implicate human epidermal growth factor receptor 2 (HER2) in the regulation of COX-2 expression. Recent reports raise the possibility that HER2 could mediate these effects through direct transcriptional mechanisms. The relationship between HER2 and COX-2 was investigated in a cohort of breast cancer patients with or without endocrine

Mary F Dillon; Anthony T Stafford; Gabrielle Kelly; Aisling M Redmond; Marie McIlroy; Thomas B Crotty; E McDermott; Arnold D Hill

349

Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: Effects of age, race, and gender  

Microsoft Academic Search

Safety monitoring is a critical element of clinical trials evaluating treatment for substance dependence, but is complicated by participants’ high levels of medical and psychiatric comorbidity. This paper describes AEs reported in a large (N=286), 29-week outpatient study of behavioral interventions for heroin and cocaine dependence in methadone-maintained outpatients. A total of 884 AEs were reported (3.1 per patient, 0.12

Jennifer R. Schroeder; John P. Schmittner; David H. Epstein; Kenzie L. Preston

2005-01-01

350

Chronic Graft-Versus-Host Disease in 52 Patients: Adverse Natural Course and Successful Treatment With Combination Immunosuppression  

Microsoft Academic Search

Fifty-two of 175 (30%) survivors of allogeneic marrow transplantation developed chronic graft-versus-host dis- ease (GVHD). Five with limited chronic GVHD had an indolent clinical course with involvement of only the skin and liver. Forty-seven with extensive chronic GVHD had an unfavorable multiorgan disorder that resembled several autoimmune diseases. Thirteen patients with extensive disease (group I) were not treated and only

Keith M. Sullivan; Howard M. Shulman; Rainer Storb; Paul L. Weiden; Robert P. Witherspoon; George B. McDonald; Mark M. Schubert; Kerry Atkinson; E. Donnall Thomas

1981-01-01

351

Management of adverse events in patients with hormone receptor-positive breast cancer treated with everolimus: observations from a phase III clinical trial.  

PubMed

Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced renal cell carcinoma, pancreatic neuroendocrine tumors, subependymal giant cell astrocytoma associated with tuberous sclerosis complex, renal angiomyolipoma and tuberous sclerosis complex, and, in combination with exemestane, for hormone receptor-positive HER2-negative advanced breast cancer after failure of treatment with letrozole or anastrozole. Results from the phase III BOLERO-2 trial demonstrated that everolimus in combination with exemestane provided significant clinical benefit to patients with advanced hormone receptor-positive breast cancer. Although everolimus is generally well tolerated, as with most therapies administered in an advanced cancer setting, drug-related adverse events (AEs) inevitably occur. Most common AEs observed in the everolimus studies include stomatitis, rash, infection, noninfectious pneumonitis, and hyperglycemia. Clinical awareness and early identification of such AEs by oncology nurses are essential to dosing (interruptions, reduction, and treatment discontinuation); quality of life; and, ultimately, patient outcomes. Because everolimus has already been shown to significantly improve clinical efficacy in patients with advanced breast cancer, a proactive approach to the practical management of AEs associated with this mTOR inhibitor as well as other most common AEs observed in this patient population has been reviewed and outlined here. PMID:23686401

Peterson, Mary E

2013-08-01

352

Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration  

PubMed Central

The objective of this paper is to analyze healthcare information technology (HIT) events associated with patient harm submitted to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. We examined the problems in 46 relevant events submitted to MAUDE from January 2008 to July 2010 to identify natural categories of problems from a clinical perspective. CPOE and PACS were involved in 93% of the events. Adverse events were associated with medications in 41%, clinical processes in 33%, radiation in 15% and surgery in 11%. There were four deaths. Strategies to improve the safety of HIT should focus on designing safe user interfaces, integrated checks of key identifiers and decision support, and engineering safer clinical processes. PMID:22195143

Magrabi, Farah; Ong, Mei-sing; Runciman, William; Coiera, Enrico

2011-01-01

353

A combination therapy with copper nicotinate complex reduces the adverse effects of 5-fluorouracil on patients with hepatocellular carcinoma.  

