Sample records for adverse patient reactions

  1. Adverse reaction; patent blue turning patient blue.

    PubMed

    Joshi, Meera; Hart, Matthew; Ahmed, Farid; McPherson, Sandy

    2012-01-01

    The authors report a severe anaphylactic reaction to Patent Blue V dye used in sentinel node biopsy for lymphatic mapping during breast cancer surgery to stage the axilla. Patent Blue dye is the most widely used in the UK; however, adverse reactions have been reported with the blue dye previously. This case highlights that reactions may not always be immediately evident and to be vigilant in all patients that have undergone procedures using blue dye. If the patients are not responding appropriately particularly during an anaesthetic, one must always think of a possible adverse reaction to the dye. All surgical patients should give consent for adverse reactions to patent blue dye preoperatively. Alternative agents such as methylene blue are considered. PMID:23203181

  2. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

    PubMed Central

    Sofian, Masoomeh; Keshavarz, Sara

    2014-01-01

    Background. Antituberculosis multidrug regimens have been associated with increased incidence of adverse drug reactions (ADRs). This study aimed to determine the incidence and associated factors of ADRs due to antituberculosis therapy. Methods. This is a retrospective cross-sectional study on tuberculosis patients who were treated in tuberculosis clinics in Markazi province in Iran. The information contained in the medical files was extracted and entered into the questionnaire. Data was descriptively analyzed by using statistical package for social sciences (SPSS 18). Results. A total of 940 TB patients of 1240 patients' medical records available in 10 medical offices were included in this study. Of the 563 ADRs found in this study, 82.4% were considered minor reactions and 17.6% were major reactions. No death from antituberculosis ADR was observed. We found that the risk of major ADRs was higher in females (P??value = 0.0241), age >50?y (P??value = 0.0223), coinfection with HIV (P??value = 0.0323), smoking (P??value = 0.002), retreatment TB (P??value = 0.0203), and comorbidities (P??value = 0.0005). Conclusions. This study showed that severe side effects of anti-TB drugs are common in patients who have risk factors of ADRs and they should be followed up by close monitoring. PMID:25506427

  3. Metal-on-Metal Hip Arthroplasty: A Review of Adverse Reactions and Patient Management.

    PubMed

    Drummond, James; Tran, Phong; Fary, Camdon

    2015-01-01

    Recent alarming joint registry data highlighting increased revision rates has prompted further research into the area of metal-on-metal hip replacements and resurfacings. This review article examines the latest literature on the topic of adverse reactions to metal debris and summarises the most up-to-date guidelines on patient management. Adverse reactions to metal debris can cause significant damage to soft tissue and bone if not diagnosed early. Furthermore, not every patient with an adverse reaction to metal debris will be symptomatic. As such, clinicians must remain vigilant when assessing and investigating these patients in order to detect failing implants and initiate appropriate management. PMID:26132653

  4. Influence of HCV or HBV coinfection on adverse drug reactions to antiretroviral drugs in HIV patients

    Microsoft Academic Search

    Emmanuelle Guitton; Jean-Louis Montastruc; Maryse Lapeyre-Mestre

    2006-01-01

    Objective  To compare the profile of adverse drug reactions (ADRs) to antiretroviral (ARV) drugs in patients coinfected with hepatitis\\u000a C virus (HCV) or hepatitis B virus (HBV) versus non-coinfected patients with human immunodeficiency virus (HIV) infection.\\u000a \\u000a \\u000a \\u000a Methods  We used the French Pharmacovigilance Database from 2000 to 2002. Selected patients were classified into four groups: HIV+HCV,\\u000a HIV+HBV, HIV+HBV+HCV and HIV patients. We compared

  5. Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance.

    PubMed

    Noah, B A; Brushwood, D B

    2000-01-01

    In the last three years, the Food and Drug Administration has withdrawn seven prescription drugs from the market, and it has required intensified warnings for a number of others, all due to the discovery of previously unforeseen side effects associated with their use. Adverse drug reactions are a leading cause of death in the United States. For a variety of physiological and socio-medical reasons, the elderly are particularly susceptible to adverse drug reactions. Because the pre-approval process cannot expose all potential risks associated with a drug, the authors assert that policymakers should consider implementing a more extensive, and more integrated, post-approval surveillance and testing system. They conclude that the recent cluster of drug withdrawals due to safety problems raises legitimate questions about the rigor and effectiveness of the post-approval monitoring system for new drugs, and these questions extend beyond the obvious difficulties associated with the collection and analysis of risk data. Traditionally viewed as a regulatory problem for the FDA, the problem of adverse drug reactions implicates patient welfare and the provision of medical care more broadly, and a purely regulatory mind set unnecessarily constrains thinking about possible approaches to improving drug safety. Possible solutions to the problem ought to contemplate more formalized involvement of the medical community, pharmacists, and patients. This Article introduces a proposed systems approach to detecting and preventing adverse drug reactions, and discusses several other incremental reforms to existing systems that may help the medical community to improve the overall safety of prescription drug therapy for the elderly, and ultimately for all patients. PMID:11184355

  6. Changes in Risk of Immediate Adverse Reactions to Iodinated Contrast Media by Repeated Administrations in Patients with Hepatocellular Carcinoma

    PubMed Central

    Fujiwara, Naoto; Tateishi, Ryosuke; Akahane, Masaaki; Taguri, Masataka; Minami, Tatsuya; Mikami, Shintaro; Sato, Masaya; Uchino, Kouji; Enooku, Kenichiro; Kondo, Yuji; Asaoka, Yoshinari; Yamashiki, Noriyo; Goto, Tadashi; Shiina, Shuichiro; Yoshida, Haruhiko; Ohtomo, Kuni; Koike, Kazuhiko

    2013-01-01

    Background To elucidate whether repeated exposures to iodinated contrast media increase the risk of adverse reaction. Materials and Methods We retrospectively reviewed 1,861 patients with hepatocellular carcinoma who visited authors’ institution, a tertiary referral center, between 2004 and 2008. We analyzed cumulative probability of adverse reactions and risk factors. We categorized all symptoms into hypersensitivity reactions, physiologic reactions, and other reactions, according to the American College of Radiology guidelines, and evaluated each category as an event. We estimated the association between hazard for adverse reactions and the number of cumulative exposures to contrast media. We also evaluated subsequent contrast media injections and adverse reactions. Results There were 23,684 contrast media injections in 1,729 patients. One hundred and thirty-two patients were excluded because they were given no contrast media during the study period. Adverse reactions occurred in 196 (0.83%) patients. The cumulative incidence at 10th, 20th, and 30th examination was 7.9%, 15.2%, and 24.1%, respectively. Presence of renal impairment was found to be one of risk factors for adverse reactions. The estimated hazard of overall adverse reaction gradually decreased until around 10th exposure and rose with subsequent exposures. The estimated hazard of hypersensitivity showed V-shaped change with cumulative number of exposures. The estimated hazard of physiologic reaction had a tendency toward decreasing and that of other reaction had a tendency toward increasing. Second adverse reaction was more severe than the initial in only one among 130 patients receiving subsequent injections. Conclusion Repeated exposures to iodinated contrast media increase the risk of adverse reaction. PMID:24098420

  7. Allergic adverse reactions to sulfonamides

    Microsoft Academic Search

    Geneviève Choquet-Kastylevsky; Thierry Vial; Jacques Descotes

    2002-01-01

    Antimicrobial sulfonamides were the first antimicrobial agents used effectively to treat infectious diseases. However, because\\u000a they may cause severe adverse drug reactions (ADRs) and because more effective agents have since been developed, sulfonamides\\u000a now are used for only a few indications in specific groups, such as AIDS patients. Skin reactions, from benign rash to potentially\\u000a lethal toxidermias, are the most

  8. Haplotype-Based Analysis of Genes Associated With Risk of Adverse Skin Reactions After Radiotherapy in Breast Cancer Patients

    Microsoft Academic Search

    Tomo Suga; Atsuko Ishikawa; Masakazu Kohda; Yoshimi Otsuka; Shigeru Yamada; Naohito Yamamoto; Yuta Shibamoto; Yoshihiro Ogawa; Kuninori Nomura; Keizen Sho; Motoko Omura; Kenji Sekiguchi; Yuzo Kikuchi; Yuichi Michikawa; Shuhei Noda; Masashi Sagara; Jun Ohashi; Shinji Yoshinaga; Junetsu Mizoe; Hirohiko Tsujii; Mayumi Iwakawa; Takashi Imai

    2007-01-01

    Purpose: To identify haplotypes of single nucleotide polymorphism markers associated with the risk of early adverse skin reactions (EASRs) after radiotherapy in breast cancer patients. Methods and Materials: DNA was sampled from 399 Japanese breast cancer patients who qualified for breast-conserving radiotherapy. Using the National Cancer Institute-Common Toxicity Criteria scoring system, version 2, the patients were grouped according to EASRs,

  9. Adverse drug reactions of nonsteroidal anti-inflammatory drugs in orthopedic patients

    PubMed Central

    Gor, Alpa Pragnesh; Saksena, Miti

    2011-01-01

    Objectives: To identify the ADRs due to NSAIDs and to know how to monitor the drug’s effect. Materials and Methods: A descriptive study was undertaken in the Orthopedic Outpatients Department of a tertiary care teaching hospital. Hundred patients were enrolled in this study to observe the risk of adverse drug reactions (ADRs) due to NSAIDs. All the ADRs were further analyzed in relation to age and sex, type of drug and its pattern. Probability scale was used for the causality assessment of the ADRs. Results: 26% of the 100 patients developed ADR due to NSAIDs. There was not much of a difference in the number of the ADRs in relation to the gender. Diclofenac was the highest prescribed drug (65 patients), followed by paracetamol (12), nimesulide (10), ibuprofen (6), piroxicam (5) and Etoricoxib (2). Diclofenac accounted for the maximum number (73%) of ADRs, followed by nimesulide (16%), paracetamol (7%), and Etoricoxib (4%). Conclusion: Pharmacovigilance improves recognition of ADRs by the medical students. It allows the treating physician to identify the ADR associated with drugs, in particular, with the ones considered relatively safe and with those commonly prescribed by the medical and non-health professionals. PMID:21701643

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

    PubMed

    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

    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

  11. Adverse reactions to drug additives.

    PubMed

    Simon, R A

    1984-10-01

    There is a long list of additives used by the pharmaceutical industry. Most of the agents used have not been implicated in hypersensitivity reactions. Among those that have, only reactions to parabens and sulfites have been well established. Parabens have been shown to be responsible for rare immunoglobulin E-mediated reactions that occur after the use of local anesthetics. Sulfites, which are present in many drugs, including agents commonly used to treat asthma, have been shown to provoke severe asthmatic attacks in sensitive individuals. Recent studies indicate that additives do not play a significant role in "hyperactivity." The role of additives in urticaria is not well established and therefore the incidence of adverse reactions in this patient population is simply not known. In double-blind, placebo-controlled studies, reactions to tartrazine or additives other than sulfites, if they occur at all, are indeed quite rare for the asthmatic population, even for the aspirin-sensitive subpopulation. PMID:6491109

  12. ISMP Adverse Drug Reactions

    PubMed Central

    2013-01-01

    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

  13. Cutaneous Adverse Reactions of Amiodarone

    PubMed Central

    Jaworski, Krzysztof; Walecka, Irena; Rudnicka, Lidia; Gnatowski, Maciej; Kosior, Dariusz A.

    2014-01-01

    Dermatological complications of amiodarone are commonly encountered problems in therapy. The incidence in the population of patients with prolonged use of amiodarone reaches nearly 75% according to various sources. Nevertheless, they are often misdiagnosed or overlooked. The aim of this review is to present the current state of knowledge about skin changes induced by amiodarone, including phototoxic and photoallergic reactions, as well as hyperpigmentation. In most cases, the adverse effects are reversible and disappear after discontinuation of the drug. Although the dermatological complications usually do not influence the outcome of the therapy and rarely cause discontinuation of treatment, they have a great impact on patient quality of life. PMID:25413691

  14. Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital

    PubMed Central

    Jha, Anshu Kumar; Gadgade, Akash; Shenoy, Ashok K.; Chowta, Mukta N.; Ramapuram, John T.

    2015-01-01

    Context: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients. Aims: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Settings and Design: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale. Results: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were ‘probable’ and 33.96% were ‘possible’. Conclusions: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females. PMID:25657900

  15. Adverse reactions after smallpox vaccination.

    PubMed

    Feery, B J

    1977-08-01

    Nine hundred and thirty-eight reports of adverse reactions of smallpox vaccination in Australia between 1960 and 1976 have been analysed according to the type of reaction, and the age and sex of vaccinee. In an estimated 5,000,000 vaccinations, the reaction rate was 188/million, and the death rate 1-5/million. Generalized vaccinia was the most common reaction. The more serious reactions--eczema vaccinatum, progressive vaccinia, and neurological and cardiac complications--accounted for 7-4% of the reports. A small number of rarely reported non-specific inflammatory reactions is also included. There was a marked difference in the number of reactions reported in females and males (the female-male ratio was 1-6:1), and this difference increased with age. Paradoxically, of eight reports of cardiac complications, seven concerned males. The administration of vaccinial immune globulin was usually followed by a rapid resolution of the adverse reactions. PMID:20557

  16. Patient-Reported Adverse Drug Reactions and Drug-Drug Interactions: A Cross-Sectional Study on Malaysian HIV\\/AIDS Patients

    Microsoft Academic Search

    Syed S. Hasan; See C. Keong; Christopher L. K. Choong; Syed I. Ahmed; Ting W. Ching; Mudassir Anwar; Keivan Ahmadi; Muneer G. Babar

    2011-01-01

    Objective: This study aimed to explore the adverse drug reactions (ADRs) reported by patients and to identify drug-drug interactions (DDIs) among human immunodeficiency virus\\/acquired immunodeficiency syndrome (HIV\\/AIDS) patients. Subjects and Methods: This cross-sectional study was conducted at the Medication Therapy Adherence Clinic, Hospital Sungai Buloh, an HIV\\/AIDS referral centre. The patients were randomly selected and were encouraged to describe ADRs

  17. Clinical spectrum of adverse reactions to tartrazine.

    PubMed

    Collins-Williams, C

    1985-01-01

    Tartrazine, a common additive in foods and drugs, often causes adverse reactions such as recurrent urticaria, angioedema, and asthma and is frequently implicated in hyperkinesis. This paper summarizes the recent literature on the subject and outlines a practical approach for the practicing physician to diagnose and treat these patients in an optimal manner. PMID:3894321

  18. Drug therapy and adverse drug reactions to terbutaline in obstetric patients: a prospective cohort study in hospitalized women

    PubMed Central

    Hernández-Hernández, Dulce María; Vargas-Rivera, María Josefa E; Nava-Ocampo, Alejandro A; Palma-Aguirre, José Antonio; Sumano-López, Héctor

    2002-01-01

    Background Adverse drug reactions (ADR's) could be expected more frequently in pregnant women. This study was performed in order to identify ADR's to tocolytic drugs in hospitalised pregnant women. Methods A prospective cohort study was performed in two General Hospitals of the Instituto Mexicano del Seguro Social (IMSS) in Mexico City. Two hundred and seven women undergoing labor, premature labor, threatened abortion or suffering any obstetric related disease were included. Drug prescription and signs and symptoms of any potential ADR were registered daily during the hospital stay. Any potential ADR to tocolytic drugs was evaluated and classified by three of the authors using the Kramer's algorithm. Results Of the 207 patients, an ADR was positively classified in 25 cases (12.1%, CI95% 8.1 to 17.5%). All ADR's were classified as minor reactions. Grouping patients with diagnosis of threatened abortion, premature labor or under labor (n= 114), 24 ADR's were related to terbutaline, accounting for a rate of 21.1 ADR's per 100 obstetric patients. Obstetric patients suffering an ADR were older than obstetric patients without any ADR. However, the former received less drugs/day × patient-1 and had a shorter hospital stay (p < 0.05) whereas the dose of terbutaline was similar between the two groups. Terbutaline inhibited uterine motility in women with and without any ADR at a similar rate, 70 and 76% respectively (x2 = 0.07; p = 0.8). Conclusion Terbutaline, used as a tocolytic drug, was related to a high frequency of minor ADRs and to a high rate of effcicacy. PMID:11934352

  19. Adverse reactions to FMD vaccine.

    PubMed

    Yeruham, I; Yadin, H; Haymovich, M; Perl, S

    2001-08-01

    A case of adverse post-vaccination allergic reactions, which occurred in a dairy cattle herd 8 days after the annual foot-and-mouth disease (FMD) vaccination, is described. The dermatologic lesions observed in these cattle included: urticaria, exudative and necrotic dermatitis, along with oedema and vesicles on the teats. These reactions occurred in 11.3% of the heifers, in 10% of the first-lactating cows and in 14.6% of the adult cows. The average loss of milk production for an affected cow on this farm was 21.5% per day, for seven consecutive days. The extent of the lesions was apparently related to concurrent diseases such as bovine virus diarrhea - mucosal disease complex (BVD-MD) and Johne's disease and, to a lesser degree, correlated with the age or breed. PMID:11493403

  20. Smallpox vaccine: contraindications, administration, and adverse reactions.

    PubMed

    Maurer, Douglas M; Harrington, Brian; Lane, J Michael

    2003-09-01

    Since the terrorist attacks of September 11, 2001, and the anthrax exposures in the following weeks, concern that smallpox could be used as a biologic weapon has increased. Public health departments and the U.S. military have begun the process of vaccinating soldiers and civilian first-responders. Smallpox vaccination carries some serious risks: approximately one in 1 million primary vaccinees and one in 4 million revaccinees will die from adverse vaccine reactions. The most serious side effects of smallpox vaccine include progressive vaccinia, postvaccinial central nervous system disease, and eczema vaccinatum. Some of these reactions can be treated with vaccinia immune globulin or cidofovir. Proper patient screening and site care are essential. Family physicians must learn to screen potential vaccinees for contraindications (e.g., immunodeficiency, immunosuppression, certain skin and eye diseases, pregnancy, lactation, allergy to the vaccine or its components, moderate or severe intercurrent illness) and to treat vaccine-associated adverse reactions. PMID:13678138

  1. Adverse reactions related to drugs for headache treatment: clinical impact

    Microsoft Academic Search

    Anna Ferrari; Alessandra Ottani; Alfio Bertolini; Arrigo Francesco Giuseppe Cicero; Ciro Pio Rosario Coccia; Sheila Leone; Emilio Sternieri

    2005-01-01

    Objective To assess the clinical impact of adverse reactions related to drugs for primary headache treatment. Methods We examined the adverse reactions to 360 medications prescribed by the specialists of the Headache Centre of the University of Modena and Reggio Emilia to 256 consecutive outpatients (214 female, 42 male; mean age: 38.88±14.06 years; range 10–72 years). Adverse reactions were reported by patients

  2. Severe cutaneous adverse drug reactions

    PubMed Central

    Verma, Rajesh; Vasudevan, Biju; Pragasam, Vijendran

    2013-01-01

    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

  3. Managing nonteratogenic adverse reactions to isotretinoin treatment for acne vulgaris.

    PubMed

    Reilly, Bridget K; Ritsema, Tamara S

    2015-07-01

    Isotretinoin is the strongest, most effective oral treatment for patients with severe acne vulgaris, with remission rates of 89% and higher. Because of its potency, isotretinoin causes many adverse reactions. This article reviews common and severe adverse reactions to isotretinoin and how providers can best manage these reactions. Because of inconclusive research on the correlation between isotretinoin and depression and irritable bowel syndrome, providers should ask patients about symptoms monthly. Prescribing micronized isotretinoin and starting at the lowest dose with gradual upward titration also can help reduce the incidence of adverse reactions. PMID:26107793

  4. Adverse Reactions of Ferric Carboxymaltose

    PubMed Central

    Patil, Navin; Shenoy, Smita; Bairy, K L; Sarma, Yashdeep

    2014-01-01

    The author reports a 55-year-old female diagnosed of chronic kidney disease grade-5 with associated co-morbidities like type 2 diabetes mellitus, diabetic retinopathy and hypothyroidism was admitted for arteriovenous fistula construction. She was started on ferric carboxymaltose for the treatment of anaemia. She was given a test dose before administering the drug intravenously and she did not develop any reaction. The drug ferric carboxymaltose was then administered over a period of one hour. About half an hour after drug administration, the patient developed breathlessness and myalgia. After half hour of the above episode of breathlessness and myalgia she also developed vomiting (one episode). Patient was managed with oxygen therapy, IV fluids and other drugs like corticosteroids, phenaramine maleate and nalbuphine which controlled the above symptoms. PMID:25478369

  5. Suspected adverse reactions to medicines during 1989

    Microsoft Academic Search

    A Gray; C Evans; A Kidd

    1990-01-01

    There was an increase in reports of suspected adverse reactions to veterinary medicines in 1989 with 329 reports (compared with 206 in 1988), from veterinary surgeons, farmers and the public, comments the Veterinary Medicines Directorate (VMD). Suspected adverse reactions to clostridial\\/pasteurella vaccines in sheep were a dominant feature and important experience was gained both in terms of liaison with the

  6. A comparative study of sertraline dosages, plasma concentrations, efficacy and adverse reactions in Chinese versus Caucasian patients.

    PubMed

    Hong Ng, Chee; Norman, Trevor R; Naing, Khin Ohnmar; Schweitzer, Isaac; Kong Wai Ho, Brian; Fan, Agnes; Klimidis, Steven

    2006-03-01

    This prospective 6-week study examined the differences in dosage and steady state plasma concentrations of sertraline in Chinese versus Caucasian depressed patients. Two groups of Chinese patients from different geographical sites and a group of Caucasian patients were evaluated with clinical measures during an initial dose of 50 mg/day, with subsequent doses adjusted clinically. The results of 17 Australian Chinese (ACHI), 13 Malaysian Chinese (MCHI) and 15 Australian Caucasians (AC) were analysed. Despite controlling for weight, the AC subjects received a significantly higher dose than both the ACHI (P = 0.002) and the MCHI groups (P = 0.012). However, the mean sertraline concentration to dose ratios at weeks 1 and 6 were not significantly different between the three groups. Sertraline was effective and well tolerated in both ethnic groups with few adverse events. Although there was a lack of difference between groups in the pharmacokinetic results, Chinese depressed patients appeared to require lower dosages with consequently lower plasma concentrations of sertraline compared to Caucasian patients to achieve clinical efficacy. Further studies of the dosages, kinetics and adverse effects of selective serotonin reuptake inhibitors linked with genotyping are necessary. PMID:16421459

  7. Adverse Reactions to Food: Allergies and Intolerances

    Microsoft Academic Search

    Massimo Montalto; Luca Santoro; Ferruccio D’Onofrio; Valentina Curigliano; Antonella Gallo; Dina Visca; Giovanni Cammarota; Antonio Gasbarrini; Giovanni Gasbarrini

    2008-01-01

    All the anomalous reactions secondary to food ingestion are defined as ‘adverse reactions to food’. In 1995 the European Academy of Allergology and Clinical Immunology suggested a classification on the basis of the responsible pathogenetic mechanism; according to this classification, non-toxic reactions can be divided into ‘food allergies’ when they recognize immunological mechanisms, and ‘food intolerances’ when there are no

  8. Mining Adverse Drug Reactions from online healthcare forums using Hidden Markov Model

    E-print Network

    Sampathkumar, Hariprasad; Chen, Xue-wen; Luo, Bo

    2014-10-23

    Background Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. ...

  9. Ranking Adverse Drug Reactions With Crowdsourcing

    PubMed Central

    Gottlieb, Assaf; Hoehndorf, Robert; Dumontier, Michel

    2015-01-01

    Background There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. Objective The intent of the study was to rank ADRs according to severity. Methods We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. Results There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. Conclusions ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making. PMID:25800813

  10. Adverse drug reactions in United States hospitals.

    PubMed

    Bond, C A; Raehl, Cynthia L

    2006-05-01

    Adverse drug reactions (ADRs) were examined in 8,208,960 hospitalized Medicare patients in 1998. A database was constructed from the 1998 MedPAR database. The study population was composed of 141,398 Medicare patients who experienced an ADR (rate of 1.73%). The most common drug classes associated with ADRs were cardiotonic glycosides, adrenal corticosteroids, antineoplastic agents, anticoagulants, and analgesics. The most common associated diagnoses were hypertension, congestive heart failure, atrial fibrillation, volume depletion disorders, and atherosclerotic heart disease. In patients who experienced an ADR, death rates were 19.18% higher with 1971 excess deaths (odds ratio 1.208, 95% confidence interval 1.184-1.234), and length of hospital stay was 8.25% higher with 77,769 excess patient-days (Mann-Whitney U test [U]=200078720610, p<0.0001). Charges for patients with an ADR were increased as follows: total Medicare 19.86% (339,496,598 US dollars, U=200,089,611,739, p<0.0001), drugs 9.15% (24,744,650 US dollars, U=208,719,928,502, p<0.0001), and laboratory charges 2.82% (6,221,512 US dollars, U=195,143,498,450, p<0.0001). We developed a list of high-risk diagnoses and drug classes to help pharmacists target patients who are more likely to experience ADRs. This is the first study to evaluate the ADRs in a large population of hospitalized Medicare patients. These findings will enable pharmacists to develop better management programs for ADRs. PMID:16637789

  11. Pilot study to assess subjective and objective reporting of potential adverse drug reactions in older versus younger HIV-infected patients using antiretroviral therapy.

    PubMed

    Hirsch, Amy A; Compan, Anita; Lawrence, Renée H; Briggs, Janet M; Yadavalli, Gopala K; Fuller, Matthew A

    2012-01-01

    Limited data exist on tolerability of antiretroviral therapy (ART) in older HIV-infected patients compared to their younger counterparts. There is also concern for overlap of ART toxicities with concomitant conditions potentially leading to an increased burden of ART-related adverse drug reactions (ADRs). A prospective, descriptive-comparative study was conducted to compare incidence and severity of ADRs secondary to ART in older (? 50 years) versus younger (<50 years) HIV-infected patients. No differences were found in the presence or severity of subjective or objective ADRs between groups. The burden of intolerance appeared to be high for certain ADRs in both age groups. Regardless of age, subjects with certain concomitant illnesses had higher rates of potential ADRs. Providers need to be aware of patient characteristics that lead to increased rates of ART intolerance; for patients with an increased comorbidity burden, providers need to be attentive to the potential impact on ART tolerability. PMID:22137548

  12. Adverse Drug Reactions Causing Admission to a Paediatric Hospital

    PubMed Central

    Gallagher, Ruairi M.; Mason, Jennifer R.; Bird, Kim A.; Kirkham, Jamie J.; Peak, Matthew; Williamson, Paula R.; Nunn, Anthony J.; Turner, Mark A.; Pirmohamed, Munir; Smyth, Rosalind L.

    2012-01-01

    Objective(s) To obtain reliable information about the incidence of adverse drug reactions, and identify potential areas where intervention may reduce the burden of ill-health. Design Prospective observational study. Setting A large tertiary children’s hospital providing general and specialty care in the UK. Participants All acute paediatric admissions over a one year period. Main Exposure Any medication taken in the two weeks prior to admission. Outcome Measures Occurrence of adverse drug reaction. Results 240/8345 admissions in 178/6821 patients admitted acutely to a paediatric hospital were thought to be related to an adverse drug reaction, giving an estimated incidence of 2.9% (95% CI 2.5, 3.3), with the reaction directly causing, or contributing to the cause, of admission in 97.1% of cases. No deaths were attributable to an adverse drug reaction. 22.1% (95% CI 17%, 28%) of the reactions were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44/249 (17.7%) of adverse drug reactions, the remainder originating from hospital. 120/249 (48.2%) reactions resulted from treatment for malignancies. The drugs most commonly implicated in causing admissions were cytotoxic agents, corticosteroids, non-steroidal anti-inflammatory drugs, vaccines and immunosuppressants. The most common reactions were neutropenia, immunosuppression and thrombocytopenia. Conclusions Adverse drug reactions in children are an important public health problem. Most of those serious enough to require hospital admission are due to hospital-based prescribing, of which just over a fifth may be avoidable. Strategies to reduce the burden of ill-health from adverse drug reactions causing admission are needed. PMID:23226510

  13. Pharmacogenetics of Idiosyncratic Adverse Drug Reactions

    Microsoft Academic Search

    Munir Pirmohamed

    Idiosyncratic adverse drug reactions are unpredictable and thought to have an underlying genetic etiology. With the completion\\u000a of the human genome and HapMap projects, together with the rapid advances in genotyping technologies, we have unprecedented\\u000a capabilities in identifying genetic predisposing factors for these relatively rare, but serious, reactions. The main roadblock\\u000a to this is the lack of sufficient numbers of

  14. Adverse drug reaction, patent blue V dye and anaesthesia

    PubMed Central

    Tripathy, Swagata; Nair, Priya V

    2012-01-01

    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

  15. Detecting Adverse Drug Reactions in the General

    E-print Network

    Aickelin, Uwe

    adverse drug reaction predictor (SAP) framework, is presented that learns from known side effects considerations are used to derive suitable attributes as in- puts into a learning algorithm. Both supervised effects. The results showed that the SAP framework im- plementing a random forest classifier outperformed

  16. Pharmacogenomics and adverse drug reactions in children

    PubMed Central

    Rieder, Michael J.; Carleton, Bruce

    2014-01-01

    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

  17. Adverse Skin Reactions to Anti-TNF-Alpha Monoclonal Antibody Therapy

    Microsoft Academic Search

    S. A. Devos; N. Van Den Bossche; M. De Vos; J. M. Naeyaert

    2003-01-01

    Various adverse cutaneous reactions to anti-TNF-? monoclonal antibody have been reported. In clinical studies with infliximab (Remicade®) adverse drug reactions were most frequently reported in the respiratory system and in the skin and appendages. We describe here 6 patients receiving anti- TNF-? therapy (infliximab) for Crohn’s disease or rheumatoid arthritis who consulted our out-patient department for adverse cutaneous reactions between

  18. Severe Cutaneous Adverse Drug Reactions: A Clinicoepidemiological Study

    PubMed Central

    Sasidharanpillai, Sarita; Riyaz, Najeeba; Khader, Anza; Rajan, Uma; Binitha, Manikoth P; Sureshan, Deepthi N

    2015-01-01

    Background: Drug eruptions range from transient erythema to the life threatening severe cutaneous adverse reactions (SCAR) that encompass Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms complex (DRESS). Aims and Objectives: To study the clinical and epidemiological aspects of cutaneous adverse drug reactions (CADR). Materials and Methods: Ethical clearance was obtained from the institutional ethics committee. All patients admitted in the Dermatology ward of our tertiary care hospital with CADR (those who fit in the category of probable or possible drug reaction as per WHO casuality assessment) from first September 2011 to 31st August 2012 were included in this cross sectional study after obtaining written informed consent. The drug reaction patterns observed in the study population were determined and the common offending drugs were identified. Results: In the study, population of males outnumbered females and the majority were between 46 and 60 years of age. The commonest reaction pattern observed was SJS- TEN spectrum of illness and aromatic anticonvulsants were the common offending drugs. Prompt withdrawal of the culprit drug and administration of systemic steroids with or without I/V Ig reverted the adverse reaction in all except one. Conclusion: Severe drug reactions predominated as the study population was comprised of inpatients of a tertiary referral centre. Though; previous authors had reported a mortality rate of up to 20% in DRESS, all our patients with this reaction pattern, responded well to treatment. The mortality rate among TEN cases was much lower than the previous reports. Early diagnosis, prompt withdrawal of the suspected drug, careful monitoring for development of complications and immediate intervention can improve the prognosis of CADR. PMID:25657416

  19. Computerized surveillance of adverse drug reactions in hospital: Implementation

    Microsoft Academic Search

    M. Levy; T. Azaz-Livshits; B. Sadan; M. Shalit; G. Geisslinger; K. Brune

    1999-01-01

    Objective: To implement and measure the effects of automatic computerized laboratory signals (ALS) as a detection support tool of adverse\\u000a drug reactions (ADRs) in hospital.\\u000a \\u000a \\u000a \\u000a Methods: This was a prospective observational study of a total of 192 patients (199 sequential medical admissions) during a 2-month\\u000a period in a 34-bed medical ward at the Hadassah University Hospital, Jerusalem, Israel. The study

  20. [Adverse ocular drug reactions of systemic antimicrobial agents].

    PubMed

    Huber, M; Stahlmann, R

    2012-01-01

    Antimicrobial therapy can cause adverse ocular drug reactions. They are most often noticed by changes of the eyes' anterior segments or by pain and visual disturbances. It is important that physicians but also patients are watchful for the symptoms and know about their potential dangerous consequences because the chance for reversibility may depend on their early detection. During therapy with voriconazol about one third of patients complain of visual disturbances soon after the first doses but symptoms generally resolve after a short period of time without sequelae. Telithromycin may impair accommodation due to its anticholinergic activity. Neuropathies of the optic nerve may be caused by ethambutol, isoniazid, streptomycin, and linezolid. The first symptoms, such as disturbances in colour vision, typically occur with a latency of several weeks after start of therapy. This adverse effect may result in serious long term impairment of visual function. Toxic effects on the mitochondria in retinal ganglion cells are discussed as underlying mechanisms. Rifabutin and cidofovir may cause intraocular inflammatory reactions. In addition cidofovir may induce a pronounced reduction of the ocular pressure. Adverse drug reactions are often dose dependent and therefore influenced by impaired kidney or liver function, pharmacogenetics, or by drug-drug interactions. Potential serious drug induced ocular side effects require close cooperation with an ophthalmologist for evaluation of the individual risk benefit ratio, if possible, even before beginning of antimicrobial therapy. PMID:22241448

  1. Smallpox vaccination and adverse reactions. Guidance for clinicians.

    PubMed

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

    2003-02-21

    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

  2. Association between Thiopurine S-methyltransferase Polymorphisms and Thiopurine-Induced Adverse Drug Reactions in Patients with Inflammatory Bowel Disease: A Meta-Analysis

    PubMed Central

    Liu, Yue-Ping; Wu, Hai-Yan; Yang, Xiang; Xu, Han-Qing; Li, Yong-Chuan; Shi, Da-Chuan; Huang, Jun-Fu; Huang, Qing; Fu, Wei-Ling

    2015-01-01

    Purpose Thiopurine drugs are well established treatments in the management of inflammatory bowel disease (IBD), but their use is limited by significant adverse drug reactions (ADRs). Thiopurine S-methyltransferase (TPMT) is an important enzyme involved in thiopurine metabolism. Several clinical guidelines recommend determining TPMT genotype or phenotype before initiating thiopurine therapy. Although several studies have investigated the association between TPMT polymorphisms and thiopurine-induced ADRs, the results are inconsistent. The purpose of this study is to evaluate whether there is an association between TPMT polymorphisms and thiopurine-induced ADRs using meta-analysis. Methods We explored PubMed, Web of Science and Embase for articles on TPMT polymorphisms and thiopurine-induced ADRs. Studies that compared TPMT polymorphisms with-ADRs and without-ADRs in IBD patients were included. Relevant outcome data from all the included articles were extracted and the pooled odds ratio (OR) with corresponding 95% confidence intervals were calculated using Revman 5.3 software. Results Fourteen published studies, with a total of 2,206 IBD patients, which investigated associations between TPMT polymorphisms and thiopurine-induced ADRs were included this meta-analysis. Our meta-analysis demonstrated that TPMT polymorphisms were significantly associated with thiopurine-induced overall ADRs and bone marrow toxicity; pooled ORs were 3.36 (95%CI: 1.82–6.19) and 6.67 (95%CI: 3.88–11.47), respectively. TPMT polymorphisms were not associated with the development of other ADRs including hepatotoxicity, pancreatitis, gastric intolerance, flu-like symptoms and skin reactions; the corresponding pooled ORs were 1.27 (95%CI: 0.60–2.71), 0.97 (95%CI: 0.38–2.48), 1.82 (95%CI: 0.93–3.53), 1.28 (95%CI: 0.47–3.46) and 2.32 (95%CI: 0.86–6.25), respectively. Conclusions Our meta-analysis demonstrated an association of TPMT polymorphisms with overall thiopurine-induced ADRs and bone marrow toxicity, but not with hepatotoxicity, pancreatitis, flu-like symptoms, gastric intolerance and skin reactions. These findings suggest that pretesting the TPMT genotype could be helpful in clinical practice before initiating thiopurine therapy. However, white blood cell count analysis should be the mainstay for follow-up. PMID:25799415

  3. Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

    PubMed Central

    Alshammari, Thamir M.; Al-Kathiri, Wa’ad H.; Louet, Hervé Le; Aljadhey, Hisham S.

    2015-01-01

    Objectives: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. Methods: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. Result: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient’s demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). Conclusion: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports. PMID:26108586

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

    PubMed Central

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

    2013-01-01

    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

  5. Pharmacogenetic markers of severe cutaneous adverse drug reactions.

    PubMed

    Borroni, R G

    2014-04-01

    Different responses, in terms both of efficacy and toxicity, are commonly observed for any drug administered to apparently homogeneous groups of patients. It is estimated that adverse drug reactions (ADRs) cause 3-6% of all hospitalizations, accounting for 5% to 9% of hospital admission costs. The skin is often involved in ADRs and although most cutaneous ADRs have a favorable course, they may present as severe adverse cutaneous drug reactions (SCARs), such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (also referred to as drug-induced hypersensitivity syndrome), and acute generalized exanthematous pustulosis. SCARs are associated with significant mortality and require prompt diagnosis and adequate treatment. Pharmacogenetics studies individual variants in the DNA sequence associated with drug efficacy and toxicity, allowing prescription of a drug to patients expected to benefit from it, and excluding from treatment those who are at risk of developing ADRs. Pharmacogenetics already achieved several important results in the prevention of SCARs, and pharmacogenetic testing is now recommended by regulatory agencies before administration of abacavir and carbamazepine, leading to reduced incidence of SCARs. In this review, the pharmacogenetic associations of SCARs that have been validated in independent, case-control association studies will be presented. By familiarizing with principles of pharmacogenetics, dermatologists should be able to correlate specific cutaneous ADR phenotypes to the underlying genotype, thus contributing to better drug safety and facilitating drug discovery, development and approval. PMID:24819643

  6. Evaluation of adverse reactions to contrast media in the hospital

    PubMed Central

    Ryu, J-H; Kim, E-Y

    2013-01-01

    Objective: To determine and analyse the characteristics of contrast media adverse reactions (CM-ARs) reported in a hospital. Methods: A retrospective review of CM-ARs from the electronic spontaneous adverse drug reaction (ADR) report system between January 2011 and August 2012 was conducted. CM-ARs were evaluated in terms of causality, severity, preventability and affected organs. Also, agreement and correlation among the tools used to evaluate CM-ARs were analysed. Results: The overall reaction rate was 1.5% (n?=?286). In total, 269 CM-ARs were identified. For ADR causality, 96.7% (n?=?260) and 98.5% (n?=?265) were evaluated as “probable” ADR using the Naranjo probability scale and the World Health Organization–Uppsala Monitoring Centre causality categories, whereas 98.1% (n?=?264) were evaluated as “certain” with Korean algorithm v. II. Of these, 91.4% (n?=?246) were mild in severity and 96.7% (n?=?260) were unpreventable. Most patients (n?=?233, 86.7%) could be managed with observation and/or simple treatment. The most frequent reaction (n?=?383, 79.5%) was dermatological. Spearman's correlation coefficient was 0.667 (p?patients undergoing CT procedures continues to increase, it is essential to identify and observe patients at risk for CM-ARs to prevent severe ADRs. Advances in knowledge: Continuous careful review of reporting and treatment protocols of CM-ARs is needed to prevent morbidity and mortality. PMID:24191123

  7. Factors affecting the development of adverse drug reactions (Review article)

    PubMed Central

    Alomar, Muaed Jamal

    2013-01-01

    Objectives To discuss the effect of certain factors on the occurrence of Adverse Drug Reactions (ADRs). Data Sources A systematic review of the literature in the period between 1991 and 2012 was made based on PubMed, the Cochrane database of systematic reviews, EMBASE and IDIS. Key words used were: medication error, adverse drug reaction, iatrogenic disease factors, ambulatory care, primary health care, side effects and treatment hazards. Summary Many factors play a crucial role in the occurrence of ADRs, some of these are patient related, drug related or socially related factors. Age for instance has a very critical impact on the occurrence of ADRs, both very young and very old patients are more vulnerable to these reactions than other age groups. Alcohol intake also has a crucial impact on ADRs. Other factors are gender, race, pregnancy, breast feeding, kidney problems, liver function, drug dose and frequency and many other factors. The effect of these factors on ADRs is well documented in the medical literature. Taking these factors into consideration during medical evaluation enables medical practitioners to choose the best drug regimen. Conclusion Many factors affect the occurrence of ADRs. Some of these factors can be changed like smoking or alcohol intake others cannot be changed like age, presence of other diseases or genetic factors. Understanding the different effects of these factors on ADRs enables healthcare professionals to choose the most appropriate medication for that particular patient. It also helps the healthcare professionals to give the best advice to patients. Pharmacogenomics is the most recent science which emphasizes the genetic predisposition of ADRs. This innovative science provides a new perspective in dealing with the decision making process of drug selection. PMID:24648818

  8. Adverse events in surgical patients in Australia

    Microsoft Academic Search

    A. K. KABLE; R. W. GIBBERD; A. D. SPIGELMAN

    2002-01-01

    Objective. To determine the adverse event (AE) rate for surgical patients in Australia. Design. A two-stage retrospective medical record review was conducted to determine the occurrence of AEs in hospital admissions. Medical records were screened for 18 criteria and positive records were reviewed by two medical officers using a structured questionnaire. Setting. Admissions in 1992 to 28 randomly selected hospitals

  9. Role of Adverse Reactions to Food in Urticaria and Exercise-Induced Anaphylaxis

    Microsoft Academic Search

    Sie-Uen Chong; Margitta Worm; Torsten Zuberbier

    2002-01-01

    In urticaria, adverse reactions to food are only a frequent finding in the subset of patients with chronic continuous urticaria. Mostly these reactions are of pseudoallergic nature, directed against artificial additives as well as naturally occurring aromatic components. IgE-mediated allergic reactions are a rare cause in acute urticaria as well as in recurrent chronic urticaria. In other types of urticaria,

  10. Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment

    PubMed Central

    Rende, Pierandrea; Paletta, Laura; Gallelli, Giuseppe; Raffaele, Gianluca; Natale, Vincenzo; Brissa, Nazareno; Costa, Cinzia; Gratteri, Santo; Giofrè, Chiara; Gallelli, Luca

    2013-01-01

    The use of cardiovascular drugs is related to the development of adverse drug reactions (ADRs) in about 24% of the patients in the Cardiovascular Care Unit. Here, we evaluated the ADRs in patients treated with antihypertensive drugs. The study was conducted in two phases: In the first phase, we performed a retrospective study on clinical records of Clinical Divisions (i.e., Internal Medicine Operative Unit and Geriatric Operative Unit) from January 1, 2012 to December 31, 2012. Moreover from January 1, 2013 to March 30, 2013 we performed a prospective study on the outpatients attending the Emergency Department (ED) of the Pugliese-Ciaccio Hospital of Catanzaro, by conducting patient interviews after their informed consent was obtained. The association between a drug and ADR was evaluated using the Naranjo scale. We recorded 72 ADRs in the Clinical Divisions and six in the ED, and these were more frequent in women. Using the Naranjo score, we showed a probable association in 92% of these reactions and a possible association in 8%. The most vulnerable age group involved in ADRs was that of the elderly patients. In conclusion, our results indicate that antihypertensive drugs may be able to induce the development of ADRs, particularly in elderly women receiving multiple drug treatment. Therefore, it is important to motivate the healthcare providers to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, as also all the essential activities for optimizing patient safety. PMID:24347982

  11. Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment.