PubMed

5-Fluorouracil (5-FU) as chemotherapy in cases of hepatocellular carcinoma (HCC), was found to initiate hepatotoxic injuries, ascites, leucopenia, thrombocytopenia and myelosupression that limit its use. Therefore, this work was conducted to investigate whether the combination of copper (I)-nicotinate complex [CuCl (HNA)2] with 5-FU may overcome such a drug resistance. Forty-eight patients with HCC were therapy-naïve and treated with 5-FU (12 mg/kg/day) for 5 days in 2 cycles with 4 weeks in between. Twenty-four of them were simultaneously given oral doses of copper (I)-nicotinate complex (0.8 mg/kg/day) started with the 5-FU treatment. The combined therapy of CuCl (HNA)2 with 5-FU could improve the prognosis of HCC-patients. Improvement of liver function was presented by significant reduction of serum bilirubin (p<0.001), transaminases and alkaline phoshatase (p<0.05). The copper complex prevented hypoproteinaemic and hypoalbuminaemic effects of 5-FU and rendered the prothrombin time to its normal value (p<0.001). Superoxide dismutase, ceruloplasmin and immunoglobulins IgG showed significant increases (p<0.001), while serum copper and lipid peroxides were reduced (p<0.001). Thrombocytopenia, leucopenia and other myelosuppressive effects of 5-FU were reduced by the co-administration of CuCl (HNA)2. In conclusion the combination with CuCl (HNA)2 given in such a dosage schedule mitigated the most frequent toxicities associating 5-FU administration and enhanced defense mechanisms against oxidative stress. PMID:15255289

El-Saadani, Muhammad A M

2004-04-01

354

ASXL1 but Not TET2 Mutations Adversely Impact Overall Survival of Patients Suffering Systemic Mastocytosis with Associated Clonal Hematologic Non-Mast-Cell Diseases  

PubMed Central

Systemic mastocytosis with associated hematologic clonal non-mast cell disease (SM-AHNMD) is a rare and heterogeneous subtype of SM and few studies on this specific entity have been reported. Sixty two patients with Systemic mastocytosis with associated hematologic clonal non-mast cell disease (SM-AHNMD) were presented. Myeloid AHNMD was the most frequent (82%) cases. This subset of patients were older, had more cutaneous lesions, splenomegaly, liver enlargement, ascites; lower bone mineral density and hemoglobin levels and higher tryptase level than lymphoid AHNMD. Defects in KIT, TET2, ASXL1 and CBL were positive in 87%, 27%, 14%, and 11% of cases respectively. The overall survival of patients with SM-AHNMD was 85.2 months. Within the myeloid group, SM-MPN fared better than SM-MDS or SM-AML (p?=?0.044,). In univariate analysis, the presence of C-findings, the AHNMD subtypes (SM-MDS/CMML/AML versus SM-MPN/hypereosinophilia) (p?=?0.044), Neutropenia (p?=?0.015), high monocyte level (p?=?0.015) and the presence of ASXL1 mutation had detrimental effects on OS (p?=?0.007). In multivariate analysis and penalized Cox model, only the presence of ASXL1 mutation remained an independent prognostic factor that negatively affected OS (p?=?0.035). SM-AHNMD is heterogeneous with variable prognosis according to the type of the AHNMD. ASXL1 is mutated in a subset of myeloid AHNMD and adversely impact on OS. PMID:24465546

Damaj, Gandhi; Joris, Magalie; Chandesris, Olivia; Hanssens, Katia; Soucie, Erinn; Canioni, Danielle; Kolb, Brigitte; Durieu, Isabelle; Gyan, Emanuel; Livideanu, Cristina; Cheze, Stephane; Diouf, Momar; Garidi, Reda; Georgin-Lavialle, Sophie; Asnafi, Vahid; Lhermitte, Ludovic; Lavigne, Christian; Launay, David; Arock, Michel; Lortholary, Olivier

2014-01-01

355

Jarisch-Herxheimer reaction in a patient with neurosyphilis.  