    PubMed

    Rende, Pierandrea; Paletta, Laura; Gallelli, Giuseppe; Raffaele, Gianluca; Natale, Vincenzo; Brissa, Nazareno; Costa, Cinzia; Gratteri, Santo; Giofrè, Chiara; Gallelli, Luca

    2013-12-01

    The use of cardiovascular drugs is related to the development of adverse drug reactions (ADRs) in about 24% of the patients in the Cardiovascular Care Unit. Here, we evaluated the ADRs in patients treated with antihypertensive drugs. The study was conducted in two phases: In the first phase, we performed a retrospective study on clinical records of Clinical Divisions (i.e., Internal Medicine Operative Unit and Geriatric Operative Unit) from January 1, 2012 to December 31, 2012. Moreover from January 1, 2013 to March 30, 2013 we performed a prospective study on the outpatients attending the Emergency Department (ED) of the Pugliese-Ciaccio Hospital of Catanzaro, by conducting patient interviews after their informed consent was obtained. The association between a drug and ADR was evaluated using the Naranjo scale. We recorded 72 ADRs in the Clinical Divisions and six in the ED, and these were more frequent in women. Using the Naranjo score, we showed a probable association in 92% of these reactions and a possible association in 8%. The most vulnerable age group involved in ADRs was that of the elderly patients. In conclusion, our results indicate that antihypertensive drugs may be able to induce the development of ADRs, particularly in elderly women receiving multiple drug treatment. Therefore, it is important to motivate the healthcare providers to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, as also all the essential activities for optimizing patient safety. PMID:24347982

  12. Adverse reaction to metal debris after Birmingham hip resurfacing arthroplasty.

    PubMed

    Junnila, Mika; Seppänen, Matti; Mokka, Jari; Virolainen, Petri; Pölönen, Tuukka; Vahlberg, Tero; Mattila, Kimmo; Tuominen, Esa K J; Rantakokko, Juho; Äärimaa, Ville; Itälä, Ari; Mäkelä, Keijo T

    2015-06-01

    Background and purpose - Concern has emerged about local soft-tissue reactions after hip resurfacing arthroplasty (HRA). The Birmingham Hip Resurfacing (BHR) was the most commonly used HRA device at our institution. We assessed the prevalence and risk factors for adverse reaction to metal debris (ARMD) with this device. Patients and methods - From 2003 to 2011, BHR was the most commonly used HRA device at our institution, with 249 implantations. We included 32 patients (24 of them men) who were operated with a BHR HRA during the period April 2004 to March 2007 (42 hips; 31 in men). The mean age of the patients was 59 (26-77) years. These patients underwent magnetic resonance imaging (MRI), serum metal ion measurements, the Oxford hip score questionnaire, and physical examination. The prevalence of ARMD was recorded, and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.7 (2.4-8.8) years. Results - 6 patients had a definite ARMD (involving 9 of the 42 hips). 8 other patients (8 hips) had a probable ARMD. Thus, there was definite or probable ARMD in 17 of the 42 hips. 4 of 42 hips were revised for ARMD. Gender, bilateral metal-on-metal hip replacement and head size were not factors associated with ARMD. Interpretation - We found that HRA with the Birmingham Hip Resurfacing may be more dangerous than previously believed. We advise systematic follow-up of these patients using metal ion levels, MRI/ultrasound, and patient-reported outcome measures. PMID:25582189

  13. Adverse reaction to metal debris after Birmingham hip resurfacing arthroplasty

    PubMed Central

    Junnila, Mika; Seppänen, Matti; Mokka, Jari; Virolainen, Petri; Pölönen, Tuukka; Vahlberg, Tero; Mattila, Kimmo; Tuominen, Esa K J; Rantakokko, Juho; Äärimaa, Ville; Itälä, Ari; Mäkelä, Keijo T

    2015-01-01

    Background and purpose Concern has emerged about local soft-tissue reactions after hip resurfacing arthroplasty (HRA). The Birmingham Hip Resurfacing (BHR) was the most commonly used HRA device at our institution. We assessed the prevalence and risk factors for adverse reaction to metal debris (ARMD) with this device. Patients and methods From 2003 to 2011, BHR was the most commonly used HRA device at our institution, with 249 implantations. We included 32 patients (24 of them men) who were operated with a BHR HRA during the period April 2004 to March 2007 (42 hips; 31 in men). The mean age of the patients was 59 (26–77) years. These patients underwent magnetic resonance imaging (MRI), serum metal ion measurements, the Oxford hip score questionnaire, and physical examination. The prevalence of ARMD was recorded, and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.7 (2.4–8.8) years. Results 6 patients had a definite ARMD (involving 9 of the 42 hips). 8 other patients (8 hips) had a probable ARMD. Thus, there was definite or probable ARMD in 17 of the 42 hips. 4 of 42 hips were revised for ARMD. Gender, bilateral metal-on-metal hip replacement and head size were not factors associated with ARMD. Interpretation We found that HRA with the Birmingham Hip Resurfacing may be more dangerous than previously believed. We advise systematic follow-up of these patients using metal ion levels, MRI/ultrasound, and patient-reported outcome measures. PMID:25582189

  14. Clinical association between pharmacogenomics and adverse drug reactions.

    PubMed

    Zhou, Zhi-Wei; Chen, Xiao-Wu; Sneed, Kevin B; Yang, Yin-Xue; Zhang, Xueji; He, Zhi-Xu; Chow, Kevin; Yang, Tianxin; Duan, Wei; Zhou, Shu-Feng

    2015-04-01

    Adverse drug reactions (ADRs) are a major public health concern and cause significant patient morbidity and mortality. Pharmacogenomics is the study of how genetic polymorphisms affect an individual's response to pharmacotherapy at the level of a whole genome. This article updates our knowledge on how genetic polymorphisms of important genes alter the risk of ADR occurrence after an extensive literature search. To date, at least 244 pharmacogenes identified have been associated with ADRs of 176 clinically used drugs based on PharmGKB. At least 28 genes associated with the risk of ADRs have been listed by the Food and Drug Administration as pharmacogenomic biomarkers. With the availability of affordable and reliable testing tools, pharmacogenomics looks promising to predict, reduce, and minimize ADRs in selected populations. PMID:25895462

  15. Severe Adverse Immunologic Reaction in a Patient with Glioblastoma Receiving Autologous Dendritic Cell Vaccines Combined with GM-CSF and Dose-Intensified Temozolomide.

    PubMed

    Mitchell, Duane A; Sayour, Elias J; Reap, Elizabeth; Schmittling, Robert; DeLeon, Gabriel; Norberg, Pamela; Desjardins, Annick; Friedman, Allan H; Friedman, Henry S; Archer, Gary; Sampson, John H

    2015-04-01

    Therapeutic vaccination of patients with cancer-targeting tumor-associated antigens is a promising strategy for the specific eradication of invasive malignancies with minimal toxicity to normal tissues. However, as increasingly potent modalities for stimulating immunologic responses are developed for clinical evaluation, the risk of inflammatory and autoimmune toxicities also may be exacerbated. In this report, we describe the induction of a severe (grade 3) immunologic reaction in a patient with newly diagnosed glioblastoma (GBM) receiving autologous RNA-pulsed dendritic cell (DC) vaccines admixed with GM-CSF and administered coordinately with cycles of dose-intensified temozolomide. Shortly after the eighth administration of the admixed intradermal vaccine, the patient experienced dizziness, flushing, conjunctivitis, headache, and the outbreak of a disseminated macular/papular rash and bilateral indurated injection sites. Immunologic workup of patient reactivity revealed sensitization to the GM-CSF component of the vaccine and the production of high levels of anti-GM-CSF autoantibodies during vaccination. Removal of GM-CSF from the DC vaccine allowed continued vaccination without incident. Despite the known lymphodepletive and immunosuppressive effects of temozolomide, these observations demonstrate the capacity for the generation of severe immunologic reactivity in patients with GBM receiving DC-based therapy during adjuvant dose-intensified temozolomide. Cancer Immunol Res; 3(4); 320-5. ©2014 AACR. PMID:25387895

  16. A case of two adverse reactions

    Microsoft Academic Search

    L-A Smith; M Harkness

    2004-01-01

    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

  17. Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.

    PubMed

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

    2006-02-01

    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

  18. Surveillance for fatal suspected adverse drug reactions in the UK

    Microsoft Academic Search

    A Clarkson; I Choonara

    2002-01-01

    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

  19. Vertigo/dizziness as a Drugs’ adverse reaction

    PubMed Central

    Chimirri, Serafina; Aiello, Rossana; Mazzitello, Carmela; Mumoli, Laura; Palleria, Caterina; Altomonte, Mariolina; Citraro, Rita; De Sarro, Giovambattista

    2013-01-01

    Introduction: Vertigo, dizziness, and nausea encompass a spectrum of balance-related symptoms caused by a variety of etiologies. Balance is affected by many systems: Proprioceptive pathways and visual, cerebellar, vestibulocochlear, and vascular / vasovagal systems. Vertigo is a subtype of dizziness, in which a subject, as a result to a dysfunction of the vestibular system, improperly experiments the perception of motion. The most useful clinical subdivision is to categorize vertigo into true vertigo and pseudovertigo, whereas from a pathophysiological point of view, vertigo can be classified into central, peripheral, and psychogenic. It is not easy to identify the cause of vertigo since the patients often are not able to precisely describe their symptoms. An impressive list of drugs may cause vertigo or dizziness. Materials and Methods: The aim of the present study was to analyze the data extracted from the reporting cards of the ADRs (adverse drug reactions), received at our Pharmacovigilance Regional Center (Calabria, Italy) in 2012. In particular, the data concerning the occurrence of vertigo and dizziness, after taking certain classes of drugs, have been considered. Results: Our results show that, among the side-effects of different classes of drugs such as anti-convulsants, anti-hypertensives, antibiotics, anti-depressants, anti-psychotics, and anti-inflammatory, also vertigo or dizziness are included. Conclusions: Spontaneous reports of vertigo or dizziness, as side-effect of certain drugs, received at our Pharmacovigilance Center, represented the 5% of all reports in 2012. Considering the high incidence of such an ADR for several drugs’ classes, it can be speculated that under-reporting also affect vertigo and dizziness. Despite the fact that these ADRs might not represent a direct threaten for life, indirectly they can cause secondary damage to patients such as falls, fractures etc. Balance should be accurately monitored during drug use and particularly in fragile patients. PMID:24347974

  20. [Analgesics in geriatric patients : Adverse side effects and interactions].

    PubMed

    Gosch, Markus

    2015-07-01

    Pain is a widespread symptom in clinical practice. Older adults and chronically ill patients are particularly affected. In multimorbid geriatric patients, pharmacological pain treatment is an extension of a previously existing multimedication. Besides the efficacy of pain treatment, drug side effects and drug-drug interactions have to be taken into account to minimize the health risk for these patients. Apart from the number of prescriptions, the age-related pharmacokinetic and pharmacodynamic changes significantly increase the risk among older adults. The use of non-steroidal anti-inflammatory drugs (NSAID) is widespread but NSAIDs have the highest risk of adverse drug reactions and drug interactions. In particular, the gastrointestinal, cardiovascular, renal and coagulation systems are affected. Apart from the known toxic effect on the liver (in high doses), paracetamol (acetaminophen) has similar risks although to a lesser degree. According to current data, metamizol is actually better than its reputation suggests. The risk of potential drug interactions seems to be low. Apart from the risk of sedation in combination with other drugs, tramadol and other opioids can induce the serotonin syndrome. Among older adults, especially in the case of polypharmacy, an individualized approach should be considered instead of sticking to the pain management recommended by the World Health Organization (WHO) in order to minimize drug-drug interactions and adverse drug reactions. PMID:26152872

  1. Building individualized medicine: prevention of adverse reactions to warfarin therapy.

    PubMed

    Krynetskiy, Evgeny; McDonnell, Patrick

    2007-08-01

    Warfarin is the most widely used oral anticoagulant in the world for patients with venous thrombosis, pulmonary embolism, chronic atrial fibrillation, and prosthetic heart valves. Approximately 30 genes contribute to therapeutic effects of warfarin, and genetic polymorphisms in these genes may modulate its anticoagulant activity. In contrast to monogenic pharmacogenetic traits, warfarin drug response is a polygenic trait, and development of diagnostic tools predictive of adverse reactions to warfarin requires a novel approach. A combination of two strategies, biochemical isolation of allelic variants and linkage disequilibrium association studies, was used to find an association between genetic polymorphisms in the candidate genes and warfarin response. A strong association was found between genetic polymorphisms in six genes, including VKORC1, CYP2C9, PROC, EPHX1, GGCX, and ORM1, and interindividual variability in the anticoagulant effect of warfarin; the strongest predictors were VKORC1 and CYP2C9. Generation of single nucleotide polymorphism (SNP)-based dense genetic maps made it possible to identify haplotypes associated with drugresponse phenotypes. Discrimination between haplotypes associated with warfarin dose phenotypes can be achieved by a limited set of informative polymorphisms (tag SNPs). The use of tag SNPs in pharmacogenomic analysis provides a promising tool for dissecting polygenic traits of drug response. PMID:17496169

  2. Large-scale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs

    E-print Network

    Liu, Mei; Wu, Yonghui; Chen, Yukun; Sun, Jingchun; Zhao, Zhongming; Chen, Xue-wen; Matheny, Michael Edwin; Xu, Hua

    2012-06-19

    Abstract Objective Adverse drug reaction (ADR) is one of the major causes of failure in drug development. Severe ADRs that go undetected until the post-marketing phase of a drug often lead to patient morbidity. Accurate prediction of potential ADRs...

  3. Characterization of metallic piercings that caused adverse reactions during use

    Microsoft Academic Search

    C. R. F. Azevedo; G. Spera; A. P. Silva

    2002-01-01

    This investigation characterizes five surgical stainless steel piercings and one niobium piercing that caused adverse reactions\\u000a during use, culminating with the removal of the jewelry. Chemical composition shows that none of the materials are in accordance\\u000a with ISO (International Organization for Standardization) standards for surgical implant materials. Additionally, none of\\u000a the stainless steel piercings passed the pitting-resistance criterion of ISO

  4. Adverse drug reactions as the cause of emergency department admission: focus on the elderly.

    PubMed

    Ventura, Maria Teresa; Laddaga, Rocco; Cavallera, Pierfranco; Pugliese, Piervito; Tummolo, Roberto A; Buquicchio, Rosalba; Pierucci, Paola; Passalacqua, Gianni

    2010-09-01

    The use of medications could be responsible of both side effects and adverse drug reaction (ADR). Identifying risk factors could improve the possibility of avoiding severe reactions in old people. We investigated the prevalence of unpredictable drug adverse reactions among patients admitted to the emergency departments (EDs) of three large Italian hospitals in the period 2005-2008. Clinical characteristics and demographics were carefully recorded in a dedicated database. The assessment of the drug reactions was carried out by an allergist after the first emergency evaluation. Over the considered period, 56,031 patients were admitted at the ED, 2644 (21.2%) of which for ADR. Out of those patients, 55 (2.1%) were identified as unpredictable ADRs. In 96% of the cases the clinical presentation was cutaneous and antibiotics were the most frequently responsible drugs. Patients over 65 years accounted for 37% of the reactions. In those patients the multiple drug regimens were significantly more frequent, as well as the presence of comorbidities. Smoking habit, alcohol abuse and personal and familiar history of atopy did not differ between the younger and the elderly. In the older group, antibiotics were more frequently involved, whereas in the <65 years, nonsteroidal antinflammatory drugs accounted for most reactions. Our date outline that in the elderly the comorbidities and correlated multiple regime therapy cause an increased incidence of ADRs, thus suggesting a careful management of therapeutics regimens by means of educational campaigns for patients and guidelines for doctors finalized to avoid excessive drug prescription. PMID:20095805

  5. Thromboprophylaxis Guidelines in Cancer with a Primary Focus on Ambulatory Patients Receiving Chemotherapy: A Review from the Southern Network on Adverse Reactions (SONAR)

    PubMed Central

    Maxwell, Whitney D.; Bennett, Charles L.

    2014-01-01

    Patients with cancer are at increased risk for venous thromboembolism (VTE). Factors related to cancer type, site, stage, duration, and extent of disease contribute to the oncology patient’s risk of VTE. Patient-specific factors such as history of prior VTE and comorbidity are also contributory. The role of treatment-related factors, including chemotherapy regimen, has been a focus of recent investigation because most cases of VTE in the oncology setting occur in ambulatory patients. Thus, an emerging area of clinical research is primary VTE prophylaxis in the ambulatory cancer setting. Clinical guidelines currently recommend primary thromboprophylaxis in cancer patients who are undergoing surgery, who are hospitalized, and who are in a specific subset of high-risk ambulatory cancer patients. Validated risk stratification tools are essential for identification of patients who are at high risk of thrombosis. Emerging data from recently published clinical trials, as well as ongoing studies, are likely to advance our understanding of the potential utility of antithrombotic agents for primary prophylaxis in ambulatory patients with cancer and may influence future clinical guideline recommendations. PMID:23111863

  6. The phenotype standardization project: improving pharmacogenetic studies of serious adverse drug reactions.

    PubMed

    Pirmohamed, M; Aithal, G P; Behr, E; Daly, A; Roden, D

    2011-06-01

    The ability to predict the risk for serious drug-induced adverse reactions first requires a large patient database for characterization and validation of genetic markers. The Phenotype Standardization Project (PSP) was initiated to standardize phenotypic definitions, thereby facilitating much-needed recruitment without sacrificing the reliability of patient classification. Three phenotypes have been considered in this initial phase: drug-induced liver injury, drug-induced skin injury, and drug-induced torsade de pointes. PMID:21593754

  7. Nurse-perceived Patient Adverse Events and Nursing Practice Environment

    PubMed Central

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

    2014-01-01

    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

  8. Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports.

    PubMed

    Egron, Adeline; Olivier-Abbal, Pascale; Gouraud, Aurore; Babai, Samy; Combret, Sandrine; Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle

    2015-06-01

    Antineoplastic drugs are one of the pharmacological classes more frequently involved in occurrence of "serious" adverse drug reactions. However, few epidemiological data are available regarding the preventability of adverse drug reactions with ambulatory cancer chemotherapy. We assessed the rate and characteristics of "preventable" or "potentially preventable" "serious" adverse drug reactions induced by oral protein kinase inhibitors (PKIs). We performed a retrospective study with all "serious" adverse drug reactions (ADRs) recorded from 1 January 2008 to 31 December 2009 in the French Pharmacovigilance Database with the eight oral protein kinase inhibitors marketed in France: sorafenib, imatinib, erlotinib, sunitinib, dasatinib, lapatinib, nilotinib and everolimus (Afinitor®) using the French adverse drug reactions preventability scale. This study was carried out on 265 spontaneous notifications. Most of adverse drug reactions were "unpreventable" (63.8 %). Around one third were "unevaluable" due to notifications poorly documented (medical history, dosage, use of drugs as first or second intention, concomitant drugs). One (0.4 %) adverse drug reaction was "preventable" with dasatinib (subdural hematoma) and three (1.1 %) were "potentially preventable" (hepatic adverse drug reactions): two with imatinib and one with sorafenib. For these four cases, we identified some characteristics: incorrect dosages, drug interactions and off-label uses. An appropriate prescription could avoid the occurrence of 1.5 % "serious" adverse drug reactions with oral PKIs. This rate is low and further studies are needed to compare our results by using other preventability instruments and to improve the French ADRs Preventability Scale. PMID:25056801

  9. Adverse drug reaction reporting by nurses in Sweden

    Microsoft Academic Search

    M. Bäckström; Elisabet Ekman; T. Mjörndal

    2007-01-01

    Aim  To investigate whether nurses could be a useful tool for improving the reporting rate of adverse drug reactions (ADRs). Furthermore,\\u000a we wanted to study how physicians working at the study departments would respond to nurses as reporters of ADRs and if the\\u000a reporting from the nurses affected the reporting rate from the physicians.\\u000a \\u000a \\u000a \\u000a Method  Three departments of internal medicine and one

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

    E-print Network

    Resende, Mauricio G. C.

    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

  11. [Food allergy and other adverse reactions caused by food].

    PubMed

    Ring, J

    1984-09-01

    Adverse reactions to foods are not infrequent. They may be mediated by immunological mechanisms (food allergy) or non-immunologically (idiosyncrasy, pseudo-allergy, intolerance). Furthermore toxic effects of foods have to be clearly distinguished from food allergy as well as poorly defined conditions such as hyperkinesis or "tension-fatigue syndrome", the causal relation of which to foods is not well established. The diagnosis of food allergy includes convincing history, positive provocation and demonstration of immunological sensitization (mostly IgE, however other types of immune reactions may also be of importance. In the treatment of food allergy specific elimination diets as well as pharmacotherapy with the use of mast cell blocking agents are recommended. In single cases oral hyposensitization may be tried. PMID:6482316

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

    PubMed Central

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

    2013-01-01

    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

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

    PubMed

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

    2013-12-01

    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

  14. Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines

    Microsoft Academic Search

    R A J Ransford; M J S Langman

    2002-01-01

    Background: 5-Aminosalicylates are extensively prescribed for the treatment of ulcerative colitis but have a wide range of described adverse effects.Aims: To determine whether serious adverse effect profiles differ for sulphasalazine and mesalazine.Methods: Analysis of suspected serious adverse reactions reported to the Committee on Safety of Medicines of the UK in 1991–1998. Adverse effect profiles were categorised for interstitial nephritis, pancreatitis,

  15. Respiratory depression: An adverse outcome during patient controlled analgesia therapy

    Microsoft Academic Search

    Lian C. Looi-Lyons; Frances F. Chung; Vincent W. Chan; Maurene McQuestion

    1996-01-01

    Patient-controlled analgesia (PCA) is one of the more popular means of controlling postoperative pain. However, there is very little in the literature concerning the adverse outcome of respiratory depression in PCA. This report is a prospective study of 4,000 patients on PCA postoperatively. Nine of these patients experienced respiratory problems while on PCA. The respiratory depressions were associated with drug

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

    PubMed

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

    2014-11-01

    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 P450 enzymes, 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

  17. Adverse events in patients with return emergency department visits

    PubMed Central

    Calder, Lisa; Pozgay, Anita; Riff, Shena; Rothwell, David; Youngson, Erik; Mojaverian, Naghmeh; Cwinn, Adam; Forster, Alan

    2015-01-01

    Objectives This study describes the proportion of emergency department (ED) returns within 7?days due to adverse events, defined as adverse outcomes related to healthcare received. Design Prospective cohort study. Setting We used an electronically triggered adverse event surveillance system at a tertiary care ED from May to June 2010 to examine ED returns within 7?days of index visit. Participants One of three trained nurses determined whether the visit was related to index emergency care. For such records, one of three trained emergency physicians conducted adverse event determinations. Main outcome measure We determined adverse event type and severity and analysed the data with descriptive statistics, ?2 tests and logistic regression. Results Of 13?495 index ED visits, 923 (6.8%) were followed by ED returns within 7?days. The median age of all patients was 47?years and 52.8% were women. After nursing review, 211 cases required physician review. Of these, 53 visits were adverse events (positive predictive value (PPV)=5.7%, 95% CI 4.4% to 7.4%) and 30 (56.6%) were preventable. Common adverse event types involved management, diagnostic or medication issues. We observed one potentially preventable death and 58.5% of adverse events resulting in transient disability. The PPV of a modified trigger with a cut-off of return within 72?h, resulting in admission was 11.9% (95% CI 6.8% to 18.9%). Conclusions Our electronic trigger efficiently identified adverse events among 12% of patients with ED returns within 72?h, requiring hospital admission. Given the high degree of preventability of the identified adverse events, this trigger also holds promise as a performance measurement tool. PMID:25540424

  18. Immunogenicity, efficacy and adverse events of adalimumab in RA patients

    Microsoft Academic Search

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

    2007-01-01

    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

  19. Severe cutaneous adverse reactions: emergency approach to non-burn epidermolytic syndromes

    Microsoft Academic Search

    Manuel Florian Struck; Peter Hilbert; Maja Mockenhaupt; Beate Reichelt; Michael Steen

    2010-01-01

    Introduction  Although severe cutaneous adverse reactions (SCARs), such as Stevens–Johnson syndrome and toxic epidermal necrolysis, are\\u000a rare, they are associated with considerable morbidity and mortality.\\u000a \\u000a \\u000a \\u000a Methods  The current knowledge regarding background, differential diagnoses, critical care and implications for inter-hospital emergency\\u000a medical service (EMS) transport of these patients is discussed.\\u000a \\u000a \\u000a \\u000a Conclusion  SCAR patients will substantially benefit from early interdisciplinary care and thorough consideration of

  20. Nurse staffing and adverse patient outcomes: A systems approach

    Microsoft Academic Search

    Sung-Hyun Cho

    2001-01-01

    The public is concerned that inadequate nurse staffing in hospitals may be jeopardizing the quality of patient care. This article proposes a conceptual model for examining the relationship between nurse staffing and adverse patient outcomes and discusses issues about methods in testing the model.

  1. Cutaneous adverse drug reactions in Indian population: A systematic review

    PubMed Central

    Patel, Tejas K; Thakkar, Sejal H; Sharma, DC

    2014-01-01

    Background: Epidemiological data is limited for cutaneous adverse drug reactions (CADRs) in India. Most of the Indian studies have small sample size and are of limited duration. Aims: The aim of this study is to analyze CADRs with reference to the causative drugs and their clinical characteristics in Indian population. Materials and Methods: As per selection criteria, electronic databases were searched for publications describing CADRs from January-1995 to April-2013 by two independent investigators. Data of the causative drugs and clinical characteristics were extracted and summarized by absolute numbers, percentages, ranges, and means as presented by the authors. The subgroup analysis of causative drugs was performed for causality assessment, severe or nonsevere reactions and occurrence of common CADRs. Studies showing “definite” and “probable” categories of causality analysis were labeled as “definite and probable causality (DPC) studies”. The other included studies were labeled as “non-DPC studies”. Results: Of 8337 retrieved references, 18 prospective studies were selected for analysis. The pooled incidence was 9.22/1000 total among outpatient and inpatient cases. Commonly observed reactions were maculopapular rash (32.39%), fixed drug eruptions (FDEs) (20.13%), urticaria (17.49%) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (6.84%). The major causative drug groups were antimicrobials (45.46%), nonsteroidal anti-inflammatory drugs (NSAIDs) (20.87%) and anti-epileptic drugs (14.57%). Commonly implicated drugs were sulfa (13.32%), ?-lactams (8.96%) and carbamazepine (6.65%). High frequency of CADRs is observed with anti-epileptic drugs in DPC studies only. Carbamazepine, phenytoin and fluoroquinolones had higher severe to nonsevere cutaneous reaction ratio than other drugs. Antimicrobials were the main causative drugs for maculopapular rash, FDEs and SJS/TEN, and NSAIDs for the urticaria. The mortality for overall CADRs, SJS/TEN, and exfoliative dermatitis were 1.71%, 16.39%, and 3.57%, respectively. “Definitely preventable”, “probably preventable” and “not preventable” categories CADRs were 15.64%, 63.14%, and 34.64%, respectively. Conclusion: Antimicrobials, NSAIDs and antiepileptic are common causative agents of CADRs in India. Antiepileptic agents show high rates of severe cutaneous reactions. PMID:25593813

  2. Telaprevir may induce adverse cutaneous reactions by a T cell immune-mediated mechanism.

    PubMed

    Federico, Alessandro; Aitella, Ernesto; Sgambato, Dolores; Savoia, Alfonso; De Bartolomeis, Fabio; Dallio, Marcello; Ruocco, Eleonora; Pezone, Luciano; Abbondanza, Ciro; Loguercio, Carmela; Astarita, Corrado

    2015-01-01

    The HCV protease inhibitor telaprevir associated with peginterferon-alpha and ribavirin, was widely used in the recent past as standard treatment in HCV genotype-1 infected patients. Telaprevir improves the sustained virology response rates, but at the same time increases the frequency of adverse cutaneous reactions. However, mechanisms through which telaprevir induces cutaneous lesions are not yet defined. A 50-year-old woman, affected by HCV genotype 1b, was admitted to our Department for a telaprevir-related severe cutaneous eruptions, eight weeks after starting a triple therapy (telaprevir associated with Peginterferon-alpha and ribavirin). Mechanisms of cutaneous reactions were investigated by skin tests with non-irritating concentrations of telaprevir and by activating in vitro T lymphocyte with different concentrations. Immediate and delayed responses to skin testing were negative, but the drug-induced lymphocytes activation was significantly higher as compared to patient's baseline values and to parallel results obtained in three healthy subjects (p < 0.05). In conclusion, adverse cutaneous reactions of our patient were caused by a telaprevir-induced T-cell dependent immune mechanism. PMID:25864225

  3. Serum Concentrations and Adverse Effects of Chloramphenicol in Pediatric Patients

    Microsoft Academic Search

    Milap C. Nahata

    1987-01-01

    Chloramphenicol serum concentration is often monitored to assure efficacy and prevent toxicity. We studied the relationship between steady-state chloramphenicol serum concentration and hematologic adverse effects in 45 pediatric patients. The mean peak serum concentration of chloramphenicol in patients with and without toxicity were not different (p > 0.1): 22.7 ?g\\/ml in neutropenic patients versus 23.1 ?g\\/ml in those without neutropenia;

  4. The Evaluation of a Recurrent Adverse Drug Reaction Prevention Program in the North-East Region of Thailand

    Microsoft Academic Search

    Anun Chaikoolvatana; Pharm D

    2006-01-01

    Objective: To investigate the effectiveness of the Adverse Drug Reaction (ADR) Prevention Program. Material and Method: This cross-sectional study is quasi-experimental with in- and out-patients. Data was collected over a period of six months on patients' histories, basic knowledge of ADR prevention, and their attitudes toward the prevention program. The effectiveness of the program was evaluated by assessing patient knowledge

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

    Microsoft Academic Search

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

    2010-01-01

    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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

    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…

  7. Cutaneous adverse drug reaction type erythema multiforme major induced by eslicarbazepine

    PubMed Central

    Massot, Andreu; Gimenez-Arnau, Ana

    2014-01-01

    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. PMID:25422574

  8. A continuous GRASP to determine the relationship between drugs and adverse reactions

    SciTech Connect

    Hirsch, Michael J. [Raytheon, Inc., Network Centric Systems, P.O. Box 12248, St. Petersburg, FL, 33733 (United States); Meneses, Claudio N.; Pardalos, Panos M.; Ragle, Michelle [Department of Industrial and Systems Engineering, University of Florida, 303 Weil Hall, Gainesville, FL, 32611 (United States); Resende, Mauricio G. C. [Algorithms and Optimization Research Department, AT and T Labs Research, 180 Park Avenue, Room C241, Florham Park, NJ 07932 (United States)

    2007-11-05

    Adverse drag reactions (ADRs) are estimated to be one of the leading causes of death. Many national and international agencies have set up databases of ADR reports for the express purpose of determining the relationship between drugs and adverse reactions that they cause. We formulate the drug-reaction relationship problem as a continuous optimization problem and utilize C-GRASP, a new continuous global optimization heuristic, to approximately determine the relationship between drugs and adverse reactions. Our approach is compared against others in the literature and is shown to find better solutions.

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

    PubMed Central

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

    2012-01-01

    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

  10. Variants in CDA and ABCB1 are predictors of capecitabine-related adverse reactions in colorectal cancer.

    PubMed

    García-González, Xandra; Cortejoso, Lucía; García, María I; García-Alfonso, Pilar; Robles, Luis; Grávalos, Cristina; González-Haba, Eva; Marta, Pellicer; Sanjurjo, María; López-Fernández, Luis A

    2015-03-20

    Adverse reactions to capecitabine-based chemotherapy limit full administration of cytotoxic agents. Likewise, genetic variations associated with capecitabine-related adverse reactions are associated with controversial results and a low predictive value. Thus, more evidence on the role of these variations is needed. We evaluated the association between nine polymorphisms in MTHFR, CDA, TYMS, ABCB1, and ENOSF1 and adverse reactions, dose reductions, treatment delays, and overall toxicity in 239 colorectal cancer patients treated with capecitabine-based regimens. The ABCB1*1 haplotype was associated with a high risk of delay in administration or reduction in the dose of capecitabine, diarrhea, and overall toxicity. CDA rs2072671 A was associated with a high risk of overall toxicity. TYMS rs45445694 was associated with a high risk of delay in administration or reduction in the dose of capecitabine, HFS >1 and HFS >2. Finally, ENOSF1 rs2612091 was associated with HFS >1, but was a poorer predictor than TYMS rs45445694. A score based on ABCB1-CDA polymorphisms efficiently predicts patients at high risk of severe overall toxicity (PPV, 54%; sensitivity, 43%) in colorectal cancer patients treated with regimens containing capecitabine. Polymorphisms in ABCB1, CDA, ENOSF1,and TYMS could help to predict specific and overall severe adverse reactions to capecitabine. PMID:25691056

  11. Variants in CDA and ABCB1 are predictors of capecitabine-related adverse reactions in colorectal cancer

    PubMed Central

    García, María I.; García-Alfonso, Pilar; Robles, Luis; Grávalos, Cristina; González-Haba, Eva; Marta, Pellicer; Sanjurjo, María; López-Fernández, Luis A.

    2015-01-01

    Adverse reactions to capecitabine-based chemotherapy limit full administration of cytotoxic agents. Likewise, genetic variations associated with capecitabine-related adverse reactions are associated with controversial results and a low predictive value. Thus, more evidence on the role of these variations is needed. We evaluated the association between nine polymorphisms in MTHFR, CDA, TYMS, ABCB1, and ENOSF1 and adverse reactions, dose reductions, treatment delays, and overall toxicity in 239 colorectal cancer patients treated with capecitabine-based regimens. The ABCB1*1 haplotype was associated with a high risk of delay in administration or reduction in the dose of capecitabine, diarrhea, and overall toxicity. CDA rs2072671 A was associated with a high risk of overall toxicity. TYMS rs45445694 was associated with a high risk of delay in administration or reduction in the dose of capecitabine, HFS >1 and HFS >2. Finally, ENOSF1 rs2612091 was associated with HFS >1, but was a poorer predictor than TYMS rs45445694. A score based on ABCB1-CDA polymorphisms efficiently predicts patients at high risk of severe overall toxicity (PPV, 54%; sensitivity, 43%) in colorectal cancer patients treated with regimens containing capecitabine. Polymorphisms in ABCB1, CDA, ENOSF1,and TYMS could help to predict specific and overall severe adverse reactions to capecitabine. PMID:25691056

  12. Pharmacogenetic potential biomarkers for carbamazepine adverse drug reactions and clinical response.

    PubMed

    Jaramillo, Nancy Monroy; Galindo, Ingrid Fricke; Vázquez, Alberto Ortega; Cook, Helgi Jung; LLerena, Adrián; López, Marisol López

    2014-01-01

    Carbamazepine (CBZ) is a first-line widely used anticonvulsant. It has a narrow therapeutic index and exhibits considerable interindividual and interethnic variability in clinical efficacy and adverse drug reactions including potentially life-threatening hypersensitivity reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The most important pharmacogenetic finding is related to the association of CBZ-induced hypersensitivity with human leukocyte antigens (HLA class I and II alleles). Moreover, genotyping for HLA-B*15:02 allele is required prior to initiating CBZ in Asians and Asian ancestry patients, demonstrating the usefulness of biomarkers to avoid adverse drug reactions. On the other hand, in order to explain the differences in the clinical response to CBZ, genetic polymorphisms in phase I (CYP3A4, CYP3A5 and EPHX1) and phase II (UGT2B7) metabolising enzymes have been assessed; additionally, the influence of transporters (ABCB1 and ABCC2), receptors (PXR) and other drug targets (voltage- gated Na+ channels) in CBZ clinical response has been evaluated. To date, these studies are controversial and require further investigations to clarify the functional role of these polymorphisms as potential biomarkers in regard to CBZ therapy. PMID:24406279

  13. Comparison of serious adverse reactions between thalidomide and lenalidomide: analysis in the French Pharmacovigilance database.

    PubMed

    Olivier-Abbal, Pascale; Teisseyre, Anne-Charlotte; Montastruc, Jean-Louis

    2013-12-01

    Thalidomide and lenalidomide are structural analogs and immunomodulatory drugs. Lenalidomide appears to have a different safety profile than thalidomide and could be less toxic, and as far as we know, we did not found any study comparing their safety profile. The objective of our study was to review and compare serious adverse drug reactions (SADRs) of thalidomide and lenalidomide spontaneously reported to the French Pharmacovigilance database. We extracted all medically confirmed spontaneous reports of SADR for lenalidomide-based regimens and thalidomide-based regimens from the French Pharmacovigilance database. A "serious" adverse drug reaction (ADR) was defined as an ADR that is fatal or life threatening, which causes hospitalization or prolongation of hospitalization, or permanent or significant disability. The study period was between marketing of 2 drugs and January 15, 2012. A total of 392 SADRs related to thalidomide-based regimens were identified in 244 patients and 377 SADRs related to lenalidomide-based regimens in 220 patients. In spite of their structural analogy, this study highlights interesting differences between lenalidomide and thalidomide's safety profile: nervous system and vascular disorders are more frequent with thalidomide-based regimens while hematologic, skin, infectious disorders and secondary primary cancers are more frequent with lenalidomide-based regimens. PMID:24078083

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

    PubMed

    Payne, P W

    2014-10-01

    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

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

    PubMed Central

    Süsskind, M.; Thürmann, P. A.; Lüke, C.; Jeschke, E.; Tabali, M.; Matthes, H.; Ostermann, T.

    2012-01-01

    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

  16. Histopathological patterns indicative of distinct adverse drug reactions.

    PubMed

    Kerl, Katrin

    2012-01-01

    Histologically, drug eruptions may present virtually all patterns of inflammation in the skin, including spongiotic, lichenoid and psoriasiform dermatitis as well as vasculitis or panniculitis. Drug reactions may mimic specific skin diseases such as lupus erythematosus, lichen planus or lymphoma. While a single drug may cause a wide range of reaction patterns, no reaction pattern is specific for a certain drug. Nevertheless, some reactions are quite characteristic for certain drugs as for example psoriasiform dermatitis for anti-TNF agents or folliculitis for epidermal growth factor receptor antagonists. Heightened awareness to the possible mimicry of other skin diseases as well as integration of clinical data is pivotal for the appropriate histological diagnosis of drug reactions in the skin. For practical reasons and in the aim of helping clinicians, the different drug reactions described in this chapter are classified according to the main histological reaction pattern present. Nevertheless, this classification may be somewhat artificial in some cases as drug reactions often reveal a coexistence of different reaction patterns. PMID:22613854

  17. A prospective study of adverse drug reactions to antiepileptic drugs in children

    PubMed Central

    Anderson, Mark; Egunsola, Oluwaseun; Cherrill, Janine; Millward, Claire; Fakis, Apostolos; Choonara, Imti

    2015-01-01

    Objectives To prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour. Setting A single centre prospective observational study. Participants Children (<18?years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. Primary and secondary outcomes Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. Results 180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR. Conclusions Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children. Trail registration number EudraCT (2007-000565-37). PMID:26033949

  18. IVIG Adverse Reactions: Potential Role of Cytokines and Vasoactive Substances

    Microsoft Academic Search

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

    1998-01-01

    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

  19. Automatic Detection Of Vaccine Adverse Reactions By Incorporating Historical Medical Conditions

    E-print Network

    Karypis, George

    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

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

    E-print Network

    Baral, Chitta

    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

  1. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the...

  2. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the...

  3. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the...

  4. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the...

  5. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...physical environment, especially in the case of ground water, and surface water and soil resources that have limited self-cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the...

  6. Research on Susceptible Genes and Immunological Pathogenesis of Cutaneous Adverse Drug Reactions in Chinese Hans.

    PubMed

    Yang, Fangping; Yang, Ying; Zhu, Qinyuan; Chen, Sheng-An; Fu, Xiaodan; Yan, Sijia; Meng, Chunjie; Ma, Li; Sun, Xinfen; Xu, Jinhua; Luo, Xiaoqun; Xing, Qinghe

    2015-07-01

    Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthems (MPE), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). We used HLA high-resolution genotyping and genome wide association analysis (GWAS) to identify the genetic markers for cADRs induced by common culprit drugs in Han Chinese population. To further understand the immunopathogenesis of cADRs, and with the goal of developing treatment strategies, we compared the expression of cytoxic cytokines between the patients with cADRs and normal controls. Our data suggested that the carbamazepine induced SJS/TEN, allopurinol induced CADRs, methazolamide induced SJS/TEN and SASP induced DRESS were respectively strongly associated with HLA-B*15:02, HLA-B*58:01, HLA-B*59:01 and HLA-B*13:01. In addition, increased expression of cytotoxic cytokines in sera and tissues of cADRs patients were found, compared with healthy controls. Our findings may shed light on prediction and prevention of cADRs, provide clues to pathogenesis, and guide treatment strategies of these reactions. PMID:26067314

  7. Adverse Reaction to Poetry Therapy: A Case Report.

    ERIC Educational Resources Information Center

    Pies, Ronald

    1993-01-01

    Describes how a patient with Borderline Personality Disorder underwent significant regression in response to poetic material during a therapy session. Offers a prototypical questionnaire (Poetic Response Assessment Scale) to assess a patient's response to a particular literary work. (SR)

  8. The genetics of pro-arrhythmic adverse drug reactions

    PubMed Central

    Petropoulou, Evmorfia; Jamshidi, Yalda; Behr, Elijah R

    2014-01-01

    Ventricular arrhythmia induced by drugs (pro-arrythmia) is an uncommon event, whose occurrence is unpredictable but potentially fatal. The ability of a variety of medications to induce these arrhythmias is a significant problem facing the pharmaceutical industry. Genetic variants have been shown to play a role in adverse events and are also known to influence an individual's optimal drug dose. This review provides an overview of the current understanding of the role of genetic variants in modulating the risk of drug induced arrhythmias. PMID:23834499

  9. Presentation and management of docetaxel-related adverse effects in patients with breast cancer

    PubMed Central

    Ho, Maria Y; Mackey, John R

    2014-01-01

    The taxane chemotherapeutic agent docetaxel has been utilized in the management of breast cancer in the adjuvant, neoadjuvant and metastatic setting. Although well tolerated by the majority of patients, docetaxel toxicity may limit the dose which can be administered. Adverse events include infusion reactions, febrile neutropenia, fatigue, fluid retention, pneumonitis, cutaneous and nail toxicity, epiphora and lacrimal duct stenosis, gastrointestinal complications, and neuropathies. In this review, we explore these complications and how they can be effectively managed to improve patient quality of life during and following docetaxel therapy. PMID:24904223

  10. [Analysis of adverse reactions and pharmacovigilance research to parenterally administered shuxuening].

    PubMed

    Yang, Wei; Xiang, Yong-Yang; Xie, Yan-Ming; Shen, Hao

    2013-09-01

    Parenterally administered Shuxuening is a commonly used Chinese medicine. There is a need to understand the characteristics of adverse drug reactions (ADRs) to it. 9 601 ADR cases reports were collected from the national adverse drug reaction monitoring center reported between January, 2005 and December, 2012. These included 326 serious ADR cases, accounting for 3.93% of the total. It was found that ADR reports increased annually from 2005, reaching a peak in the third quarter of 2009. The number of ADR cases reports were greatest in the third quarter of each year. ADRs in patients aged 60-74, accounted for 3 348 (34.87%) of all cases. 9 391(97.81%) cases were administered by intravenous infusion. In 8 431 cases, the dosage was in accordance with instructions. 61.61% ADR cases occurred on first administration. The ten most frequent symptoms were, rashes, itching, dizziness, palpitations, chills, allergic reactions, shortness of breath, nausea, phlebitis and vomiting. Systemic damage mainly affected the skin and its accessories damage, or the nervous system damage. Through the use of proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) and propensity score applying generalized boosted models (GBM) to control for 17 confounding factors, analysis of the 10 kinds of ADRs found that for the ADR signals of dizziness, palpitations, phlebitis, and vomiting, BCPNN found that dizziness and phlebitis were early warning signals. This research found that in the 60-89 age group, higher dosages of parenterally administered Shuxuening gave rise to more phlebitis. This study provides important information for parenterally administered Shuxuening research, and guidance for its risk management. PMID:24471322

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

    PubMed Central

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

    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

  12. The radiology of adverse drug reactions and toxic hazards

    SciTech Connect

    Ansell, G.

    1985-01-01

    Dr. Ansell has produced a scholarly review of the radiology of drug reactions and toxic hazards in his latest book, which is based on over 1,200 articles in the world literature. About 800 of these articles are taken from outside the radiology literature, which indicates the need for this subject to be brought to the attention of the radiologist, particularly as concern about drug reactions and toxic hazards is always increasing. The book includes sections covering the chest, gastrointestinal tract, renal tract, skeletal system and soft tissues, and skull and central nervous system. Each section treats specific substances, such as steroids and heavy metals; specific radiologic signs, such as ureteric dilation; specific symptoms, such as dysphagia; industrial toxins; radiographic abnormalities are discussed; and numerous high-quality radiographs.

  13. Natural Inhibitors of Cholinesterases: Implications for Adverse Drug Reactions

    PubMed Central

    Krasowski, Matthew D.; McGehee, Daniel S.

    2010-01-01

    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

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

    PubMed Central

    Simonet, Daniel

    2011-01-01

    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

  15. Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases

    PubMed Central

    2014-01-01

    Background Analyzing time-to-onset of adverse drug reactions from treatment exposure contributes to meeting pharmacovigilance objectives, i.e. identification and prevention. Post-marketing data are available from reporting systems. Times-to-onset from such databases are right-truncated because some patients who were exposed to the drug and who will eventually develop the adverse drug reaction may do it after the time of analysis and thus are not included in the data. Acknowledgment of the developments adapted to right-truncated data is not widespread and these methods have never been used in pharmacovigilance. We assess the use of appropriate methods as well as the consequences of not taking right truncation into account (naive approach) on parametric maximum likelihood estimation of time-to-onset distribution. Methods Both approaches, naive or taking right truncation into account, were compared with a simulation study. We used twelve scenarios for the exponential distribution and twenty-four for the Weibull and log-logistic distributions. These scenarios are defined by a set of parameters: the parameters of the time-to-onset distribution, the probability of this distribution falling within an observable values interval and the sample size. An application to reported lymphoma after anti TNF- ??treatment from the French pharmacovigilance is presented. Results The simulation study shows that the bias and the mean squared error might in some instances be unacceptably large when right truncation is not considered while the truncation-based estimator shows always better and often satisfactory performances and the gap may be large. For the real dataset, the estimated expected time-to-onset leads to a minimum difference of 58 weeks between both approaches, which is not negligible. This difference is obtained for the Weibull model, under which the estimated probability of this distribution falling within an observable values interval is not far from 1. Conclusions It is necessary to take right truncation into account for estimating time-to-onset of adverse drug reactions from spontaneous reporting databases. PMID:24490673

  16. Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

    PubMed Central

    Yu, Yun Mi; Shin, Wan Gyoon; Lee, Ju-Yeun; Choi, Soo An; Jo, Yun Hee; Youn, So Jung; Lee, Mo Se; Choi, Kwang Hoon

    2015-01-01

    Purpose To evaluate the clinical manifestations and causative drugs associated with adverse drug reactions (ADRs) spontaneously reported by community pharmacists and to compare the ADRs by age. Methods ADRs reported to the Regional Pharmacovigilance Center of the Korean Pharmaceutical Association by community pharmacists from January 2013 to June 2014 were included. Causality was assessed using the WHO-Uppsala Monitoring Centre system. The patient population was classified into three age groups. We analyzed 31,398 (74.9%) ADRs from 9,705 patients, identified as having a causal relationship, from a total pool of 41,930 ADRs from 9,873 patients. Median patient age was 58.0 years; 66.9% were female. Results Gastrointestinal system (34.4%), nervous system (14.4%), and psychiatric (12.1%) disorders were the most frequent symptoms. Prevalent causative drugs were those for acid-related disorders (11.4%), anti-inflammatory products (10.5%), analgesics (7.2%), and antibacterials (7.1%). Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001), whereas dizziness was prevalent in the elderly (p < 0.001). Anaphylactic reaction was the most frequent serious event (19.7%), mainly associated with cephalosporins and non-steroidal anti-inflammatory drugs. Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6%) and non-steroidal anti-inflammatory drugs (16.2%), respectively. Conclusions According to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups. PMID:26172050

  17. Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions

    Microsoft Academic Search

    Guruprasad P Aithal; Michael D Rawlins; Christopher P Day

    2000-01-01

    Background\\/Aim: Due to an absence of specific markers, the diagnosis of drug-induced hepatotoxicity is necessarily based on circumstantial evidence and is often inaccurate. We have evaluated the use of the clinical diagnostic scale (CDS) in the causality assessment of hepatotoxic adverse drug reaction (ADR) reports.Methods: 135 hepatic adverse ADRs reported to the Committee on Safety of Medicines in North East

  18. Adverse reactions with angiotensin converting enzyme (ACE) inhibitors.

    PubMed

    DiBianco, R

    1986-01-01

    Teprotide, a nonapeptide isolated from the venom of a Brazilian pit viper, Bothrops jararaca, was the first angiotensin converting enzyme (ACE) inhibitor to be discovered and tested. It was found to be an effective, non-toxic antihypertensive agent as well as an afterload-reducing agent for patients with congestive heart failure (CHF). The primary activity of teprotide resulted from blockade of the angiotensin I converting enzyme--the pivotal step in the renin-angiotensin-aldosterone system (RAAS), and consequent reductions in angiotensin II levels. There was limited clinical testing for teprotide because of: its scarcity; the need for parenteral administration; and the subsequent discovery and synthesis of captopril, the first orally active angiotensin converting enzyme inhibitor. Captopril is the prototype oral angiotensin converting enzyme inhibitor and has been extensively studied since the initiation of formal studies in 1976. Perhaps one of the most closely researched drugs in modern times, the experience with captopril now includes more than 12,000 patients studied in formalized trials and over 4,000,000 patients treated world-wide by physicians for hypertension and congestive heart failure. Enalapril (MK421) is the first of what appears to be a growing number of analogues which are structurally and pharmacodynamically different from captopril; yet, they possess the same capacity for inhibiting the activity of angiotensin converting enzyme. The side effect profile of enalapril (and presumably future) angiotensin converting enzyme inhibitors appears to be similar to captopril, though clearly more experience is needed with newer agents. The initial use of captopril was troubled by a relatively high incidence of side effects which will form the focus of this discussion. Partially the result of incomplete pharmacokinetic information, captopril was administered in early studies at dosages now recognised to be far in excess of those necessary for drug action. In addition, dosages were given without regard for deficiencies of renal function, now known to be the main excretory route of captopril. The population of those patients studied frequently had chronic, treatment-resistant hypertension, often associated with concomitant end-organ disease (especially renal disease); and many additional factors further complicating the clinical setting, e.g. a relatively high incidence of collagen vascular disease and immunosuppressive treatments.(ABSTRACT TRUNCATED AT 400 WORDS) PMID:3023783

  19. Low dose subcutaneous adrenaline to prevent acute adverse reactions to antivenom serum in people bitten by snakes: randomised, placebo controlled trial

    Microsoft Academic Search

    S B Gunatilake; de Silva

    Objective To assess the efficacy and safety of low dose adrenaline injected subcutaneously to prevent acute adverse reactions to polyspecific antivenom serum in patients admitted to hospital after snake bite. Design Prospective, double blind, randomised, placebo controlled trial. Setting District general hospital in Sri Lanka. Subjects 105 patients with signs of envenomation after snake bite, randomised to receive either adrenaline

  20. Electronic Health Records and Adverse Drug Events after Patient Transfer

    PubMed Central

    Boockvar, Kenneth S.; Livote, Elayne E.; Goldstein, Nathan; Nebeker, Jonathan R.; Siu, Albert; Fried, Terri

    2009-01-01

    Background Our objective was to examine the frequencies of medication error and adverse drug events (ADEs) at the time of patient transfer in a system with an electronic health record (EHR) as compared to a system without an EHR. We hypothesized that the frequencies of these events would be lower in the EHR system because of better information exchange across sites of care. Methods 469 patients transferred between 7 nursing homes and 3 hospitals in New York and Connecticut between 1999-2005 were followed retrospectively. 2 groups of patients were compared: U.S. Veterans Affairs (VA) patients, with an EHR, and non-VA patients, without an EHR, on the following measures: 1) Medication prescribing discrepancies at nursing home/hospital transfer; 2) High-risk medication discrepancies; and 3) ADEs caused by medication discrepancies according to structured medical record review by pairs of physician and pharmacist raters. Results The overall incidence of ADE caused by medication discrepancies was 0.20 per hospitalization episode. After controlling for demographic and clinical covariates, there were no significant differences between VA and non-VA groups in medication discrepancies (mean difference 0.02; 95%CI ?0.81 to 0.85), high-risk medication discrepancies (?0.18; 95%CI ?0.22 to 0.58), or occurrence of an ADE caused by a medication discrepancy (odds ratio 0.96; 95%CI 0.18 to 5.01). Conclusions There was no difference, with and without an EHR, in the occurrence of medication discrepancies or ADEs caused by medication discrepancies at the time of transfer between sites of care. Reducing such problems may require specialized computer tools to facilitate medication review. PMID:20724395

  1. Personalized pharmacogenomics: predicting efficacy and adverse drug reactions.

    PubMed

    Pirmohamed, Munir

    2014-01-01

    Drug response varies between individuals owing to disease heterogeneity, environmental factors, and genetic factors. Genetic factors can affect both the pharmacokinetics and pharmacodynamics of a drug, leading to changes in local and systemic drug exposure and/or changes in the function of the drug target, altering drug response. Several pharmacogenetic biomarkers are already utilized in clinical practice and have been shown to improve clinical outcomes. However, a large number of other biomarkers have never made it beyond the discovery stage. Concerted effort is needed to improve the translation of pharmacogenetic biomarkers into clinical practice, and this will involve the use of standardized phenotyping and genotyping strategies, collaborative work, multidisciplinary approaches to identifying and replicating associations, and cooperation with industry to facilitate translation and commercialization. Acceptance of these approaches by clinicians, regulators, patients, and the public will be important in determining future success. PMID:24898040

  2. Treatment of osteoporosis: recognizing and managing cutaneous adverse reactions and drug-induced hypersensitivity

    Microsoft Academic Search

    P. Musette; M. L. Brandi; P. Cacoub; J. M. Kaufman; R. Rizzoli; J.-Y. Reginster

    2010-01-01

    Summary  Cutaneous adverse reactions are reported for many treatments including antiosteoporotic agents. This position paper includes\\u000a an algorithm for their recognition. With early recognition and proper management, including immediate and permanent withdrawal\\u000a of the culprit agent, accompanied by hospitalization, rehydration, and systemic corticosteroids, if necessary, the prognosis\\u000a is good.\\u000a \\u000a \\u000a \\u000a \\u000a Introduction  Cutaneous adverse reactions are reported for many therapeutic agents and observed in

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

    PubMed Central

    Fattinger, Karin; Roos, Malgorzata; Vergères, 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

    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

  4. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011

    PubMed Central

    Nordanger, Dag Ø.; Breivik, Kyrre; Haugland, Bente Storm; Lehmann, Stine; Mæhle, Magne; Braarud, Hanne Cecilie; Hysing, Mari

    2014-01-01

    Background Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care. PMID:24872862

  5. Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine.

    PubMed

    Luykx, J; Mason, M; Ferrari, M D; Carpay, J

    2009-03-01

    To compare adverse drug reactions (ADRs) to topiramate in patients with migraine and patients with epilepsy, we systematically reviewed all published randomized controlled trials (RCTs) that compare topiramate monotherapy in epilepsy and migraine. We included four epilepsy RCTs (N = 1,179 patients; vs. active comparators) and six migraine RCTs (N = 1,723 patients; vs. placebo). Behavioral ADRs and headache were found only in the case of epilepsy, whereas cognitive complaints and alteration of taste were found only in the case of migraine. The risk ratios (RRs) for paresthesia in migraine vs. epilepsy trials were 2.5 (99% confidence interval (CI): 1.66-3.77) for 50 mg, 2.7 (99% CI: 1.80-3.97) for 100 mg, and 3.0 (99% CI: 1.95-4.56) for 200 mg. For ADR-related dropouts, the RR was 2.5 (95% CI: 2.03-2.98) for 50 mg but no different for the other doses. We conclude that when treated with the same doses of topiramate, migraineurs show different ADRs than patients with epilepsy and are more likely to drop out because of ADRs. PMID:18987621

  6. Reported adverse drug reactions and their determinants in Dutch children outside the hospital

    Microsoft Academic Search

    Eric Schirm; Hilde Tobi; Eugène P. van Puijenbroek; Margje H. Monster-Simons; Lolkje T. W. de Jong-van den Berg

    2004-01-01

    SUMMARY Purpose The interpretation of the available studies on adverse drug reactions (ADRs) in children outside the hospital is hampered because none of these studies used a control group. The aim of this study was to describe ADRs in children outside the hospital, controlled for drug use in the paediatric background population. Methods Using a case-control design, we compared drugs

  7. ADRTrace: Detecting Expected and Unexpected Adverse Drug Reactions from User Reviews on Social Media Sites

    E-print Network

    " and "arthral- gia" refer to the same ADR). Our contributions are: (1) creating an annotated breast cancer drug for five commonly used breast cancer drugs: Anastro- zole, Exemestane, Letrozole, Raloxifene, and TamoxifenADRTrace: Detecting Expected and Unexpected Adverse Drug Reactions from User Reviews on Social

  8. Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998–2005

    PubMed Central

    Patel, Hitesh; Bell, Derek; Molokhia, Mariam; Srishanmuganathan, Janakan; Patel, Mitesh; Car, Josip; Majeed, Azeem

    2007-01-01

    Background Adverse drug reactions (ADRs) are a frequent cause of mortality and morbidity to patients worldwide, with great associated costs to the healthcare providers including the NHS in England. We examined trends in hospital admissions associated with adverse drug reaction in English hospitals and the accuracy of national reporting. Methods Data from the Hospital Episode Statistics database (collected by the Department of Health) was obtained and analysed for all English hospital episodes (1998–2005) using ICD-10 codes with a primary (codes including the words ('drug-induced' or 'due to') or secondary diagnosis of ADR (Y40–59). More detailed analysis was performed for the year 2004–2005 Results Between 1998 and 2005 there were 447 071 ADRs representing 0.50% of total hospital episodes and over this period the number of ADRs increased by 45%. All ADRs with an external code increased over this period. In 2005 the total number of episodes (all age groups) was 13,706,765 of which 76,692 (0.56%) were drug related. Systemic agents, which include anti-neoplastic drugs, were the most implicated class (15.7%), followed by analgesics (11.7%) and cardiovascular drugs (10.1%). There has been a 6 fold increase in nephropathy secondary to drugs and a 65% decline in drug induced extra-pyramidal side effects. 59% of cases involving adverse drug reactions involved patients above 60 years of age. Conclusion ADRs have major public health and economic implications. Our data suggest that national Hospital Episode Statistics in England have recognised limitations and that consequently, admissions associated with adverse drug reactions continue to be under-recorded. External causes of ADR have increased at a greater rate than the increase in total hospital admissions. Improved and more detailed reporting combined with educational interventions to improve the recording of ADRs are needed to accurately monitor the morbidity caused by ADRs and to meaningfully evaluate national initiatives to reduce adverse drug reactions. PMID:17894876

  9. A method for post-marketing screening of adverse reactions to drugs: initial results.

    PubMed

    Knapp, D E; Zax, B B; Rossi, A C; O'Neill, R T

    1980-01-01

    The FDA is pilot-testing a methodology for signaling previously unsuspected relationships between drugs and important adverse events. This method uses data it receives through the FDA spontaneous reporting program. Reviewing drugs used primarily on an outpatient basis, this screening methodology focuses on "tracer" adverse events and the organization of these reactions into body/functional systems. This review process enables a clinical evaluator to perceive more easily the clinically important drug-adverse event patterns. The method can incorporate drug use data; this enables a drug's proportional share of specific adverse events, relative to its therapeutic class, to be compared to its respective proportional share of drug use. The assumption is that the adverse event distribution of drugs in a therapeutic class should be the same as the distribution of drug use in that class, if all drugs in the class were to carry the same risk. Actual examples of drug-adverse event associations signaled by the screening method are presented. The potential uses of this methodology in other settings, and under other data situations, are discussed. PMID:10245773

  10. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

    PubMed Central

    Moore, Nicholas; Pollack, Charles; Butkerait, Paul

    2015-01-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC) analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs) including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs) between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available.

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

    PubMed Central

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

    2012-01-01

    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

  12. Incidence and types of preventable adverse events in elderly patients: population based review of medical records

    Microsoft Academic Search

    Eric J Thomas; Troyen A Brennan

    2000-01-01

    Objective To determine the incidence and types of preventable adverse events in elderly patients. Design Review of random sample of medical records in two stage process by nurses and physicians to detect adverse events. Two study investigators then judged preventability. Setting Hospitals in US states of Utah and Colorado, excluding psychiatric and Veterans Administration hospitals. Subjects 15 000 hospitalised patients

  13. Adverse effects of ?-Blocker therapy for patients with heart failure: A quantitative overview of randomized trials

    Microsoft Academic Search

    Dennis T. Ko; Patricia R. Hebert; Christopher S. Coffey

    2004-01-01

    Background: -Blockers substantially improve sur- vival in patients with chronic heart failure (HF) with left ventricular systolic dysfunction, but concerns about car- diovascular adverse effects may deter physicians from pre- scribing this therapy. We performed an overview of ran- domized-blocker trials in patients with HF to quantify the risks of these adverse effects. Methods: Heart failure trials of -blockers were

  14. Variation in GNB3 predicts response and adverse reactions to antidepressants

    Microsoft Academic Search

    Robert Keers; Cristian Bonvicini; Catia Scassellati; Rudolf Uher; Anna Placentino; Caterina Giovannini; Marcella Rietschel; Neven Henigsberg; Dejan Kozel; Ole Mors; Wolfgang Maier; Joanna Hauser; Daniel Souery; Julien Mendlewicz; Christine Schmäl; Astrid Zobel; Erik R Larsen; Aleksandra Szczepankiewicz; Zrnka Kovacic; Amanda Elkin; Ian Craig; Peter McGuffin; Anne E Farmer; Katherine J Aitchison; Massimo Gennarelli

    2011-01-01

    There is substantial inter-individual variation in response and adverse reactions to antidepressants, and genetic variation may, in part, explain these differences. GNB3 encodes the ?3 subunit of the G protein complex, which is involved in the downstream signalling cascade following monoamine receptor activation. A functional polymorphism in this gene (C825T) has been associated with response to antidepressants. Several lines of

  15. Detection and incidence of muscular adverse drug reactions: a prospective analysis from laboratory signals

    Microsoft Academic Search

    A. Dugué; H. Bagheri; M. Lapeyre-Mestre; J. F. Tournamille; L. Sailler; G. Dedieu; R. Salvayre; J. P. Thouvenot; P. Massip; J. L. Montastruc

    2004-01-01

    Aims The awareness of muscular adverse drug reactions (ADRs) increased since the withdrawal of cerivastatin, a HMG-CoA reductase inhibitor, from the market in August 2001. Our objectives were to assess the detection and incidence of muscular ADRs in a University Hospital using biochemical laboratory data and to evaluate the underreporting rate of drug-induced muscular disorders. Methods A prospective study was

  16. Reported adverse food reactions overestimate true food allergy in the community

    Microsoft Academic Search

    RK Woods; RM Stoney; J Raven; EH Walters; M Abramson; FCK Thien

    2002-01-01

    Objective: To determine the extent to which perceived adverse food reactions were associated with IgE mediated food allergy, as defined by skin prick testing (SPT).Design: A cohort epidemiological study. Participants underwent SPT to five common food allergens (cow's milk, peanut mix, egg white, shrimp and whole grain wheat mix) and were asked whether they had ever suffered any food ‘illness\\/trouble’,

  17. Adverse drug reactions in childhood: a review of prospective studies and safety alerts

    Microsoft Academic Search

    A Clavenna; M Bonati

    2009-01-01

    Objective:To assess the incidence of adverse drug reactions (ADRs) in the paediatric population and the safety alerts concerning children and adolescents issued by international drug regulatory agencies since 2001.Methods:A bibliographic search was performed in the Medline and Embase databases for prospective studies published between January 2001 and December 2007 evaluating the ADR incidence in the paediatric population. Data were analysed

  18. Internally-Developed Online Adverse Drug Reaction and Medication Error Reporting Systems

    Microsoft Academic Search

    Kelly M. Smith; Philip J. Trapskin; Philip E. Empey; Keith A. Hecht; John A. Armitstead

    2006-01-01

    Online reporting systems for adverse drug reaction (ADR) and medication error (ME) reporting were developed at the University of Kentucky Chandler Medical Center. Collaboration between Phar- macy Services, Information Services, and the Drug Information Center resulted in the creation of two stand-alone systems that input data directly into centrally-stored databases. Web forms were designed using Web-authoring tools, as well as

  19. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India

    PubMed Central

    Sharma, Ajitha; Kumari, K. Meena; Manohar, Hasitha Diana; Bairy, K. L.; Thomas, Joseph

    2015-01-01

    Purpose: Studies regarding pattern of adverse drug reactions (ADRs) in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. Materials and Methods: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO) causality assessment scale and Naranjo's algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. Results: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%), nausea/vomiting (21.6%) and febrile neutropenia (13%). Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be “probable” and 35% to be “possible”, while Naranjo's algorithm indicated that 65.6% of ADRs were “probable” and 34.4% were “possible”. Modified Hartwig and Siegel scale showed most reactions (41.4%) to be of “moderate level 4(a)” severity, while 30.6% of reactions were of “mild level 1” severity. About 30.8% of the ADRs were “definitely preventable” according to the modified Schumock and Thornton scale. Conclusion: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased. PMID:25878957

  20. Recent advances of pharmacogenomics in severe cutaneous adverse reactions: immune and nonimmune mechanisms.

    PubMed

    Dao, Ro-Lan; Su, Shih-Chi; Chung, Wen-Hung

    2015-04-01

    Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) are severe cutaneous adverse reactions (SCAR) which are majorly caused by drugs. Though the incidence rate is low, SCAR sometimes can be life-threatening and leads to lifelong sequelae. Many pharmacogenomic associations in immune and nonimmune related genes with the development of SCAR have been discovered recently and the pharmacogenetic tests have been applied to prevent specific drug-induced SCAR. In this review, we discuss the recent advances of pharmacogenomics in SCAR. PMID:25938070

  1. Effect of the UK’s revised paracetamol poisoning management guidelines on admissions, adverse reactions and costs of treatment

    PubMed Central

    Bateman, D Nicholas; Carroll, Robert; Pettie, Janice; Yamamoto, Takahiro; Elamin, Muhammad E M O; Peart, Lucy; Dow, Margaret; Coyle, Judy; Cranfield, Kristina R; Hook, Christopher; Sandilands, Euan A; Veiraiah, Aravindan; Webb, David; Gray, Alasdair; Dargan, Paul I; Wood, David M; Thomas, Simon H L; Dear, James W; Eddleston, Michael

    2014-01-01

    Aims In September 2012 the UK’s Commission on Human Medicines (CHM) recommended changes in the management of paracetamol poisoning: use of a single ‘100 mg l?1’ nomogram treatment line, ceasing risk assessment, treating all staggered/uncertain ingestions and increasing the duration of the initial acetylcysteine (NAC) infusion from 15 to 60 min. We evaluated the effect of this on presentation, admission, treatment, adverse reactions and costs of paracetamol poisoning. Methods Data were prospectively collected from adult patients presenting to three large UK hospitals from 3 September 2011 to 3 September 2013 (year before and after change). Infusion duration effect on vomiting and anaphylactoid reactions was examined in one centre. A cost analysis from an NHS perspective was performed for 90 000 patients/annum with paracetamol overdose. Results There were increases in the numbers presenting to hospital (before 1703, after 1854; increase 8.9% [95% CI 1.9, 16.2], P = 0.011); admitted (1060/1703 [62.2%] vs. 1285/1854 [69.3%]; increase 7.1% [4.0, 10.2], P < 0.001) and proportion treated (626/1703 [36.8%] vs. 926/1854 [50.0%]; increase: 13.2% [95% CI 10.0, 16.4], P < 0.001). Increasing initial NAC infusion did not change the proportion of treated patients developing adverse reactions (15 min 87/323 [26.9%], 60 min 145/514 [28.2%]; increase: 1.3% [95% CI –4.9, 7.5], P = 0.682). Across the UK the estimated cost impact is £8.3 million (6.4 million–10.2 million) annually, with a cost-per-life saved of £17.4 million (13.4 million–21.5 million). Conclusions The changes introduced by the CHM in September 2012 have increased the numbers of patients admitted to hospital and treated with acetylcysteine without reducing adverse reactions. A safety and cost-benefit review of the CHM guidance is warranted, including novel treatment protocols and biomarkers in the assessment of poisoning. PMID:24666324

  2. Harvesting Candidate Genes Responsible for Serious Adverse Drug Reactions from a Chemical-Protein Interactome

    PubMed Central

    Yang, Lun; Chen, Jian; He, Lin

    2009-01-01

    Identifying genetic factors responsible for serious adverse drug reaction (SADR) is of critical importance to personalized medicine. However, genome-wide association studies are hampered due to the lack of case-control samples, and the selection of candidate genes is limited by the lack of understanding of the underlying mechanisms of SADRs. We hypothesize that drugs causing the same type of SADR might share a common mechanism by targeting unexpectedly the same SADR-mediating protein. Hence we propose an approach of identifying the common SADR-targets through constructing and mining an in silico chemical-protein interactome (CPI), a matrix of binding strengths among 162 drug molecules known to cause at least one type of SADR and 845 proteins. Drugs sharing the same SADR outcome were also found to possess similarities in their CPI profiles towards this 845 protein set. This methodology identified the candidate gene of sulfonamide-induced toxic epidermal necrolysis (TEN): all nine sulfonamides that cause TEN were found to bind strongly to MHC I (Cw*4), whereas none of the 17 control drugs that do not cause TEN were found to bind to it. Through an insight into the CPI, we found the Y116S substitution of MHC I (B*5703) enhances the unexpected binding of abacavir to its antigen presentation groove, which explains why B*5701, not B*5703, is the risk allele of abacavir-induced hypersensitivity. In conclusion, SADR targets and the patient-specific off-targets could be identified through a systematic investigation of the CPI, generating important hypotheses for prospective experimental validation of the candidate genes. PMID:19629158

  3. Clinical Analysis of Adverse Drug Reactions between Vincristine and Triazoles in Children with Acute Lymphoblastic Leukemia.

    PubMed

    Yang, Lihua; Yu, Lihua; Chen, Xinxin; Hu, Yanqun; Wang, Bin

    2015-01-01

    BACKGROUND Vincristine (VCR) is a major chemotherapy drug for treatment of childhood acute lymphoblastic leukemia (ALL). Triazole antifungal drugs (AFD) are the main agents for the prevention/treatment of invasive fungal infection (IFI), a common complication during the treatment of ALL. This study investigated the adverse drug reactions (ADRs) between VCR and AFD. MATERIAL AND METHODS A retrospective study was performed on 68 children with ALL (39 boys and 29 girls, median age: 5 years) who were treated with VCR chemotherapy (a total of 136 cases, including both induction and reinduction phases) from January 2012 to December 2013 in our hospital. These cases were divided into 4 groups: the control group without AFD prevention/treatment (n=44), the Itra group receiving itraconazole oral solution (n=44), the Fluc group receiving intravenous fluconazole (n=42), and the Vori group receiving voriconazole oral tablets (n=6). The ADRs in each group was recorded and compared. RESULTS The incidence of ADRs in the Itra and Vori groups were significantly higher compared with the Fluc and the control group (P<0.05). The incidence of ADRs in the Itra group was significantly higher than that in the Vori group, whereas there was no difference in the incidence between the Fluc and control group. CONCLUSIONS Given the lower incidence of ADRs between VCR and fluconazole compared with voriconazole or itraconazole, it is relatively safer to use fluconazole in ALL patients receiving VCR chemotherapy. The occurrence of ADRs should be closely monitored when triazoles must be administered concomitantly with VCR. PMID:26050202

  4. Clinical Analysis of Adverse Drug Reactions between Vincristine and Triazoles in Children with Acute Lymphoblastic Leukemia

    PubMed Central

    Yang, Lihua; Yu, Lihua; Chen, Xinxin; Hu, Yanqun; Wang, Bin

    2015-01-01

    Background Vincristine (VCR) is a major chemotherapy drug for treatment of childhood acute lymphoblastic leukemia (ALL). Triazole antifungal drugs (AFD) are the main agents for the prevention/treatment of invasive fungal infection (IFI), a common complication during the treatment of ALL. This study investigated the adverse drug reactions (ADRs) between VCR and AFD. Material/Methods A retrospective study was performed on 68 children with ALL (39 boys and 29 girls, median age: 5 years) who were treated with VCR chemotherapy (a total of 136 cases, including both induction and reinduction phases) from January 2012 to December 2013 in our hospital. These cases were divided into 4 groups: the control group without AFD prevention/treatment (n=44), the Itra group receiving itraconazole oral solution (n=44), the Fluc group receiving intravenous fluconazole (n=42), and the Vori group receiving voriconazole oral tablets (n=6). The ADRs in each group was recorded and compared. Results The incidence of ADRs in the Itra and Vori groups were significantly higher compared with the Fluc and the control group (P<0.05). The incidence of ADRs in the Itra group was significantly higher than that in the Vori group, whereas there was no difference in the incidence between the Fluc and control group. Conclusions Given the lower incidence of ADRs between VCR and fluconazole compared with voriconazole or itraconazole, it is relatively safer to use fluconazole in ALL patients receiving VCR chemotherapy. The occurrence of ADRs should be closely monitored when triazoles must be administered concomitantly with VCR. PMID:26050202

  5. Factors Associated with the Reporting of Adverse Drug Reactions by Health Workers in Nnewi Nigeria

    PubMed Central

    Ezeuko, Amaka Y.; Ebenebe, Uzo E.; Nnebue, Chinomnso C; Ugoji, John O.

    2015-01-01

    Background: Under-reporting of adverse drug reactions (ADRs) by the prescribers is a common public health problem. Monitoring of factors that influence ADR reporting will reduce risks associated with drug use; improve patients care, safety and treatment outcome. The aim of this study was to determine the factors associated with the reporting of ADRs by health workers in Nnewi Nigeria. Methods: A cross-sectional study of 372 health workers in different health facilities in Nnewi North Local Government Area of Anambra state, selected using multistage sampling technique was done. Data collection employed pretested, self-administered structured questionnaires. Data were analyzed using Statistical Package for Social Sciences version 17. Tests of statistical significance were carried out using Chi-square tests for proportions. A P < 0.05 was considered significant. Results: Out of the 372 respondents studied, 255 (68.5%) were females, and 117 (31.5%) were males. The modal age range (37.6%) was 31–40 years. Factors related by the respondents to influence ADR reporting include: Unavailability of electronic reporting (83.6%), unavailability of reporting forms (66.4%) and ignorance (58.2%). The difference among medical practitioners who related unavailability of electronic reporting process as obstacle to ADR reporting was not significant (P = 0.18). Conclusions: The study results revealed the factors associated with the reporting of ADRs among health workers in Nnewi Nigeria. It is desirable to initiate electronic reporting process, training programs on ADR reporting and make reporting forms/guidelines available to relevant health workers. PMID:25949775

  6. Large-scale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs

    PubMed Central

    Liu, Mei; Wu, Yonghui; Chen, Yukun; Sun, Jingchun; Zhao, Zhongming; Chen, Xue-wen; Matheny, Michael Edwin

    2012-01-01

    Objective Adverse drug reaction (ADR) is one of the major causes of failure in drug development. Severe ADRs that go undetected until the post-marketing phase of a drug often lead to patient morbidity. Accurate prediction of potential ADRs is required in the entire life cycle of a drug, including early stages of drug design, different phases of clinical trials, and post-marketing surveillance. Methods Many studies have utilized either chemical structures or molecular pathways of the drugs to predict ADRs. Here, the authors propose a machine-learning-based approach for ADR prediction by integrating the phenotypic characteristics of a drug, including indications and other known ADRs, with the drug's chemical structures and biological properties, including protein targets and pathway information. A large-scale study was conducted to predict 1385 known ADRs of 832 approved drugs, and five machine-learning algorithms for this task were compared. Results This evaluation, based on a fivefold cross-validation, showed that the support vector machine algorithm outperformed the others. Of the three types of information, phenotypic data were the most informative for ADR prediction. When biological and phenotypic features were added to the baseline chemical information, the ADR prediction model achieved significant improvements in area under the curve (from 0.9054 to 0.9524), precision (from 43.37% to 66.17%), and recall (from 49.25% to 63.06%). Most importantly, the proposed model successfully predicted the ADRs associated with withdrawal of rofecoxib and cerivastatin. Conclusion The results suggest that phenotypic information on drugs is valuable for ADR prediction. Moreover, they demonstrate that different models that combine chemical, biological, or phenotypic information can be built from approved drugs, and they have the potential to detect clinically important ADRs in both preclinical and post-marketing phases. PMID:22718037

  7. Perioperative Hyperglycemia and Risk of Adverse Events Among Patients With and Without Diabetes

    PubMed Central

    Kotagal, Meera; Symons, Rebecca G.; Hirsch, Irl B.; Umpierrez, Guillermo E.; Dellinger, E. Patchen; Farrokhi, Ellen T.; Flum, David R.

    2014-01-01

    Objective To study the association between diabetes status, perioperative hyperglycemia, and adverse events in a statewide surgical cohort. Background Perioperative hyperglycemia may increase the risk of adverse events more significantly in patients without diabetes (NDM) than in those with diabetes (DM). Methods Using data from the Surgical Care and Outcomes Assessment Program, a cohort study (2010–2012) evaluated diabetes status, perioperative hyperglycemia, and composite adverse events in abdominal, vascular, and spine surgery at 53 hospitals in Washington State. Results Among 40,836 patients (mean age, 54 years; 53.6% women), 19% had diabetes; 47% underwent a perioperative blood glucose (BG) test, and of those, 18% had BG ?180 mg/dL. DM patients had a higher rate of adverse events (12% vs 9%, P < 0.001) than NDM patients. After adjustment, among NDM patients, those with hyperglycemia had an increased risk of adverse events compared with those with normal BG. Among NDM patients, there was a dose-response relationship between the level of BG and composite adverse events [odds ratio (OR), 1.3 for BG 125–180 (95% confidence interval (CI), 1.1–1.5); OR, 1.6 for BG ?180 (95% CI, 1.3–2.1)]. Conversely, hyperglycemic DM patients did not have an increased risk of adverse events, including those with a BG 180 or more (OR, 0.8; 95% CI, 0.6–1.0). NDM patients were less likely to receive insulin at each BG level. Conclusions For NDM patients, but not DM patients, the risk of adverse events was linked to hyperglycemia. Underlying this paradoxical effect may be the underuse of insulin, but also that hyperglycemia indicates higher levels of stress in NDM patients than in DM patients. PMID:25133932

  8. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors

    PubMed Central

    2013-01-01

    Background Transport of critically ill patients for diagnostic or therapeutic procedures is at risk of complications. Adverse events during transport are common and may have significant consequences for the patient. The objective of the study was to collect prospectively adverse events that occurred during intrahospital transports of critically ill patients and to determine their risk factors. Methods This prospective, observational study of intrahospital transport of consecutively admitted patients with mechanical ventilation was conducted in a 38-bed intensive care unit in a university hospital from May 2009 to March 2010. Results Of 262 transports observed (184 patients), 120 (45.8%) were associated with adverse events. Risk factors were ventilation with positive end-expiratory pressure >6 cmH2O, sedation before transport, and fluid loading for intrahospital transports. Within these intrahospital transports with adverse events, 68 (26% of all intrahospital transports) were associated with an adverse event affecting the patient. Identified risk factors were: positive end-expiratory pressure >6 cmH2O, and treatment modification before transport. In 44 cases (16.8% of all intrahospital transports), adverse event was considered serious for the patient. In our study, adverse events did not statistically increase ventilator-associated pneumonia, time spent on mechanical ventilation, or length of stay in the intensive care unit. Conclusions This study confirms that the intrahospital transports of critically ill patients leads to a significant number of adverse events. Although in our study adverse events have not had major consequences on the patient stay, efforts should be made to decrease their incidence. PMID:23587445

  9. Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors Engineering Approach

    Microsoft Academic Search

    Laura Lin; Kim J. Vicente; D. John Doyle

    2001-01-01

    Adverse drug events are the single leading threat to patient safety. Human factors engineering has been repeatedly proposed, but largely untested, as the key to improving patient safety. The value of this approach was investigated in the context of a commercially available patient-controlled analgesia device that has been linked with several alleged patient injuries and deaths. Several reports have stated

  10. Identification of allergens responsible for canine cutaneous adverse food reactions to lamb, beef and cow's milk.

    PubMed

    Martín, Aurea; Sierra, María-Paz; González, José L; Arévalo, María-Angeles

    2004-12-01

    Lamb, beef and cow's milk are common causes of cutaneous adverse food reactions in dogs. The aim of this study was to identify the proteins responsible for cutaneous adverse reactions to these foods. Ten dogs with allergen-specific serum immunoglobulin (Ig)E to lamb, beef and cow's milk were included in the study. These dogs had been diagnosed with cutaneous adverse food reactions by convincing clinical history and food-elimination diet trials followed by challenge exposure. Sera were analysed by enzyme-linked immunosorbent assay with bovine proteins and SDS-PAGE immunoblots with lamb, beef and cow's milk extracts. All the dogs had specific IgE against bovine IgG, and it was the only protein in the cow's milk extract that bound IgE from the sera studied. In the lamb and beef extracts, the major allergens recognized by the specific IgE of most sera had molecular masses between 51 and 58 kDa, which were identified as phosphoglucomutase and the IgG heavy chain. Other IgE-binding proteins with molecular masses of 27, 31, 33, 37 and 42 kDa were also detected with some sera. Our results indicate that bovine IgG is a major allergen in cow's milk and hence it appears to be a source of cross-reactivity with beef and probably with lamb because of the high homology with ovine immunoglobulins. These results are similar to those found for meat allergy in humans. However, this is the first time that phosphoglucomutase has been identified as an important allergen involved in allergic reactions to lamb and beef. PMID:15585009

  11. Clinical pharmacy services, pharmacy staffing, and adverse drug reactions in United States hospitals.

    PubMed

    Bond, C A; Raehl, Cynthia L

    2006-06-01

    Adverse drug reactions (ADRs) were examined in 1,960,059 hospitalized Medicare patients in 584 United States hospitals in 1998. A database was constructed from the MedPAR database and the National Clinical Pharmacy Services survey. The 584 hospitals were selected because they provided specific information on 14 clinical pharmacy services and on pharmacy staffing; they also had functional ADR reporting systems. The study population consisted of 35,193 Medicare patients who experienced an ADR (rate of 1.8%). Of the 14 clinical pharmacy services, 12 were associated with reduced ADR rates. The most significant reductions occurred in hospitals offering pharmacist-provided admission drug histories (odds ratio [OR] 1.864, 95% confidence interval [CI] 1.765-1.968), drug protocol management (OR 1.365, 95% CI 1.335-1.395), and ADR management (OR 1.360, 95% CI 1.328-1.392). Multivariate analysis, performed to further evaluate these findings, showed that nine variables were associated with ADR rate: pharmacist-provided in-service education (slope -0.469, p=0.018), drug information (slope -0.488, p=0.005), ADR management (slope -0.424, p=0.021), drug protocol management (slope -0.732, p=0.002), participation on the total parenteral nutrition team (slope 0.384, p=0.04), participation on the cardiopulmonary resuscitation team (slope -0.506, p=0.008), medical round participation (slope -0.422, p=0.037), admission drug histories (slope -0.712, p=0.008), and increased clinical pharmacist staffing (slope -4.345, p=0.009). As clinical pharmacist staffing increased from the 20th to the 100th percentile (from 0.93+/-0.77/100 to 5.16+/-4.11/100 occupied beds), ADRs decreased by 47.88%. In hospitals without pharmacist-provided ADR management, the following increases were noted: mean number of ADRs/100 admissions by 34.90% (OR 1.360, 95% CI 1.328-1.392), length of stay 13.64% (Mann-Whitney U test [U]=11047367, p=0.017), death rate 53.64% (OR 1.574, 95% CI 1.423-1.731), total Medicare charges 6.88% (U=111298871, p=0.018), and drug charges 8.16% (U=108979074, p<0.001). Patients in hospitals without pharmacist-provided ADR management had an excess of 4266 ADRs, 443 deaths, 85,554 patient-days, $11,745,342 in total Medicare charges, and $1,857,744 in drug charges. The implications of these findings are significant for our health care system, especially considering that the study population represented 15.55% of 12,261,737 Medicare patients and 5.71% of the 34,345,436 patients admitted to all U.S. hospitals. PMID:16716127

  12. Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

    PubMed Central

    Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-01-01

    Aim: The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). Methodology: A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Results: Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. Conclusion: The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting will add more benefits to the existing programmes in Malaysia, although the barrier that we are facing now is the doubt that they hold over patients’ ability to write valid reports which are similar to reports which are made by healthcare professionals (HCPs). Therefore, the consumers need to be educated more about their medications, on how to validate any complaints that they had about the drug consumption and on how to file a proper report and channel it to the ‘right’ person or bodies. Equally importantly, the media and the non-governmental organizations (NGOs) should play an important role in determining the success of consumer reporting. PMID:24298470

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

    PubMed Central

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

    2014-01-01

    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

  14. A potential causal association mining algorithm for screening adverse drug reactions in postmarketing surveillance.

    PubMed

    Ji, Yanqing; Ying, Hao; Dews, Peter; Mansour, Ayman; Tran, John; Miller, Richard E; Massanari, R Michael

    2011-05-01

    Early detection of unknown adverse drug reactions (ADRs) in postmarketing surveillance saves lives and prevents harmful consequences. We propose a novel data mining approach to signaling potential ADRs from electronic health databases. More specifically, we introduce potential causal association rules (PCARs) to represent the potential causal relationship between a drug and ICD-9 (CDC. (2010). International Classification of Diseases, Ninth Revision (ICD-9). [Online]. Available: http://www.cdc.gov/nchs/icd/icd9.html) coded signs or symptoms representing potential ADRs. Due to the infrequent nature of ADRs, the existing frequency-based data mining methods cannot effectively discover PCARs. We introduce a new interestingness measure, potential causal leverage, to quantify the degree of association of a PCAR. This measure is based on the computational, experience-based fuzzy recognition-primed decision (RPD) model that we developed previously (Y. Ji, R. M. Massanari, J. Ager, J. Yen, R. E. Miller, and H. Ying, "A fuzzy logic-based computational recognition-primed decision model," Inf. Sci., vol. 177, pp. 4338-4353, 2007) on the basis of the well-known, psychology-originated qualitative RPD model (G. A. Klein, "A recognition-primed decision making model of rapid decision making," in Decision Making in Action: Models and Methods, 1993, pp. 138-147). The potential causal leverage assesses the strength of the association of a drug-symptom pair given a collection of patient cases. To test our data mining approach, we retrieved electronic medical data for 16,206 patients treated by one or more than eight drugs of our interest at the Veterans Affairs Medical Center in Detroit between 2007 and 2009. We selected enalapril as the target drug for this ADR signal generation study. We used our algorithm to preliminarily evaluate the associations between enalapril and all the ICD-9 codes associated with it. The experimental results indicate that our approach has a potential to better signal potential ADRs than risk ratio and leverage, two traditional frequency-based measures. Among the top 50 signal pairs (i.e., enalapril versus symptoms) ranked by the potential causal-leverage measure, the physicians on the project determined that eight of them probably represent true causal associations. PMID:21435986

  15. Adverse Reactions to Field Vaccination Against Lumpy Skin Disease in Jordan.

    PubMed

    Abutarbush, S M; Hananeh, W M; Ramadan, W; Al Sheyab, O M; Alnajjar, A R; Al Zoubi, I G; Knowles, N J; Bachanek-Bankowska, K; Tuppurainen, E S M

    2014-08-01

    Lumpy skin disease (LSD) is an emerging disease in the Middle East region and has been recently reported in Jordan. The aim of this study was to investigate the adverse reactions that were reported after vaccine administration. Geographical areas enrolled in the study were free of the disease and away from the outbreak governorate. Sixty-three dairy cattle farms, with a total of 19,539 animals, were included in the study. Of those, 56 farms reported adverse clinical signs after vaccine administration. The duration between vaccine administration and appearance of adverse clinical signs ranged from 1 to 20 days (Mean = 10.3, SD ± 3.9). Clinical signs were similar to those observed with natural cases of lumpy skin disease. These were mainly fever, decreased feed intake, decreased milk production and variable sized cutaneous nodules (a few millimetres to around 2 cm in diameter) that could be seen anywhere on the body (head, neck, trunk, perineum), udder, and/or teats. Nodules were raised and firm initially and then formed dry scabs that could be peeled off the skin. The characteristic deep 'sit fast' appearance was rarely seen and most lesions were superficial. Some cattle had swollen lymph nodes, while a few pregnant animals aborted. The percentage of affected cattle ranged from 0.3 to 25% (Mean = 8, SD ± 5.1). Fever, decreased feed intake, and decreased milk production were seen in 83.9, 85.7, and 94.6% in cattle on the affected farms, respectively. All affected cattle displayed skin nodules over their entire bodies, while 33.9 and 7.1% of the affected farms reported nodular lesions present on the udders and teats, respectively. No mortalities were reported due to vaccine adverse reactions. Duration (course) of clinical signs ranged from 3 to 20 days (Mean = 13.7, SD ± 4.1). Two types of LSD vaccines were used by the farmers in this study. The first one was a sheep pox virus (SPPV) vaccine derived from the RM65 isolate [Jovivac(®) , manufactured by Jordan Bioindustries Centre (JOVAC)] and the other an unlabelled one, which was later identified using PCR as a strain of lumpy skin disease virus (LSDV). Blood and skin samples collected from cattle vaccinated with the LSDV vaccine were positive for LSDV using both general and species-specific PCR primers, whereas those from cattle vaccinated with the Jovivac(®) vaccine were negative. Adverse reactions observed in cattle after administration of the LSDV vaccine were reported to be more severe than those seen after Jovivac(®) vaccine administration and were comparable with clinical signs observed in natural infections. PMID:25098267

  16. Postmarketing surveillance of adverse drug reactions in general practice. II: Prescription-event monitoring at the University of Southampton

    Microsoft Academic Search

    W H Inman

    1981-01-01

    An independent, non-regulatory drug surveillance research unit has been established at the University of Southampton. Its first task will be to set up a prescription-event monitoring scheme in general practice to enable the pattern of adverse events, as distinct from suspected adverse reactions associated with new drugs to be compared with that of older medicines. Prescriptions for selected drugs will

  17. Adverse tissue reactions in modular exchangeable neck implants: a report of two cases.

    PubMed

    Werner, S Douglas; Bono, James V; Nandi, Sumon; Ward, Daniel M; Talmo, Carl T

    2013-03-01

    Dual-modular femoral stems with exchangeable necks theoretically allow optimization of hip joint biomechanics via selective restoration of femoral anteversion, offset, and limb length. A potential disadvantage is the possible generation of metal ions and debris by fretting and crevice corrosion at the additional stem-neck interface. We present 2 cases of early-onset adverse inflammatory tissue reactions as a result of accelerated corrosion at the stem-neck interface of a dual-modular implant, requiring subsequent revision of well-fixed components. PMID:23141863

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

    PubMed Central

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

    2014-01-01

    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

  19. Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*

    PubMed Central

    Santini, Valeria; Fenaux, Pierre; Mufti, Ghulam J.; Hellström-Lindberg, Eva; Silverman, Lewis R.; List, Alan; Gore, Steven D.; Seymour, John F.; Backstrom, Jay; Beach, Charles L.