PubMed Central

A 40 year old man presented with progressive personality changes in the previous six months. Specific serological tests for syphilis in blood and CSF were highly positive and CSF sedimentation showed signs of an inflammatory process. Ten hours after the start of penicillin treatment a severe symptomatic Jarisch-Herxheimer reaction with alteration of level of consciousness, pupillary changes, and focal neurological signs developed. Jarisch-Herxheimer reaction may occur in various settings, particularly in the treatment of syphilis. Investigation of CSF before the treatment may predict a potential risk. Corticosteroid treatment has been suggested for prevention. PMID:8021683

Zifko, U; Lindner, K; Wimberger, D; Volc, B; Grisold, W

1994-01-01

356

Mucosal polymerase chain reaction for diagnosing Helicobacter pylori infection in patients with bleeding peptic ulcers  

PubMed Central

AIM: Helicobacter pylori (H pylori) has been linked to chronic gastritis, peptic ulcers, gastric cancer and MALT-lymphoma. Conventional invasive tests are less sensitive than non-invasive tests in diagnosing H pylori infection in patients with bleeding peptic ulcers. Polymerase chain reaction is a sensitive and accurate method for diagnosing H pylori infection. The aim of this study was to evaluate the diagnostic role of mucosal polymerase chain reaction for H pylori infection in patients with bleeding peptic ulcers. METHODS: In patients with bleeding, non-bleeding peptic ulcers and chronic gastritis, we checked rapid urease test, histology, bacterial culture and mucosal polymerase chain reaction for detecting H pylori infection. Positive H pylori infection was defined as positive culture or both a positive histology and a positive rapid urease test. For mucosal polymerase chain reaction of H pylori, we checked vacA (s1a, s1b, s1c, s2, m1, m1T, m2), iceA1, iceA2 and cag A. RESULTS: Between October 2000 and April 2002, 88 patients with bleeding peptic ulcers (males/females: 60/28, gastric ulcers/duodenal ulcers: 55/33), 81 patients with non-bleeding peptic ulcers (males/females: 54/27, gastric ulcers/duodenal ulcers: 45/36) and 37 patients with chronic gastritis (males/females: 24/13) were enrolled in this study. In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, 45 patients (51%), 71 patients (88%) and 20 patients (54%) respectively were found to have positive H pylori infection (P<0.001). In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, polymerase chain reaction for H pylori infection was positive in 54 patients (61%), 70 patients (86%) and 20 patients (54%) respectively (P<0.001). The sensitivity, positive predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori infection were significantly lower in patients with bleeding peptic ulcers (84%, 79% and 81%) than in patients with non-bleeding peptic ulcers (99%, 99% and 98%) (P<0.001, P<0.01 and P<0.001 respectively). The sensitivity, negative predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori were significantly lower in patients with bleeding peptic ulcers (84%, 83% and 81%) than in patients with chronic gastritis (100%, 100% and 100%) (P = 0.02, P = 0.02 and P = 0.001). CONCLUSION: Mucosal polymerase chain reaction for detecting H pylori infection is not reliable in patients with bleeding peptic ulcers. PMID:15637749

Lin, Hwai-Jeng; Lo, Wen-Ching; Perng, Chin-Lin; Tseng, Guan-Ying; Li, Anna Fen-Yau; Ou, Yueh-Hsing

2005-01-01

357

Loss of ALCAM expression is linked to adverse phenotype and poor prognosis in breast cancer: A TMA-based immunohistochemical study on 2,197 breast cancer patients.  