    2013-01-01

    Objective Myelodysplastic syndrome (MDS) treatment can initially worsen patients’ clinical condition and they may discontinue therapy before achieving benefit. We present previously unpublished data from two large phase III trials describing common adverse events (AEs) associated with azacitidine and methods to manage them. Methods In the Cancer and Leukemia Group B (CALGB) 9221 study, patients with any French-American-British (FAB) subtype of MDS were randomized to azacitidine or best supportive care (BSC). After 56 d, patients randomized to BSC with disease progression could cross over to receive azacitidine. In the AZA-001 study, patients with higher-risk MDS (FAB-defined refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocitic leukaemia and IPSS int-2 or high) were randomized to azacitidine or to conventional care regimens (CCR), which included low-dose ara-C, BSC, or intensive chemotherapy. In both studies, azacitidine dose was 75 mg/m2/d SC for 7 d every 28 d. AEs were graded per National Cancer Institute’s Common Toxicity Criteria version 2.0 (AZA-001) or CALGB Expanded CTC (CALGB 9221). Results In safety-evaluable patients in AZA-001 (N = 175) or CALGB 9221 (N = 150), the most common AEs with azacitidine included hematologic (eg, cytopenias) and non-hematologic administration-related events (eg, injection-site reactions and gastrointestinal disorders). Most AEs were transient and resolved during ongoing therapy (> 83%). Hematologic AEs, most frequently observed during early treatment cycles, decreased during subsequent cycles and were usually managed with dosing delays (23–29%). Gastrointestinal symptoms were primarily managed with anti-emetics and laxatives. Conclusion Hematologic and non-hematologic AEs with azacitidine decreased in frequency as treatment continued. Awareness of the onset, duration and management of AEs can facilitate treatment, permitting patients to continue therapy for maximum benefit. PMID:20394651

  20. Adverse effects of intravenous immunoglobulin therapy in patients with antibody deficiency.

    PubMed

    Aghamohammadi, Asghar; Farhoudi, A; Moin, M; Pourpak, Zahra; Rezaei, N; Nikzad, M; Movahedi, M; Gharagozlou, M; Atarod, Lida; Ahmadi Afshar, Akefeh; Bazargan, Nasrin; Abolmaali, K; Mahmoudi, Maryam

    2003-09-01

    Long-term intravenous immunoglobulin (IVIG) infusion is an effective treatment for children with humoral immunodeficiencies, already be complicated by systemic adverse effects. In order to determine the adverse effects of intravenous immunoglobulin in patients with antibody deficiency, 45 immunodeficient patients receiving intravenous immunoglobulin were studied during a 36 month period at Children's Medical Center. The investigated group included 25 patients with common variable immunodeficiency, 14 patients with X-linked agammaglobulinemia and 6 patients with IgG subclass deficiency. A total of fifty adverse effects occurred through 955 infusions (5.2%). The most frequent immediate adverse effects were mild (40 infusions out of 955) in 22 cases, including: chills, flushing, fever, nausea and headache. Three patients experienced moderate effects (10 infusions out of 955) such as rash, severe headache, joint pain and chest tightness. None of the effects was anaphylactic type. It can be concluded that intravenous immunoglobulin is generally a well-tolerated medical agent for patients with antibody deficiency, but all patients should be monitored by a physician who is familiar with its indications, risks, adverse effects and their appropriate management. PMID:17301367

  1. Addressing Psychosocial Adversity Within the Patient-Centered Medical Home: Expert-Created Measurable Standards.

    PubMed

    Bair-Merritt, Megan H; Mandal, Mahua; Garg, Arvin; Cheng, Tina L

    2015-08-01

    The Patient-Centered Medical Home (PCMH) may be improved by embedding identification and response for patients' experiences with psychosocial adversity, but how this might optimally occur in practice has not been well-specified. We sought input from an expert panel to define feasible elements that could adapt the PCMH to adequately respond to patients' experiences with psychosocial adversity. From December 2012 through September 2013, we used a Delphi process to systematically obtain expert opinions and reach consensus. We invited 37 experts to participate in three successive and iterative rounds of questionnaires, with each round based on aggregated, de-identified data from the prior round. We first asked experts to generate elements to adapt the PCMH, using the National Committee for Quality Assurance (NCQA's) established six PCMH standards as the foundation. We then asked the experts to rate these elements on a 5-point Likert scale, and finally specify what they considered the most and least valuable elements. Eighteen of the 37 (49 %) invited experts responded to the first survey, and constituted our sample. Experts identified 35 elements that fell under the six NCQA standards. The top rated elements included using a screening tool to identify adversity; training providers to address psychosocial adversity; having a team member with mental health expertise; providing culturally-competent care; and having written patient information related to adversity and coping. This study derived key elements that may enhance the PCMH's ability to improve patient outcomes by purposefully identifying and responding to their psychosocial adversity. PMID:25787893

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

    PubMed Central

    2013-01-01

    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

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

    PubMed Central

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

    2014-01-01

    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. PMID:25346917

  4. Adverse drug events in hospitalized patientsA comparison of doctors, nurses and patients as sources of reports

    Microsoft Academic Search

    P. M. L. A. van den Bemt; A. C. G. Egberts; A. W. Lenderink; J. M. Verzijl; K. A. Simons; W. S. C. J. M. van der Pol; H. G. M. Leufkens

    1999-01-01

    Objective: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients.\\u000a \\u000a \\u000a \\u000a Methods: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients)\\u000a of two peripheral hospitals in the Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse\\u000a reports) and by daily ward

  5. Psychiatric adverse events in patients with epilepsy and learning disabilities taking levetiracetam

    Microsoft Academic Search

    MARCO MULA; MICHAEL R TRIMBLE; JOSEMIR W. A. S SANDER

    2004-01-01

    Purpose: To investigate the prevalence and psychopathological features of psychiatric adverse events (PAEs) in patients with learning disabilities (LD) in therapy with levetiracetam (LEV).Method: From a population of 517 consecutively patients with epilepsy started on LEV, we identified 118 patients with epilepsy and LD.Results: Fifteen patients (12.7%) experienced PAEs during LEV therapy. Two (1.7%) developed an affective disorder, nine (7.6%)

  6. 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

    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

    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

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

    E-print Network

    Boyer, Edmond

    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

  8. Ibuprofen-Induced Hypokalemia and Distal Renal Tubular Acidosis: A Patient's Perceptions of Over-the-Counter Medications and Their Adverse Effects

    PubMed Central

    Salter, Mark D.

    2013-01-01

    We highlight a case of distal renal tubular acidosis secondary to ibuprofen and codeine use. Of particular interest in this case are the patient's perception of over-the-counter (OTC) medication use, her own OTC use prior to admission, and her knowledge of adverse reactions or side effects of these medications prior to taking them. PMID:24829833

  9. Adverse effects associated with the 577- and 585-nanometer pulsed dye laser in the treatment of cutaneous vascular lesions: A study of 500 patients

    Microsoft Academic Search

    Vicki J. Levine; Roy G. Geronemus

    1995-01-01

    Background:The flashlamp-pumped pulsed dye laser has been used in the treatment of cutaneous vascular disorders since 1986. Although this laser is now widely used for the treatment of port-wine stains, telangiectases, and hemangiomas, the incidence of adverse reactions has not been clearly defined in a large series of patients.

  10. Adverse effects of paclitaxel in patients with alcohol abuse histories.

    PubMed

    Henderson-Martin, B

    2000-01-01

    Paclitaxel is a taxane antineoplastic agent formulated in polyoxyethylated castor oil (Cremophor El) and dehydrated alcohol. This case report describes the development of central nervous system toxicity and threatened sobriety related to the alcohol content in a paclitaxel infusion. Nurses need to be aware of the alcohol contained in paclitaxel and other drugs used in oncology practice and document previous and current alcohol use prior to beginning therapy. Alternative chemotherapy regimens may need to be offered to patients with alcohol abuse histories. PMID:10865578

  11. Identifying plausible adverse drug reactions using knowledge extracted from the literature.

    PubMed

    Shang, Ning; Xu, Hua; Rindflesch, Thomas C; Cohen, Trevor

    2014-12-01

    Pharmacovigilance involves continually monitoring drug safety after drugs are put to market. To aid this process; algorithms for the identification of strongly correlated drug/adverse drug reaction (ADR) pairs from data sources such as adverse event reporting systems or Electronic Health Records have been developed. These methods are generally statistical in nature, and do not draw upon the large volumes of knowledge embedded in the biomedical literature. In this paper, we investigate the ability of scalable Literature Based Discovery (LBD) methods to identify side effects of pharmaceutical agents. The advantage of LBD methods is that they can provide evidence from the literature to support the plausibility of a drug/ADR association, thereby assisting human review to validate the signal, which is an essential component of pharmacovigilance. To do so, we draw upon vast repositories of knowledge that has been extracted from the biomedical literature by two Natural Language Processing tools, MetaMap and SemRep. We evaluate two LBD methods that scale comfortably to the volume of knowledge available in these repositories. Specifically, we evaluate Reflective Random Indexing (RRI), a model based on concept-level co-occurrence, and Predication-based Semantic Indexing (PSI), a model that encodes the nature of the relationship between concepts to support reasoning analogically about drug-effect relationships. An evaluation set was constructed from the Side Effect Resource 2 (SIDER2), which contains known drug/ADR relations, and models were evaluated for their ability to "rediscover" these relations. In this paper, we demonstrate that both RRI and PSI can recover known drug-adverse event associations. However, PSI performed better overall, and has the additional advantage of being able to recover the literature underlying the reasoning pathways it used to make its predictions. PMID:25046831

  12. Revised National Tuberculosis Control Program regimens with and without directly observed treatment, short-course: A comparative study of therapeutic cure rate and adverse reactions

    PubMed Central

    Sivaraj, Rengaraj; Umarani, Sivaraj; Parasuraman, Subramani; Muralidhar, Pyapti

    2014-01-01

    Objective: To compare the therapeutic cure rate and adverse reactions in the regimens of the Revised National Tuberculosis Control Program (RNTCP) with directly observed treatment, short-course (DOTS) and without DOTS. Materials and Methods: Fifty patients in the DOTS regimen and 50 patients in the non-DOTS regimen were enrolled in the study. All the participants were asked to come regularly for 3 consecutive days for sputum collection, and the sputum samples were examined for acid-fast bacilli. If tuberculosis (TB) was confirmed, the disease status was confirmed through a chest X-ray (PA view). The participants were monitored for adverse events arising from the use of anti-TB drugs for the next 6 months. Results: The TB cure rates for RNTCP with DOTS and RNTCP with non-DOTS were 80% and 66%, respectively. The DOTS therapy had a better cure rate for radiologically positive, sputum-positive cases compared with the non-DOTS regimen group. The non-DOTS treatment regimen had significantly increased numbers of adverse events in the hepatic and hematinic systems. Conclusion: The DOTS regimen has higher cure rates and a lower incidence of adverse reactions compared with the non-DOTS regimen. PMID:24551582

  13. Assessment of individual radiosensitivity in human lymphocytes of cancer patients and its correlation with adverse side effects to radiation therapy

    E-print Network

    Di Giorgio, M; Busto, E; Mairal, L; Menendez, P; Roth, B; Sardi, M; Taja, M R; Vallerga, M B

    2003-01-01

    Background and purpose: Individual radiosensitivity is an inherent characteristic, associated with an increased reaction to ionizing radiation on the human body. Biological endpoints such as clonogenic survival, chromosome aberration formation and repair capacity of radiation-induced damage have been applied to evaluate individual radiosensitivity in vitro. 5%-7% of cancer patients develop adverse side effects to radiation therapy in normal tissues within the treatment field, which are referred as 'clinical radiation reactions' and include acute effects, late effects and cancer induction. It has been hypothesized that the occurrence and severity of these reactions are mainly influenced by genetic susceptibility to radiation. Additionally, the nature of the genetic disorders associated with hypersensitivity to radiotherapy suggests that DNA repair mechanisms are involved. Consequently, the characterization of DNA repair in lymphocytes through cytokinesis blocked micronucleus (MN) and alkaline single-cell micro...

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

    Microsoft Academic Search

    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

    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

  15. Titanium Alloy Stem as a Cause for Adverse Reaction to Metal Debris after Bipolar Hemiarthroplasty

    PubMed Central

    Watanabe, Hitoshi; Kubosawa, Hitoshi

    2014-01-01

    A 68-year-old male with failure of bipolar hemiarthroplasty consistent with adverse reaction to metal debris (ARMD) who presented with a painful cystic lesion and lower extremity swelling was encountered. However, revision surgical findings showed no apparent cause of ARMD previously described in the literature, such as corrosion at the head-neck junction and articular abrasion. Therefore, it was difficult to make a definite diagnosis of failure secondary to ARMD, which consequently led to the decision to perform two-stage revision procedure, though the stem was firmly fixed. Postoperative analysis in the retrieval tissues showed that the metal debris mainly originated from the titanium alloy stem itself. Although this is a very rare case, one should be aware that even the well-fixed femoral components themselves have the potential to be the cause of ARMD. PMID:24716061

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

    PubMed Central

    Chung, Wen-Hung

    2014-01-01

    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

  17. Ci4SeR--curation interface for semantic resources--evaluation with adverse drug reactions.

    PubMed

    Souvignet, Julien; Asfari, Hadyl; Declerck, Gunnar; Lardon, Jérémy; Trombert-Paviot, Béatrice; Jaulent, Marie-Christine; Bousquet, Cédric

    2014-01-01

    Evaluation and validation have become a crucial problem for the development of semantic resources. We developed Ci4SeR, a Graphical User Interface to optimize the curation work (not taking into account structural aspects), suitable for any type of resource with lightweight description logic. We tested it on OntoADR, an ontology of adverse drug reactions. A single curator has reviewed 326 terms (1020 axioms) in an estimated time of 120 hours (2.71 concepts and 8.5 axioms reviewed per hour) and added 1874 new axioms (15.6 axioms per hour). Compared with previous manual endeavours, the interface allows increasing the speed-rate of reviewed concepts by 68% and axiom addition by 486%. A wider use of Ci4SeR would help semantic resources curation and improve completeness of knowledge modelling. PMID:25160157

  18. [Research on foreign countries laws and regulations on surveillance and reporting of postmarketing drugs adverse reactions].

    PubMed

    Tian, Feng; Xie, Yanming

    2009-06-01

    Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry. PMID:19771884

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

    PubMed Central

    Najam, Rahila; Mateen, Ahmed

    2013-01-01

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

  20. Adverse events in older patients undergoing ERCP: a systematic review and meta-analysis

    PubMed Central

    Day, Lukejohn W.; Lin, Lisa; Somsouk, Ma

    2014-01-01

    Background and study aims: Biliary and pancreatic diseases are common in the elderly; however, few studies have addressed the occurrence of adverse events in elderly patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Our objective was to determine the incidence rates of specific adverse events in this group and calculate incidence rate ratios (IRRs) for selected comparison groups. Patients and methods: Bibliographical searches were conducted in Medline, EMBASE, and Cochrane library databases. The studies included documented the incidence of adverse events (perforation, pancreatitis, bleeding, cholangitis, cardiopulmonary adverse events, mortality) in patients aged???65 who underwent ERCP. Pooled incidence rates were calculated for each reported adverse event and IRRs were determined for available comparison groups. A parallel analysis was performed in patients aged???80 and???90. Results: Our literature search yielded 7429 articles, of which 69 studies met our inclusion criteria. Pooled incidence rates for adverse events (per 1000 ERCPs) in patients aged???65 were as follows: perforation 3.8 (95?%CI 1.8?–?7.0), pancreatitis 13.1 (95?%CI 11.0?–?15.5), bleeding 7.7 (95?%CI 5.7?–?10.1), cholangitis 16.1 (95?%CI 11.7?–?21.7), cardiopulmonary events 3.7 (95?%CI 1.5?–?7.6), and death 7.1 (95?%CI 5.2?–?9.4). Patients???65 had lower rates of pancreatitis (IRR 0.3, 95?%CI 0.3?–?0.4) compared with younger patients. Octogenarians had higher rates of death (IRR 2.4, 95?%CI 1.3?–?4.5) compared with younger patients, whereas nonagenarians had increased rates of bleeding (IRR 2.4, 95?%CI 1.1?–?5.2), cardiopulmonary events (IRR 3.7, 95?%CI 1.0?–?13.9), and death (IRR 3.8, 95?%CI 1.0?–?14.4). Conclusions ERCP appears to be safe in elderly patients, except in the very elderly who are at higher risk of some adverse events. These data on adverse event rates can help to inform clinical decision-making, the consent process, and comparative effectiveness analyses.

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

    SciTech Connect

    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

    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.

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

    PubMed Central

    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

    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

  3. Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery

    Microsoft Academic Search

    ROBERT J. ANDERSON; MAUREEN O'BRIEN; SAMANTHA MAWHINNEY; CATHERINE B. VILLANUEVA; THOMAS E. MORITZ; GULSHAN K. SETHI; WILLIAM G. HENDERSON; KARL E. HAMMERMEISTER; FREDERICK L. GROVER; A. LAURIE SHROYER

    1999-01-01

    Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery.BackgroundMore than 600,000 coronary artery bypass graft (CABG) procedures are done annually in the United States. Some data indicate that 10 to 20% of patients who are undergoing a CABG procedure have a serum creatinine of more than 1.5 mg\\/dl. There are few data on the impact of a

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

    PubMed Central

    Dang, Amit; Bhandare, P. N.

    2012-01-01

    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

  5. Rate of Influenza Vaccination and Its Adverse Reactions Seen in Health Care Personnel in a Single Tertiary Hospital in Korea

    Microsoft Academic Search

    Chang-Seop Lee; Kang-Hyu Lee; Min-Hee Jung; Heung-Bum Lee

    2008-01-01

    SUMMARY: To determine the vaccination rate and its adverse reactions after influenza vaccination, we admin- istered an anonymous questionnaire survey during the last three influenza seasons from 2005 - 2006 to 2007 - 2008. In total, the rate of influenza vaccination was 82.3% in health-care personnel. Dividing the subjects into four groups by work category, the vaccine coverage rates were

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

    Microsoft Academic Search

    Izhar Wallach; Navdeep Jaitly; Ryan Lilien; Ulrich Zanger

    2010-01-01

    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

  7. Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms.

    PubMed

    Bousquet, Cédric; Sadou, Éric; Souvignet, Julien; Jaulent, Marie-Christine; Declerck, Gunnar

    2014-06-01

    Although MedDRA has obvious advantages over previous terminologies for coding adverse drug reactions and discovering potential signals using data mining techniques, its terminological organization constrains users to search terms according to predefined categories. Adding formal definitions to MedDRA would allow retrieval of terms according to a case definition that may correspond to novel categories that are not currently available in the terminology. To achieve semantic reasoning with MedDRA, we have associated formal definitions to MedDRA terms in an OWL file named OntoADR that is the result of our first step for providing an "ontologized" version of MedDRA. MedDRA five-levels original hierarchy was converted into a subsumption tree and formal definitions of MedDRA terms were designed using several methods: mappings to SNOMED-CT, semi-automatic definition algorithms or a fully manual way. This article presents the main steps of OntoADR conception process, its structure and content, and discusses problems and limits raised by this attempt to "ontologize" MedDRA. PMID:24680984

  8. Innovations in monitoring of adverse drug reactions: the role of a technical advisor.

    PubMed

    Ramalingam, S; Ponnuswamy, T K; Sivan, Y S

    2013-01-01

    Adverse drug reactions (ADRs) have ethical implications. These include assessment of the risk-benefit ratio and re-administering informed consent based on the new ADRs identified. The Indian Council of Medical Research ethical guidelines mandate the scrutiny of ADR; and the standard operating procedures of the ethics committee of the authors' medical school endorse this line. However, institutional review board members are often hardpressed for time and are unable to analyse all the reported ADRs as thoroughly as required. This calls for a dedicated system for the scrutiny of ADRs. This paper seeks to share the experience of development and implementation of a review mechanism for ADR monitoring. The authors report an innovation in ADR monitoring by appointing a technical advisor on ADR (TA-ADR). During routine assessment, an unusual occurrence of ADRs was noticed from internal and external sites which were related to the study drug, which in turn resulted in the trial being put on hold. This system is being reported here for possible adoption by others. PMID:23912733

  9. A Systematic Investigation of Computation Models for Predicting Adverse Drug Reactions (ADRs)

    PubMed Central

    Kuang, Qifan; Wang, MinQi; Li, Rong; Dong, YongCheng; Li, Yizhou; Li, Menglong

    2014-01-01

    Background Early and accurate identification of adverse drug reactions (ADRs) is critically important for drug development and clinical safety. Computer-aided prediction of ADRs has attracted increasing attention in recent years, and many computational models have been proposed. However, because of the lack of systematic analysis and comparison of the different computational models, there remain limitations in designing more effective algorithms and selecting more useful features. There is therefore an urgent need to review and analyze previous computation models to obtain general conclusions that can provide useful guidance to construct more effective computational models to predict ADRs. Principal Findings In the current study, the main work is to compare and analyze the performance of existing computational methods to predict ADRs, by implementing and evaluating additional algorithms that have been earlier used for predicting drug targets. Our results indicated that topological and intrinsic features were complementary to an extent and the Jaccard coefficient had an important and general effect on the prediction of drug-ADR associations. By comparing the structure of each algorithm, final formulas of these algorithms were all converted to linear model in form, based on this finding we propose a new algorithm called the general weighted profile method and it yielded the best overall performance among the algorithms investigated in this paper. Conclusion Several meaningful conclusions and useful findings regarding the prediction of ADRs are provided for selecting optimal features and algorithms. PMID:25180585

  10. Correlation of adverse effects of cisplatin administration in patients affected by solid tumours: A retrospective evaluation

    PubMed Central

    ASTOLFI, LAURA; GHISELLI, SARA; GUARAN, VALERIA; CHICCA, MILVIA; SIMONI, EDI; OLIVETTO, ELENA; LELLI, GIORGIO; MARTINI, ALESSANDRO

    2013-01-01

    Cisplatin is the most common antineoplastic drug used for the therapy of solid tumours. To date, researchers have focused on the dosage to be administered for each specific tumour, mainly considering the local adverse effects. The aim of this study was to correlate the severity of the adverse effects with: i) the dosage of cisplatin; ii) the specific site of the tumour; iii) the association with other drugs; and iv) the symptoms. We analysed data from 123 patients with 11 different tumour classes undergoing therapy from 2007 to 2008 at St. Anna Hospital (Ferrara, Italy), using the Spearman non-parametric correlation index. Even though significant correlations were found among the variables, the overall results showed that the main factor influencing the severity of the adverse effects was the dosage of cisplatin administered. PMID:23404427

  11. Validation of the Spanish version of the Liverpool Adverse Events Profile in patients with epilepsy.

    PubMed

    Carreño, Mar; Donaire, Antonio; Falip, Mercè; Maestro, Iratxe; Fernández, Santiago; Nagel, Antonio Gil; Serratosa, Jose; Salas, Javier; Viteri, César; Llorens, Jordi; Baró, Eva

    2009-06-01

    The objective of the study was to validate the Spanish version of the Liverpool Adverse Events Profile (LAEP). An observational, cross-sectional, multicenter study was carried out on patients with epilepsy treated with a stable dose of antiepileptic drugs. Patients completed the LAEP, Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and Hospital Anxiety and Depression Scale (HADS). Two hundred sixty-six patients were recruited. The LAEP was completed in a short time, perceived as easy to complete, and there was no relevant information missing. Ceiling/floor effects were negligible. Internal consistency (Cronbach's alpha=0.84) and test-retest reliability (ICC=0.81) were satisfactory. LAEP scores consistently correlated with QOLIE-31 (r=0.71) and HADS (r=0.52-0.63) scores. When the LAEP was used to discriminate between patients with and without adverse events, the scores on the QOLIE and HADS corresponded. The Spanish version of the LAEP scale exhibits adequate psychometric properties, suggesting that it is an appropriate instrument to measure adverse events among Spanish-speaking patients with epilepsy. PMID:19435575

  12. Incidence of adverse events requiring intervention after initiation of oral beta-blocker in pediatric cardiac intensive care patients.

    PubMed

    Britt, Jolie; Moffett, Brady S; Bronicki, Ronald A; Checchia, Paul A

    2014-08-01

    Only limited clinical data are available to establish the risk factors for adverse events and their frequency among children who have received oral beta-blockers in a critical care unit setting. The authors aimed to analyze the frequency of adverse events experienced by children treated with oral beta-blockers in a cardiovascular intensive care unit (CVICU) and sought out independent risk factors for these adverse events in a tertiary care hospital. The primary end point in this retrospective descriptive study was the incidence of adverse events associated with enteral beta-blocker administration, and the secondary end point was the incidence of readmission to the CVICU after transfer of patients to an acute care floor. At least one clinical adverse event occurred for 38% of the patients. Specifically, the profile of the clinical adverse events included bradycardia in 27 patients (11%), hypoglycemia in 46 patients (19%), and the initiation or escalation of inotropes in 36 patients (15%) after oral beta-blocker administration. Additionally, 41 patients (17%) were readmitted to the CVICU after transfer during the same hospital admission. The patients receiving propranolol were predisposed to have at least one adverse event (p = 0.045). No other patient-specific characteristics significantly predisposed patients to adverse events. The patients admitted after a cardiac procedure had fewer readmissions to the intensive care unit (ICU) during the same hospital admission (p = 0.002). The results demonstrated that adverse events are relatively common among patients receiving oral beta-blockers in a CVICU population. Because these children have less physiologic reserve, more must be done to ensure that the correct beta-blocker is prescribed to avoid clinically significant adverse events that may hamper the recovery of these patients and lead to increased ICU time. PMID:24718848

  13. Systematic Review of Antiretroviral-Associated Lipodystrophy: Lipoatrophy, but Not Central Fat Gain, Is an Antiretroviral Adverse Drug Reaction

    PubMed Central

    de Waal, Reneé; Cohen, Karen; Maartens, Gary

    2013-01-01

    Background Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART). Both are assumed to be antiretroviral adverse drug reactions. Methods We conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals. Results Twenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs) showed more limb fat loss (or less fat gain) with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs)); efavirenz (versus protease inhibitors (PIs)); and NRTI-containing (versus NRTI-sparing). RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens. Conclusions There is clear evidence of a causal relationship between NRTIs (especially thymidine analogues) and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching. PMID:23723990

  14. Transgenic mouse model reveals an unsuspected role of the acetylcholine receptor in statin-induced neuromuscular adverse drug reactions.

    PubMed

    Grajales-Reyes, G E; Báez-Pagán, C A; Zhu, H; Grajales-Reyes, J G; Delgado-Vélez, M; García-Beltrán, W F; Luciano, C A; Quesada, O; Ramírez, R; Gómez, C M; Lasalde-Dominicci, J A

    2013-08-01

    High cholesterol levels are an established risk factor for cardiovascular disease (CVD), the world's leading cause of death. Inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (statins) are prescribed to lower serum cholesterol levels and reduce the risk of CVD. Despite the success of statins, many patients abandon treatment owing to neuromuscular adverse drug reactions (ADRs). Genome-wide association studies have identified the single-nucleotide polymorphism (SNP) rs4149056 in the SLCO1B1 gene as being associated with an increased risk for statin-induced ADRs. By studying slow-channel syndrome transgenic mouse models, we determined that statins trigger ADRs in mice expressing the mutant allele of the rs137852808 SNP in the nicotinic acetylcholine receptor (nAChR) ?-subunit gene CHRNA1. Mice expressing this allele show a remarkable contamination of end-plates with caveolin-1 and develop early signs of neuromuscular degeneration upon statin treatment. This study demonstrates that genes coding for nAChR subunits may contain variants associated with statin-induced ADRs. PMID:22688219

  15. DRAR-CPI: a server for identifying drug repositioning potential and adverse drug reactions via the chemical–protein interactome

    PubMed Central

    Luo, Heng; Chen, Jian; Shi, Leming; Mikailov, Mike; Zhu, Huang; Wang, Kejian; He, Lin; Yang, Lun

    2011-01-01

    Identifying new indications for existing drugs (drug repositioning) is an efficient way of maximizing their potential. Adverse drug reaction (ADR) is one of the leading causes of death among hospitalized patients. As both new indications and ADRs are caused by unexpected chemical–protein interactions on off-targets, it is reasonable to predict these interactions by mining the chemical–protein interactome (CPI). Making such predictions has recently been facilitated by a web server named DRAR-CPI. This server has a representative collection of drug molecules and targetable human proteins built up from our work in drug repositioning and ADR. When a user submits a molecule, the server will give the positive or negative association scores between the user’s molecule and our library drugs based on their interaction profiles towards the targets. Users can thus predict the indications or ADRs of their molecule based on the association scores towards our library drugs. We have matched our predictions of drug–drug associations with those predicted via gene-expression profiles, achieving a matching rate as high as 74%. We have also successfully predicted the connections between anti-psychotics and anti-infectives, indicating the underlying relevance of anti-psychotics in the potential treatment of infections, vice versa. This server is freely available at http://cpi.bio-x.cn/drar/. PMID:21558322

  16. [Patient safety - definition and epidemiology of adverse events, errors and incidents].

    PubMed

    Koppenberg, J

    2012-06-01

    Multiple studies in the last years on patient safety brought this issue into focus for healthcare workers, but also politics and public. It is evident, that patient safety in health care is not longer a "nice to have", but an absolutely "must", analog others high risk industries. This article presents the most important basis principles of patient safety. The development from the error- to the safety culture is described. The terms adverse event, error and incident are defined as well other important terms and possible human pitfalls. At the end epidemiology correlations are presented, to underline the importance of patient safety in medicine. This article should help to understand the terminology of patient safety, to be able to understand the real important ideas and context of patient safety. PMID:22653716

  17. Is researching adverse events in hospital deaths a good way to describe patient safety in hospitals: a retrospective patient record review study

    PubMed Central

    Baines, Rebecca J; Langelaan, Maaike; de Bruijne, Martine C; Wagner, Cordula

    2015-01-01

    Objective Adverse event studies often use patient record review as a way to assess patient safety. As this is a time-consuming method, hospitals often study inpatient deaths. In this article we will assess whether this offers a representative view of the occurrence of adverse events in comparison to patients who are discharged while still living. Design Retrospective patient record review study. Setting and participants A total of 11?949 hospital admissions; 50% of inpatient deaths; the other half of patients discharged while alive. The data originated from our two national adverse event studies in 2004 and 2008. Main outcome measures Overall adverse events and preventable adverse events in inpatient deaths, and in admissions of patients discharged alive. We looked at size, preventability, clinical process and type of adverse events. Results Patients who died in hospital were on an average older, had a longer length of stay, were more often urgently admitted and were less often admitted to a surgical unit. We found twice as many adverse events and preventable adverse events in inpatient deaths than in patients discharged alive. Consistent with the differences in patient characteristics, preventable adverse events in inpatient deaths were proportionally less and were often related to the surgical process. Most types of adverse events and preventable adverse events occur in inpatient deaths as well as in patients discharged alive; however, these occur more often in inpatient deaths and are differently distributed. Conclusions Reviewing patient records of inpatient deaths is more efficient in identifying preventable AEs than reviewing records of those discharged alive. Although many of the same types of adverse events are found, it does not offer a representative view of the number or type of adverse events. PMID:26159451

  18. The effect of patient sex on the incidence of early adverse effects in a population of elderly patients.

    PubMed

    Conti, D; Ballo, P; Boccalini, R; Boccherini, A; Cantini, S; Venni, A; Pezzati, S; Gori, S; Franconi, F; Zuppiroli, A; Pedullà, A

    2014-07-01

    Patient sex is known to influence the response to general and regional anaesthesia and recovery after surgery. However, most studies come from analyses carried out on middle-aged patients. As most of the patients admitted to the post-anaesthesia recovery room in our institution are elderly, we took the opportunity to investigate the association between sex and incidence of early adverse events in this older population of patients after major surgery. Consecutive patients undergoing general, orthopaedic, urological and gynaecological surgery, admitted to the recovery room of our institution over a 15-month period, were retrospectively studied. The following adverse events were considered in the analysis: shivering, postoperative nausea and vomiting, hypotension and hypertensive responses, new arrhythmias requiring treatment, acute respiratory failure and desaturation. A total of 1347 patients (mean age 73.3±15.1 years, 61.4% women) were included. Women showed a higher incidence of shivering (relative difference +48%, P=0.0003), postoperative nausea and vomiting (+91%, P<0.0001), hypotension (+32%, P=0.044) and desaturation (+60%, P=0.0030) than men. The incidence of hypertensive response, arrhythmias and acute respiratory failure were not statistically significantly different. The findings of this exploratory study suggest that women have a higher risk of early postoperative adverse events even in a more elderly population. PMID:24967759

  19. Occurrence and preventability of adverse drug events in surgical patients: a systematic review of literature

    PubMed Central

    2013-01-01

    Background Adverse drug events (ADEs) are a considerable cause of inhospital morbidity and mortality. Patient flow differs substantially for surgical and nonsurgical patients: surgical patients are subjected to multiple medication changes related to surgical intervention or postoperative care. The objective of this study is to systematically review the occurrence and nature of ADEs in surgical patients. Also, a comparison with nonsurgical patients was made. Methods A search was conducted in Embase and Medline identifying studies that reported observational data on the occurrence and nature of ADEs in surgical hospitalised adult patients. If sufficient data were available, the occurrence of (preventable) ADEs was compared between surgical and nonsurgical patients. Results Six studies fulfilled the inclusion criteria. The occurrence of ADEs in surgical patients ranged from 2.0 to 27.7 per 100 admissions, from 4.7 to 8.9 per 1,000 patient days, or involved 8.9% of the patients. Proportions of preventable ADEs in surgical patients were 18% and 54%, described in two studies. A head-to-head comparison of surgical patients and nonsurgical patients was possible for five of six studies. The occurrence of ADEs in nonsurgical patients was significantly higher than in surgical patients in three studies. Conclusions ADEs are a relevant problem in surgical patients and nonsurgical patients, with a high proportion of preventable ADEs. The occurrence of ADEs appears to be higher in nonsurgical patients than in surgical patients. However, studies lack details on the differences in nature of ADEs between hospital populations. To improve medication safety this knowledge is essential. PMID:24074346

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

    PubMed Central

    2014-01-01

    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

  1. The skin tissue is adversely affected by TNF-alpha blockers in patients with chronic inflammatory arthritis: a 5-year prospective analysis

    PubMed Central

    Machado, Natalia P.; dos Reis Neto, Edgard Torres; Soares, Maria Roberta M. P.; Freitas, Daniele S.; Porro, Adriana; Ciconelli, Rozana M.; Pinheiro, Marcelo M.

    2013-01-01

    OBJECTIVE: We evaluated the incidence of and the main risk factors associated with cutaneous adverse events in patients with chronic inflammatory arthritis following anti-TNF-? therapy. METHODS: A total of 257 patients with active arthritis who were taking TNF-? blockers, including 158 patients with rheumatoid arthritis, 87 with ankylosing spondylitis and 12 with psoriatic arthritis, were enrolled in a 5-year prospective analysis. Patients with overlapping or other rheumatic diseases were excluded. Anthropometric, socioeconomic, demographic and clinical data were evaluated, including the Disease Activity Score-28, Bath Ankylosing Spondylitis Disease Activity Index and Psoriasis Area Severity Index. Skin conditions were evaluated by two dermatology experts, and in doubtful cases, skin lesion biopsies were performed. Associations between adverse cutaneous events and clinical, demographic and epidemiological variables were determined using the chi-square test, and logistic regression analyses were performed to identify risk factors. The significance level was set at p<0.05. RESULTS: After 60 months of follow-up, 71 adverse events (73.85/1000 patient-years) were observed, of which allergic and immune-mediated phenomena were the most frequent events, followed by infectious conditions involving bacterial (47.1%), parasitic (23.5%), fungal (20.6%) and viral (8.8%) agents. CONCLUSION: The skin is significantly affected by adverse reactions resulting from the use of TNF-? blockers, and the main risk factors for cutaneous events were advanced age, female sex, a diagnosis of rheumatoid arthritis, disease activity and the use of infliximab. PMID:24141833

  2. Association between the rs342293 polymorphism and adverse cardiac events in patients undergoing percutaneous coronary intervention.

    PubMed

    Siller-Matula, Jolanta M; Arbesu, Iciar; Jilma, Bernd; Maurer, Gerald; Lang, Irene M; Mannhalter, Christine

    2014-06-01

    The single nucleotide polymorphism (SNP) rs342293 has been shown to influence platelet number and mean platelet volume (MPV). We investigated the association between the rs342293 polymorphism and cardiovascular outcome in a prospective cohort study. The rs342293 polymorphism was analysed in 404 patients with coronary artery disease undergoing percutaneous coronary intervention. The rates of cardiac adverse events were recorded during two years of follow-up. The polymorphism was associated with MPV (median 10.1 fL, interquartile range [IQR]: 9.6 to 10.6 in patients with the CC-allele vs 10.4 fL, IQR: 9.9 to 11.1 in G>C SNP carriers; p<0.001), but not with platelet count. Survival analysis indicated that carriers of the rs342293 G variant had a substantially higher risk to develop cardiac adverse events compared with wild type carriers during two years of follow-up (33% vs 22%; adjusted hazard ratio = 1.63, 95% confidence interval = 1.06-2.52, p=0.027). The rs342293 SNP could explain 2.9% of the variability in MPV (p=0.01). In conclusion, patients undergoing coronary stenting who carry the G-variant of the rs342293 SNP which is associated with larger MPV are at higher risk for adverse cardiovascular outcome. PMID:24652536

  3. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    PubMed Central

    Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe

    2014-01-01

    Objective The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. Conclusion ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. PMID:25506231

  4. A method for controlling complex confounding effects in the detection of adverse drug reactions using electronic health records

    PubMed Central

    Li, Ying; Salmasian, Hojjat; Vilar, Santiago; Chase, Herbert; Friedman, Carol; Wei, Ying

    2014-01-01

    Objective Electronic health records (EHRs) contain information to detect adverse drug reactions (ADRs), as they contain comprehensive clinical information. A major challenge of using comprehensive information involves confounding. We propose a novel data-driven method to identify ADR signals accurately by adjusting for confounders. Materials and methods We focused on two serious ADRs, rhabdomyolysis and pancreatitis, and used information in 264?155 unique patient records. We identified an ADR using established criteria, selected potential confounders, and then used penalized logistic regressions to estimate confounder-adjusted ADR associations. A reference standard was created to evaluate and compare the precision of the proposed method and four others. Results Precision was 83.3% for rhabdomyolysis and 60.8% for pancreatitis when using the proposed method, and we identified several drug safety signals that are interesting for further clinical review. Discussion The proposed method effectively estimated ADR associations after adjusting for confounders. A main cause of error was probably due to the nature of the dataset in that a substantial number of patients had a single visit only and, therefore, it was not possible to determine correctly the appropriate sequence of events for them. It is likely that performance will be improved with use of EHR data that contain more longitudinal records. Conclusions This data-driven method is effective in controlling for confounding, resulting in either a higher or similar precision when compared with four comparators, has the unique ability to provide insight into confounders for each specific medication–ADR pair, and can be easily adapted to other EHR systems. PMID:23907285

  5. Usefulness of clinical and electrocardiographic data for predicting adverse cardiac events in patients with myotonic dystrophy

    PubMed Central

    Breton, Robert; Mathieu, Jean

    2009-01-01

    BACKGROUND: Myotonic dystrophy type 1 (DM1) has been associated with an increased risk of sudden death, either by heart block or malignant ventricular arrhythmias. Identifying patients at risk remains difficult and no consensus has been reached regarding the best approach for follow-up and prevention of sudden death. OBJECTIVES: To identify noninvasive clinical and electrocardiographic predictors of adverse cardiac events in patients with DM1. METHODS: Clinical and serial electrocardiographic data on 428 patients with a DNA-proven diagnosis of DM1, followed during a mean period of 11.7 years, were reviewed. Variables associated with adverse cardiac events were identified. RESULTS: Eleven patients (2.6%) experienced sudden death and 13 (3.0%) required implantation of a pacemaker. On univariate analysis, adverse events were associated with advancing age, prolongation of the PR, QRS and corrected QT (QTc) intervals, as well as the degree of neuromuscular impairment. No such relationship was found with the extent of genetic anomaly (number of cytosine-thymine-guanine repeats). However, multivariate analysis using Cox proportional hazards models showed that only baseline PR and QTc intervals were significantly linked to the end points of sudden death or pacemaker implantation; the age-adjusted RR was 3.7 (95% CI 1.5 to 8.6) if baseline PR was 200 ms or longer (P=0.003), and 3.0 (95% CI 1.0 to 8.8) if the baseline QTc was 450 ms or longer (P=0.047). CONCLUSIONS: In a large unselected cohort of 428 patients with DM1, the cumulative incidence of sudden death was relatively low, and the delayed conduction on surface electrocardiogram was found to be potentially helpful for identifying patients at risk for sudden death or pacemaker implantation. PMID:19214296

  6. Platinum Agent-Induced Hypersensitivity Reactions: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS

    PubMed Central

    Sakaeda, Toshiyuki; Kadoyama, Kaori; Yabuuchi, Hiroaki; Niijima, Satoshi; Seki, Kyoko; Shiraishi, Yukinari; Okuno, Yasushi

    2011-01-01

    Objective: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions. Methods: Authorized pharmacovigilance tools were used for quantitative signal detection, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Excess2, given by the multi-item gamma Poisson Shrinker algorithm, was used to evaluate the effects of dexamethasone and diphenhydramine on oxaliplatin-induced hypersensitivity reactions. Results: Based on 1,644,220 AERs from 2004 to 2009, carboplatin and oxaliplatin proved to cause mild, severe, and lethal hypersensitivity reactions, whereas cisplatin did not. Dexamethasone affected oxaliplatin-induced mild hypersensitivity reactions, but had lesser effects on severe and lethal reactions. The effects of diphenhydramine were not confirmed. Conclusion: The FDA's adverse event reporting system, AERS, with optimized data mining tools is useful to authorize potential associations between platinum agents and hypersensitivity reactions. PMID:21611115

  7. Anaphylaxis and other adverse reactions to blue dyes: a case series.

    PubMed

    Howard, J D; Moo, V; Sivalingam, P

    2011-03-01

    We report three cases of anaphylaxis during anaesthesia confirmed on intradermal testing to be related to patent blue V dye (Guerbet - Chemical Abstract Service 3536-49-0). All three cases were associated with moderate to severe hypotension. Two cases had delayed onset, and two were associated with a rash. None of the cases were associated with bronchospasm. In all three patients the interference with pulse oximetry readings contributed to difficulties in management. We recommend the use of a test dose of blue dye prior to surgery, as suggested in the manufacturer's product information. We also recommend high vigilance for possible allergic reactions when patent blue dyes are used for sentinel lymph node mapping, because the presentations may be atypical and the reduced pulse oximetry readings may be a distraction. PMID:21485680

  8. Patient safety in home hemodialysis: quality assurance and serious adverse events in the home setting.

    PubMed

    Pauly, Robert P; Eastwood, Deborah O; Marshall, Mark R

    2015-04-01

    Interest in home hemodialysis (HD) is high because of the reported benefits and its excellent safety record. However, the potential for serious adverse events (AEs) exists when patients perform HD in their homes without supervision. We review the epidemiology of dialysis-related emergencies during home HD, and present a conceptual and practical framework for the prevention and management of serious AEs for those patients performing home HD. In addition, we describe a formal monitored and iterative quality assurance program, and make suggestions for the future development of safety strategies to mitigate the risk of AEs in home HD. PMID:25925825

  9. Neurosyphilis presenting with dementia, chronic chorioretinitis and adverse reactions to treatment: a case report.

    PubMed

    Mehrabian, Shima; Raycheva, Margarita Radoslavova; Petrova, Elena Petrova; Tsankov, Nikolay Konstantinov; Traykov, Latchezar Dintchov

    2009-01-01

    Neurosyphilis results from infection of the brain, meninges or spinal cord by Treponema pallidum and develops in about 25%-40% of persons who are not treated for syphilis. This article reports a rare case of active neurosyphilis with mild dementia, chronic chorioretinitis, and hearing loss. During the treatment with Penicillin, a rare combination of complications such as Jarisch-Herxheimer and Hoigné reactions were observed.The clinical feature is characterized by a slow progressive cognitive decline and behavior changes for the last 2 years. Neuropsychological examination revealed mild dementia (MMSE = 23) with impaired memory and attention and executive function. Left sided chronic chorioretinitis and hearing loss were documented. High dose intravenous penicillin therapy was complicated by Jarisch-Herxheimer and Hoigne reactions. During the follow up examinations at 6 and 12 months, the clinical signs, neuropsychological examination, and cerebrospinal fluid (CFS) samples showed improvement of dementia, CSF findings, and hydrocephalus.In conclusion, this atypical presentation of neurosyphilis in combination with rare complications of treatment is worthy of attention. Neurosyphilis should be part of the differential diagnosis of each patient showing cognitive deterioration and behaviour disturbances. PMID:19918420

  10. Patient Suicide: A Survey of Therapists' Reactions

    ERIC Educational Resources Information Center

    Wurst, Friedrich Martin; Mueller, Sandra; Petitjean, Sylvie; Euler, Sebastian; Thon, Natasha; Wiesbeck, Gerhard; Wolfersdorf, Manfred

    2010-01-01

    A substantial proportion of therapists will at some point in their professional life experience the loss of a patient to suicide. Our aims were to assess how therapists react to patient's suicide over time and which factors contribute to the reaction. One third of the therapists, mostly women, suffer from severe distress. The impact is not…

  11. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India

    PubMed Central

    Tandon, Vishal R.; Mahajan, Vivek; Khajuria, Vijay; Gillani, Zahid

    2015-01-01

    Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. Materials and Methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students. Conclusion: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting. PMID:25821314

  12. [Events and adverse reactions in biovigilance: Descriptive analysis of French national data following a four-year practical experience].

    PubMed

    Martinière, K; Lucas, S; Zorzi, P

    2008-09-01

    Biovigilance is defined as the surveillance of therapeutic use in man of organs, tissues and cells. Four years after the implementation of the French biovigilance system, a first analysis of data collected has been performed by Afssaps. Quantitatively, with the exception of 2004, the first year of implementation, the average number of annual notifications reaches 166. Taking into account the total number of human applications, it has to be noted that events and adverse reactions notified and involving tissues are rather low compared to those involving organs and cells. From a qualitative point of view, this analysis allows to identify different categories of events and adverse reactions with the corresponding number of notifications for each of them. This descriptive analysis should constitute for the French National Commission of Biovigilance the starting point of a reflection aiming at improving both exhaustiveness and quality of notifications in order to facilitate further analysis of data collected. This improvement should aim first at identifying more precisely the categories of events and adverse reactions to be notified or not in biovigilance. It should also allow updating the notification form. Before completion of his first three-year mandate, the National Commission of Biovigilance should be able to set up all the necessary tools of the biovigilance network and to make them available and understandable by all the stakeholders. PMID:18538607

  13. Physicians' Reactions to Overweight Patients

    NSDL National Science Digital Library

    Lane, David M.

    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.

  14. [Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].

    PubMed

    Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming

    2013-09-01

    This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety. PMID:24471321

  15. Managing adverse effects of glaucoma medications

    PubMed Central

    Inoue, Kenji

    2014-01-01

    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

  16. A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting

    PubMed Central

    Alhawassi, Tariq M; Krass, Ines; Bajorek, Beata V; Pont, Lisa G

    2014-01-01

    Adverse drug reactions (ADRs) are an important health issue. While prevalence and risk factors associated with ADRs in the general adult population have been well documented, much less is known about ADRs in the elderly population. The aim of this study was to review the published literature to estimate the prevalence of ADRs in the elderly in the acute care setting and identify factors associated with an increased risk of an ADR in the elderly. A systematic review of studies published between 2003 and 2013 was conducted in the Cochrane Database of Systematic Reviews, EMBASE, Google Scholar and MEDLINE. Key search terms included: “adverse drug reactions”, “adverse effects”, “elderly patients and hospital admission”, “drug therapy”, “drug adverse effects”, “drug related”, “aged”, “older patients”, “geriatric”, “hospitalization”, and “emergency admissions”. For inclusion in the review, studies had to focus on ADRs in the elderly and had to include an explicit definition of what was considered an ADR and/or an explicit assessment of causality, and a clear description of the method used for ADR identification, and had to describe factors associated with an increased risk of an ADR. Fourteen hospital-based observational studies exploring ADRs in the elderly in the acute care setting were eligible for inclusion in this review. The mean prevalence of ADRs in the elderly in the studies included in this review was 11.0% (95% confidence interval [CI]: 5.1%–16.8%). The median prevalence of ADRs leading to hospitalization was 10.0% (95% CI: 7.2%–12.8%), while the prevalence of ADRs occurring during hospitalization was 11.5% (95% CI: 0%–27.7%). There was wide variation in the overall ADR prevalence, from 5.8% to 46.3%. Female sex, increased comorbid complexity, and increased number of medications were all significantly associated with an increased risk of an ADR. Retrospective studies and those relying on identification by the usual treating team reported lower prevalence rates. From this review, we can conclude that ADRs constitute a significant health issue for the elderly in the acute care setting. While there was wide variation in the prevalence of ADRs in the elderly, based on the findings of this study, at least one in ten elderly patients will experience an ADR leading to or during their hospital stay. Older female patients and those with multiple comorbidities and medications appear to be at the highest risk of an ADR in the acute care setting. PMID:25489239

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

    PubMed Central

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

    2013-01-01

    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

  18. Stress-rest myocardial perfusion scintigraphy and adverse cardiac events in heart failure patients.

    PubMed

    Peix, Amalia; Macides, Yanisbel; Rodríguez, Lydia; Cabrera, Lázaro O; Padrón, Kenia; Heres, Flor; Consuegra, Dania; Fernández, Yoel; Mena, Erick

    2015-04-01

    INTRODUCTION Heart failure, primarily in the elderly, is a growing epidemic in today's world. It leads to high rates of disability and mortality, as well as significant health care expenditures, making it important to assess possible predictors of adverse cardiac events. In Cuba, heart failure mortality is 19.1/100,000 population. OBJECTIVES Assess the value of stress-rest protocol gated-SPECT for identifying patients with symptomatic heart failure likely to suffer adverse cardiac events. METHODS A study was conducted of 52 patients (mean age 59 years, SD 9; 62% women) with functional capacity II/III (New York Heart Association scale) and left ventricular ejection fraction <40%. Patients were divided into two groups based on coronary heart disease diagnosis: those with coronary heart disease (41), labeled ischemic; and those without (11), labeled nonischemic. All underwent gated SPECT myocardial perfusion scintigraphy with technetium-99m-labeled methoxyisobutyl isonitrile, using a two-day stress-rest protocol, including evaluation of intraventricular synchrony by phase analysis. Patients were followed over 36 months for adverse cardiac effects. RESULTS No significant differences were observed between the two groups during the stress test with regard to exercise time, metabolic equivalents or percentage of maximal heart rate during maximal stress. Summed stress, rest and difference scores, however, were significantly different between the ischemic and nonischemic groups: 16.82 (SD 6.37) vs. 7.54 (SD 5.8), p <0.001; 14.43 (SD 6.28) vs. 6.45 (SD 3.77), p = 0.001; and 2.39 (SD 4.89) vs. 1.09 (SD 3.7), p = 0.034. No differences were found in ventricular function, although stress-minus-rest left ventricular ejection fraction was slightly lower in patients with ischemic heart disease (-1.29, SD 5.8) than in patients without ischemic heart disease (1.27, SD 4.31). Dyssynchrony was greater in patients with ischemic heart disease than in those without, primarily during stress (p <0.01). The only variable that showed a possible association with the occurrence of adverse events was <5 metabolic equivalents on the stress test (p = 0.03), while resting phase SD showed only a tendency toward association (p = 0.05). CONCLUSIONS Information on myocardial perfusion, functional capacity and intraventricular synchrony obtained from stress-rest gated SPECT may help identify patients with symptomatic heart failure who are likely to develop adverse cardiac events, enabling better management of higher-risk cases and improved allocation of resources. KEYWORDS Heart failure, congestive heart failure, myocardial ischemia, ischemic heart disease, coronary artery disease, gated SPECT, perfusion, ventricular function, intraventricular synchrony, phase analysis, Cuba. PMID:26027585

  19. Ambulance Personnel Perceptions of Near Misses and Adverse Events in Pediatric Patients

    PubMed Central

    Cushman, Jeremy T; Fairbanks, Rollin J; O’Gara, Kevin G; Crittenden, Crista N; Pennington, Elliot C; Wilson, Matthew A; Chin, Nancy P; Shah, Manish N

    2010-01-01

    Objective To identify Emergency Medical Services (EMS) provider perceptions of factors that may affect the occurrence, identification, reporting, and reduction of near misses and adverse events in the pediatric EMS patient. Methods This was a subgroup analysis of a qualitative study examining the nature of near misses and adverse events in EMS as it relates to pediatric prehospital care. Complimentary qualitative methods of focus groups, interviews, and anonymous event reporting were used to collect results and emerging themes were identified and assigned to specific analytic domains. Results Eleven anonymous event reports, 17 semi-structured interviews, and 2 focus groups identified 61 total events, of which 12 (20%) were child-related. Eight (66%) of those were characterized by participants as having resulted in no injury, 2 (16%) resulted in potential injury, and 2 (16%) involved an ultimate fatality. Three analytic domains were identified which included the following five themes: reporting is uncommon, blaming errors on others, provider stress/discomfort, errors of omission, and limited training. Among perceived causes of events, participants noted factors relating to management problems specific to pediatrics, problems with procedural skill performance, medication problems/calculation errors, improper equipment size, parental interference, and omission of treatment related to providers’ discomfort with the patient’s age. Few participants spoke about errors they had themselves committed; most discussions centered on errors participants observed being made by others. Conclusions It appears that adverse events and near misses in the pediatric EMS environment may go unreported in a large proportion of cases. Participants attributed the occurrence of errors to the stress and anxiety produced by a lack of familiarity with pediatric patients and to a reluctance to cause pain or potential harm, as well as to inadequate practical training and experience in caring for the pediatric population. Errors of omission, rather than those of commission, were perceived to predominate. This study provides a foundation on which to base additional studies of both qualitative and quantitative nature that will shed further light on the factors contributing to the occurrence, reporting, and mitigation of adverse events and near misses in the pediatric EMS setting. PMID:20662679

  20. Oral adverse effects of gastrointestinal drugs and considerations for dental management in patients with gastrointestinal disorders

    PubMed Central

    Karthik, Ramya; Karthik, K. S.; David, Chaya; Ameerunnisa; Keerthi, G.

    2012-01-01

    Gastrointestinal disease is associated with alterations in the mouth or influence the course of the dental diseases, and the dental health care workers are expected to recognize, diagnose, and treat oral conditions associated with gastrointestinal diseases and also provide safe and appropriate dental care for afflicted individuals. Drugs used in the management of these diseases result in oral adverse effects and also are known to interact with those prescribed during dental care. Hence, this article has reviewed the drug considerations and guidelines for drug use during dental management of patients with gastrointestinal diseases. PMID:23066260

  1. Endothelial dysfunction is associated with major adverse cardiovascular events in peritoneal dialysis patients.

    PubMed

    Lee, Mi Jung; Han, Seung Hyeok; Lee, Jung Eun; Choi, Hoon Young; Yoon, Chang-Yun; Kim, Eun Jin; Han, Jae Hyun; Han, Ji Suk; Oh, Hyung Jung; Park, Jung Tak; Kang, Shin-Wook; Yoo, Tae-Hyun

    2014-09-01

    Endothelial dysfunction is implicated in increased cardiovascular risk in nondialyzed population. However, the prognostic impact of endothelial dysfunction on cardiovascular outcome has not been investigated in peritoneal dialysis (PD) patients. We prospectively determined endothelial function by brachial artery endothelium-dependent vasodilation (flow-mediated dilation [FMD]) in 143 nondiabetic PD patients and 32 controls. Primary outcome was a major adverse cardiac and cerebrovascular event (MACCE). Brachial FMD was significantly lower in PD patients than in controls (2.9% [1.3-4.7] vs 6.2% [5.4-8.3], P?patients (17.5%). When patients were dichotomized by the median value of FMD (2.9%), incidence rates of MACCEs were significantly higher in the group with lower FMD compared with higher FMD (7.2 vs 3.0/100 person-years, P?=?0.03). In multivariate Cox analysis, low FMD (?2.9%) was a significant independent predictor of MACCEs (hazard ratio?=?2.73, 95% confidence interval?=?1.03-7.22, P?=?0.04). Furthermore, multivariate fractional polynomial analysis showed that the risk of MACCE decreased steadily with higher FMD values. Impaired brachial FMD was a significant independent predictor of MACCEs in PD patients. Estimating endothelial dysfunction by brachial FMD could be useful for stratifying cardiovascular risk in these patients. PMID:25192486

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

    PubMed Central

    2014-01-01

    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

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

    PubMed Central

    Mujeeb, Rakshinda; Patel, Muhammad Junaid

    2014-01-01

    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

  4. Risk factors for seizures and antiepileptic drug-associated adverse effects in high-grade glioma patients: A multicentre, retrospective study in Hong Kong

    PubMed Central

    Woo, Peter Yat-Ming; Chan, Danny Tat-Ming; Chan, Kwong-Yau; Wong, Wai-Kei; Po, Yin-Chung; Kwok, John Ching-Kong; Poon, Wai-Sang

    2015-01-01

    Aim The aim of this present study was to determine the frequency, as well as risk factors, for seizures and antiepileptic drug (AED)-associated adverse effects among high-grade glioma (HGG) patients. Patients and Methods A multicentre, retrospective study of adult Chinese Hong Kong patients from three neurosurgical centres diagnosed with supratentorial HGG between 1 January 2001 and 31 December 2010 was performed. Results A total of 198 patients, with a mean age of 55?years (range: 18–88) and a mean follow up of 15 months, was recruited. Most suffered from glioblastoma multiforme (GBM) (63 per cent) followed by anaplastic astrocytoma (25 per cent). Median overall survival for patients with GBM was 8?months, and 11?months for those with grade III gliomas. Prophylactic AED was prescribed in 165 patients (83 per cent), and 64 per cent of patients were continued until end of life or last follow up. A total of 112 patients (57 per cent) experienced seizures at a mean duration of 8?months postoperatively (range: 1?day–75?months). Independent predictors for seizures were a diagnosis of GBM [adjusted odds ratio (OR): 2.33, 95 per cent confidence interval (CI): 1.21–4.52] and adjuvant radiotherapy (adjusted OR: 2.97, 95 per cent CI: 1.49–6.62). One-fifth of patients (21 per cent) experienced AED adverse effects, with idiosyncratic cutaneous reactions and hepatotoxicity most frequently observed. An independent predictor for adverse effects was exposure to aromatic AED, such as phenytoin, carbamazepine and phenobarbital (adjusted OR: 3.32, 95 per cent CI: 1.32–8.40). Conclusions Antiepileptic drug prescription for primary seizure prophylaxis is both pervasive and prolonged for HGG patients. Seizures occur frequently, but most were delayed and none were life threatening. Judicious prescription of AED is required, especially when a significant proportion of patients experience adverse effects. Patients with a diagnosis of GBM and exposure to radiotherapy are at risk. We suggest, contrary to present practice, that primary seizure prophylaxis be given only during the perioperative period and resumed when they occur. We also recommend avoidance of aromatic AED due to their association with idiosyncratic adverse effects.

  5. Surgical Correction of Scoliosis in Children with Spastic Quadriplegia: Benefits, Adverse Effects, and Patient Selection

    PubMed Central

    Legg, Julian; Davies, Evan; Raich, Annie L.; Dettori, Joseph R.; Sherry, Ned

    2014-01-01

    Study Rationale?Cerebral palsy (CP) is a group of nonprogressive syndromes of posture and motor impairment associated with lesions of the immature brain. Spastic quadriplegia is the most severe form with a high incidence of scoliosis, back pain, respiratory compromise, pelvic obliquity, and poor sitting balance. Surgical stabilization of the spine is an effective technique for correcting deformity and restoring sitting posture. The decision to operate in this group of patients is challenging. Objectives?The aim of this study is to determine the benefits of surgical correction of scoliosis in children with spastic quadriplegia, the adverse effects of this treatment, and what preoperative factors affect patient outcome after surgical correction. Materials and Methods?A systematic review was undertaken to identify studies describing benefits and adverse effects of surgery in spastic quadriplegia. Factors affecting patient outcome following surgical correction of scoliosis were assessed. Studies involving adults and nonspastic quadriplegia were excluded. Results?A total of 10 case series and 1 prospective and 3 retrospective cohort studies met inclusion criteria. There was significant variation in the overall risk of complications (range, 10.9?70.9%), mortality (range, 2.8?19%), respiratory/pulmonary complications (range, 26.9?57.1%), and infection (range, 2.5?56.8%). Factors associated with a worse outcome were a significant degree of thoracic kyphosis, days in the intensive care unit, and poor nutritional status. Conclusion?Caregivers report a high degree of satisfaction with scoliosis surgery for children with spastic quadriplegia. There is limited evidence of preoperative factors that can predict patient outcome after scoliosis. There is a need for well-designed prospective studies of scoliosis surgery in spastic quadriplegia. PMID:24715871

  6. Cognitive adverse events of topiramate in patients with epilepsy and intellectual disability.

    PubMed

    Brandt, Christian; Lahr, Denise; May, Theodor W

    2015-04-01

    Topiramate (TPM) is an effective antiepileptic drug (AED). A high proportion of patients, however, experiences cognitive adverse events (CAEs), especially in verbal fluency, memory spans, and working memory. To our knowledge, CAEs of TPM have not been studied systematically in patients with intellectual disability (ID). This may be due to the fact that many of those patients are not able to follow test instructions properly and that neuropsychological instruments are not validated for that group. Cognitive deterioration in patients with ID may thus easily be overlooked. Topiramate is in frequent use in persons with ID. We included 26 consecutive patients with epilepsy and ID in this observational study who had undergone neuropsychological examinations as part of clinical routine before and after the introduction of TPM into the therapeutic regimen (n=4) or before and after the withdrawal of TPM (n=22). Examinations under TPM showed reduced cognitive speed, reduced verbal memory, reduced verbal fluency, and reduced flexibility compared to examinations without TPM. Despite some limitations (especially small sample size, high interindividual variation of the results dependent on the degree of ID, effects of other - limited - changes in the therapeutic regimen), our study indicates that TPM in persons with epilepsy and ID may lead to CAEs comparable to those in persons with normal intelligence. Neuropsychological testing is mandatory in order not to miss CAEs that might severely impair quality of life. PMID:25843340

  7. A review of adverse cutaneous drug reactions resulting from the use of interferon and ribavirin

    PubMed Central

    Mistry, Nisha; Shapero, Jonathan; Crawford, Richard I

    2009-01-01

    Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions. PMID:19826642

  8. Prescribing Discrepancies Likely to Cause Adverse Drug Events after Patient Transfer

    PubMed Central

    Boockvar, Kenneth S.; Liu, Sophia; Goldstein, Nathan; Nebeker, Jonathan; Siu, Albert; Fried, Terri

    2009-01-01

    Background Medication prescribing discrepancies are used as a quality measure for patients transferred between sites of care. The objective of this study was to quantify the rate of adverse drug events (ADEs) caused by prescribing discrepancies and the discrimination of an index of high-risk transition drug prescribing. Methods We examined medical records of patients transferred between 7 nursing homes and 3 hospitals between 1999–2005 in New York and Connecticut for transfer-associated prescribing discrepancies. ADEs caused by discrepancies were determined by 2 clinician raters. We calculated the fraction of medication discrepancies that caused ADEs in each of 22 drug classes by calculating positive predictive values (PPVs). We calculated the discrimination of a count of high-risk drug discrepancies, selected from published lists of high-risk medications and using observed PPVs. Results 208 patients were hospitalized 304 times. Overall, 65 of 1350 prescribing discrepancies caused ADEs, for a PPV of .048 (95%CI .037–.061). PPVs by drug class ranged from 0 – .28. Drug classes with the highest PPVs were opioid analgesics, metronidazole, and non-opioid analgesics. Patients with 0, 1–2, and ? 3 high-risk discrepancies had a 13%, 23%, and 47% chance of experiencing a discrepancy-related ADE, respectively. Conclusions Discrepancies in certain drug classes more often caused ADEs than other types of discrepancies in hospitalized nursing home patients. Information about ADEs caused by medication discrepancies can be used to enhance measurement of care quality, identify high-risk patients, and inform development of decision-support tools at the time of patient transfer. PMID:19204129

  9. Anti-CCP antibody in patients with established rheumatoid arthritis: Does it predict adverse cardiovascular profile?

    PubMed Central

    Arnab, Banerjee; Biswadip, Ghosh; Arindam, Pande; Shyamash, Mandal; Anirban, Ghosh; Rajan, Palui

    2013-01-01

    Background Rheumatoid arthritis (RA) is an independent risk factor for adverse cardiovascular (CV) events that accounts for a significant proportion of mortality among these patients. Anti-CCP antibodies are associated with higher frequency of extra-articular manifestations and poorer outcomes in RA. Aims To determine the role of anti-cyclic citrullinated peptide (CCP) antibody as an independent risk factor for developing CV complications as documented by carotid intima medial thickness and abnormal echocardiography in established RA patients. Materials and methods Eighty patients of RA having disease duration of at least 3 years participated in this hospital-based, cross-sectional, and observational study. Forty patients were anti-CCP antibody positive. Patients of established RA having known CV risk factors, known heart disease, or family history of premature ischemic heart disease were excluded. Results Anti-CCP positive group had early morning stiffness, tender and swollen joint count, and c-reactive protein (CRP) level significantly higher than those in anti-CCP negative group. Average intima-medial thicknesses of common carotid arteries were also significantly higher among anti-CCP positive group (P = 0.029) and were positively correlated with patients' age and disease duration. Lower left ventricular ejection fraction and left ventricular diastolic dysfunction were more commonly dispersed among the anti-CCP positive patients with P values of 0.01 and 0.034, respectively. Mild pericardial thickening was documented among 12.5% patients of anti-CCP positive group, while none of the anti-CCP negative patients had similar findings in echocardiography. Conclusion This study stressed on the important role of anti-CCP antibody in myocardial dysfunction due to inflammation in RA patients. Both atherosclerotic vascular involvement and cardiac abnormalities including pericardial, myocardial, and endocardial involvements were higher among anti-CCP positive RA patients. Hence, patients with high titer of anti-CCP antibody associated with prolonged disease duration and increased disease activity should be evaluated for CV morbidity more meticulously. PMID:24027365

  10. A Clinical Prediction Model to Estimate Risk for Thirty Day Adverse Events in Emergency Department Patients with Symptomatic Atrial Fibrillation

    PubMed Central

    Barrett, Tyler W.; Martin, Amy R.; Storrow, Alan B.; Jenkins, Cathy A; Harrell, Frank E.; Russ, Stephan; Roden, Dan M.; Darbar, Dawood

    2010-01-01

    Study Objective Atrial fibrillation (AF) affects over 2 million people in the United States and accounts for nearly 1% of emergency department (ED) visits. Physicians have little information to guide risk stratification of patients with symptomatic AF and admit more than 65%. Our aim was to assess whether data available in the ED management of symptomatic AF can estimate a patient's risk of experiencing a 30-day adverse event. Methods We systematically reviewed the electronic medical records of all ED patients presenting with symptomatic AF between August 2005 and July 2008. Predefined adverse outcomes included 30-day ED return visit, unscheduled hospitalization, cardiovascular complication or death. We performed multivariable logistic regression to identify predictors of 30-day adverse events. The model was validated using 300 bootstrap replications. Results During the 3-year study period, 914 patients accounted for 1228 ED visits. Eighty patients were excluded for non-AF related complaints and 2 patients had no follow-up recorded. Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Increasing age (odds ratio [OR] and [95% CI]: 1.20 per decade [1.06, 1.36]), complaint of dyspnea (OR: 1.57 [1.12, 2.20]), smokers (OR: 2.35 [1.47, 3.76]), inadequate ventricular rate control (OR: 1.58 [1.13, 2.21]), and patients taking beta-blockers (OR: 1.44 [1.02, 2.04]) were independently associated with higher risk for adverse events. C-index was 0.67. Conclusion In ED patients with symptomatic AF, increased age, inadequate ED ventricular rate control, dyspnea, smoking, and beta-blocker treatment were associated with an increased risk of a 30-day adverse event. PMID:20728962

  11. ADReCS: an ontology database for aiding standardization and hierarchical classification of adverse drug reaction terms.

    PubMed

    Cai, Mei-Chun; Xu, Quan; Pan, Yan-Jing; Pan, Wen; Ji, Nan; Li, Yin-Bo; Jin, Hai-Jing; Liu, Ke; Ji, Zhi-Liang

    2015-01-01

    Adverse drug reactions (ADRs) are noxious and unexpected effects during normal drug therapy. They have caused significant clinical burden and been responsible for a large portion of new drug development failure. Molecular understanding and in silico evaluation of drug (or candidate) safety in laboratory is thus so desired, and unfortunately has been largely hindered by misuse of ADR terms. The growing impact of bioinformatics and systems biology in toxicological research also requires a specialized ADR term system that works beyond a simple glossary. Adverse Drug Reaction Classification System (ADReCS; http://bioinf.xmu.edu.cn/ADReCS) is a comprehensive ADR ontology database that provides not only ADR standardization but also hierarchical classification of ADR terms. The ADR terms were pre-assigned with unique digital IDs and at the same time were well organized into a four-level ADR hierarchy tree for building an ADR-ADR relation. Currently, the database covers 6544 standard ADR terms and 34,796 synonyms. It also incorporates information of 1355 single active ingredient drugs and 134,022 drug-ADR pairs. In summary, ADReCS offers an opportunity for direct computation on ADR terms and also provides clues to mining common features underlying ADRs. PMID:25361966

  12. Effects of moderate-dose versus high-dose trimethoprim on serum creatinine and creatinine clearance and adverse reactions.

    PubMed Central

    Naderer, O; Nafziger, A N; Bertino, J S

    1997-01-01

    The effects of a 10-day course of moderate-dose (10 mg/kg/day) or high-dose (20 mg/kg/day) trimethoprim therapy on serum creatinine, measured creatinine clearance, urinary creatinine excretion, and serum folate were studied in 20 healthy volunteers. Serum creatinine concentrations increased significantly during trimethoprim therapy, began to decrease near day 10, and returned to baseline during the washout phase at both dosage levels. At the same time, measured creatinine clearance and urine creatinine changed in the opposite direction. No clinical or statistical differences were noted between changes in the moderate- versus the high-dose phases. Serum folate concentration decreases during high-dose trimethoprim therapy were statistically significant. Adverse drug reactions in the two groups were statistically different during the first study period, with the high-dose group having a 75% incidence rate and the moderate-dose group having an 11% incidence rate (P < 0.02). Serum creatinine, measured creatinine clearance, and urinary creatinine excretion demonstrated statistically, but not clinically, significant changes during trimethoprim therapy. In addition, high-dose trimethoprim caused significantly more adverse drug reactions than moderate-dose trimethoprim in normal volunteers. PMID:9371351

  13. Adverse reactions to metal debris in metal-on-polyethylene total hip arthroplasty using a titanium-molybdenum-zirconium-iron alloy stem.

    PubMed

    Kiran, Manish; Boscainos, Petros J

    2015-02-01

    We report a series of three patients who underwent uncemented total hip arthroplasty with a modular titanium-molybdenum-zirconium-iron stem and a cobalt-chrome-molybdenum head on an ultra-high molecular weight highly cross-linked polyethylene liner bearing. All three cases subsequently developed pain and adverse reaction to metal debris, leading to revision of the implants within thirty-six months. They were subsequently found to have hypersensitivity to cobalt or chromium. However where tested, blood metal ion levels were within MHRA guideline limits. Corrosion was noted at the taper-trunnion junction. It is possible, that the multi alloy head-neck combination may lead to corrosion. Hypersensitivity to metal ions may result to ARMD at lower metal ion levels. The use of ceramic heads may help avoid this risk. PMID:25466166

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

    ERIC Educational Resources Information Center

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

    2010-01-01

    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…

  15. The JCAHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events

    Microsoft Academic Search

    ANDREW CHANG; PAUL M. SCHYVE; RICHARD J. CROTEAU; DENNIS S. O'LEARY; JEROD M. LOEB

    2005-01-01

    Background. The current US national discussions on patient safety are not based on a common language. This hinders system- atic application of data obtained from incident reports, and learning from near misses and adverse events. Objective. To develop a common terminology and classification schema (taxonomy) for collecting and organizing patient safety data. Methods. The project comprised a systematic literature review;

  16. Adverse Event Management of Oral Mucositis in Patients with Breast Cancer

    PubMed Central

    Seiler, Sabine; Kosse, Jens; Loibl, Sibylle; Jackisch, Christian

    2014-01-01

    Summary Oral mucositis (OM) is a clinically important and frequent adverse event (AE) associated with cancer treatment with conventional chemotherapy as well as new targeted agents. Incidence and severity of OM vary from treatment to treatment and from patient to patient. The pathogenesis of chemotherapy-induced OM can be divided into 5 phases. OM induced by targeted therapies differs among other things in appearance, course, concomitant AEs and toxicity, and thus could be perceived as an entity distinct from chemotherapy-induced OM with an innate pathogenic mechanism. OM has a severe impact on a patient's quality of life (QoL) by causing complications such as pain and discomfort. Even more important are associated restrictions in nutrition and hydration. Thus, the efficacy of cancer therapy might be impaired due to the necessity of dose delays and dose reductions. Numerous preventive and therapeutic approaches have been evaluated, but currently no single agent has changed the standard of care in preventing and treating OM. Thus, the current management has evolved from clinical experience rather than clinical evidence. This article will review the AE ‘OM’ induced by breast cancer treatment with chemotherapy and targeted agents in order to provide practical guidance for management and prevention. PMID:25404881

  17. Clinical Pharmacology, Uses, and Adverse Reactions of Iodinated Contrast Agents: A Primer for the Non-radiologist

    PubMed Central

    Pasternak, Jeffrey J.; Williamson, Eric E.

    2012-01-01

    Iodinated contrast agents have been in use since the 1950s to facilitate radiographic imaging modalities. Physicians in almost all specialties will either administer these agents or care for patients who have received these drugs. Different iodinated contrast agents vary greatly in their properties, uses, and toxic effects. Therefore, clinicians should be at least superficially familiar with the clinical pharmacology, administration, risks, and adverse effects associated with iodinated contrast agents. This primer offers the non-radiologist physician the opportunity to gain insight into the use of this class of drugs. PMID:22469351

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

    PubMed Central

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

    2011-01-01

    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

  19. Clinical characteristics associated with adverse events in patients with exacerbation of chronic obstructive pulmonary disease: a prospective cohort study

    PubMed Central

    Stiell, Ian G.; Clement, Catherine M.; Aaron, Shawn D.; Rowe, Brian H.; Perry, Jeffrey J.; Brison, Robert J.; Calder, Lisa A.; Lang, Eddy; Borgundvaag, Bjug; Forster, Alan J.; Wells, George A.

    2014-01-01

    Background: To assist physicians with difficult decisions about hospital admission for patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) presenting in the emergency department, we sought to identify clinical characteristics associated with serious adverse events. Methods: We conducted this prospective cohort study in 6 large Canadian academic emergency departments. Patients were assessed for standardized clinical variables and then followed for serious adverse events, defined as death, intubation, admission to a monitored unit or new visit to the emergency department requiring admission. Results: We enrolled 945 patients, of whom 354 (37.5%) were admitted to hospital. Of 74 (7.8%) patients with a subsequent serious adverse event, 36 (49%) had not been admitted after the initial emergency visit. Multivariable modelling identified 5 variables that were independently associated with adverse events: prior intubation, initial heart rate ? 110/minute, being too ill to do a walk test, hemoglobin < 100 g/L and urea ? 12 mmol/L. A preliminary risk scale incorporating these and 5 other clinical variables produced risk categories ranging from 2.2% for a score of 0 to 91.4% for a score of 10. Using a risk score of 2 or higher as a threshold for admission would capture all patients with a predicted risk of adverse events of 7.2% or higher, while only slightly increasing admission rates, from 37.5% to 43.2%. Interpretation: In Canada, many patients with COPD suffer a serious adverse event or death after being discharged home from the emergency department. We identified high-risk characteristics and developed a preliminary risk scale that, once validated, could be used to stratify the likelihood of poor outcomes and to enable rational and safe admission decisions. PMID:24549125

  20. Evaluating the risk of patient re-identification from adverse drug event reports

    PubMed Central

    2013-01-01

    Background Our objective was to develop a model for measuring re-identification risk that more closely mimics the behaviour of an adversary by accounting for repeated attempts at matching and verification of matches, and apply it to evaluate the risk of re-identification for Canada’s post-marketing adverse drug event database (ADE).Re-identification is only demonstrably plausible for deaths in ADE. A matching experiment between ADE records and virtual obituaries constructed from Statistics Canada vital statistics was simulated. A new re-identification risk is considered, it assumes that after gathering all the potential matches for a patient record (all records in the obituaries that are potential matches for an ADE record), an adversary tries to verify these potential matches. Two adversary scenarios were considered: (a) a mildly motivated adversary who will stop after one verification attempt, and (b) a highly motivated adversary who will attempt to verify all the potential matches and is only limited by practical or financial considerations. Methods The mean percentage of records in ADE that had a high probability of being re-identified was computed. Results Under scenario (a), the risk of re-identification from disclosing the province, age at death, gender, and exact date of the report is quite high, but the removal of province brings down the risk significantly. By only generalizing the date of reporting to month and year and including all other variables, the risk is always low. All ADE records have a high risk of re-identification under scenario (b), but the plausibility of that scenario is limited because of the financial and practical deterrent even for highly motivated adversaries. Conclusions It is possible to disclose Canada’s adverse drug event database while ensuring that plausible re-identification risks are acceptably low. Our new re-identification risk model is suitable for such risk assessments. PMID:24094134

  1. Local adverse effects associated with the use of inhaled corticosteroids in patients with moderate or severe asthma*

    PubMed Central

    Pinto, Charleston Ribeiro; Almeida, Natalie Rios; Marques, Thamy Santana; Yamamura, Laira Lorena Lima; Costa, Lindemberg Assunção; Souza-Machado, Adelmir

    2013-01-01

    OBJECTIVE: To describe and characterize local adverse effects (in the oral cavity, pharynx, and larynx) associated with the use of inhaled corticosteroids (ICSs) in patients with moderate or severe asthma. METHODS: This was a cross-sectional study involving a convenience sample of 200 asthma patients followed in the Department of Pharmaceutical Care of the Bahia State Asthma and Allergic Rhinitis Control Program Referral Center, located in the city of Salvador, Brazil. The patients were ? 18 years of age and had been using ICSs regularly for at least 6 months. Local adverse effects (irritation, pain, dry throat, throat clearing, hoarseness, reduced vocal intensity, loss of voice, sensation of thirst, cough during ICS use, altered sense of taste, and presence of oral candidiasis) were assessed using a 30-day recall questionnaire. RESULTS: Of the 200 patients studied, 159 (79.5%) were women. The mean age was 50.7 ± 14.4 years. In this sample, 55 patients (27.5%) were using high doses of ICS, with a median treatment duration of 38 months. Regarding the symptoms, 163 patients (81.5%) reported at least one adverse effect, and 131 (65.5%) had a daily perception of at least one symptom. Vocal and pharyngeal symptoms were identified in 57 (28.5%) and 154 (77.0%) of the patients, respectively. The most commonly reported adverse effects were dry throat, throat clearing, sensation of thirst, and hoarseness. CONCLUSIONS: Self-reported adverse effects related to ICS use were common among the asthma patients evaluated here. PMID:24068261

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

    PubMed Central

    2013-01-01

    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

  3. Malaria chemoprophylaxis among European tourists in tropical Africa: use, adverse reactions, and efficacy.

    PubMed Central

    Steffen, R.; Heusser, R.; Mächler, R.; Bruppacher, R.; Naef, U.; Chen, D.; Hofmann, A. M.; Somaini, B.

    1990-01-01

    In order to determine knowledge, attitudes and practices towards malaria prophylaxis, as well as its side-effects and efficacy, a self-administered questionnaire was distributed to European travellers on return flights from tropical Africa to Europe. Between 1985 and 1988 the questionnaire was completed by 44,472 passengers (80.1% of those on board) on 242 flights. A follow-up questionnaire was completed by 42,202 (94.9%) of the same travellers 3 months later. Almost all knew about the risk of malaria, but 10% relied solely on advice from nonmedical sources. While 55.6% had taken at least one measure against mosquito bites, only 4.5% adopted three such measures (used repellents and insecticides and wore long clothing after dusk). Compliance with chemoprophylaxis use was reported by 57.0% of travellers who spent less than 3 months in Africa, compared with 29.2% who stayed 3-12 months. Depending on the antimalaria regimen taken, 11-44% of the travellers experienced adverse effects, while four deaths were attributed to the chemoprophylaxis. The incidence of malaria per month of exposure for travellers who took no chemoprophylaxis was 15.2 per 1000 in East Africa and 24.2 per 1000 in West Africa. In East Africa, the prophylactic efficacy of the currently recommended antimalaria regimens (relative to that of no chemoprophylaxis) was zero for a chloroquine dosage of 300 mg base per week (4 malaria fatalities), 64.1% for a chloroquine dosage of 600 mg base per week (P = 0.03), and 94.0% for mefloquine (P = 0.003). PMID:2393977

  4. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

    PubMed

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. PMID:25576362

  5. Using SNOMED CT in combination with MedDRA for reporting signal detection and adverse drug reactions reporting

    PubMed Central

    Bodenreider, Olivier

    2009-01-01

    Objective: To investigate the feasibility of using SNOMED CT as an entry point for coding adverse drug reactions and map them automatically to MedDRA for reporting purposes and interoperability with legacy repositories. Methods: On the one hand, we attempt to map SNOMED CT concepts to MedDRA concepts through the UMLS, using synonymy and explicit mapping relations. On the other, we compute the set of all fine-grained concepts that can be reached from concepts having a mapping to MedDRA. Results: 58% of the Preferred Terms in MedDRA have a mapping to SNOMED CT. Through the descendants in SNOMED CT, 108,305 additional SNOMED CT concepts can be linked to MedDRA. Conclusions: Fine-grained SNOMED CT concepts can be mapped automatically to MedDRA. This approach has the potential to enable the collection of adverse events related to drugs directly from clinical repositories. The quality of the mapping needs to be evaluated. PMID:20351820

  6. Cardiovascular and pulmonary adverse events in patients treated with BCR-ABL inhibitors: Data from the FDA Adverse Event Reporting System.

    PubMed

    Cortes, Jorge; Mauro, Michael; Steegmann, Juan Luis; Saglio, Giuseppe; Malhotra, Rachpal; Ukropec, Jon A; Wallis, Nicola T

    2015-04-01

    Rare but serious cardiovascular and pulmonary adverse events (AEs) have been reported in patients with chronic myeloid leukemia treated with BCR-ABL inhibitors. Clinical trial data may not reflect the full AE profile of BCR-ABL inhibitors because of stringent study entry criteria, relatively small sample size, and limited duration of follow-up. To determine the utility of the FDA AE Reporting System (FAERS) surveillance database for identifying AEs possibly associated with the BCR-ABL inhibitors imatinib, dasatinib, and nilotinib in the postmarketing patient population, we conducted Multi-Item Gamma Poisson Shrinker disproportionality analyses of FAERS reports on AEs in relevant system organ classes. Signals consistent with the known safety profiles of these agents as well as signals for less well-described AEs were detected. Bone marrow necrosis, conjunctival hemorrhage, and peritoneal fluid retention events were uniquely associated with imatinib. AEs that most commonly reached the threshold for dasatinib consisted of terms relating to hemorrhage and fluid retention, including pleural effusion and pericardial effusion. Most terms that reached the threshold solely with nilotinib were related to peripheral and cardiac vascular events. Although this type of analysis cannot determine AE incidence or establish causality, these findings elucidate the AEs reported in patients treated with BCR-ABL inhibitors across multiple clinical trials and in the community setting for all approved and nonapproved indications, suggesting drug-AE associations warrant further investigation. These findings emphasize the need to consider patient comorbidities when selecting amongst BCR-ABL inhibitors. PMID:25580915

  7. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    SciTech Connect

    Pan, Jian-Bo [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Nan; Pan, Wen; Hong, Ru [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Wang, Hao [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Zhi-Liang, E-mail: appo@xmu.edu.cn [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China)

    2014-01-01

    Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified.

  8. The Effect of Prophylactic Antipyretic Administration on Post-Vaccination Adverse Reactions and Antibody Response in Children: A Systematic Review

    PubMed Central

    Das, Rashmi Ranjan; Panigrahi, Inusha; Naik, Sushree Samiksha

    2014-01-01

    Background Prophylactic antipyretic administration decreases the post-vaccination adverse reactions. Recent study finds that they may also decrease the antibody responses to several vaccine antigens. This systematic review aimed to assess the evidence for a relationship between prophylactic antipyretic administration, post-vaccination adverse events, and antibody response in children. Methods A systematic search of major databases including MEDLINE and EMBASE was carried out till March 2014. Randomized controlled trials (RCTs) comparing prophylactic antipyretic treatment versus placebo post-vaccination in children ?6 years of age were included. Two reviewers independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data [PROSPERO registration: CRD42014009717]. Results Of 2579 citations retrieved, a total of 13 RCTs including 5077 children were included in the review. Prophylactic antipyretic administration significantly reduced the febrile reactions (?38.0°C) after primary and booster vaccinations. Though there were statistically significant differences in the antibody responses between the two groups, the prophylactic PCM group had what would be considered protective levels of antibodies to all of the antigens given after the primary and booster vaccinations. No significant difference in the nasopharyngeal carriage rates (short-term and long-term) of H. influenzae or S. pneumoniae serotypes was found between the prophylactic and no prophylactic PCM group. There was a significant reduction in the local and systemic symptoms after primary, but not booster vaccinations. Conclusions Though prophylactic antipyretic administration leads to relief of the local and systemic symptoms after primary vaccinations, there is a reduction in antibody responses to some vaccine antigens without any effect on the nasopharyngeal carriage rates of S. pneumoniae & H. influenza serotypes. Future trials and surveillance programs should also aim at assessing the effectiveness of programs where prophylactic administration of PCM is given. The timing of administration of antipyretics should be discussed with the parents after explaining the benefits & risks. PMID:25180516

  9. Pharmacogenetics and Pharmacogenomics II: Genetic Determinants of Drug Responses and Adverse Drug Reactions

    Microsoft Academic Search

    Stephane Dalle; Sandra Knowles; Neil H. Shear

    \\u000a The ability to predict efficacy and safety is crucial for drug discovery and development. To date, there are only a few genetic\\u000a biomarkers whose clinical validity in predicting drug response has been clearly established; for example, HER-2\\/neu-positivity\\u000a in breast cancer as a predictor of response to trastuzumab (Herceptin) [1]. Patient variability in response to medications\\u000a can range from failure to

  10. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia.

    PubMed

    Abdel-Latif, Mohamed M M; Abdel-Wahab, Basel A

    2015-04-01

    Adverse Drug Reactions (ADRs) are scantly reported with poor contribution by healthcare professionals worldwide and in particular in developing countries. The aim of this study was to assess the knowledge and awareness of adverse drug reactions (ADRs) reporting and pharmacovigilance system among healthcare professionals in Al-Madinah Al-Munawwarah hospitals, Kingdom of Saudi Arabia. A questionnaire was designed addressing; awareness of ADRs, knowledge of pharmacovigilance system, availability of ADRs reporting system, patient counseling about ADRs and documentation of ADRs. The questionnaire was distributed to randomly selected healthcare professionals (n = 585) such as physicians, pharmacists, nurses and pharmacists' technicians of hospitals. Completed questionnaires were collected and data were analyzed. Data were expressed in number as well as percentage. Of the 585 questionnaires circulated, a total of 384 healthcare professionals responded. Healthcare professional categories involved in the study were 148 physicians, 37 pharmacists, 158 nurses and 41 pharmacist technicians. The percent of the respondents who accepted to enroll in the study was 65.64%. Most of the respondents were unable to correctly define the pharmacovigilance term, but they were aware of ADRs. The awareness among healthcare professionals of the national pharmacovigilance system was 39.6%. Pharmacists had a good knowledge of pharmacovigilance and ADRs terminology and showed a more positive attitude to report ADRs. A greater number of the healthcare professionals were aware of ADRs reporting, but practically it is not implemented in hospitals. Most hospitals had follow-up documentation systems, but did not include ADRs reporting. There was no distinct pharmacovigilance system in place. Our study has demonstrated a lack of knowledge and awareness of pharmacovigilance and ADRs reporting among healthcare professionals in hospitals. The poor knowledge of ADRs reporting emphasized the urgent need to implement the appropriate strategies to improve the awareness of pharmacovigilance practices and ADRs reporting in Al-Madinah Al-Munawwarah hospitals. PMID:25972735

  11. Excessive Daytime Sleepiness is Associated with Longer Culprit Lesion and Adverse Outcomes in Patients with Coronary Artery Disease

    PubMed Central

    Lee, Chi-Hang; Ng, Wai-Yee; Hau, William; Ho, Hee-Hwa; Tai, Bee-Choo; Chan, Mark Y.; Richards, A. Mark; Tan, Huay-Cheem

    2013-01-01

    Study Objectives: We assessed whether excessive daytime sleepiness was associated with coronary plaque phenotype and subsequent adverse cardiovascular events. Methods: Prospective cohort study. Intravascular ultrasound (IVUS) examination of the culprit coronary stenosis was performed. The Epworth Sleepiness Scale (ESS) questionnaire was administered, and the patients were divided into 2 groups—(1) sleepier and (2) less sleepy—based on the ESS score. Adverse cardiovascular outcomes were defined as cardiac death, myocardial infarction, stroke, unplanned revascularization, or heart failure admission. Results: One hundred seventeen patients undergoing urgent or non-urgent coronary angiography were recruited. Compared with the less sleepy group (ESS ? 10, n = 87), the sleepier group (ESS > 10, n = 30) had higher serum levels of total cholesterol and of low-density-lipoprotein cholesterols (p < 0.05 for both). The IVUS examinations indicated coronary stenoses were longer in the sleepier group than in the less sleepy group (p = 0.011). The cumulative incidence of adverse cardiovascular events at 16-month follow-up was higher in the sleepier than the less sleepy group (12.5% versus 6.9%, p = 0.03). Cox regression analysis adjusting for age and smoking showed increased hazard of adverse cardiovascular events in sleepier group as compared to less sleepy group (HR = 3.44, 95% CI 1.01-11.72). Conclusion: In patients presenting with coronary artery disease, excessive daytime sleepiness based on ESS > 10 was associated with longer culprit lesions and future adverse cardiovascular events. Citation: Lee CH; Ng WY; Hau W; Ho HH; Tai BC; Chan MY; Richards AM; Tan HC. Excessive daytime sleepiness is associated with longer culprit lesion and adverse outcomes in patients with coronary artery disease. J Clin Sleep Med 2013;9(12):1267-1272. PMID:24340288

  12. Effects of Video Games on the Adverse Corollaries of Chemotherapy in Pediatric Oncology Patients: A Single-Case Analysis.

    ERIC Educational Resources Information Center

    Kolko, David J.; Rickard-Figueroa, Jorge L.

    1985-01-01

    Assessed effects of video games on adverse corollaries of chemotherapy in three pediatric oncology patients. Results indicated that access to video games resulted in reduction in the number of anticipatory symptoms experienced and observed, as well as a diminution in the aversiveness of chemotherapy side effects. (Author/NRB)

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

    ERIC Educational Resources Information Center

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

    2008-01-01

    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…

  14. Adverse Effects of Plasma Transfusion

    PubMed Central

    Pandey, Suchitra; Vyas, Girish N.

    2012-01-01

    Plasma utilization has increased over the last two decades, and there is a growing concern that many plasma transfusions are inappropriate. Plasma transfusion is not without risk, and certain complications are more likely with plasma than other blood components. Clinical and laboratory investigations of the patients suffering reactions following infusion of fresh frozen plasma (FFP) define the etiology and pathogenesis of the panoply of adverse effects. We review here the pathogenesis, diagnosis, and management of the risks associated with plasma transfusion. Risks commonly associated with FFP include: (1) transfusion related acute lung injury; (2) transfusion associated circulatory overload, and (3) allergic/anaphylactic reactions. Other less common risks include (1) transmission of infections, (2) febrile non-hemolytic transfusion reactions, (3) RBC allo-immunization, and (4) hemolytic transfusion reactions. The affect of pathogen inactivation/reduction methods on these risks are also discussed. Fortunately, a majority of the adverse effects are not lethal and are adequately treated in clinical practice. PMID:22578374

  15. Meta-Analysis of the Adverse Effects of Long-Term Azithromycin Use in Patients with Chronic Lung Diseases

    PubMed Central

    Li, Hui; Liu, Ding-Hui; Chen, Lu-Lu; Zhao, Qi; Yu, Yan-Zhe; Ding, Jing-Jing; Miao, Li-Yun; Xiao, Yong-Long; Zhang, De-Ping; Guo, Yu-Biao; Xie, Can-Mao

    2014-01-01

    The adverse effects of azithromycin on the treatment of patients with chronic lung diseases (CLD) were evaluated in the present study. MEDLINE and other databases were searched for relevant articles published until August 2013. Randomized controlled trials that enrolled patients with chronic lung diseases who received long-term azithromycin treatment were selected, and data on microbiological studies and azithromycin-related adverse events were abstracted from articles and analyzed. Six studies were included in the meta-analysis. The risk of bacterial resistance in patients receiving long-term azithromycin treatment was increased 2.7-fold (risk ratio [RR], 2.69 [95% confidence interval {95% CI}, 1.249, 5.211]) compared with the risk in patients receiving placebo treatment. On the other hand, the risk of bacterial colonization decreased in patients receiving azithromycin treatment (RR, 0.551 [95% CI, 0.460, 0.658]). Patients receiving long-term azithromycin therapy were at risk of increased impairment of hearing (RR, 1.168 [95% CI, 1.030, 1.325]). This analysis provides evidence supporting the idea that bacterial resistance can develop with long-term azithromycin treatment. Besides the increasingly recognized anti-inflammatory role of azithromycin used in treating chronic lung diseases, we should be aware of the potential for adverse events with its long-term use. PMID:24189261

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

    PubMed

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

    2013-12-01

    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

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

    PubMed Central

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

    2013-01-01

    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

  18. [Modern microbiological methods in diagnosis of adverse reactions after BCG vaccination. Case reports].