PubMed

Activated leukocyte cell adhesion molecule (ALCAM) is a membranous cell adhesion protein that is often expressed in breast cancer. Data on the prognostic impact of ALCAM expression is highly controversial in this cancer. To evaluate the clinical impact of ALCAM expression in a sufficiently large patient cohort, we utilized a tissue microarray (TMA) containing more than 2,100 primary breast cancers with clinical follow-up data by immunohistochemistry. TMA spots containing normal breast epithelium showed moderate to strong membranous ALCAM staining. ALCAM staining was strong in 66.2%, moderate in 10.9%, weak in 11.1% and absent in 11.8% of 1,778 (80.9%) interpretable breast cancer tissue spots. Decreased ALCAM expression was significantly associated with advanced tumor size (p=0.0017), unfavorable tumor grade (p<0.0001), negative ER and PR status (p<0.0001 each) as well as high Ki67 labeling index (p<0.0001). Cancers with ACLAM expression loss had a significantly poorer overall (p<0.0001) and disease-specific survival (p=0.0088). This association also held true in the subset of nodal positive cancers (p<0.0001). In conclusion, these data demonstrate that ALCAM is generally expressed in normal and cancerous breast epithelium and that a marked reduction of ALCAM expression characterizes a subset of breast cancer patients with adverse tumor characteristics and unfavorable clinical outcome. PMID:25270339

Burandt, Eike; Bari Noubar, Tanaz; Lebeau, Annette; Minner, Sarah; Burdelski, Christoph; Jänicke, Fritz; Müller, Vollkmar; Terracciano, Luigi; Simon, Ronald; Sauter, Guido; Wilczak, Waldemar; Lebok, Patrick

2014-12-01

358

[Adverse reactions and changes in norepinephrine and epinephrine in the plasma after intravenous thyroliberin in persons with normal and abnormal thyroid function].  

PubMed

14 normal volunteers, 23 patients with euthyroid goiter, 9 patients with hypothyroidism and 17 patients with hyperthyroidism were injected with 400 micrograms thyroliberin (thyrotropin releasing hormone, TRH). The documented side effects were the same in all the 4 groups studied. Subjective symptoms such as flushing, nausea, urinary urgency, dizziness and headache in decreasing sequence were mentioned by 86% of subjects. Shortly after thyroliberin injection, a mean increase of 26 +/- 13 mm Hg for systolic and 14 +/- 6 mm Hg for diastolic blood pressure as well as an increased heart rate by 7.2 +/- 6.6 min-1 was demonstrated. Plasma catecholamines were lowered in patients with euthyroid goiter and hyperthyroidism and raised in patients with hypothyroidism, compared with the controls. Thyroliberin administration was associated with an activation of the sympathoadrenal system. The increments in plasma epinephrine and norepinephrine concentrations were proportional to initial values, but were insufficient to affect blood pressure. The mean increase of 28% for plasma epinephrine and 21% for norepinephrine were maximal in the second to the forth minute, where subjective symptoms, blood pressure and heart rate were already decreasing. In view of the rapid onset of the subjective symptoms as well as the chronotropic and the pressor response, thyroliberin may partly exert these effects centrally or directly on the vascular system, independently of catecholamines. Since individual systolic blood pressure increased by as much as 64 mm Hg, caution is advised in selecting patients with risk factors for testing. PMID:3116148

Ratge, D; Barthels, U; Wisser, H; Bode, J C

1987-07-01

359

Adverse events following an emergency department visit  

PubMed Central

Background Many studies demonstrate a high rate of treatment?related adverse outcomes or adverse events. No studies have prospectively evaluated adverse events in patients discharged home from the emergency department (ED). Objective To describe the types of adverse events in patients discharged home from an ED. Patients Patients who were sent home directly from the ED of an urban, academic teaching hospital in Ottawa, Canada. Methods Patient records were reviewed to identify demographic and medical history information. Two weeks following the ED visit, patients completed a standard telephone interview to record post ED visit outcomes. Two physicians reviewed outcomes to identify all adverse events and their cause. Results Follow?up was complete for 399 of 408 enrolled patients. The median age was 49 years (interquartile range 36–68) and 50% were male. The most common diagnosis was “chest pain”, occurring in 74 patients (18%), followed by “bone and joint disorders” in 55 patients (14%). 24 patients experienced an adverse event (incidence 6% (95% CI 4% to 9%)), of which 17 were preventable (incidence 4% (95% CI 3% to 7%)). Five of the unpreventable adverse events were medication side effects and two were minor, procedure?related complications. Of all 24 adverse events, 15 (63%; 95% CI 43 to 79%) led to an additional ED visit or a hospitalisation. Preventable adverse events occurred in 5 of 78 chest pain patients (incidence 6% (95% CI 3% to 14%)). Conclusion Most adverse events occurring following an ED visit are preventable and often relate to diagnostic or management errors. PMID:17301197

Forster, Alan J; Rose, Nicholas G W; van Walraven, Carl; Stiell, Ian

2007-01-01

360

Patient Reactions to Vital Sign Measures: Comparing Home Monitoring Technology to Face-to-Face Delivery  

PubMed Central

Increasingly home health agencies are using home-based technologies to monitor vital signs of chronically ill patients. Patients receive measurements such as blood pressure and weight that indicate risks to their health. Cognitive reactions to risk measures have been studied for face-to-face delivery; however, it is unknown whether the same reactions exist with technology delivery. Reported in this article are study results of a comparative content expert analysis of reactions to technology-delivered health-risk measures. Results suggest that patients have the similar reactions but may be more likely to just accept, without evaluating or considering threats to their health. As home telemonitoring applications continue to evolve, care must be taken avoid creating passive patients and develop best practices that use technology to encourage beneficial self-care behaviors. PMID:22337499

Shea, Kimberly; Chamoff, Breanna

2012-01-01

361

Detection of Chlamydia trachomatis by the polymerase chain reaction in young patients with acute epididymitis  

Microsoft Academic Search

Specimens from 11 patients presenting with acute epididymitis were tested for the presence ofChlamydia trachomatis by an enzyme immunoassay (EIA), growth in McCoy cells and the polymerase chain reaction (PCR), and for other microorganisms by standard laboratory techniques.Chlamydia trachomatis urethral infection was detected in four patients by tissue culture, in three patients by EIA and in nine patients by PCR.

A. Eley; K. M. Oxley; R. C. Spencer; G. R. Kinghorn; E. T. Ben-Ahmeida; C. W. Potter

1992-01-01

362

Body mass index and risk of perioperative cardiovascular adverse events and mortality in 34,744 Danish patients undergoing hip or knee replacement  

PubMed Central

Background and purpose Obesity is a risk factor for osteoarthritis in the lower limb, yet the cardiovascular risks associated with obesity in hip or knee replacement surgery are unknown. We examined associations between body mass index (BMI) and the risk of a major adverse cardiovascular event (MACE: ischemic stroke, acute myocardial infarction, or cardiovascular death) or the risk of all-cause mortality in a nationwide Danish cohort of patients who underwent primary hip or knee replacement surgery. Methods Using Danish nationwide registries, we identified 34,744 patients aged ? 20 years who underwent elective primary hip or knee replacement surgery between 2005 and 2011. We used multivariable Cox regression models to calculate the 30-day risks of MACE and mortality associated with 5 BMI groups (underweight (BMI < 18.5 kg/m2), normal weight (18.5–24 kg/m2), overweight (25–29 kg/m2), obese 1 (30–34 kg/m2), and obese 2 (? 35 kg/m2)). Results In total, 232 patients (0.7%) had a MACE and 111 (0.3%) died. Compared with overweight, adjusted hazard ratios (HRs) were 1.2 (95% CI: 0.4–3.3), 1.3 (0.95–1.8), 1.6 (1.1–2.2), and 1.0 (0.6–1.9) for underweight, normal weight, obese 1, and obese 2 regarding MACE. Regarding mortality, the corresponding HRs were 7.0 (2.8–15), 2.0 (1.2–3.2), 1.5 (0.9–2.7), and 1.9 (0.9–4.2). Cubic splines suggested a significant U-shaped relationship between BMI and risks with nadir around 27–28. Interpretation In an unselected cohort of patients undergoing elective primary hip or knee replacement surgery, U-shaped risks of perioperative MACE and mortality were found in relation to BMI. Patients within the extreme ranges of BMI may warrant further attention. PMID:24954493

Gislason, Gunnar H; K?ber, Lars; Jensen, Per F?ge; Torp-Pedersen, Christian; Andersson, Charlotte

2014-01-01

363