    PubMed

    Zwolska, Zofia; Augustynowicz-Kope?, Ewa; Zabost, Anna; Zió?kowski, Jerzy; Buchwald, Joachim; P?o?czak, Marian; Walas, Wojciech; Ziebi?ski, Marek

    2004-01-01

    The attenuated bacilli Calmette-Guerin (BCG) vaccine is administered worldwide to prevent tuberculosis and is considered to have an excellent safety profile. In Poland, since 1955 BCG mass vaccinations have been compulsory. More than 95% newborns and 80% of older children of the population have been vaccinated. Complications of vaccination are uncommon. Although BCG has been used safely for many years, it can cause disease in humans, especially those with cellular immunodeficiencies. The risks associated with BCG vaccination include local complications, extraregional localized disease, and disseminated BCG disease. Identification of M. bovis BCG in laboratory is a very difficult process. Routine identification of mycobacterial isolates in clinical laboratories involves culture of Mycobacterium tuberculosis complex which includes M. tuberculosis, M. bovis, M. africanum and M. microti and the vaccine strain M.bovis BCG. Most laboratories cannot quickly differentiate between BCG and other members of M. tuberculosis complex and some cases of BCG complications in children may be considered and treated as tuberculosis. Because of difficulties in proper identification of BCG strains isolated from the patients, the prevalence of BCG infections is not know exactly. Knowledge of BCG infection would be of particular interest to the clinician responsible for the therapy. We describe the several methods using in mycobacterial laboratory for identification and suggest the modern algorithm of BCG strains identification including mycolic acids profile by HPLC and 14C PZA resistance methods. The methods allowed us fast and accurate identify M. bovis BCG infection in 5 children which have been described in our paper. Preliminary diagnosis for four children among five tested was tuberculosis. One immunocompromised HIV negative child died, one still excretes BCG bacilli. To our knowledge, this is the first report of BCG complication (AEFI) in Polish children in which HPLC and 14 C PZA methods have been used for rapid identification of M. bovis BCG infection and/or complication. PMID:16329351

  19. Serious adverse drug reaction in a woman with hyperemesis gravidarum after first exposure to vitamin B complex containing vitamins B1, B6 and B12.

    PubMed

    Kuwata, Yoshimine; Tsuruoka, Shuichi; Ohkuchi, Akihide; Matsubara, Shigeki; Izumi, Akio; Suzuki, Mitsuaki

    2009-08-01

    We report the case of a pregnant woman who suffered from hypotension after first exposure to intravenous administration of a combination drug containing vitamins B1, B6 and B12 (Vitamedin; Daiichi-Sankyo, Tokyo, Japan). A 27-year-old Japanese woman received an intravenous infusion of fluid containing a vitamin B complex due to hyperemesis gravidarum. Thirty minutes after the start of infusion she was found to be in hypotension. The patient had stupor, general sweating, blood pressure of 82/50 mmHg, and low percutaneous oxygen saturation (SpO(2)) of 88%. We immediately stopped the infusion, lifted her legs and administered oxygen. Three minutes after these treatments, she quickly recovered to a good general condition. A skin prick test for vitamin B12 was positive, but tests for B1, B6, mannitol and saline were negative, indicating this adverse reaction was one of drug hypersensitivity due to the vitamin B12 in Vitamedin. Patients should be observed carefully immediately after the administration of Vitamedin. PMID:19751344

  20. Pharmacotherapy for Adverse Events Reduces the Length of Hospital Stay in Patients Admitted to Otolaryngology Ward: A Single Arm Intervention Study

    PubMed Central

    Suzuki, Akio; Kobayashi, Ryo; Okayasu, Shinji; Kuze, Bunya; Aoki, Mitsuhiro; Mizuta, Keisuke; Itoh, Yoshinori

    2014-01-01

    Background To determine whether adverse events extend the duration of hospitalization, and to evaluate the effectiveness of medical intervention in ameliorating adverse events and reducing the prolonged hospital stay associated with adverse events. Methods A single arm intervention study was conducted from October 2012 to March 2014 in the otolaryngology ward of a 614-bed, university-affiliated hospital. Adverse events were monitored daily by physicians, pharmacists and nurses, and recorded in the electronic medical chart for each patient. Appropriate drug management of adverse events was performed by physicians in liaison with pharmacists. The Kaplan-Meier method was used to assess the length of hospitalization of patients who underwent medical intervention for adverse events. Results Of 571 patients admitted to the otolaryngology ward in a year, 219 patients (38.4%) experienced adverse events of grade ?2. The duration of hospitalization was affected by the grade of adverse events, with a mean duration of hospital stay of 9.2, 17.2, 28.3 and 47.0 days for grades 0, 1, 2, and 3–4, respectively. Medical intervention lowered the incidence of grade ?2 adverse events to 14.5%. The length of hospitalization was significantly shorter in patients who showed an improvement of adverse events after medical intervention than those who did not (26.4 days vs. 41.6 days, hazard ratio 1.687, 95% confidence interval: 1.260–2.259, P<0.001). A multivariate Cox proportional hazard analysis indicated that insomnia, constipation, nausea/vomiting, infection, non-cancer pain, oral mucositis, odynophagia and neutropenia were significant risk factors for prolongation of hospital stay. Conclusion Patients who experienced adverse events are at high risk of prolonged hospitalization. Medical intervention for adverse events was found to be effective in reducing the length of hospital stay associated with adverse events. PMID:25549093

  1. Intravenous administration of equine-derived whole IgG antivenom does not induce early adverse reactions in non-envenomed horses and cows

    Microsoft Academic Search

    Ricardo Estrada; María Herrera; Álvaro Segura; Javier Araya; Carlos Boschini; José María Gutiérrez; Guillermo León

    2010-01-01

    Administration of antivenoms to treat snakebite envenomings has the potential risk of inducing early adverse reactions. The mechanisms involved in these reactions are unclear. In this study, polyspecific antivenom consisting of whole IgG purified from equine plasma by caprylic acid precipitation was administered intravenously to non-envenomed horses (n = 47) and cows (n = 20) at a dose of 0.4 mL\\/kg. It has been reported

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

    PubMed Central

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

    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

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

    PubMed Central

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

    2010-01-01

    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

  4. Adverse Reactions to Foods

    Microsoft Academic Search

    Anna Nowak-Wegrzyn; Hugh A. Sampson

    2006-01-01

    Over the past 20 years, food allergy has emerged as an important clinical problem in Westernized countries. Not only has food allergy prevalence al- most doubled but its severity and scope have increased. Consequently, research focusing on characterization, mapping, and cloning of food allergens, as well as on deciphering the nature of immune responses to food allergens and the mechanisms

  5. Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU–ADR project

    PubMed Central

    Avillach, Paul; Dufour, Jean-Charles; Diallo, Gayo; Salvo, Francesco; Joubert, Michel; Thiessard, Frantz; Mougin, Fleur; Trifirò, Gianluca; Fourrier-Réglat, Annie; Pariente, Antoine; Fieschi, Marius

    2013-01-01

    Objectives The aim of this research was to automate the search of publications concerning adverse drug reactions (ADR) by defining the queries used to search MEDLINE and by determining the required threshold for the number of extracted publications to confirm the drug/event association in the literature. Methods We defined an approach based on the medical subject headings (MeSH) ‘descriptor records’ and ‘supplementary concept records’ thesaurus, using the subheadings ‘chemically induced’ and ‘adverse effects’ with the ‘pharmacological action’ knowledge. An expert-built validation set of true positive and true negative drug/adverse event associations (n=61) was used to validate our method. Results Using a threshold of three of more extracted publications, the automated search method presented a sensitivity of 90% and a specificity of 100%. For nine different drug/event pairs selected, the recall of the automated search ranged from 24% to 64% and the precision from 93% to 48%. Conclusions This work presents a method to find previously established relationships between drugs and adverse events in the literature. Using MEDLINE, following a MeSH approach to filter the signals, is a valid option. Our contribution is available as a web service that will be integrated in the final European EU–ADR project (Exploring and Understanding Adverse Drug Reactions by integrative mining of clinical records and biomedical knowledge) automated system. PMID:23195749

  6. Renal Function Interferes with Copeptin in Prediction of Major Adverse Cardiac Events in Patients Undergoing Vascular Surgery

    PubMed Central

    Sahlmann, Bianca; Meinders, Antje; Larmann, Jan; Wilhelmi, Mathias; Aper, Thomas; Rustum, Saad; Lichtinghagen, Ralf; Theilmeier, Gregor; Teebken, Omke E.

    2015-01-01

    Objective Precise perioperative risk stratification is important in vascular surgery patients who are at high risk for major adverse cardiovascular events (MACE) peri- and postoperatively. In clinical practice, the patient’s perioperative risk is predicted by various indicators, e.g. revised cardiac index (RCRI) or modifications thereof. Patients suffering from chronic kidney disease (CKD) are stratified into a higher risk category. We hypothesized that Copeptin as a novel biomarker for hemodynamic stress could help to improve the prediction of perioperative cardiovascular events in patients undergoing vascular surgery including patients with chronic kidney disease. Methods 477 consecutive patients undergoing abdominal aortic, peripheral arterial or carotid surgery from June 2007 to October 2012 were prospectively enrolled. Primary endpoint was 30-day postoperative major adverse cardiovascular events (MACE). Results 41 patients reached the primary endpoint, including 63.4% aortic, 26.8% carotid, and 9.8% peripheral surgeries. Linear regression analysis showed that RCRI (P< .001), pre- (P< .001), postoperative Copeptin (P< .001) and Copeptin level change (P= .001) were associated with perioperative MACE, but CKD remained independently associated with MACE and Copeptin levels. Multivariate regression showed that increased Copeptin levels added risk predictive information to the RCRI (P= .003). Especially in the intermediate RCRI categories was Copeptin significantly associated with the occurrence of MACE. (P< .05 Kruskal Wallis test). Subdivision of the study cohort into CKD stages revealed that preoperative Copeptin was significantly associated with CKD stages (P< .0001) and preoperative Copeptin measurements could not predict MACE in patients with more severe CKD stages. Conclusion Preoperative Copeptin loses its risk predictive potential for perioperative MACE in patients with chronic kidney disease undergoing vascular surgery. PMID:25875814

  7. Automatic Identification of Messages Related to Adverse Drug Reactions from Online User Reviews using Feature-based Classification

    PubMed Central

    LIU, Jingfang; ZHANG, Pengzhu; LU, Yingjie

    2014-01-01

    Abstract Background User-generated medical messages on Internet contain extensive information related to adverse drug reactions (ADRs) and are known as valuable resources for post-marketing drug surveillance. The aim of this study was to find an effective method to identify messages related to ADRs automatically from online user reviews. Methods We conducted experiments on online user reviews using different feature set and different classification technique. Firstly, the messages from three communities, allergy community, schizophrenia community and pain management community, were collected, the 3000 messages were annotated. Secondly, the N-gram-based features set and medical domain-specific features set were generated. Thirdly, three classification techniques, SVM, C4.5 and Naïve Bayes, were used to perform classification tasks separately. Finally, we evaluated the performance of different method using different feature set and different classification technique by comparing the metrics including accuracy and F-measure. Results In terms of accuracy, the accuracy of SVM classifier was higher than 0.8, the accuracy of C4.5 classifier or Naïve Bayes classifier was lower than 0.8; meanwhile, the combination feature sets including n-gram-based feature set and domain-specific feature set consistently outperformed single feature set. In terms of F-measure, the highest F-measure is 0.895 which was achieved by using combination feature sets and a SVM classifier. In all, we can get the best classification performance by using combination feature sets and SVM classifier. Conclusion By using combination feature sets and SVM classifier, we can get an effective method to identify messages related to ADRs automatically from online user reviews.

  8. Impaired Global Right Ventricular Longitudinal Strain Predicts Long-Term Adverse Outcomes in Patients with Pulmonary Arterial Hypertension

    PubMed Central

    Park, Jae-Hyeong; Park, Margaret M.; Farha, Samar; Sharp, Jacqueline; Lundgrin, Erika; Comhair, Suzy; Tang, Wai Hong; Erzurum, Serpil C.

    2015-01-01

    Background New 2-dimensional strain echocardiography enables quantification of right ventricular (RV) mechanics by assessing global longitudinal strain of RV (GLSRV) in patients with pulmonary arterial hypertension (PAH). However, the prognostic significance of impaired GLSRV is unclear in these patients. Methods Comprehensive echocardiography was performed in 51 consecutive PAH patients without atrial fibrillation (40 females, 48 ± 14 years old) with long-term follow-up. GLSRV was measured with off-line with velocity vector imaging (VVI, Siemens Medical System, Mountain View, CA, USA). Results GLSRV showed significant correlation with RV fractional area change (r = -0.606, p < 0.001), tricuspid annular plane systolic excursion (r = -0.579, p < 0.001), and RV Tei index (r = 0.590, p < 0.001). It showed significant correlations with pulmonary vascular resistance (r = 0.469, p = 0.001) and B-natriuretic peptide concentration (r = 0.351, p = 0.012). During a clinical followup time (45 ± 15 months), 20 patients experienced one or more adverse events (12 death, 2 lung transplantation, and 15 heart failure hospitalization). After multivariate analysis, age [hazard ratio (HR) = 2.343, p = 0.040] and GLSRV (HR = 2.122, p = 0.040) were associated with adverse clinical events. Age (HR = 3.200, p = 0.016) and GLSRV (HR = 2.090, p = 0.042) were also significant predictors of death. Impaired GLSRV (? -15.5%) was associated with lower event-free survival (HR = 4.906, p = 0.001) and increased mortality (HR = 8.842, p = 0.005). Conclusion GLSRV by VVI showed significant correlations with conventional echocardiographic parameters indicating RV systolic function. Lower GLSRV (? -15.5%) was significantly associated with presence of adverse clinical events and deaths in PAH patients. PMID:26140151

  9. Drug-induced blood consumption: the impact of adverse drug reactions on demand for blood components in German departments of internal medicine.

    PubMed

    Rottenkolber, Dominik; Schmiedl, Sven; Rottenkolber, Marietta; Thuermann, Petra A; Hasford, Joerg

    2012-10-01

    Therapy for adverse drug reactions (ADRs) often results in the application of blood components. This study aims to assess the demand for blood components and the resulting economic burden (hospital perspective) in German hospitals induced by ADRs leading to admissions to departments of internal medicine. In this prospective study, ADRs leading to hospitalization were surveyed in four regional pharmacovigilance centres in Germany during the years 2000-2007. ADRs assessed as 'possible', 'likely' or 'very likely' were included. Market prices for blood components and hospitalization data were determined by desktop research. A probabilistic sensitivity analysis was performed. A total of 6099 patients were admitted to internal medicine departments because of an outpatient ADR of whom 1165 patients (19.1%; mean age, 73.0 ± 13.0 years) required treatment with blood components owing to major bleeding events. Overall consumption was 4185 erythrocyte concentrates (EC), 426 fresh frozen plasma (FFP) and 48 thrombocyte (TC) units. On the basis of statistical hospital data, we estimated a nationwide demand of approximately 132,020 EC, 13,440 FFP and 1515 TC units, resulting in total costs of €12.66 million per year for all German hospitals. Some 19.2% of all ADR cases were assessed as preventable. Theoretically, a nationwide decreased demand for blood components and a savings potential of €2.43 million per year could be achieved by preventing ADRs in Germany. Blood components are used in one-fifth (mainly gastrointestinal bleeding) of all ADRs, leading to hospitalizations in internal medicine departments. Both blood demand and hospital procurement costs can be significantly lowered by preventing ADRs. PMID:22487717

  10. Management of patients with nonaspirin-exacerbated respiratory disease aspirin hypersensitivity reactions.

    PubMed

    Saff, Rebecca R; Banerji, Aleena

    2015-01-01

    Because of widespread use, nonsteroidal anti-inflammatory drugs (NSAIDs) are the second most common cause of all adverse drug reactions, with hypersensitivity reported in ?1% of the population. NSAID hypersensitivity can be categorized into five types by the underlying disease, symptoms of reaction, and timing of reaction. These include rhinitis and asthma induced by NSAIDs (also known as aspirin-exacerbated respiratory disease), NSAID-exacerbated cutaneous disease (NECD), urticaria or angioedema induced by multiple NSAIDs, single NSAID-induced reactions, and delayed NSAID reactions. NECD occurs in one-third of patients with chronic urticaria who develop an exacerbation of their urticaria, sometimes with angioedema, typically beginning 30-90 minutes after ingestion of NSAIDs that inhibit cyclooxygenase (COX)-1. In urticaria or angioedema induced by multiple NSAIDs, patients without underlying disease develop urticaria or angioedema 30-90 minutes after ingestion of COX-1-inhibiting NSAIDs including aspirin. Single NSAID-induced reactions are immediate and specific to a single NSAID and are thought to occur because of an IgE-mediated reaction against a specific epitope of the NSAID. Delayed NSAID reactions occur days to weeks after initiating an NSAID. These are T-cell mediated and not amenable to desensitization or rechallenge. Classifying the type of NSAID hypersensitivity is important because many patients with a prior history of urticaria or angioedema induced by multiple NSAIDs will often tolerate aspirin test dose. This would allow the use of an aspirin for primary or secondary prevention in patients with coronary artery disease despite a presumed history of NSAID hypersensitivity. PMID:25562554

  11. [Therapist's reactions on the treatment of suicidal patients].

    PubMed

    Nivoli, Alessandra M A; Nivoli, Fabrizia L G; Nivoli, Gian Carlo; Lorettu, Liliana

    2011-01-01

    In the present study, we describe fourteen therapists' reactions (Avoidance, Rejection, Suicidal collusion, Over-involvement, Overprotection, Loss of patients' responsibilities, Loss of therapists' responsibilities, Reaction to the feeling of being exploited, Creation of dependency, Manipolatory acting out, Feeling of undergoing an iniquity, Patients psychopathology inflation, Therapists' psychopathology inflation, Suicidal Burnout Syndrome), based on emotions, behaviors and cognitivity, toward patients with suicidal risk. These responses can interfere with a correct assessment and management of suicidal risk in psychiatric patients. The purpose of the present clinical study was to improve therapist's professional skills through the recognition and management of his own responses to suicidal patients. PMID:21446112

  12. EuroPrevall survey on prevalence and pattern of self-reported adverse reactions to food and food allergies among primary schoolchildren in Vilnius, Lithuania.

    PubMed

    Kavali?nas, Andrius; Surkien?, Gen?; Dubakien?, R?ta; Stukas, Rimantas; Zagminas, K?stutis; Saulyt?, Jurgita; Burney, Peter G; Kummeling, Ischa; Mills, Clare

    2012-01-01

    The aim of the research was to assess the prevalence and pattern of self-reported adverse reactions to food and food allergies among primary schoolchildren in Vilnius. MATERIAL AND METHODS. Vilnius University was a partner in the EuroPrevall project. A total of 4333 schoolchildren from 13 primary schools participated in the study. Of all 4333 questionnaires distributed, 3084 were returned (response rate, 71.2%). This screening phase was followed by the second (clinical) part with an objective confirmative laboratory analysis of blood samples for the diagnosis of food allergy. For the research purposes, 186 blood samples for IgE were analyzed. RESULTS. Almost half of the children had an illness or a disorder caused by eating food. The prevalence of adverse reactions to food was found to be increasing with age from 6 to 10 years. Food allergy was diagnosed in 16.4% of children. Boys had food allergy more frequently than girls. Diarrhea or vomiting and a rash, urticarial rash, or itchy skin were the most commonly mentioned symptoms. Fruits, berries, and milk and dairy were found to be the most common foods to cause adverse reactions. The most relevant foods for children with IgE-mediated food allergy were cow's milk and hazelnuts. CONCLUSIONS. The prevalence of self-reported food hypersensitivity among primary schoolchildren was observed in almost half of the studied population. Fruits, berries, and milk and dairy were the most common foods to cause adverse reactions among primary schoolchildren in Lithuania. The determined differences in the prevalence of food hypersensitivity and IgE-mediated food allergy and associations with gender and age need further scientific analysis for the development of prognostic and diagnostic tools. PMID:22864274

  13. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting

    PubMed Central

    Kharkar, Mala; Bowalekar, Suresh

    2012-01-01

    Objective: The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. Materials and Methods: A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. Results: 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. Conclusion: The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right perception toward ADR reporting. However, as far as practice of ADR reporting is concerned it is discouraging. PMID:23125959

  14. Adverse Cardiac Outcomes After Noncardiac Surgery in Patients with Prior Percutaneous Transluminal Coronary Angioplasty

    Microsoft Academic Search

    Karen L. Posner; Gail A. Van Norman; Victor Chan

    1999-01-01

    In this retrospective cohort study, we compared ad- verse cardiac outcomes after noncardiac surgery among patients with prior percutaneous transluminal coronary angioplasty (PTCA), patients with nonrevas- cularized coronary artery disease (CAD), and normal controls. Inpatient hospital discharge abstracts from all nonfederal acute care hospitals in Washington State linked to death certificates were evaluated. Patients $45 yr old with prior PTCA

  15. The Comparison of Intrathecal Morphine and IV Morphine PCA on Pain Control, Patient Satisfaction, Morphine Consumption, and Adverse Effects in Patients Undergoing Reduction Mammoplasty

    PubMed Central

    Akda?, Osman; Kara, ?nci; Y?ld?ran, Gokce Unal; Tosun, Zekeriya

    2015-01-01

    Background: Following breast reduction procedures, the level of postoperative pain can be severe, and sufficient pain control influences a patient's physiological, immunological, and psychological status. Objective: The aim of this study was to examine the use of intrathecal morphine (ITM) in breast reduction surgery with patient-controlled analgesia (PCA). Methods: Sixty-two female patients who underwent breast reductions with the same technique participated in this study. The study group (ITM + PCA) included 32 patients; a single shot (0.2 mg) of ITM and intravenous morphine with PCA were administered. In the control group, morphine PCA alone was intravenously administered to 30 patients. Comparisons between the groups of cumulative morphine consumption, visual analog scale scores, and patient satisfaction scores, which were the primary outcome measures, and adverse effects, which were the secondary outcome measures, were conducted. Results: The patients in the 2 groups had similar degrees of pain and satisfaction scores. The study group had lower cumulative morphine consumption (P = .001) than the PCA-only control group; there was no statistically significant difference in adverse effects between the 2 groups. Conclusion: Intrathecal morphine may effectively control pain with lower total morphine consumption following breast reduction surgery. PMID:25987940

  16. Association of the diplotype configuration at the N-acetyltransferase 2 gene with adverse events with co-trimoxazole in Japanese patients with systemic lupus erythematosus

    PubMed Central

    Soejima, Makoto; Sugiura, Tomoko; Kawaguchi, Yasushi; Kawamoto, Manabu; Katsumata, Yasuhiro; Takagi, Kae; Nakajima, Ayako; Mitamura, Tadayuki; Mimori, Akio; Hara, Masako; Kamatani, Naoyuki

    2007-01-01

    Although co-trimoxazole (trimethoprim-sulphamethoxazole) is an effective drug for prophylaxis against and treatment of Pneumocystis pneumonia, patients often experience adverse events with this combination, even at prophylactic doses. With the aim being to achieve individual optimization of co-trimoxazole therapy in patients with systemic lupus erythematosus (SLE), we investigated genetic polymorphisms in the NAT2 gene (which encodes the metabolizing enzyme of sulphamethoxazole). Of 166 patients with SLE, 54 patients who were hospitalized and who received prophylactic doses of co-trimoxazole were included in the cohort study. Adverse events occurred in 18 patients; only two experienced severe adverse events that lead to discontinuation of the drug. These two patients and three additional ones with severe adverse events (from other institutions) were added to form a cohort sample and were analyzed in a case-control study. Genotype was determined using TaqMan methods, and haplotype was inferred using the maximum-likelihood method. In the cohort study, adverse events occurred more frequently in those without the NAT2*4 haplotype (5/7 [71.4%]) than in those with at least one NAT2*4 haplotype (13/47 [27.7%]; P = 0.034; relative risk = 2.58, 95% confidence interval = 1.34–4.99). In the case-control study the proportion of patients without NAT2*4 was significantly higher among those with severe adverse events (3/5 [60%]) than those without severe adverse events (6/52 [11.5%]; P = 0.024; odds ratio = 11.5, 95% confidence interval = 1.59–73.39). We conclude that lack of NAT2*4 haplotype is associated with adverse events with co-trimoxazole in Japanese patients with SLE. PMID:17335581

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

    PubMed Central

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

    2014-01-01

    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

  18. Adverse Outcomes after Non-Chest Surgeries in Patients with Pulmonary Tuberculosis: A Nationwide Study

    PubMed Central

    Lin, Chao-Shun; Yeh, Chun-Chieh; Chung, Chi-Li; Hung, Chih-Jen; Chen, Ta-Liang

    2015-01-01

    Background The association between pulmonary tuberculosis (TB) and postoperative outcomes remains unknown. This study investigated outcomes following non-chest surgeries in patients with previous pulmonary TB. Methods Using Taiwan’s National Health Insurance Research Database, we analyzed 6911 patients (aged ? 20 years) with preoperative diagnosis of pulmonary TB and 6911 propensity score-matched controls receiving non-chest surgeries in 2008–2010. Postoperative outcomes were compared between patients with or without pulmonary TB by calculating adjusted odds ratios (ORs) and 95% confidence intervals (CIs) in the multivariate logistic regressions. Results Surgical patients with pulmonary TB had a significantly higher postoperative complication rates than controls, including septicemia, pneumonia, acute renal failure, deep wound infection, overall complications, and 30-day postoperative mortality (OR 1.41; 95% CI 1.07–1.86). The ORs of patients with low-income status were as high as 2.27 (95% CI 1.03–5.03). Preoperative use of TB drugs and TB-related medical expenditure also associated with higher postoperative mortality among surgical patients with pulmonary TB. Conclusions Surgical patients with pulmonary TB have significantly increased risks of postoperative complications and mortality after non-chest surgeries. This study suggests the need to improve postoperative care for surgical patients with pulmonary TB. PMID:26172153

  19. New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment.

    PubMed

    Basch, Ethan

    2014-01-01

    Patient-reported outcomes (PROs) are data elements directly reported by patients or their surrogates about experiences with care, including symptoms, functional status, or quality of life. PROs have commonly been evaluated in clinical trials for drug and medical device development. Interest is growing in the ability to integrate PROs into additional contexts, particularly product safety evaluation, comparative effectiveness research, and measurement of care quality. This interest reflects a growing focus on patient-centeredness in health care broadly and on provisions of the US Patient Protection and Affordable Care Act of 2010. Multiple initiatives demonstrate the feasibility and value of patient reporting in these areas. Inclusion of PROs in electronic health records and hospital patient portals, as well as longitudinal registries, can facilitate use of these data for multiple analytic purposes as well as enhance delivery of care and patient-provider communication. Challenges include the logistics and cost of implementing PRO programs; missing data, particularly from hard-to-reach and ill patients; and the need for standardization of outcome measures and electronic data representation. These challenges have been surmounted in limited initiatives and now must be translated to larger implementations. PMID:24274179

  20. Adverse Hospital Events for Mentally Ill Patients Undergoing Coronary Artery Bypass Surgery

    PubMed Central

    Li, Yue; Glance, Laurent G; Cai, Xueya; Mukamel, Dana B

    2008-01-01

    Context Patients with mental disorders show higher burden of coronary heart disease, and may face special safety issues during in-hospital cardiac care. Objectives To compare the postoperative complication rate between patients with and without mental disorders undergoing isolated coronary artery bypass graft (CABG) surgery. Design, Setting, and Patients Retrospective analyses of New York state hospital claims between 1997 and 2004 (N=135,701). Complications were defined using the Agency for Healthcare Research and Quality Patient Safety Indicators (AHRQ PSI). Principal Findings Mental disorders were significantly associated with higher anesthesia complications (adjusted odds ratio [AOR]=6.44, p<.001), decubitus ulcer (AOR=1.42, p=.006), postoperative hip fracture (AOR=3.29, p<.001), and overall complication rate representing nine PSIs (AOR=1.27, p<.001). Conclusions Mentally ill patients undergoing CABG surgery are more likely to experience potentially preventable complications and injuries. The mechanism underlying this observation warrants further study. PMID:18665856

  1. Association of common genetic variants of HOMER1 gene with levodopa adverse effects in Parkinson's disease patients.

    PubMed

    Schumacher-Schuh, A F; Altmann, V; Rieck, M; Tovo-Rodrigues, L; Monte, T L; Callegari-Jacques, S M; Medeiros, M S; Rieder, C R M; Hutz, M H

    2014-06-01

    Levodopa is the most effective symptomatic therapy for Parkinson's disease, but its chronic use could lead to chronic adverse outcomes, such as motor fluctuations, dyskinesia and visual hallucinations. HOMER1 is a protein with pivotal function in glutamate transmission, which has been related to the pathogenesis of these complications. This study investigates whether polymorphisms in the HOMER1 gene promoter region are associated with the occurrence of the chronic complications of levodopa therapy. A total of 205 patients with idiopathic Parkinson's disease were investigated. Patients were genotyped for rs4704559, rs10942891 and rs4704560 by allelic discrimination with Taqman assays. The rs4704559 G allele was associated with a lower prevalence of dyskinesia (prevalence ratio (PR)=0.615, 95% confidence interval (CI) 0.426-0.887, P=0.009) and visual hallucinations (PR=0.515, 95% CI 0.295-0.899, P=0.020). Our data suggest that HOMER1 rs4704559 G allele has a protective role for the development of levodopa adverse effects. PMID:24126708

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

    PubMed Central

    Khasawneh, Fadi T.; Shankar, Gollapudi S.

    2014-01-01

    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

  3. Value of thallium-201 imaging in detecting adverse cardiac events after myocardial infarction and thrombolysis: a follow up of 100 consecutive patients.

    PubMed Central

    Basu, S.; Senior, R.; Dore, C.; Lahiri, A.

    1996-01-01

    OBJECTIVE: To determine the prognostic role of thallium-201 imaging compared with that of exercise electrocardiography in patients with acute myocardial infarction treated by thrombolysis. DESIGN: Patients who remained free of adverse cardiac events six weeks after myocardial infarction had stress and rest 201TI imaging and exercise electrocardiography and were followed up for 8-32 months. Adverse cardiac events (death, reinfarction, unstable angina, and congestive heart failure) were documented. SETTING: Large district general hospital, Middlesex. SUBJECTS: 100 consecutive male and female patients who were stable six weeks after thrombolysis for myocardial infarction. MAIN OUTCOME MEASURES: Prediction of occurrence of adverse cardiac events after myocardial infarction by exercise cardiography and 201TI myocardial perfusion imaging. RESULTS: Reversible ischaemia on 201TI imaging predicted adverse cardiac events in 33 out of 37 patients with such events during follow up (hazard ratio 8.1 (95% confidence interval 2.7 to 23.8), P < 0.001). Exercise electrocardiography showed reversible ischaemia in 33 patients, of whom 13 had subsequent events, and failed to predict events in 24 patients (hazard ratio 1.1 (0.56 to 2.2), P = 0.8). CONCLUSION: 201TI imaging is a sensitive predictor of subsequent adverse cardiac events in patients who have received thrombolysis after acute myocardial infarction, whereas exercise electrocardiography fails to predict outcome. Images Fig 1 PMID:8870569

  4. Trauma patient adverse outcomes are independently associated with rib cage fracture burden and severity of lung, head, and abdominal injuries

    PubMed Central

    Dunham, C Michael; Hileman, Barbara M; Ransom, Kenneth J; Malik, Rema J

    2015-01-01

    Objective: We hypothesized that lung injury and rib cage fracture quantification would be associated with adverse outcomes. Subjects and methods: Consecutive admissions to a trauma center with Injury Severity Score ? 9, age 18-75, and blunt trauma. CT scans were reviewed to score rib and sternal fractures and lung infiltrates. Sternum and each anterior, lateral, and posterior rib fracture was scored 1 = non-displaced and 2 = displaced. Rib cage fracture score (RCFS) = total rib fracture score + sternal fracture score + thoracic spine Abbreviated Injury Score (AIS). Four lung regions (right upper/middle, right lower, left upper, and left lower lobes) were each scored for % of infiltrate: 0% = 0; ? 20% = 1, ? 50% = 2, > 50% = 3; total of 4 scores = lung infiltrate score (LIS). Results: Of 599 patients, 193 (32%) had 854 rib fractures. Rib fracture patients had more abdominal injuries (p < 0.001), hemo/pneumothorax (p < 0.001), lung infiltrates (p < 0.001), thoracic spine injuries (p = 0.001), sternal fractures (p = 0.0028) and death or need for mechanical ventilation ? 3 days (Death/Vdays ? 3) (p < 0.001). Death/Vdays ? 3 was independently associated with RCFS (p < 0.001), LIS (p < 0.001), head AIS (p < 0.001) and abdominal AIS (p < 0.001). Of the 193 rib fracture patients, Glasgow Coma Score 3-12 or head AIS ? 2 occurred in 43%. A lung infiltrate or hemo/pneumothorax occurred in 55%. Thoracic spine injury occurred in 23%. RCFS was 6.3 ± 4.4 and Death/Vdays ? 3 occurred in 31%. Death/Vdays ? 3 rates correlated with RCFS values: 19% for 1-3; 24% for 4-6; 42% for 7-12 and 65% for ? 13 (p < 0.001). Death/Vdays ? 3 was independently associated with RCFS (p = 0.02), LIS (p = 0.001), head AIS (p < 0.001) and abdominal AIS (p < 0.001). Death/Vdays ? 3 association was better for RCFS (p = 0.005) than rib fracture score (p = 0.08) or number of fractured ribs (p = 0.80). Conclusion: Rib fracture patients have increased risk for truncal injuries and adverse outcomes. Adverse outcomes are independently associated with rib cage fracture burden. Severity of head, abdominal, and lung injuries also influence rib fracture outcomes.

  5. Deficits in metacognitive capacity distinguish patients with schizophrenia from those with prolonged medical adversity.

    PubMed

    Lysaker, Paul H; Vohs, Jenifer; Hamm, Jay A; Kukla, Marina; Minor, Kyle S; de Jong, Steven; van Donkersgoed, Rozanne; Pijnenborg, Marieke H M; Kent, Jerillyn S; Matthews, Sean C; Ringer, Jamie M; Leonhardt, Bethany L; Francis, Michael M; Buck, Kelly D; Dimaggio, Giancarlo

    2014-08-01

    Research has suggested that many with schizophrenia experience decrements in synthetic metacognition, or the abilities to form integrated representations of oneself and others and then utilize that knowledge to respond to problems. Although such deficits have been linked with functional impairments even after controlling for symptoms and neurocognition, it is unclear to what extent these deficits can distinguish persons with schizophrenia from others experiencing significant life adversity but without psychosis. To explore this issue we conducted logistic regression analysis to determine whether assessment of metacognition could distinguish between 166 participants with schizophrenia and 51 adults with HIV after controlling for social cognition and education. Metacognition was assessed with the Metacognitive Assessment Scale Abbreviated (MAS-A), and social cognition with the Bell Lysaker Emotion Recognition Test. We observed that the MAS-A total score was able to correctly classify 93.4% of the schizophrenia group, with higher levels of metacognition resulting in increased likelihood of accurate categorization. Additional exploratory analyses showed specific domains of metacognition measured by the MAS-A were equally able to predict membership in the schizophrenia group. Results support the assertion that deficits in the abilities to synthesize thoughts about oneself and others into larger representations are a unique feature of schizophrenia. PMID:24811777

  6. Urinary Catheterization May Not Adversely Impact Quality of Life in Multiple Sclerosis Patients

    PubMed Central

    Frasure, Heidi E.; Mahajan, Sangeeta T.

    2014-01-01

    Background. Multiple sclerosis (MS) healthcare providers (HCP) have undergone considerable educational efforts regarding the importance of evaluating and treating pelvic floor disorders, specifically, urinary dysfunction. However, limited data are available to determine the impact of catheterization on patient quality of life (QoL). Objectives. To describe the use of urinary catheterization among MS patients and determine the differences between those who report positive versus negative impact of this treatment on QoL. Methods. Patients were queried as part of the 2010 North American Research Committee On Multiple Sclerosis survey; topics included 1) urinary/bladder, bowel, or sexual problems; 2) current urine leakage; 3) current catheter use; 4) catheterizing and QoL. Results. Respondents with current urine leakage were 5143 (54.7%), of which 1201 reported current catheter use (12.8%). The types of catheters (intermittent self-catheterization and Foley catheter (indwelling and suprapubic)) did not differ significantly. Of the current catheter users, 304 (25.35%) respondents reported catheterization negatively impacting QoL, 629 (52.4%) reported a positive impact on QoL, and 223 (18.6%) reported neutral QoL. Conclusions. A large proportion of catheterized MS patients report negative or positive changes in QoL associated with urinary catheterization. Urinary catheterization does not appear to have a universally negative impact on patient QoL. PMID:25006498

  7. Estimating the incidence of adverse events in Portuguese hospitals: a contribution to improving quality and patient safety

    PubMed Central

    2014-01-01

    Background Several review studies have shown that 3.4% to 16.6% of patients in acute care hospitals experience one or more adverse events. Adverse events (AEs) in hospitals constitute a significant problem with serious consequences and a challenge for public health. The occurrence of AEs in Portuguese hospitals has not yet been systematically studied. The main purpose of this study is to estimate the incidence, impact and preventability of adverse events in Portuguese hospitals. It is also our aim to examine the feasibility of applying to Portuguese acute hospitals the methodology of detecting AEs through record review, previously used in other countries. Methods This work is based on a retrospective cohort study and was carried out at three acute care hospitals in the Administrative Region of Lisbon. The identification of AEs and their impact was done using a two-stage structured retrospective medical records review based on the use of 18 screening criteria. A random sample of 1,669 medical records (representative of 47,783 hospital admissions) for the year 2009 was analyzed. Results The main results found in this study were an incidence rate of 11.1% AEs, of which around 53.2% were considered preventable. The majority of AEs were associated with surgical procedures (27%), drug errors (18.3%) and hospital acquired infections (12.2%). Most AEs (61%) resulted in minimal or no physical impairment or disability, and 10.8% were associated with death. In 58.6% of the AEs’ cases, the length of stay was prolonged on average 10.7 days. Additional direct costs amounted to €470,380.00. Conclusion The magnitude of these results was critical, reinforcing the need of more detailed studies in this area. The knowledge of the incidence and nature of AEs that occur in hospitals should be seen as a first step towards the improvement of quality and safety in health care. PMID:25034870

  8. Plasma Klotho is not related to kidney function and does not predict adverse outcome in patients with chronic kidney disease.

    PubMed

    Seiler, Sarah; Wen, Ming; Roth, Heinz J; Fehrenz, Michael; Flügge, Franziska; Herath, Esther; Weihrauch, Anja; Fliser, Danilo; Heine, Gunnar H

    2013-01-01

    A decreased expression of the fibroblast growth factor (FGF)-23 coreceptor Klotho was postulated as an early alteration in chronic kidney disease mineral and bone disorder, resulting in a compensatory increase in plasma FGF-23 levels. Klotho exists in both membrane-bound and secreted (sKlotho) forms, the latter of which may exert vasculoprotective effects. Here we analyzed plasma sKlotho levels in a large cohort of 312 patients with stage 2-4 chronic kidney disease, and assessed plasma levels of FGF-23, sKlotho, parathyroid hormone, and urinary fractional phosphate excretion. Patients were prospectively followed for an average of 2.2 years for the occurrence of death or initiation of renal replacement therapy. The levels of sKlotho were significantly associated with age, but not with the glomerular filtration rate or other parameters of calcium-phosphate metabolism. Moreover, while patients with high FGF-23 levels faced worst outcome even after adjustment for confounders, we found no prognostic impact of sKlotho. Thus, plasma levels of sKlotho were not related to kidney function and did not predict adverse outcome in patients with chronic kidney disease. Future studies are needed to understand how tissue expression, urinary excretion, and plasma levels of Klotho diverge in progressive chronic kidney disease. PMID:22895520

  9. Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality

    PubMed Central

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

    2014-01-01

    Objectives To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies. Design Cross-sectional study of screened patients. Setting 10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011. Participants The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications. Primary outcome measures Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality. Results Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE. Conclusions A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based. PMID:24682573

  10. Serum parathyroid hormone and risk of adverse outcomes in patients with stable coronary heart disease

    Microsoft Academic Search

    Norma Christine Grandi; Lutz Philipp Breitling; Harry Hahmann; Bernd Wüsten; Winfried März; Dietrich Rothenbacher; Hermann Brenner

    2011-01-01

    Background and objectiveRecent longitudinal studies have suggested an association of high serum parathyroid hormone levels (PTH) with elevated cardiovascular risk in the general population. This study presents analyses of the prognostic value of baseline PTH for subsequent cardiovascular events and all-cause mortality in a high-risk population with stable coronary heart disease.MethodsBased on measurements of PTH levels in 1133 patients recruited

  11. One Fourth of Unplanned Transfers to a Higher Level of Care Are Associated With a Highly Preventable Adverse Event: A Patient Record Review in Six Belgian Hospitals

    PubMed Central

    Claes, Neree; De Troy, Elke; Kox, Gaby; Droogmans, Martijn; Schrooten, Ward; Weekers, Frank; Vlayen, Annemie; Vandersteen, Marjan; Vleugels, Arthur

    2015-01-01

    Objective: The objectives of this study are to determine the prevalence and preventability of adverse events requiring an unplanned higher level of care, defined as an unplanned transfer to the ICU or an in-hospital medical emergency team intervention, and to assess the type and the level of harm of each adverse event. Design: A three-stage retrospective review process of screening, record review, and consensus judgment was performed. Setting: Six Belgian acute hospitals. Patients: During a 6-month period, all patients with an unplanned need for a higher level of care were selected. Interventions: The records 6-month period, the records of all patients with an unplanned need for a higher level of care were assessed by a trained clinical team consisting of a research nurse, a physician, and a clinical pharmacist. Measurements and Main Results: Adverse events were found in 465 of the 830 reviewed patient records (56%). Of these, 215 (46%) were highly preventable. The overall incidence rate of patients being transferred to a higher level of care involving an adverse event was 117.6 (95% CI, 106.9–128.3) per 100,000 patient days at risk, of which 54.4 (95% CI, 47.15–61.65) per 100,000 patient days at risk involving a highly preventable adverse event. This means that 25.9% of all unplanned transfers to a higher level of care were associated with a highly preventable adverse event. The adverse events were mainly associated with drug therapy (25.6%), surgery (23.7%), diagnosis (12.4%), and system issues (12.4%). The level of harm varied from temporary harm (55.7%) to long-term or permanent impairment (19.1%) and death (25.2%). Although the direct causality is often hard to prove, it is reasonable to consider these adverse events as a contributing factor. Conclusion: Adverse events were found in 56% of the reviewed records, of which almost half were considered highly preventable. This means that one fourth of all unplanned transfers to a higher level of care were associated with a highly preventable adverse event. PMID:25756416

  12. Amelioration of sexual adverse effects in the early breast cancer patient

    PubMed Central

    Goldman, Mindy; Rugo, Hope S.

    2010-01-01

    Background As the number of breast cancer survivors increases, the long term consequences of breast cancer treatment are gaining attention. Sexual dysfunction is a common complaint amongst breast cancer survivors, and there are few evidence based recommendations and even fewer well designed clinical trials to establish what treatments are safe or effective in this patient population. Design We conducted a PubMed search for articles published between 1995–2009 containing the terms breast cancer, sexual dysfunction, libido, vaginal dryness, testosterone, and vaginal estrogen. We initially reviewed articles focusing exclusively on sexual issues in breast cancer patients. Given the paucity of clinical trials addressing sexual issues in breast cancer patients, we also included studies evaluating both hormone and non-hormone based interventions for sexual dysfunction in post-menopausal women in general. Conclusions Among breast cancer survivors, vaginal dryness and loss of libido represent some of the most challenging long term side effects of breast cancer treatment. In the general post-menopausal population, topical preparations of estrogens and testosterone both appear to improve sexual function; however there are conflicting reports about the efficacy and safety of these interventions in women with a history of breast cancer, and further research is warranted. PMID:20602189

  13. Prediction of adverse cardiac events in emergency department patients with chest pain using machine learning for variable selection

    PubMed Central

    2014-01-01

    Background The key aim of triage in chest pain patients is to identify those with high risk of adverse cardiac events as they require intensive monitoring and early intervention. In this study, we aim to discover the most relevant variables for risk prediction of major adverse cardiac events (MACE) using clinical signs and heart rate variability. Methods A total of 702 chest pain patients at the Emergency Department (ED) of a tertiary hospital in Singapore were included in this study. The recruited patients were at least 30 years of age and who presented to the ED with a primary complaint of non-traumatic chest pain. The primary outcome was a composite of MACE such as death and cardiac arrest within 72 h of arrival at the ED. For each patient, eight clinical signs such as blood pressure and temperature were measured, and a 5-min ECG was recorded to derive heart rate variability parameters. A random forest-based novel method was developed to select the most relevant variables. A geometric distance-based machine learning scoring system was then implemented to derive a risk score from 0 to 100. Results Out of 702 patients, 29 (4.1%) met the primary outcome. We selected the 3 most relevant variables for predicting MACE, which were systolic blood pressure, the mean RR interval and the mean instantaneous heart rate. The scoring system with these 3 variables produced an area under the curve (AUC) of 0.812, and a cutoff score of 43 gave a sensitivity of 82.8% and specificity of 63.4%, while the scoring system with all the 23 variables had an AUC of 0.736, and a cutoff score of 49 gave a sensitivity of 72.4% and specificity of 63.0%. Conventional thrombolysis in myocardial infarction score and the modified early warning score achieved AUC values of 0.637 and 0.622, respectively. Conclusions It is observed that a few predictors outperformed the whole set of variables in predicting MACE within 72 h. We conclude that more predictors do not necessarily guarantee better prediction results. Furthermore, machine learning-based variable selection seems promising in discovering a few relevant and significant measures as predictors. PMID:25150702

  14. The influence of a triclosan toothpaste on adverse events in patients with cardiovascular disease over 5-years.

    PubMed

    Cullinan, Mary P; Palmer, Janet E; Carle, Anne D; West, Malcolm J; Westerman, Bill; Seymour, Gregory J

    2015-03-01

    Adverse effects of long-term usage of triclosan-containing toothpaste in humans are currently unknown. We assessed the effect of long-term use of 0.3% triclosan-toothpaste on serious adverse events (SAEs) in patients with cardiovascular disease (CVD). 438 patients with a history of stable CVD were entered into the 5-year longitudinal Cardiovascular and Periodontal Study at Prince Charles Hospital, Brisbane, Australia and randomised into test (triclosan) or placebo groups. There were no significant differences in demographics or clinical features between the groups. Patients were examined at baseline, and annually for 5-years. SAEs were classified according to the System Organ Classes defined by MedDRA (Medical Dictionary for Regulatory Activities). Results were analysed using chi square and Kaplan Meier analysis. Overall, 232 patients (123 in the triclosan group; 109 in the placebo group) experienced 569 SAEs (288 in the triclosan group and 281 in the placebo group). There was no significant difference between the groups in numbers of patients experiencing SAEs (p=0.35) or specific cardiovascular SAEs (p=0.82), nor in time to the first SAE or first cardiovascular SAE, irrespective of gender, age or BMI after adjusting for multiple comparisons (p>0.05). The adjusted odds of experiencing an SAE were estimated to increase by 2.7% for each year of age (p=0.02) and the adjusted odds of experiencing a cardiovascular SAE were estimated to increase by 5.1% for each unit increase in BMI (p=0.02). Most cardiovascular events were related to unstable angina or myocardial infarcts, 21 were associated with arrhythmia and 41 were vascular events such as aortic aneurysm and cerebrovascular accident. Within the limitations of the present study the data suggest that the use of triclosan-toothpaste may not be associated with any increase in SAEs in this CVD population. The long-term impact of triclosan on hormone-related disease, such as cancer, in humans remains to be determined. PMID:25442641

  15. Dynamical System Modeling of Immune Reconstitution after Allogeneic Stem Cell Transplantation Identifies Patients at Risk for Adverse Outcomes.

    PubMed

    Toor, Amir A; Sabo, Roy T; Roberts, Catherine H; Moore, Bonny L; Salman, Salman R; Scalora, Allison F; Aziz, May T; Shubar Ali, Ali S; Hall, Charles E; Meier, Jeremy; Thorn, Radhika M; Wang, Elaine; Song, Shiyu; Miller, Kristin; Rizzo, Kathryn; Clark, William B; McCarty, John M; Chung, Harold M; Manjili, Masoud H; Neale, Michael C

    2015-07-01

    Systems that evolve over time and follow mathematical laws as they evolve are called dynamical systems. Lymphocyte recovery and clinical outcomes in 41 allograft recipients conditioned using antithymocyte globulin (ATG) and 4.5-Gy total body irradiation were studied to determine if immune reconstitution could be described as a dynamical system. Survival, relapse, and graft-versus-host disease (GVHD) were not significantly different in 2 cohorts of patients receiving different doses of ATG. However, donor-derived CD3(+) cell reconstitution was superior in the lower ATG dose cohort, and there were fewer instances of donor lymphocyte infusion (DLI). Lymphoid recovery was plotted in each individual over time and demonstrated 1 of 3 sigmoid growth patterns: Pattern A (n = 15) had rapid growth with high lymphocyte counts, pattern B (n = 14) had slower growth with intermediate recovery, and pattern C (n = 10) had poor lymphocyte reconstitution. There was a significant association between lymphocyte recovery patterns and both the rate of change of donor-derived CD3(+) at day 30 after stem cell transplantation (SCT) and clinical outcomes. GVHD was observed more frequently with pattern A, relapse and DLI more so with pattern C, with a consequent survival advantage in patients with patterns A and B. We conclude that evaluating immune reconstitution after SCT as a dynamical system may differentiate patients at risk of adverse outcomes and allow early intervention to modulate that risk. PMID:25849208

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

    PubMed

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

    2014-11-01

    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

  17. The adverse effects of smoking on postoperative outcomes in cancer patients

    PubMed Central

    Gajdos, Csaba; Hawn, Mary T; Campagna, Elizabeth J; Henderson, William G.; Singh, Jasvinder A.; Houston, Thomas

    2014-01-01

    Background The possible negative effects of smoking on postoperative outcomes have not been well-studied in cancer patients. Methods We used the VA Surgical Quality Improvement Program (VASQIP) database for the years 2002–2008, which assesses pre-operative risk factors and post-operative outcomes for patients undergoing major surgery within the VA healthcare system. Results Compared to never smokers, prior smokers and current smokers with GI malignancies were significantly more likely to have surgical site infection (SSI)( Odds ratio, OR:1.25, 95%CI:1.09–1.44)(OR:1.20, 95%CI:1.05–1.38), combined pulmonary complications (CPO: pneumonia, failure to wean from ventilator, reintubation) (OR:1.60, 95%CI:1.38–1.87)(OR:1.96, 95%CI:1.68–2.29) and return to the operating room (OR:1.20, 95%CI:1.03–1.39)(OR:1.31 95%CI:1.13–1.53), respectively. Both prior and current smokers had a significantly higher mortality at 30 days (OR:1.50, 95%CI:1.19–1.89)(OR: 1.41, 95%CI:1.08–1.82) and one year (OR:1.22, 95%CI:1.08–1.38)(OR:1.62, 95%C I:1.43–1.85). Thoracic surgery patients who were current smokers were more likely to develop CPO (OR:1.62, 95%CI:1.25–2.11), and mortality within one year (OR:1.50, 95%CI:1.17–1.92) compared to non-smokers, but SSI rates were not affected by smoking status. Current smokers had a significant increase in postsurgical length of stay (overall 4.3% [p<0.001], GI 4.7% [p=0.003], thoracic 9.0% [p<0.001]) compared to prior smokers. Conclusions Prior and current smoking status is a significant risk factor for major postoperative complications and mortality following GI cancer and thoracic operations in veterans. Smoking cessation should be encouraged prior to all major cancer surgery in the VA population to decrease postoperative complications and length of stay. PMID:22065194

  18. A prospective study of patients' psychological reactions to rhinoplasty.

    PubMed

    Goin, M K; Rees, T D

    1991-09-01

    One hundred twenty-one of 200 patients requesting a rhinoplasty completed a study designed to assess their psychological reactions to the operation. Preoperatively, each patient filled out a questionnaire about their expectations (both cosmetic and psychological), relationships, self-confidence, self-esteem, what they disliked about their noses, and other questions pertinent to an evaluation of the psychological effects of rhinoplasty. They also completed the Brief Symptom Inventory (BSI), a standardized psychological test. One month and 6 months postoperatively, they completed similar questionnaires. Preoperative and postoperative information was also obtained from the surgeon and nurse. Statistical analysis showed several interesting findings. A number of patients had increased self-confidence and self-esteem. Male patients did not show any sustained changes on the BSI, but female patients did with improved scores on the obsessive-compulsive, interpersonal sensitivity, depression, anxiety, and phobic anxiety scales. A number of patients described mild-to-moderate depression postoperatively. This was correlated with preoperatively high levels of anxiety. The surgeon was usually more critical of the surgical result than were the patients. The patients whose strong positive feelings about the results he most misjudged were actually depressed. These and other findings are noteworthy to enhance the understanding of postoperative psychological reactions and provide insight into the psychological management of rhinoplasty patients. PMID:1952747

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

    SciTech Connect

    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

    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.

  20. Evaluation of clinically significant adverse events in patients discharged from a tertiary-care emergency department in Taiwan

    PubMed Central

    Wang, Lee-Min; How, Chorng-Kuang; Yang, Ming-Chin; Su, Syi

    2013-01-01

    Objective To investigate the reasons for the occurrence of clinically significant adverse events (CSAEs) in emergency department-discharged patients through emergency physicians' (EPs) subjective reasoning and senior EPs' objective evaluation. Design This was a combined prospective follow-up and retrospective review of cases of consecutive adult non-traumatic patients who presented to a tertiary-care emergency department in Taiwan between 1 September 2005 and 31 July 2006. Data were extracted from ‘on-duty EPs' subjective reasoning for discharging patients with CSAEs (study group) and without CSAEs (control group)’ and ‘objective evaluation of CSAEs by senior EPs, using clinical evidences such as recording history, physical examinations, laboratory/radiological examinations and observation of inadequacies in the basic management process (such as recording history, physical examinations, laboratory/radiological examinations and observation) as the guide’. Subjective reasons for discharging patients’ improvement of symptoms, and the certainty of safety of the discharge were compared in the two groups using ?2 statistics or t test. Results Of the 20?512 discharged cases, there were 1370 return visits (6.7%, 95% CI 6.3% to 7%) and 165 CSAEs due to physicians' factors (0.82%, 95% CI 0.75% to 0.95%). In comparisons between the study group and the control group, only some components of discharge reasoning showed a significant difference (p<0.001). Inadequacies in the basic management process were the main cause of CSAEs (164/165). Conclusion The authors recommended that EP follow-up of the basic management processes (including history record, physical examination, laboratory and radiological examinations, clinical symptoms/signs and treatment) using clinical evidence as a guideline should be made mandatory. PMID:22433586

  1. Local and regional adverse reactions to BCG-SSI vaccination: a 12-month cohort follow-up study.

    PubMed

    Dommergues, M A; de La Rocque, F; Guy, C; Lécuyer, A; Jacquet, A; Guérin, N; Fagot, J P; Boucherat, M; d'Athis, Ph; Cohen, R

    2009-11-23

    In a 12-month cohort follow-up study of 2435 children vaccinated in 2007 by Statens Serum Institute BCG strain (BCG SSI, 17.8% had an adverse event (AE): erythema 12.4%, induration 12.2%, abscesses 2.5%, ulceration 0.9%, lymphadenitis 0.1%. The factors associated with a lower risk of AE were: age at vaccination <1 year compared to age >1 year (OR=0.35 [0.2-0.6] for age <28 days, 0.29 [0.2-0.42] for age 29 days to 2 months, and 0.53 [0.37-0.74] for age 3-11 months), a visible papule (OR=0.48 [0.36-0.63]), and a low vaccine dose (OR=0.42 [0.31-0.58]). AE to BCG SSI vaccination were frequent but rarely severe. PMID:19800440

  2. Severe Adverse Events Related to Tattooing: An Retrospective Analysis of 11 Years

    PubMed Central

    Wollina, Uwe

    2012-01-01

    Background: The incidence of tattoos has been increased markedly during the last 20 years. Aims: To analyze the patient files for severe adverse medical reactions related to tattooing. Settings: Academic Teaching Hospital in South-East Germany. Materials and Methods: Retrospective investigation from March 2001 to May 2012. Results: The incidence of severe adverse medical reactions has been estimated as 0.02%. Infectious and non-infectious severe reactions have been observed. The consequences were medical drug therapies and surgery. Conclusions: Tattooing may be associated with severe adverse medical reactions with significant morbidity. Regulations, education and at least hygienic controls are tools to increase consumer safety. PMID:23248361

  3. Adverse reaction to ceftriaxone in a 28-day-old infant undergoing urgent craniotomy due to epidural hematoma: review of neonatal biliary pseudolithiasis

    PubMed Central

    Bartkowska-?niatkowska, Alicja; Jo?czyk-Potoczna, Katarzyna; Zieli?ska, Marzena; Rosada-Kurasi?ska, Jowita

    2015-01-01

    The debate as to whether to administer ceftriaxone to neonates is likely to continue. Ceftriaxone has numerous advantages for critically ill pediatric patients. However, it is also known to contribute substantially to the development of biliary pseudolithiasis. Although pediatric patients rarely develop gallbladder disorders, this complication may lead to adverse events in high-risk patients with predisposing factors, particularly in neonates and infants treated with ceftriaxone. In this paper we present an interesting case report of a 28-day-old neonate with spontaneous severe epidural hematoma who developed biliary pseudolithiasis related to the use of ceftriaxone. We also discuss the efficacy of ceftriaxone in neonates and infants. Neonatologists and pediatric intensivists should be aware of the higher risk of co-existence of hyperbilirubinemia and gallbladder disorders while using ceftriaxone in pediatric settings. PMID:26170682

  4. A human leukocyte antigen locus haplotype confers risk for allopurinol-related adverse effects in Caucasian patients with gout.

    PubMed

    Roberts, Rebecca L; Wallace, Mary C; Harrison, Andrew; Dalbeth, Nicola; Merriman, Tony R; Stamp, Lisa K

    2015-08-01

    A human leukocyte antigen haplotype comprising six single-nucleotide polymorphisms (SNPs) confers risk for allopurinol hypersensitivity syndrome in Caucasians. The objective of the current study was to test for association of this haplotype with other, less severe adverse effects (AEs) of allopurinol therapy in a large New Zealand gout cohort. A total of 626 Caucasian and 766 Polynesian patients were genotyped for six SNPs (rs2844665, rs9263715, rs3130931, rs3130501, rs3094188, rs9469003) using TaqMan SNP assays. The CACGAC haplotype occurred at a frequency of 0.018 in Caucasians and 0.009 in Polynesians. The CACGAC haplotype occurred at a significantly higher frequency in Caucasian patients who experienced allopurinol-related AEs (13.3 vs. 1.7%, P=8.9e-06, odds ratio=8.9, 95% confidence interval 2.8-27.9), but it was not associated with overall allopurinol toxicity in Polynesians (P>0.05). Our study is the first to demonstrate the potential utility of this six-SNP haplotype as a predictor of milder allopurinol AEs. PMID:26049586

  5. Relationship between Inflammatory Cytokines and Uric Acid Levels with Adverse Cardiovascular Outcomes in Patients with Stable Coronary Heart Disease

    PubMed Central

    Rothenbacher, Dietrich; Kleiner, Andrea; Koenig, Wolfgang; Primatesta, Paola; Breitling, Lutz P.; Brenner, Hermann

    2012-01-01

    Background So far it is unclear whether the association between serum uric acid (SUA), inflammatory cytokines and risk of atherosclerosis is causal or an epiphenomenon. The aim of the project is to investigate the independent prognostic relationship of inflammatory markers and SUA levels with adverse cardiovascular outcomes in a patient population with stable coronary heart disease (CHD). Methods SUA, C-reactive protein (CRP) and interleukin (IL)-6 were measured at baseline in a cohort of 1,056 patients aged 30–70 years with CHD. Cox proportional hazards model was used to determine the prognostic value of these markers on a combined CVD endpoint during eight year follow-up after adjustment for covariates. Results For 1,056 patients with stable coronary heart disease aged 30–70 years (mean age 58.9 years, SD 8.0) follow-up information and serum measurements were complete and n?=?151 patients (incidence 21.1 per 1000 patients years) experienced a fatal or non-fatal CVD event during follow-up (p-value?=?0.05 for quartiles of SUA, p?=?0.002 for quartiles of CRP, p?=?0.13 for quartiles of IL-6 in Kaplan-Meier analysis). After adjustment for age, gender and hospital site the hazard ratio (HR) for SUA increased from 1.37 to 1.65 and 2.27 in the second, third, and top quartile, when compared to the bottom one (p for trend <0.0005). The HR for CRP increased from 0.85 to 0.98 and 1.64 in the respective quartiles (p for trend 0.02). After further adjustment for covariates SUA still showed a clear statistically significant relationship with the outcome (p for trend 0.045), whereas CRP did not (p for trend 0.10). Conclusion The data suggest that compared to inflammatory markers such as CRP and IL-6 serum uric acid levels may predict future CVD risk in patients with stable CHD with a risk increase even at levels considered normal. PMID:23029307

  6. A systematic review of the identification of seniors at risk (ISAR) tool for the prediction of adverse outcome in elderly patients seen in the emergency department

    PubMed Central

    Yao, Jin-Lan; Fang, Juan; Lou, Qing-Qing; Anderson, Robert M

    2015-01-01

    The purpose of this systematic review was to evaluate the predictive validity of the Identification of Seniors at Risk (ISAR) Tool in identifying elderly patients at risk of adverse outcomes after a visit to the emergency department (ED). Since older adults are frequently sent to the ED, screening for risk of adverse outcomes in elderly patients is increasingly important in the ED. Also it is a way to ensure that interventions based on a comprehensive geriatric assessment (CGA) are provided to patients identified at risk to reduce the risk of adverse outcomes. The ISAR is a six-item risk-screening tool for elderly patients seen in the ED. However the predictive validity of ISAR is controversial. Relevant studies from January 1999 through December 2014 were searched systematically in PubMed, Cochrane Library, Web of Knowledge, Scopus, CINAHL, Elsevier ScienceDirect databases. The language was restricted to English. This review was based on the recommendations of the Cochrane Handbook of Diagnostic Test Accuracy Reviews. Ten studies (8680 patients) were included in this review. With a cutoff score at least 2, the ISAR was proved to have poor validity related to revisiting the ED (AUC: 0.59-0.60) and hospital readmission (AUC: 0.59-0.60). The predictive validity of the ISAR related to mortality and composite outcomes was graded as poor to fair. It is not suitable to use the ISAR alone for identifying seniors at risk for adverse outcomes in the ED.

  7. The Risk of Adverse Events Associated With Atropine Administration During Dobutamine Stress Echocardiography in Cardiac Transplant Patients: A 28-Year Single-Center Experience

    PubMed Central

    JI, JAMES WANG; YE, SIQIN; HAYTHE, JENNIFER; SCHULZE, P. CHRISTIAN; SHIMBO, DAICHI

    2014-01-01

    Background Although dobutamine stress echocardiography (DSE) is performed in heart transplant patients, the safety profile of atropine administration in DSE in this setting is unclear. Methods and Results We identified heart transplant patients who received atropine during DSE from January 1984 to August 2011 at our institution and compared them with a propensity-scored matched control group of heart transplant patients who underwent DSE without atropine. Adverse events were defined as significant arrhythmias (sinus arrest, Mobitz type II heart block, complete heart block, ventricular tachycardia, or ventricular fibrillation), hypotension requiring hospitalization, syncope or presyncope, myocardial infarction, and death. Forty-five heart transplant patients (median age 62 years, 82% male) received 0.2–1 mg atropine during DSE. Of these, 1 patient (2.2%) developed temporary complete heart block. No adverse events were identified in the control group of 154 patients who received dobutamine without atropine. Conclusions Our findings suggest that complete heart block can occur infrequently with the administration of atropine in heart transplant patients undergoing DSE. Therefore, patients should be appropriately monitored for these adverse events during and after DSE. PMID:24263121

  8. Metal on metal total hip arthroplasty and a large groin mass: Not always adverse reaction to metallic debris.

    PubMed

    Krishnan, Harry; Magnussen, Alex; Sharma, Aadhar; Skinner, John

    2015-01-01

    Due to their improved wear rates, Metal-on-metal bearings have been increasingly used in the past decade by orthopaedic surgeons carrying out total hip arthroplasty. However there is increasing evidence that there are significant complications associated with such implants. One well documented complication is that of metallic debris leading to pseudotumour formation, however there is less known about associations with other tumours within the pelvis. We present two cases where an intra-pelvic mass in patients with metal-on-metal implants were diagnosed as being of a different aetiology. This highlights the need for careful assessment of such patients in order to guide appropriate management. PMID:25560054

  9. A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013.

    PubMed

    Hoban, Claire L; Byard, Roger W; Musgrave, Ian F

    2015-07-01

    Herbal medicines are perceived to be safe by the general public and medical practitioners, despite abundant evidence from clinical trials and case reports that show herbal preparations can have significant adverse effects. The overall impact of adverse events to herbal medicines in Australia is currently unknown. Post marketing surveillance of medications through spontaneous adverse drug reaction (ADR) reports to the Therapeutic Goods Administration (TGA) is one way to estimate this risk. The patterns of spontaneously reported ADRs provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADRs to St. John's Wort (Hypericum perforatum), a common herbal treatment for depression which contains selective serotonin reuptake inhibitors (SSRI), to fluoxetine, a commonly prescribed synthetic SSRI antidepressant. Spontaneous ADR reports sent to the TGA between 2000-2013 for St. John's Wort (n = 84) and fluoxetine (n = 447) were obtained and analysed. The demographic information, types of interaction, severity of the ADR, and the body systems affected (using the Anatomical Therapeutic Chemical classification system) were recorded for individual ADR cases. The majority of spontaneously reported ADRs for St. John's Wort and fluoxetine were concerning females aged 26-50 years (28.6%, 22.8%). The organ systems affected by ADRs to St John's Wort and fluoxetine have a similar profile, with the majority of cases affecting the central nervous system (45.2%, 61.7%). This result demonstrates that herbal preparations can result in ADRs similar to those of prescription medications. PMID:25988866

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

    Microsoft Academic Search

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

    2002-01-01

    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

  11. Relation between paradoxical decrease in high-density lipoprotein cholesterol levels after statin therapy and adverse cardiovascular events in patients with acute myocardial infarction.

    PubMed

    Ota, Tomoyuki; Ishii, Hideki; Suzuki, Susumu; Tanaka, Akihito; Shibata, Yohei; Tatami, Yosuke; Harata, Shingo; Shimbo, Yusaku; Takayama, Yohei; Kawamura, Yoshihiro; Osugi, Naohiro; Maeda, Kengo; Kondo, Takahisa; Murohara, Toyoaki

    2015-02-15

    Statin therapy moderately increases high-density lipoprotein cholesterol (HDL-C) levels. Contrary to this expectation, a paradoxical decrease in HDL-C levels after statin therapy is seen in some patients. We evaluated 724 patients who newly started treatment with statins after acute myocardial infarction (AMI). These patients were divided into 2 groups according to change in HDL-C levels between baseline and 6 to 9 months after initial AMI (?HDL). In total, 620 patients had increased HDL-C levels and 104 patients had decreased HDL-C levels. Both groups achieved follow-up low-density lipoprotein cholesterol levels <100 mg/dl. Adverse cardiovascular events (a composite of all-cause death, myocardial infarction, and stroke) have more frequently occurred in the decreased HDL group compared with the increased HDL group (15.4% vs 7.1%, p = 0.01). Multivariate analysis showed that decreased HDL, onset to balloon time, and multivessel disease were the independent predictors of adverse cardiovascular events (hazard ratio [HR] 1.95, 95% confidence interval [CI] 1.08 to 3.52; HR 1.05, 95% CI 1.01 to 1.09; and HR 2.08, 95% CI 1.22 to 3.56, respectively). In conclusion, a paradoxical decrease in serum HDL-C levels after statin therapy might be an independent predictor of long-term adverse cardiovascular events in patients with AMI. PMID:25555656

  12. Improvement of attention span and reaction time with hyperbaric oxygen treatment in patients with toxic injury due to mold exposure

    PubMed Central

    Ezra, N.; Dang, K.

    2010-01-01

    It is, by now, well established that mold toxins (mycotoxins) can cause significant adverse health effects. In this study, 15 subjects who developed an attention deficit disorder (ADD) and slowing of reaction time at the time of exposure to mold toxins were identified. Deficits in attention span and reaction time were documented not only by taking a careful history, but also by performing a Test of Variables of Attention (TOVA). The TOVA test provides an objective measure of these two variables. It was found that mold-exposed subjects show statistically significant decreases in attention span and significant increases in reaction time to stimuli compared to controls. After ten sessions of hyperbaric oxygen treatment (HBOT), a statistically significant improvement was seen in both measures. This preliminary study suggests promising outcomes in treating mold-exposed patients with hyperbaric oxygen. PMID:20978814

  13. Thiamin supplementation does not reduce the frequency of adverse events after anti-malarial therapy among patients with falciparum malaria in southern Laos

    PubMed Central

    2014-01-01

    Background In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency, which was associated with a higher incidence of adverse events. Thiamin supplementation might, therefore, reduce adverse events in this population. Methods An exploratory, double-blind, parallel group, placebo-controlled, superiority trial of thiamin supplementation in patients of all ages with uncomplicated and severe falciparum malaria was conducted in Xepon District, Savannakhet Province, southern Laos. Patients were randomly assigned to either oral thiamin 10 mg/day for 7 days immediately after standard anti-malarial treatment then 5 mg daily until day 42, or identical oral placebo. Results After interim analyses when 630 patients (314 in thiamin and 316 in placebo groups) had been recruited, the trial was discontinued on the grounds of futility. On admission biochemical thiamin deficiency (alpha???25%) was present in 27% of patients and 9% had severe deficiency (alpha?>?31%). After 42 days of treatment, the frequency of thiamin deficiency was lower in the thiamin (2%, 1% severe) compared to the placebo (11%, 3% severe) groups (p?adverse events were not significantly different between the groups (p?>?0.05). Clinical, haematological, and parasitological responses to treatment did not differ significantly between the two groups. Conclusion Thiamin supplementation reduced biochemical thiamin deficiency among Lao malaria patients following anti-malarial drug treatment, but it did not reduce the frequency of adverse events after anti-malarial therapy or have any detected clinical or parasitological impact. Trial registration ISRCTN 85411059 PMID:25027701

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

    PubMed Central

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

    2014-01-01

    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

  15. Anaphylactic reactions to cinoxacin

    Microsoft Academic Search

    B. H. Stricker; G. Slagboom; R. Demaeseneer; V. Slootmaekers; I. Thijs; S. Olsson

    1988-01-01

    During 1981 to mid-1988 three cases of anaphylactic shock after treatment with the quinolone derivative cinoxacin were reviewed by the Netherlands Centre for Monitoring of Adverse Reactions to Drugs and 17 cases of an anaphylactic type of reaction notified to the World Health Organisation Collaborating Centre for International Drug Monitoring. In five out of six patients for whom data were

  16. Genetics of Adverse Reactions to Haloperidol in a Mouse Diallel: A Drug–Placebo Experiment and Bayesian Causal Analysis

    PubMed Central

    Crowley, James J.; Kim, Yunjung; Lenarcic, Alan B.; Quackenbush, Corey R.; Barrick, Cordelia J.; Adkins, Daniel E.; Shaw, Ginger S.; Miller, Darla R.; de Villena, Fernando Pardo-Manuel; Sullivan, Patrick F.; Valdar, William

    2014-01-01

    Haloperidol is an efficacious antipsychotic drug that has serious, unpredictable motor side effects that limit its utility and cause noncompliance in many patients. Using a drug–placebo diallel of the eight founder strains of the Collaborative Cross and their F1 hybrids, we characterized aggregate effects of genetics, sex, parent of origin, and their combinations on haloperidol response. Treating matched pairs of both sexes with drug or placebo, we measured changes in the following: open field activity, inclined screen rigidity, orofacial movements, prepulse inhibition of the acoustic startle response, plasma and brain drug level measurements, and body weight. To understand the genetic architecture of haloperidol response we introduce new statistical methodology linking heritable variation with causal effect of drug treatment. Our new estimators, “difference of models” and “multiple-impute matched pairs”, are motivated by the Neyman–Rubin potential outcomes framework and extend our existing Bayesian hierarchical model for the diallel (Lenarcic et al. 2012). Drug-induced rigidity after chronic treatment was affected by mainly additive genetics and parent-of-origin effects (accounting for 28% and 14.8% of the variance), with NZO/HILtJ and 129S1/SvlmJ contributions tending to increase this side effect. Locomotor activity after acute treatment, by contrast, was more affected by strain-specific inbreeding (12.8%). In addition to drug response phenotypes, we examined diallel effects on behavior before treatment and found not only effects of additive genetics (10.2–53.2%) but also strong effects of epistasis (10.64–25.2%). In particular: prepulse inhibition showed additivity and epistasis in about equal proportions (26.1% and 23.7%); there was evidence of nonreciprocal epistasis in pretreatment activity and rigidity; and we estimated a range of effects on body weight that replicate those found in our previous work. Our results provide the first quantitative description of the genetic architecture of haloperidol response in mice and indicate that additive, dominance-like inbreeding and parent-of-origin effects contribute strongly to treatment effect heterogeneity for this drug. PMID:24240528

  17. Cadec: A corpus of adverse drug event annotations.

    PubMed

    Karimi, Sarvnaz; Metke-Jimenez, Alejandro; Kemp, Madonna; Wang, Chen

    2015-06-01

    CSIRO Adverse Drug Event Corpus (Cadec) is a new rich annotated corpus of medical forum posts on patient-reported Adverse Drug Events (ADEs). The corpus is sourced from posts on social media, and contains text that is largely written in colloquial language and often deviates from formal English grammar and punctuation rules. Annotations contain mentions of concepts such as drugs, adverse effects, symptoms, and diseases linked to their corresponding concepts in controlled vocabularies, i.e., SNOMED Clinical Terms and MedDRA. The quality of the annotations is ensured by annotation guidelines, multi-stage annotations, measuring inter-annotator agreement, and final review of the annotations by a clinical terminologist. This corpus is useful for studies in the area of information extraction, or more generally text mining, from social media to detect possible adverse drug reactions from direct patient reports. The corpus is publicly available at https://data.csiro.au.(1). PMID:25817970

  18. SePreSA: a server for the prediction of populations susceptible to serious adverse drug reactions implementing the methodology of a chemical–protein interactome

    PubMed Central

    Yang, Lun; Luo, Heng; Chen, Jian; Xing, Qinghe; He, Lin

    2009-01-01

    Serious adverse drug reactions (SADRs) are caused by unexpected drug–human protein interactions, and some polymorphisms within binding pockets make the population carrying these polymorphisms susceptible to SADR. Predicting which populations are likely to be susceptible to SADR will not only strengthen drug safety, but will also assist enterprises to adjust R&D and marketing strategies. Making such predictions has recently been facilitated by the introduction of a web server named SePreSA. The server has a comprehensive collection of the structural models of nearly all the well known SADR targets. Once a drug molecule is submitted, the scale of its potential interaction with multi-SADR targets is calculated using the DOCK program. The server utilizes a 2-directional Z-transformation scoring algorithm, which computes the relative drug–protein interaction strength based on the docking-score matrix of a chemical–protein interactome, thus achieve greater accuracy in prioritizing SADR targets than simply using dock scoring functions. The server also suggests the binding pattern of the lowest docking score through 3D visualization, by highlighting and visualizing amino acid residues involved in the binding on the customer's browser. Polymorphism information for different populations for each of the interactive residues will be displayed, helping users to deduce the population-specific susceptibility of their drug molecule. The server is freely available at http://SePreSA.Bio-X.cn/. PMID:19417066

  19. Ethnic minority patients not at increased risk of adverse events during hospitalisation in urban hospitals in the Netherlands: results of a prospective observational study

    PubMed Central

    van Rosse, Floor; Essink-Bot, Marie-Louise; Stronks, Karien; de Bruijne, Martine; Wagner, Cordula

    2014-01-01

    Objectives We analysed potential differences in incidence, type, nature, impact and preventability of adverse events (AEs) during hospitalisation between ethnic Dutch and ethnic minority patients, and the role of patient-related determinants. We hypothesised an increased AE incidence for ethnic minority patients. Setting We conducted a prospective cohort study in four urban hospitals. Participants 763 Dutch patients and 576 ethnic minority patients aged between 45 and 75, admitted for at least one night, were included in the study. All patients completed a questionnaire on patient-related determinants (eg, language proficiency). Outcome measures Incidence, type (eg, diagnostic AEs), impact and nature of AEs were assessed with a two-stage medical record review. Logistic regression analysis was used to adjust for patient and admission characteristics, and to investigate the contribution of patient-related determinants to AE risk. Results There was no significant difference in the incidence of AEs: 11% (95% CI 9% to 14%) in Dutch patients and 10% (95% CI 7% to 12%) in ethnic minority patients. Also, there was no significant difference in the incidence of preventable AEs: 3% (95% CI 1% to 4%) in Dutch patients and 1% (95% CI 0% to 2%) in ethnic minority patients. Low language proficiency, inadequate health literacy and low educational level did not increase the risk of an AE. Conclusions Compared with Dutch patients, ethnic minority patients were not at increased risk of AEs while receiving care in Dutch hospitals. Healthcare providers seem to have responded effectively to specific patient care needs, but we do not know whether this occurred in an ad hoc or in a systematic way. PMID:25550290

  20. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring

    PubMed Central

    2011-01-01

    Background In spite of enhanced control efforts, malaria remains a major public health problem causing close to a million deaths annually. With support from several donors, large amounts of artemisinin-based combination therapy (ACT) are being deployed in endemic countries raising safety concerns as little is known about the use of ACT in several of the settings where they are deployed. This project was undertaken to profile the provenance of the pharmacovigilance reporting of all anti-malarials, including ACT to the WHO adverse drug reaction (ADR) database (Vigibase™) over the past 40 years. Methods The WHO Programme for International Drug Monitoring, the Uppsala Monitoring Centre (UMC) provided anonymized extracts of Vigibase™ covering the period 1968-2008. All countries in the programme were clustered according to their malaria control phase and income status. The number of individual case safety reports (ICSRs) of anti-malarials was analyzed according to those clusters. Results From 1968 to 2008, 21,312 ICSRs suspecting anti-malarials were received from 64 countries. Low-income countries, that are also malaria-endemic (categorized as priority 1 countries) submitted only 1.2% of the ICSRs. Only 60 out of 21,312 ICSRs were related to ACT, 51 of which were coming from four sub-Saharan African countries. Although very few ICSRs involved artemisinin-based compounds, many of the adverse events reported were potentially serious. Conclusions This paper illustrates the low reporting of ADRs to anti-malarials in general and ACT in particular. Most reports were submitted by non-endemic and/or high-income countries. Given the current mix of large donor funding, the insufficient information on safety of these drugs, increasing availability of ACT and artemisinin-based monotherapies in public and private sector channels, associated potential for inappropriate use and finally a pipeline of more than 10 new novel anti-malarials in various stages of development, the presence of well functioning national pharmacovigilance systems is vital to ensure safe and responsible scale up of ACT deployment. Bringing together the competencies of national pharmacovigilance centres and various types of organizations in the NGO, academic and private sectors with global coordination to create short- and long-term solutions may help address the lag between rapidly growing ACT use and poor ADR reporting. PMID:21388536

  1. A survey of adverse events in 11 241 patients with chronic viral hepatitis treated with alfa interferon

    Microsoft Academic Search

    Giovanna Fattovich; Giuliano Giustina; Susanna Favarato; Arturo Ruol

    1996-01-01

    Aims: The aim of this study was to assess the incidence of fatal, life-threatening side effects and the de novo appearance of non-hepatic morbidity during interferon alfa therapy for chronic viral hepatitis. The relationship of these adverse events to actual total dose and duration of interferon was also evaluated.Methods: We conducted a retrospective study at 73 Italian centers of 11

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

    Microsoft Academic Search

    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

    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

  3. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association

    PubMed Central

    2011-01-01

    Background According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem. Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. In Sweden it is mandatory for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there are no such regulations for consumers. The non-profit and independent organization Consumer Association for Medicines and Health, KILEN has launched the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector. This study aimed to analyze these consumer reports. Methods All reports submitted from January 2002 to April 2009 to an open web site in Sweden where anyone could report their experience with the use of pharmaceuticals were analyzed with focus on common psychiatric side effects related to antidepressant usage. More than one ADR for a specific drug could be reported. Results In total 665 reports were made during the period. 442 reports concerned antidepressant medications and the individual antidepressant reports represented 2392 ADRs and 878 (37%) of these were psychiatric ADRs. 75% of the individual reports concerned serotonin-reuptake inhibitor (SSRI) and the rest serotonin-norepinephrine reuptake inhibitor (SNRI). Women reported more antidepressant psychiatric ADRs (71%) compared to men (24%). More potentially serious psychiatric ADRs were frequently reported to KILEN and withdrawal symptoms during discontinuation were also reported as a common issue. Conclusions The present study indicates that consumer reports may contribute with important information regarding more serious psychiatric ADRs following antidepressant treatment. Consumer reporting may be considered a complement to traditional ADR reporting. PMID:22026961

  4. Drug-induced hepatic injury in children: a case/non-case study of suspected adverse drug reactions in VigiBase

    PubMed Central

    Ferrajolo, Carmen; Capuano, Annalisa; Verhamme, Katia M C; Schuemie, Martijn; Rossi, Francesco; Stricker, Bruno H; Sturkenboom, Miriam C J M

    2010-01-01

    AIM To identify which drugs are associated with reports of suspected hepatic injury in children and adolescents. METHODS Using a worldwide pharmacovigilance database, VigiBase, we conducted a case/non-case study on suspected adverse drug reactions (ADRs) occurring in the population <18 years old. Cases were all the records with hepatic ADRs and non-cases were all the other ADR records. Records regarding topically administered drugs were excluded from both groups. The association between drug and suspected hepatic ADRs was calculated using the reporting odds ratio (ROR) as a measure of disproportionality while adjusting for gender, country, reporter and calendar year. Sub-analyses were performed within therapeutic class and by excluding vaccination-related reports to reduce confounding. RESULTS Overall, 6595 (1%) out of 624 673 ADR records in children and adolescents concerned hepatic injury. Most of the reported hepatic injuries concerned children 12–17 years of age. Drugs that were most frequently reported as suspected cause and were associated with hepatic injury comprised paracetamol, valproic acid, carbamazepine, methotrexate, minocycline, zidovudine, pemoline, ceftriaxone, bosentan, ciclosporin, atomoxetine, olanzapine, basiliximab, erythromycin and voriconazole. The association between hepatotoxicity and all these drugs, except for basiliximab, is already known. CONCLUSIONS Drug-induced hepatic injury is infrequently reported (only 1% of total) as a suspected ADR in children and adolescents. The drugs associated with reported hepatotoxicity (paracetamol, antiepileptic and anti-tuberculosis agents) are known to be hepatotoxic in adults as well, but age related changes in associations were observed. VigiBase is useful as a start to plan further drug safety studies in children. PMID:21039766

  5. Angiotensin-converting enzyme inhibitor or angiotensin receptor blocker use is associated with reduced major adverse cardiovascular events among patients with critical limb ischemia.

    PubMed

    Armstrong, Ehrin J; Chen, Debbie C; Singh, Gagan D; Amsterdam, Ezra A; Laird, John R

    2015-06-01

    Angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are recommended for secondary prevention in peripheral artery disease, but their effectiveness in patients with critical limb ischemia (CLI) is uncertain. We reviewed 464 patients with CLI who underwent diagnostic angiography or endovascular intervention from 2006-2013 at a multidisciplinary vascular center. ACEI or ARB use was assessed at the time of angiography. Major adverse cardiovascular events (MACE), mortality, and major adverse limb events (MALE) were assessed during three-year follow-up. Propensity weighting was used to adjust for baseline differences between patients taking and not taking ACEIs or ARBs. ACEIs or ARBs were prescribed to 269 (58%) patients. Patients prescribed ACEIs or ARBs had more baseline comorbidities including diabetes and hypertension (p<0.05). Patients prescribed ACEIs or ARBs had lower three-year unadjusted rates of MACE (40% versus 47%) and mortality (33% versus 43%). After propensity weighting, ACEI or ARB use was associated with significantly lower rates of MACE (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.58-0.99, p=0.04) and overall mortality (HR 0.71, 95% CI 0.53-0.95, p=0.02). There was no significant association between ACEI or ARB use and MALE (HR 0.97, 95% CI 0.69-1.35, p=0.2) or major amputation (HR 0.74, 95% CI 0.47-1.18, p=0.1). ACEI/ARB use is associated with lower MACE and mortality in patients with CLI, but there was no effect on limb-related outcomes. PMID:25835349

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

    SciTech Connect

    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

    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.

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

    PubMed Central

    2014-01-01

    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

  8. Factors prognostic of eligibility for allogeneic HCT among older patients with AML-CR1 and adverse- or intermediate-risk cytogenetics.

    PubMed

    Yamasaki, Satoshi; Yoshimoto, Goichi; Ogawa, Ryosuke; Aoki, Kenichi; Higuchi, Masakazu; Harada, Naoki; Arima, Fumito; Kondo, Seiji; Matubara, Fujio; Takahashi, Tsutomu; Uike, Naokuni; Miyamoto, Toshihiro; Okamura, Seiichi; Akashi, Koichi

    2015-07-01

    The introduction of reduced-intensity conditioning (RIC) regimens has made possible allogeneic hematopoietic cell transplantation (allo-HCT) in older patients with acute myeloid leukemia (AML). However, the optimal timing of allo-HCT in these patients and its relative risks and benefits when compared with chemotherapies have not been determined. This retrospective study by the Fukuoka Blood and Marrow Transplant Group compared RIC allo-HSCT with non-transplant therapies, the choice based on donor availability, in AML patients in their first complete remission (CR1). The prognostic value of various patient characteristics and disease-specific variables were investigated in 299 patients aged ?60 years with AML in CR1. Among the 107 patients aged 60-65 years, 54 of whom received allo-HCT and 53 of whom continued chemotherapies; allo-HCT, adverse-risk group, and hematopoietic cell transplantation-comorbidity index were significant predictors of survival outcomes. Among 192 patients aged ?66 years deemed ineligible for allo-HCT, relapse and Karnofsky performance status after induction therapy were significant predictors of survival outcomes. Findings from this study may facilitate a new standard of care for older AML patients in CR1 who are considered candidates for allo-HCT. PMID:25704584

  9. Delayed foreign-body reaction to silk sutures in pediatric neurosurgical patients

    Microsoft Academic Search

    Eugene Rossitch; Dennis E. Bullard; W. Jerry Oakes

    1987-01-01

    Nonabsorbable silk sutures have been a frequently used foreign material in neurosurgery. In general, they are reliable and safe with minimal bio-incompatibility. Three pediatric neurosurgical patients came to clinical attention, however, because of delayed foreign-body reactions to silk sutures. The delayed atypical presentation of these patients delayed appropriate diagnosis and therapy. In two patients, the reaction presented as a delayed

  10. EARLY INITIATION OF DIALYSIS AND LATE IMPLANTATION OF CATHETERS ADVERSELY AFFECT OUTCOMES OF PATIENTS ON CHRONIC PERITONEAL DIALYSIS

    Microsoft Academic Search

    Chih-Chung Shiao; Jenq-Wen Huang; Kuo-Liong Chien; Hsueh-Fang Chuang; Yung-Ming Chen; Kwan-Dun Wu

    ? ? ? ? ? Objectives: Predialysis nephrology care is thought to af- fect morbidity and mortality in hemodialysis patients. This study evaluated the impact of different patterns of predial- ysis care on outcomes of patients undergoing chronic peri- toneal dialysis (PD). ? ? ? ? ? Design: Retrospective cohort. ? ? ? ? ? Setting and Participants: 275 patients

  11. [The reaction of mental patients to medical diagnosis].

    PubMed

    Faust, V; Hole, G

    1983-11-17

    According to the results of a social psychiatric research on hand of reflected image transformulated questionnaire for clinical healthy persons and hospitalized patients the following result is: 9/10 of all registered laymen are afraid of dramatic scenes (manifold naming). In each second case such a situation however happens obviously extensive deactivated. More than five times of the shocked persons as healthy respondents refuse at these questions a comment. But in laymen circles they believe double till three times so frequently in sadness and desperation respectively revolted rebel of the patients. In reality you can find very often the still resignation or the facilitated acceptance of the necessary steps. The more simple the origin class the more exists resignation or cooperation. In reverse rebel, depressive reaction and desperation again continuously on relevance due to the medicine diagnosis from the primary to the upper class. Depressives react sadly and desperatedly as well as female maniacs. People who are free from alcohol will have found the expected silence. The schizophrenes as well as the male maniacs seem to rebel revolted. PMID:6654297

  12. Adverse Effects of Bisphosphonates

    Microsoft Academic Search

    Bo Abrahamsen

    2010-01-01

    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

  13. [Acute adverse effects of dialysis].

    PubMed

    Opatrný, K

    2003-02-01

    Adverse reactions to dialyzers are a not very frequent, but because of the serious, sometimes fatal course, a dreaded complication of haemodialysis treatment. Most important among these reactions are hypersensitive reactions (anaphylactoid, reaction type A to dialyzer), which develop as a rule within the 10th minute of the procedure, and the reaction caused by the action of perfluorohydrocarbon which develop hours after onset or even completion of haemodialysis. Explanation of the development of hypersensitive reactions (HSR) by complement activation and formation of anaphylatoxins C3a and C5a during contact of blood with the bioincompatible dialysis membrane has been abandoned. Evidence of the etiological role of ethylene oxide (ETO) in the development of HSR influenced the selection of materials for the production of dialyzers and sterilization during manufacture, it emphasized the importance of rinsing of the dialyzer in the dialysis centre and led to the wide application of alternative methods of sterilization by gamma radiation and steam. HSR may be also caused by overproduction of bradykinin and inhibition of its degradation or degradation of its metabolites. Excessive bradykinin production caused by dialysis membranes with a negative charge is potentiated e.g. by a lower pH and increased plasma dilution in the initial stage of haemodialysis. Inhibition of bradykinin degradation develops during treatment with angiotensin converting enzyme inhibitors (ACEI). In prevention of HSR associated with bradykinin in addition to elimination of a combination of a negatively charged dialysis membrane and ACEI treatment a part is played also by rinsing of the dialyzer before haemodialysis with a bicarbonate solution and the modification of the membrane surface (implemented by the manufacturer) which reduces its negative charge. The first reaction to the dialyzer in conjunction with perfluorohydrocarbon (PF-5070), used in production of some dialyzers for testing the integrity of their capillaries were first described in 2001 and have caused since then at least 50 deaths. Reactions associated with PF-5070 are still the subject of research and forensic investigations. Despite this they draw already now attention to the failure in manufacture of dialyzers, to the inadequacy of hitherto accepted testing procedures of dialyzers and the constant necessity of careful clinical, laboratory and post-mortem examination of dialyzed patients. PMID:12733493

  14. Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802)?

    PubMed Central

    Lamont, Elizabeth B.; Yu, Menggang; He, Yulei; Saltz, Leonard; Muss, Hyman; Zaslavsky, Alan M.

    2014-01-01

    Objective Medicare claims can be useful in chemotherapy-related comparative effectiveness research (CER) estimating survival, but methods for estimating patients’ treatment morbidity are currently lacking. We sought to determine if patients’ health care use in the claims is a marker of treatment morbidity. Materials and Methods For 249 elderly Medicare patients with breast or colon cancer who were treated in two adjuvant clinical trials, we merged patients’ National Cancer Institute Common Toxicity Criteria for Adverse Events (CTC AEs) trial data with their contemporaneous Medicare claims. We estimated associations of patients’ grade ?3 CTC AE counts and their use of two types of hospital-based health care in claims (i.e., emergency room (ER) visits and hospitalizations). Results ER visits and hospitalizations were significantly positively associated with grade ?3 CTC AE counts incurred by patients during the study. Eight percent of patients without any grade ?3 CTC AEs had one or more hospitalizations during the observation period compared to 43% of patients with three or more grade ?3 CTC AEs (p < 0.01). Those who were hospitalized at least once had more than three times the rate of grade ?3 CTC AEs (IRR 3.70, 95% CI: 2.53–5.40) compared to those who were not. With each hospitalization, the daily incidence rate of any grade ?3 CTC AE more than doubled (IRR 2.10, 95% CI: 1.54–2.86). Conclusions Because hospitalization is strongly associated with clinically significant toxicity it may be a useful outcome for Medicare claim-based CER comparing treatment morbidity for elderly patients receiving different adjuvant chemotherapy regimens. PMID:24594119

  15. The relationship between childhood adversity and dysphoric inner States among borderline patients followed prospectively for 10 years.

    PubMed

    Reed, Lawrence Ian; Fitzmaurice, Garrett; Zanarini, Mary C

    2015-06-01

    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

  16. Hospital acquired blood stream infection as an adverse outcome for patients admitted to hospital with other principle diagnosis

    PubMed Central

    Al-Hazmi, Hamdan H.; Al-Zahrani, Tariq; Elmalky, Ahmed M.

    2014-01-01

    Background: Hospital acquired infections (HAI) have emerged as an important public health problem and are a leading cause of morbidity and mortality worldwide. They affect both developed and resource-poor countries and constitute a significant burden both for the patient and for the health care system. Specific objectives in this study are assessment of HAI rate among patients admitted with other principle diagnosis, to identifying the causative agents of hospital acquired infections and to identify some possible risk factors associated with each type of infection, both health related and non-health related. Patients and Methods: The study was done on selected diagnosis groups during year 2010. The infections were found among 250 patients (43.6% males) have been exposed to episodes of infections. Median age of patients was 56. Data were abstracted from the archived patients’ files in medical record department using the annually infection control log-book prepared by the infection control department. The Data collected were demographic information about the patients (age and sex), clinical condition (diagnosis and the length of hospital stay) and possible risk factors for infection as smoking, diabetes mellitus, hypertension and exposure to invasive devices or exposure to surgical procedures. Results: Liver diseases 22.8%, cardiac diseases 22.8%, Gastro-Intestinal System diseases 20%, urinary system diseases 13.6%, and endocrinal disorder 13.6% Prostate gland diseases 7.2%. Episodes of infections caused by 9 types of organisms divided into 47.2% for blood stream infection and 52.8% for other types. 66% acquired blood stream infection were exposed to central venous line. Conclusion: Most common type of HAIs was blood stream infections. Liver, cardiac diseases and gastro-intestinal diseased patients show more proportion of HAIs while urinary system and prostate disease patients show less proportion of HAIs. Gram negative bacilli were the most common organisms found in our study (60%). PMID:25538530

  17. Nosocomial Bacterial Pneumonia in HIV-Infected Patients: Risk Factors for Adverse Outcome and Implications for Rational Empiric Antibiotic Therapy

    Microsoft Academic Search

    F. Franzetti; A. Grassini; M. Piazza; M. Degl’Innocenti; A. Bandera; L. Gazzola; G. Marchetti; A. Gori

    2006-01-01

    Background:  Nosocomial bacterial pneumonia (NBP) was once considered a common cause of morbidity and mortality among advanced AIDS patients.\\u000a However, clinical and microbiological characteristics and outcome-associated risk factors in this population are poorly defined.\\u000a \\u000a \\u000a \\u000a Patients:  We conducted a retrospective study of all HIV-infected patients admitted during the period 1988–2002 at the Infectious Diseases\\u000a Clinic of Milan, Italy, to determine incidence rate and

  18. Whole blood gene expression testing for coronary artery disease in nondiabetic patients: major adverse cardiovascular events and interventions in the PREDICT trial.

    PubMed

    Rosenberg, Steven; Elashoff, Michael R; Lieu, Hsiao D; Brown, Bradley O; Kraus, William E; Schwartz, Robert S; Voros, Szilard; Ellis, Stephen G; Waksman, Ron; McPherson, John A; Lansky, Alexandra J; Topol, Eric J

    2012-06-01

    The majority of first-time angiography patients are without obstructive coronary artery disease (CAD). A blood gene expression score (GES) for obstructive CAD likelihood was validated in the PREDICT study, but its relation to major adverse cardiovascular events (MACE) and revascularization was not assessed. Patients (N = 1,160) were followed up for MACE and revascularization 1 year post-index angiography and GES, with 1,116 completing follow-up. The 30-day event rate was 23% and a further 2.2% at 12 months. The GES was associated with MACE/revascularizations (p < 0.001) and added to clinical risk scores. Patients with GES >15 trended towards increased >30 days MACE/revascularization likelihood (odds ratio = 2.59, 95% confidence interval = 0.89-9.14, p = 0.082). MACE incidence overall was 1.5% (17 of 1,116) and 3 of 17 patients had GES ? 15. For the total low GES group (N = 396), negative predictive value was 90% for MACE/revascularization and >99% for MACE alone, identifying a group of patients without obstructive CAD and highly unlikely to suffer MACE within 12 months. PMID:22396313

  19. Overview and management of cardiac and pulmonary adverse events in patients with relapsed and/or refractory multiple myeloma treated with single-agent carfilzomib.

    PubMed

    Wang, Michael; Cheng, Jie

    2013-12-01

    Cardiac events and pulmonary complications are commonly seen in patients with multiple myeloma (MM), most of whom are over 60 years of age at the time of their diagnosis. These events and complications may be consequences of age-related comorbidities, or effects of the disease itself or current or previous treatment received. In this last category, patients who receive autologous stem cell transplant or treatment with anthracyclines, alkylating agents, immunomodulatory agents, or the proteasome inhibitor bortezomib have been found to be at increased risk for cardiovascular complications. In addition, treatment with an immunomodulatory agent or bortezomib has also been associated with pulmonary complications, which often manifest as dyspnea. An understanding of the cardiopulmonary adverse events associated with anti-MM treatment is, therefore, an important component of therapy selection. Carfilzomib is a selective proteasome inhibitor that was recently approved in the United States for the treatment of patients with relapsed and/or refractory MM who had received two or more prior therapies, including bortezomib and an immunomodulatory agent, and who demonstrated disease progression within 60 days of completion of the last therapy. This article presents an overview of the cardiac and pulmonary safety profile of single-agent carfilzomib therapy in patients with relapsed and/or refractory MM from an analysis of four phase II clinical studies, and provides practical recommendations for the management of patients at risk for cardiac events and pulmonary complications. PMID:25184233

  20. Countertransference Reactions to Adolescents with Eating Disorders: Relationships to Clinician and Patient Factors

    PubMed Central

    Satir, Dana A.; Thompson-Brenner, Heather; Boisseau, Christina L.; Crisafulli, Michele A.

    2009-01-01

    Objective Clinical report suggests therapists have strong and sometimes difficult-to-manage reactions to patients with eating disorders (EDs), however, systematic research is largely absent. The purpose of this study was to explore the emotional responses, or countertransference (CT) reactions, clinicians experience when working with patients with EDs, and to identify clinician, patient, and therapy variables associated with these responses. Method One hundred twenty clinicians reported on multiple variables related to an adolescent female patient they were treating for an ED. Results Six patterns of reactions were identified: Angry/Frustrated, Warm/Competent, Aggressive/Sexual, Failing/Incompetent, Bored/Angry at Parents and Overinvested/Worried feelings. The factors showed meaningful relationships across clinician demographics, patient characteristics, and treatment techniques. Conclusion Overall, clinician’s reactions were most frequently associated with the clinician’s gender, patients’ level of functioning and improvement during treatment, and patient personality style. These issues have important implications for training and supervision. PMID:19189302

  1. Suicide of a Patient: Gender Differences in Bereavement Reactions of Therapists.

    ERIC Educational Resources Information Center

    Grad, Onja T.; Zavasnik, Anka; Groleger, Urban

    1997-01-01

    Explores therapists' (N=63) emotional reactions to patient suicide. Results indicate that the most frequently reported reactions were increased caution in the treatment of patients and an increase in conferring with colleagues, partners, and supervisors. Female therapists more often reported shame, depression, and loss. (RJM)

  2. Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products?-?part 1: Achillea millefolium-Curcuma longa.

    PubMed

    Calapai, Gioacchino; Miroddi, Marco; Minciullo, Paola L; Caputi, Achille P; Gangemi, Sebastiano; Schmidt, Richard J

    2014-07-01

    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

  3. Bortezomib mitigates adverse prognosis conferred by Bcl-2 overexpression in patients with relapsed/refractory multiple myeloma.

    PubMed

    Ailawadhi, Sikander; Miecznikowski, Jeff; Gaile, Dan P; Wang, Dongliang; Sher, Taimur; Mulligan, George; Bryant, Barb; Wilding, Gregory E; Mashtare, Terry; Stein, Leighton; Masood, Aisha; Neuwirth, Rachel; Lee, Kelvin P; Chanan-Khan, Asher

    2012-06-01

    Overexpression of the Bcl-2 family of genes results in increased transcription of anti-apoptotic proteins. In vitro data suggest that this may enhance acquired chemoresistance and correlate with extramedullary invasion. This has led to pursuing the Bcl-2 family of proteins as therapeutic targets in several malignant disorders, including multiple myeloma (MM). The impact of novel therapeutic agents such as bortezomib on these molecular markers is not known. We investigated the association between the expression of anti-apoptotic members of the Bcl-2 family and the efficacy of bortezomib in patients with relapsed/refractory MM. Gene expression data generated prospectively from large clinical trials were utilized. Hypothesis testing using a multisample test for equivalence was performed. The association between Bcl-2 expression levels and clinical response was negated in bortezomib-treated patients (p = 0.014), while not so in dexamethasone-treated patients (p = 0.92). Similar results were noted for variant 2 of the Mcl-1 gene (p = 0.003). Results for Bcl-xl did not meet the level of significance. Thus, the importance of the Bcl-2 family of proteins as prognostic markers in MM should be reassessed in the novel therapeutic agent era. Our data suggest that bortezomib may overcome the prognostic effect conferred by overexpression of some of the anti-apoptotic Bcl-2 family of genes in patients with relapsed/refractory MM. PMID:22054286

  4. Natalizumab-related anaphylactoid reactions in MS patients are associated with HLA class II alleles

    PubMed Central

    de la Hera, Belén; Urcelay, Elena; Brassat, David; Chan, Andrew; Vidal-Jordana, Angela; Salmen, Anke; Villar, Luisa Maria; Álvarez-Cermeño, José Carlos; Izquierdo, Guillermo; Fernández, Oscar; Oliver, Begoña; Saiz, Albert; Ara, Jose Ramón; Vigo, Ana G.; Arroyo, Rafael; Meca, Virginia; Malhotra, Sunny; Fissolo, Nicolás; Horga, Alejandro; Montalban, Xavier

    2014-01-01

    Objectives: We aimed to investigate potential associations between human leukocyte antigen (HLA) class I and class II alleles and the development of anaphylactic/anaphylactoid reactions in patients with multiple sclerosis (MS) treated with natalizumab. Methods: HLA class I and II genotyping was performed in patients with MS who experienced anaphylactic/anaphylactoid reactions and in patients who did not develop infusion-related allergic reactions following natalizumab administration. Results: A total of 119 patients with MS from 3 different cohorts were included in the study: 54 with natalizumab-related anaphylactic/anaphylactoid reactions and 65 without allergic reactions. HLA-DRB1*13 and HLA-DRB1*14 alleles were significantly increased in patients who developed anaphylactic/anaphylactoid reactions (pM-H = 3 × 10?7; odds ratio [OR]M-H = 8.96, 95% confidence interval [CI] = 3.40–23.64), with a positive predictive value (PPV) of 82%. In contrast, the HLA-DRB1*15 allele was significantly more represented in patients who did not develop anaphylactic/anaphylactoid reactions to natalizumab (pM-H = 6 × 10?4; ORM-H = 0.2, 95% CI = 0.08–0.50), with a PPV of 81%. Conclusions: HLA-DRB1 genotyping before natalizumab treatment may help neurologists to identify patients with MS at risk for developing serious systemic hypersensitivity reactions associated with natalizumab administration. PMID:25520955

  5. Coexistence of Low Vitamin D and High Fibroblast Growth Factor-23 Plasma Levels Predicts an Adverse Outcome in Patients with Coronary Artery Disease

    PubMed Central

    Tuñón, José; Cristóbal, Carmen; Tarín, Nieves; Aceña, Álvaro; González-Casaus, María Luisa; Huelmos, Ana; Alonso, Joaquín; Lorenzo, Óscar; González-Parra, Emilio; Mahíllo-Fernández, Ignacio; Pello, Ana María; Carda, Rocío; Farré, Jerónimo; Rodríguez-Artalejo, Fernando

    2014-01-01

    Objective Vitamin D and fibroblast growth factor-23 (FGF-23) are related with cardiovascular disorders. We have investigated the relationship of calcidiol (vitamin D metabolite) and FGF-23 plasma levels with the incidence of adverse outcomes in patients with coronary artery disease. Methods Prospective follow-up study of 704 outpatients, attending the departments of Cardiology of four hospitals in Spain, 6–12 months after an acute coronary event. Baseline calcidiol, FGF-23, parathormone, and phosphate plasma levels were assessed. The outcome was the development of acute ischemic events (any acute coronary syndrome, stroke, or transient ischemic attack), heart failure, or death. Cox regression adjusted for the main confounders was performed. Results Calcidiol levels showed a moderate-severe decrease in 57.3% of cases. Parathormone, FGF-23, and phosphate levels were increased in 30.0%, 11.5% and 0.9% of patients, respectively. Only 22.4% of patients had glomerular filtration rate<60 ml/min1.73 m2. After a mean follow-up was 2.15±0.99 years, 77 patients developed the outcome. Calcidiol (hazard ratio [HR]?=?0.67; 95% confidence interval [CI]?=?0.48–0.94; p?=?0.021) and FGF-23 (HR?=?1.13; 95% CI?=?1.04–1.23; p?=?0.005) plasma levels predicted independently the outcome. There was a significant interaction between calcidiol and FGF-23 levels (p?=?0.025). When the population was divided according to FGF-23 levels, calcidiol still predicted the outcome independently in patients with FGF-23 levels higher than the median (HR?=?0.50; 95% CI?=?0.31–0.80; p?=?0.003) but not in those with FGF-23 levels below this value (HR?=?1.03; 95% CI?=?0.62–1.71; p?=?0.904). Conclusions Abnormalities in mineral metabolism are frequent in patients with stable coronary artery disease. In this population, low calcidiol plasma levels predict an adverse prognosis in the presence of high FGF-23 levels. PMID:24748388

  6. High-level CD34 expression on megakaryocytes independently predicts an adverse outcome in patients with myelodysplastic syndromes.

    PubMed

    Tang, Guilin; Wang, Sa A; Menon, Madhu; Dresser, Karen; Woda, Bruce A; Hao, Suyang

    2011-06-01

    Expression of CD34 on mature-appearing megakaryocytes can be seen in various intrinsic bone marrow (BM) disorders as well as reactive bone marrows. In this study we investigate the clinical significance of CD34+ megakaryocytes in myelodysplastic syndromes (MDSs). Expression of CD34 on megakaryocytes was assessed on BM biopsies obtained from 202 patients with MDS. High-level (?20%) CD34 expression on megakaryocytes was found in BM of 29 patients (14%). The expression of CD34 on megakaryocytes is correlated with severe cytopenia, higher numbers of myeloblasts, more frequent and higher risk cytogenetic abnormalities, and a shorter overall survival. Multivariate analysis indicated that the expression of CD34 on megakaryocytes could be a strong and an independent poor prognostic factor in MDS, with a hazard ratio of 2.53. PMID:21367453

  7. Absence of clinically overt atherosclerotic vascular disease and adverse changes in cardiovascular risk factors in 70 patients with insulinoma.

    PubMed

    Leonetti, F; Iozzo, P; Giaccari, A; Sbraccia, P; Buongiorno, A; Tamburrano, G; Andreani, D

    1993-12-01

    Hyperinsulinemia has been assumed to contribute to the pathogenesis of atherosclerosis. To assess the reliability of such claim we planned a retrospective study on a cohort of patients with pancreatic insulin producing neoplasm. A correlation was sought between fasting insulin plasma levels and the metabolic profile emerging from those parameters known to be cardiovascular risk factors, i.e. plasma triglycerides and cholesterol, insulin resistance, hypertension. Special attention was paid to the duration of disease, because the time exposure to hyperinsulinemia could play an important role in developing cardiovascular disease. Seventy patients, 41 females and 29 males, aged 44.9 +/- 1.96 yr (range 15-80), with surgically proved insulinoma were included in the study. Chronic exposure to hyperinsulinemia was documented through the measurement of insulin plasma levels either in the fasting state or post-prandially, resulting in 44.7 +/- 3.28 and 149.9 +/- 12.22 microU/ml, respectively. Fasting glycemia in average was 45.3 +/- 1.34 mg/dl. Plasma triglycerides and cholesterol concentrations were 136.3 +/- 7.93 and 195.8 +/- 5.18 mg/dl, respectively, their distribution overlapping that anticipated for the general population. No correlation arose between the degree of hyperinsulinemia and the lipidic profile. Preoperative blood pressure was 136.9 +/- 2.87 mmHg, systolic and 81.9 +/- 1.32 mmHg, diastolic. Hypertension was present in 5 (7.1%) out of 70 patients and persisted after tumor removal. A condition of insulin resistance (M = 4.06 +/- 0.4 mg/kg min vs 7.41 +/- 0.21) was documented through the euglycemic hyperinsulinemic clamp technique in 20 patients and showed a positive and significant correlation with fasting insulinemia.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8144864

  8. Anaphylactic reactions to cinoxacin.

    PubMed

    Stricker, B H; Slagboom, G; Demaeseneer, R; Slootmaekers, V; Thijs, I; Olsson, S

    1988-12-01

    During 1981 to mid-1988 three cases of anaphylactic shock after treatment with the quinolone derivative cinoxacin were reviewed by the Netherlands Centre for Monitoring of Adverse Reactions to Drugs and 17 cases of an anaphylactic type of reaction notified to the World Health Organisation Collaborating Centre for International Drug Monitoring. In five out of six patients for whom data were available the reaction began shortly after taking a single capsule of a second or next course of treatment. Cinoxacin is related to nalidixic acid, and one patient previously treated with that agent subsequently had an anaphylactoid reaction to cinoxacin and later developed a skin reaction to nalidixic acid. There were no deaths, and patients treated as an emergency with plasma expanders or with adrenaline and corticosteroids generally recovered promptly and uneventfully. In view of the potentially fatal consequences of anaphylactic reactions to cinoxacin and other quinolones doctors should take care when prescribing these drugs. PMID:3147004

  9. Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration

    PubMed Central

    Magrabi, Farah; Ong, Mei-sing; Runciman, William; Coiera, Enrico

    2011-01-01

    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

  10. Patient safety in external beam radiotherapy - guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.

    PubMed

    Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Martin, Carlos Prieto; Przybylska, Kamila; Skroba?a, Agnieszka; Valero, Marc; Jarvinen, Hannu

    2014-08-01

    In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated "ACCIRAD", recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled "Guidelines for patient safety in external beam radiotherapy - Guidelines on risk assessment and analysis of adverse-error events and near misses". The present article describes the aims and current status of the project, including results of the surveys. PMID:25245556

  11. [Management of adverse effects with antituberculosis chemotherapy].

    PubMed

    Tsuyuguchi, Kazunari; Wada, Masako

    2011-02-01

    Tuberculosis has now become a curable disease with chemotherapy. So it is natural that the present issues in tuberculosis management are focused on how to complete standard chemotherapy. In this context, management of adverse effects constitutes an essential part of antituberculosis chemotherapy, as well as directly observed therapy. In this symposium, discussions were held about three major subjects on this issue. First, hepatotoxicity develops frequently and has sometimes fatal outcome, which makes it the most problematic adverse effect. "Management of hepatotoxicity during antituberculosis chemotherapy" was published by the Japanese Society for Tuberculosis (JST) in 2006. Dr. Shinsho Yoshiba evaluated this recommendation and pointed out that the criteria for discontinuation of drug based on AST, ALT and bilirubin levels is too sensitive and the concept of predicting fulminant hepatic failure (FHF) is lacking. He stressed the importance of monitoring serum prothrombin time for predicting FHF. Next, allergic drug reaction such as fever or skin rash often causes distress, although rarely fatal. As isoniazid (INH) and rifampicin (RFP) are key drugs for the cure, readministration of these drugs is often attempted by desensitization therapy. "Recommendation about desensitization therapy of antituberculosis drugs" was also published by JST in 1997. Dr. Yoshihiro Kobashi reported high success rates of 79 percent for INH and 75 percent for RFP according to this recommendation. He also reported correlated factor with the success, such as the longer period from the discontinuation to the desensitization therapy and lower doses of drugs at starting desensitization. Finally, we sometimes experience transient worsening of radiographical findings and general symptoms during antituberculosis chemotherapy. This is presumed to be due to allergic reaction to dead bacilli without requiring discontinuation of the drug. Differential diagnosis includes drug-induced pneumonia requring discontinuation and true worsening of pulmonary tuberculosis due to drug resistance requiring change in therapy. Dr. Masanori Akira reported that presence of ground-glass attenuation and/or consolidation by HRCT suggests transient worsening or drug-induced pneumonia, whereas presence of centrilobular nodules and/or tree-in bud suggests true worsening. We believe that these findings from the symposium will add useful information for management of adverse effects and be helpful for implementation of antituberculosis chemotherapy. (1) Hepatotoxicity of antituberculosis drugs: Shinsho YOSHIBA (Sempo Tokyo Takanawa Hospital) Antituberculosis drugs are sometimes hepatotoxic. Doctors who are responsible for the treatment of patients with tuberculosis should always be aware of their hepatotoxicity, because it seldom leads to fulminant hepatic failure. The Japanese Society for Tuberculosis proposed criteria based on the levels of AST, ALT and bilirubin for the prevention of such grave hepatic injury in 2006. In recent years attempts have been made to predict fulminant hepatic failure (FHF) before patients develop coma. Yoshiba's formula using prothrombin time, etiology, cholinesterase and bilirubin is widely accepted as useful to predict FHF. Introduction of the formula to this area is recommended. (2) Desensitization therapy for allergic reactions of antituberculous drugs: Yoshihiro KOBASHI, Mikio OKA (Division of Respiratory Diseases, Department of Medicine, Kawasaki Medical School) We evaluated the usefulness of desensitization therapy for patients showing allergic reactions of INH and RFP according to the guideline proposed by the Japanese Society for Tuberculosis. Adverse reactions were 22 patients with drug eruption, 22 with drug fever and 6 with drug fever plus eruption. The clinical effect of desensitization therapy was good in 27 out of 36 patients for RFP (75%), and in 19 out of 24 patients for INH (79%). The comparative study between patient group with success desensitization therapy and that with failure desensitization therapy was not a

  12. Adverse events in healthcare: learning from mistakes.

    PubMed

    Rafter, N; Hickey, A; Condell, S; Conroy, R; O'Connor, P; Vaughan, D; Williams, D

    2015-04-01

    Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety. PMID:25078411

  13. miR-205 negatively regulates the androgen receptor and is associated with adverse outcome of prostate cancer patients

    PubMed Central

    Hagman, Z; Haflidadóttir, B S; Ceder, J A; Larne, O; Bjartell, A; Lilja, H; Edsjö, A; Ceder, Y

    2013-01-01

    Background: The microRNA-205 (miR-205) has been shown to be deregulated in prostate cancer (PCa). Here we continue to investigate the prognostic and therapeutic potential of this microRNA. Methods: The expression of miR-205 is measured by qRT–PCR and in situ hybridisation in a well-documented PCa cohort. An AGO2-based RIP-Chip assay is used to identify targets that are verified with western blots, luciferase reporter assay, ELISA and immunohistochemistry. Results: The expression of miR-205 is inversely correlated to the occurrence of metastases and shortened overall survival, and is lower in castration-resistant PCa patients. The miR-205 expression is mainly localised to the basal cells of benign prostate tissues. Genes regulated by miR-205 are enriched in, for example, the MAPK/ERK, Toll-like receptor and IL-6 signaling pathways. We demonstrate binding of miR-205 to the 3?UTR of androgen receptor (AR) and decrease of both AR transcript and protein levels. This finding was corroborated in the patient cohort were miR-205 expression inversely correlated to AR immunostaining in malignant prostate cells and to serum levels of prostate-specific antigen, an androgen-regulated protein. Conclusion: Taken together, these findings imply that miR-205 might have therapeutic potential, especially for the castration resistant and currently untreatable form of PCa. PMID:23571738

  14. Oxidative reactions in the tear fluid of patients suffering from dry eyes

    Microsoft Academic Search

    Albert J. Augustin; Manfred Spitznas; Nahid Kaviani; Daniel Meller; Frank H. J. Koch; Franz Grus; Martin J. Göbbels

    1995-01-01

    • Purpose: To evaluate whether products of oxidative and inflammatory reactions are detectable in the tear fluid of patients suffering from dry eyes. • Methods: The tear fluid of 217 patients (397 eyes) was sampled. Criteria for grouping of the patients were (1) basic secretion test (“sicca l”: BST = 0–5 mm, n = 78 eyes; “sicca 2”: BST =

  15. Reactions of psychiatric patients to the Three Mile Island nuclear accident

    Microsoft Academic Search

    E. Bromet; H. C. Schulberg; L. Dunn

    1982-01-01

    The reaction of patients in the community mental health system to the nuclear accident at Three Mile Island (TMI), Middletown, Pa, were assessed. The sample was composed of 151 patients from the TMI area and 64 patients from a comparison site where a similar nuclear plant is located. Mental health status was determined for the period immediately after the accident,

  16. Meta-Analysis of Randomized Controlled Trials Comparing Risk of Major Adverse Cardiac Events and Bleeding in Patients With Prasugrel Versus Clopidogrel.

    PubMed

    Chen, Hai-Bin; Zhang, Xin-Lu; Liang, Hong-Bin; Liu, Xue-Wei; Zhang, Xin-Yu; Huang, Bao-Yi; Xiu, Jiancheng

    2015-08-01

    The use of prasugrel in patients with coronary artery disease (CAD) has been associated with decreased major adverse cardiac events (MACEs) compared with clopidogrel but with an increased risk of bleeding. However, it remains unclear if the risks of bleeding outweigh those of MACEs in patients on prasugrel treatment. We systematically reviewed randomized controlled trials comparing prasugrel with clopidogrel in patients with CAD. We performed a literature search of PubMed, EMBASE, and Cochrane Central Register of Controlled Trial databases from inception to November 25, 2014, and reviewed the reference lists of retrieved articles. A comparative estimate was made for the combined rates of MACEs and bleeding from the same trials in the framework of this meta-analysis and expressed as odds ratios (ORs) and 95% confidence intervals (CIs) in both random- and fixed-effects models. Nine studies involving 25,214 patients were included in our meta-analysis. In both the random- and fixed-effects models, the risks of MACEs outweighed those of major bleeding (OR 7.48, 95% CI 3.75 to 14.94, p <0.0001, random effects) and of minor bleeding (OR 3.77, 95% CI 1.73 to 8.22, p = 0.009, random effects). Results were corroborated in a standard-dose clopidogrel subgroup analysis (OR 7.46, 95% CI 3.54 to 15.68, p <0.0001, and OR 6.44, 95% CI 2.80 to 14.80, p <0.0001, random effects, respectively). In conclusion, despite the increased risk of bleeding associated with prasugrel treatment compared with clopidogrel, the risk of MACEs far outweighed the risk of bleeding. PMID:26051379

  17. Association Between Vascular Access Dysfunction and Subsequent Major Adverse Cardiovascular Events in Patients on Hemodialysis: A Population-Based Nested Case-Control Study.

    PubMed

    Kuo, Te-Hui; Tseng, Chien-Tzu; Lin, Wei-Hung; Chao, Jo-Yen; Wang, Wei-Ming; Li, Chung-Yi; Wang, Ming-Cheng

    2015-07-01

    The association between dialysis vascular access dysfunction and the risk of developing major adverse cardiovascular events (MACE) in hemodialysis patients is unclear and has not yet been investigated. We analyzed data from the National Health Insurance Research Database of Taiwan to quantify this association. Adopting a case-control design nested within a cohort of patients who received hemodialysis from 2001 to 2010, we identified 9711 incident cases of MACE during the stage of stable maintenance dialysis and 19,422 randomly selected controls matched to cases on age, gender, and duration of dialysis. Events of vascular access dysfunction in the 6-month period before the date of MACE onset (ie, index date) for cases and before index dates for controls were evaluated retrospectively. The presence of vascular access dysfunction was associated with a 1.385-fold higher odds of developing MACE as estimated from the logistic regression analysis. This represents a significantly increased adjusted odds ratio (OR) at 1.268 (95% confidence interval [CI]?=?1.186-1.355) after adjustment for comorbidities and calendar years of initiating dialysis. We also noted a significant exposure-response trend (P?patients with ?3 vascular access events. We concluded that dialysis vascular access dysfunction was significantly associated with an increased risk of MACE. Hence, vascular access failure can be an early sign for MACE in patients receiving maintenance hemodialysis. Active monitoring and treatment of cardiovascular risk factors and related diseases, not merely managing vascular access dysfunction, would be required to reduce the risk of MACE. PMID:26131808

  18. Incidence and Timing of Taper/Posttherapy–Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder

    PubMed Central

    Musgnung, Jeff; Messig, Michael; Buckley, Gina; Guico-Pabia, Christine J.; Ramey, Tanya S.

    2015-01-01

    Objective: The purpose of this post hoc analysis was to evaluate the incidence and timing of taper/posttherapy–emergent adverse events (TPAEs) following discontinuation of long-term treatment with desvenlafaxine (administered as desvenlafaxine succinate). Method: This was a phase 4, randomized, double-blind, placebo-controlled study conducted at 38 research centers within the United States between March 2010 and February 2011. Adult outpatients with major depressive disorder (MDD; DSM-IV-TR criteria) who completed 24 weeks of open-label treatment with desvenlafaxine 50 mg/d were randomly assigned to 1 of 3 groups for the double-blind taper phase: desvenlafaxine 50 mg/d for 4 weeks (no discontinuation), desvenlafaxine 25 mg/d for 1 week followed by placebo for 3 weeks (taper), or placebo for 4 weeks (abrupt discontinuation). The primary endpoint, Discontinuation-Emergent Signs and Symptoms Scale (DESS) score over the first 2 weeks of the taper phase, was described previously. Secondary assessments included incidence and timing of TPAEs (any adverse event that started or increased in severity during the double-blind phase) and the percentage of patients who could not continue the taper phase due to discontinuation symptoms. The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) assessed MDD status. Results: A total of 480 patients enrolled in the open-label phase; the full analysis set included 357 patients (taper, n = 139; abrupt discontinuation, n = 146; no discontinuation, n = 72). TPAEs occurred in all groups through week 4. The incidence of any TPAE was lower for taper versus abrupt discontinuation at week 1 (P < .001), similar at week 2, and lower for taper versus abrupt discontinuation at weeks 3 and 4 (P ? .034). The most common TPAEs (incidence ? 3%) in the taper group were nausea and headache (3% each) at week 1 and dizziness (5%) and headache (4%) at week 2. The most common TPAEs in the abrupt discontinuation group were dizziness (8%), headache (8%), nausea (4%), irritability (3%), and diarrhea (3%) at week 1 and headache (3%) at weeks 2 and 3. The most common TPAE in the no discontinuation group was nausea (6%) at week 2. Conclusion: The overall incidence of any TPAE was lower in the taper versus abrupt discontinuation groups. Trial Registration: ClinicalTrials.gov identifier: NCT01056289

  19. Gene expression profiling of whole blood in ipilimumab-treated patients for identification of potential biomarkers of immune-related gastrointestinal adverse events

    PubMed Central

    2013-01-01

    Background Treatment with ipilimumab, a fully human anti-CTLA-4 antibody approved for the treatment of advanced melanoma, is associated with some immune-related adverse events (irAEs) such as colitis (gastrointestinal irAE, or GI irAE) and skin rash, which are managed by treatment guidelines. Nevertheless, predictive biomarkers that can help identify patients more likely to develop these irAEs could enhance the management of these toxicities. Methods To identify candidate predictive biomarkers associated with GI irAEs, gene expression profiling was performed on whole blood samples from 162 advanced melanoma patients at baseline, 3 and 11 weeks after the start of ipilimumab treatment in two phase II clinical trials (CA184004 and CA184007). Overall, 49 patients developed Grade 2 or higher (grade 2+) GI irAEs during the course of treatment. A repeated measures analysis of variance (ANOVA) was used to evaluate the differences in mean expression levels between the GI irAE and No-GI irAE groups of patients at the three time points. Results In baseline samples, 27 probe sets showed differential mean expression (? 1.5 fold, P ? 0.05) between the GI irAE and No-GI irAE groups. Most of these probe sets belonged to three functional categories: immune system, cell cycle, and intracellular trafficking. Changes in gene expression over time were also characterized. In the GI irAE group, 58 and 247 probe sets had a ? 1.5 fold change in expression from baseline to 3 and 11 weeks after first ipilimumab dose, respectively. In particular, on-treatment expression increases of CD177 and CEACAM1, two neutrophil-activation markers, were closely associated with GI irAEs, suggesting a possible role of neutrophils in ipilimumab-associated GI irAEs. In addition, the expression of several immunoglobulin genes increased over time, with greater increases in patients with grade 2+ GI irAEs. Conclusions Gene expression profiling of peripheral blood, sampled before or early in the course of treatment with ipilimumab, resulted in the identification of a set of potential biomarkers that were associated with occurrence of GI irAEs. However, because of the low sensitivity of these biomarkers, they cannot be used alone to predict which patients will develop GI irAEs. Further investigation of these biomarkers in a larger patient cohort is warranted. PMID:23521917

  20. Enhanced mucosal reactions in AIDS patients receiving oropharyngeal irradiation

    SciTech Connect

    Watkins, E.B.; Findlay, P.; Gelmann, E.; Lane, H.C.; Zabell, A.

    1987-09-01

    The oropharynx and hypopharynx are common sites of involvement in AIDS patients with mucocutaneous Kaposi's sarcoma. The radiotherapist is often asked to intervene with these patients due to problems with pain, difficulty in swallowing, or impending airway obstruction. We have noted an unexpected decrease in normal tissue tolerance of the oropharyngeal mucosa to irradiation in AIDS patients treated in our department. Data on 12 patients with AIDS and Kaposi's sarcoma receiving oropharyngeal irradiation are presented here. Doses ranged from 1000 cGy to 1800 cGy delivered in 150-300 cGy fractions. Seven of eight patients receiving doses of 1200 cGy or more developed some degree of mucositis, four of these developed mucositis severe enough to require termination of treatment. All patients in this study received some form of systemic therapy during the course of their disease, but no influence on mucosal response to irradiation was noted. Four patients received total body skin electron treatments, but no effect on degree of mucositis was seen. Presence or absence of oral candidiasis was not an obvious factor in the radiation response of the oral mucosa in these patients. T4 counts were done on 9 of the 12 patients. Although the timing of the T4 counts was quite variable, no correlation with immune status and degree of mucositis was found. The degree of mucositis seen in these patients occurred at doses much lower than expected based on normal tissue tolerances seen in other patient populations receiving head and neck irradiations. We believe that the ability of the oral mucosa to repair radiation damage is somehow altered in patients with AIDS.

  1. Psychosocial reaction patterns to alopecia in female patients with gynecological cancer undergoing chemotherapy.

    PubMed

    Ishida, Kazuko; Ishida, Junko; Kiyoko, Kanda

    2015-01-01

    This study aims to clarify the psychosocial reactions of female patients with gynecological cancer undergoing chemotherapy and in the process of suffering from alopecia and to examine their nursing support. The target group comprised female patients who had received two or more cycles of chemotherapy, were suffering from alopecia, and were aged 30-65. Data were collected from semi-structured interviews, conducted from the time the patients were informed by their doctors that they might experience alopecia due to chemotherapy to the time they actually experienced alopecia and until they were able to accept the change. Inductive qualitative analysis was employed to close in on the subjective experiences of the cancer patients. The results showed the existence of six phases in the psychosocial reactions in the process of alopecia: phase one was the reaction after the doctor's explanation; phase two was the reaction when the hair starts to fall out; phase three was the reaction when the hair starts to intensely fall out; phase four was the reaction when the hair has completely fallen out; phase five was the reaction to behavior for coping with alopecia; and phase six was the reaction to change in interpersonal human relationships. The results also made it clear that there are five types of reaction patterns as follows: 1) treatment priority interpersonal relationship maintenance type; 2) alopecia agitated interpersonal relationship maintenance type; 3) alopecia agitated interpersonal relationship reduction type; 4) alopecia denial interpersonal relationship reduction type; and 5) alopecia denial treatment interruption type. It is important to find out which of the five types the patients belong to early during treatment and provide support so that nursing intervention that suits each individual can be practiced. The purpose of this study is to make clear the process in which patients receiving chemotherapy come to accept alopecia and to examine evidence-based nursing care on patients with strong mental distress from alopecia. PMID:25735360

  2. Patch-test reaction patterns in patients with a predisposition to atopic dermatitis.

    PubMed

    Brasch, Jochen; Schnuch, Axel; Uter, Wolfgang

    2003-10-01

    Patients with a predisposition to atopic dermatitis often need to be patch tested in order to detect possible contact sensitization. However, it is unknown whether immunologic or other peculiarities of atopic skin are related to altered patch-test reaction patterns. Our study was aimed at answering this question, because patch-test reaction patterns are of considerable practical importance in the reading and interpretation of patch tests. Therefore, we compared patterns of patch-test reactions in patients with a predisposition to atopic dermatitis and in control patients matched for sex, age, reason for testing and test centre. Patch-test results from 9 centres (2322 patients with a disposition to atopic dermatitis and 2126 matched controls) were evaluated retrospectively. All patients were tested with nickel sulfate, fragrance mix, potassium dichromate, lanolin alcohol, formaldehyde and mercury ammonium chloride. Patch tests applied for 1 day with readings on days 1, 2 and 3 were evaluated in order to cover the early phase of the reactions. Not unexpectedly, we found that, compared to the matched controls, patients with a predisposition to atopic dermatitis tended to have more doubtful and irritant reactions on day 1. As a new observation, it turned out that they had less reactions of crescendo pattern and more strong reactions on day 3. All these differences were slight/insignificant. A higher skin irritability in patients with a predisposition to atopic dermatitis is a likely explanation. In conclusion, standard methods for patch testing can be applied in patients with a predisposition to atopic dermatitis, but minor differences in reaction patterns should be considered. PMID:14996068

  3. Gender and age effects on the continuous reaction times method in volunteers and patients with cirrhosis.

    PubMed

    Lauridsen, Mette Munk; Grønbæk, Henning; Næser, Esben B; Leth, Steffen T; Vilstrup, Hendrik

    2012-12-01

    Minimal hepatic encephalopathy (MHE) is a metabolic brain disorder occurring in patients with liver cirrhosis. MHE lessens a patient's quality of life, but is treatable when identified. The continuous reaction times (CRT) method is used in screening for MHE. Gender and age effects on the CRT method are unknown and may confound the results. The aim of this study was to standardise the CRT method outcomes for age and gender effects. We studied 121 volunteers without known disease and 181 patients with cirrhosis by a CRT test. Reaction time to an auditory signal was measured 100 times, the 10th, 50th, and 90th reaction time percentiles were recorded, and the CRT index was calculated as the 50th percentile/(90th percentile-10th percentile), as a measure of intra-individual stability in reaction times. In volunteers, men reacted faster than women and their reaction times slowed with age. However, neither the gender nor the age effect was present regarding the CRT index. The patients with cirrhosis reacted slower and with a higher degree of instability than volunteers. Male patients reacted faster than female patients, and reaction times tended to slow with age. As among the volunteers, there was no gender or age effect on CRT index for the patients with cirrhosis. Age and gender influenced reaction times of both volunteers and patients with cirrhosis. The CRT index, however, was independent of age and gender in both groups. Screening of patients with cirrhosis using the CRT index, therefore, identifies brain dysfunction rather than effects of gender and age. PMID:22614824

  4. Reduction of adverse effects by a mushroom product, active hexose correlated compound (AHCC) in patients with advanced cancer during chemotherapy--the significance of the levels of HHV-6 DNA in saliva as a surrogate biomarker during chemotherapy.

    PubMed

    Ito, Toshinori; Urushima, Hayato; Sakaue, Miki; Yukawa, Sayoko; Honda, Hatsumi; Hirai, Kei; Igura, Takumi; Hayashi, Noriyuki; Maeda, Kazuhisa; Kitagawa, Toru; Kondo, Kazuhiro

    2014-01-01

    Chemotherapy improves the outcome of cancer treatment, but patients are sometimes forced to discontinue chemotherapy or drop out of a clinical trial due to adverse effects, such as gastrointestinal disturbances and suppression of bone marrow function. The objective of this study was to evaluate the safety and effectiveness of a mushroom product, active hexose correlated compound (AHCC), on chemotherapy-induced adverse effects and quality of life (QOL) in patients with cancer. Twenty-four patients with cancer received their first cycle of chemotherapy without AHCC and then received their second cycle with AHCC. During chemotherapy, we weekly evaluated adverse effects and QOL via a blood test, EORTC QLQ-C30 questionnaire, and DNA levels of herpes virus type 6 (HHV-6) in saliva. The DNA levels of HHV-6 were significantly increased after chemotherapy. Interestingly, administration of AHCC significantly decreased the levels of HHV-6 in saliva during chemotherapy and improved not only QOL scores in the EORTC QLQ-C30 questionnaire but also hematotoxicity and hepatotoxicity. These findings suggest that salivary HHV-6 levels may be a good biomarker of QOL in patients during chemotherapy, and that AHCC may have a beneficial effect on chemotherapy-associated adverse effects and QOL in patients with cancer undergoing chemotherapy. PMID:24611562

  5. Body mass index and risk of perioperative cardiovascular adverse events and mortality in 34,744 Danish patients undergoing hip or knee replacement

    PubMed Central

    Gislason, Gunnar H; Køber, Lars; Jensen, Per Føge; Torp-Pedersen, Christian; Andersson, Charlotte

    2014-01-01

    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

  6. Identification of responsible volatile chemicals that induce hypersensitive reactions to multiple chemical sensitivity patients

    Microsoft Academic Search

    Naohide Shinohara; Atsushi Mizukoshi; Yukio Yanagisawa

    2004-01-01

    Multiple chemical sensitivity (MCS) has become a serious problem as a result of airtight techniques in modern construction. The mechanism of the MCS, however, has not been clarified. Responsible chemicals and their exposure levels for patient's hypersensitive reactions need to be identified. We measured the exposure of 15 MCS patients to both carbonyl compounds and volatile organic compounds (VOCs) that

  7. Prospective comparison of in vitro normal cell radiosensitivity and normal tissue reactions in radiotherapy patients

    Microsoft Academic Search

    Fady B. Geara; Lester J. Peters; K. Kian Ang; Jennifer L. Wike; William A. Brock

    1993-01-01

    This pilot study was undertaken to assess the relationship between in vitro radiosensitivity of different normal cell types and the type and severity of normal tissue reactions in individual patients after radiotherapy. Twenty-one patients with head and neck cancer were studied prospectively; four with head and neck and two with breast cancer were studied retrospectively. The retrospective cases were chosen

  8. Diagnosis and Treatment of Leprosy Reactions in Integrated Services - The Patients' Perspective in Nepal

    PubMed Central

    Raffe, Sonia F.; Thapa, Min; Khadge, Saraswoti; Tamang, Krishna; Hagge, Deanna; Lockwood, Diana N. J.

    2013-01-01

    Leprosy care has been integrated with peripheral health services, away from vertical programmes. This includes the diagnosis and management of leprosy reactions, which cause significant morbidity. We surveyed patients with leprosy reactions at two leprosy hospitals in Nepal to assess their experience of leprosy reaction management following integration to identify any gaps in service delivery. Methods Direct and referral patients with leprosy reactions were interviewed in two of Nepal's leprosy hospitals. We also collected quantitative and qualitative data from clinical examination and case-note review to document the patient pathway. Results Seventy-five patients were interviewed. On development of reaction symptoms 39% presented directly to specialist services, 23% to a private doctor, 17% to a district hospital, 10% to a traditional healer, 7% to a health post and 4% elsewhere. Those who presented directly to specialist services were 6.6 times more likely to start appropriate treatment than those presenting elsewhere (95% CI: 3.01 to 14.45). The average delay between symptom onset to commencing corticosteroids was 2.9 months (range 0–24 months). Obstacles to early presentation and treatment included diagnostic challenge, patients' lack of knowledge and the patients' view of health as a low priority. 40% received corticosteroids for longer than 12 weeks and 72% required an inpatient stay. Treatment follow-up was conducted at locations ranging from health posts to specialist hospitals. Inconsistency in the availability of corticosteroids peripherally was identified and 41% of patients treated for leprosy and a reaction on an outpatient basis attended multiple sites for follow-up treatment. Conclusion This study demonstrates that specialist services are necessary and continue to provide significant critical support within an integrated health system approach towards the diagnosis and management of leprosy reactions. PMID:23505585

  9. Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.

    PubMed

    Abraham, John

    2002-11-01

    Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors' spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm's commitment to search effectively for evidence against the safety of its own product in order to confirm doctors' warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market 'early warning systems' about drug hazards imply that the regulatory policies of 'early licensing' and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors' warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal. PMID:12297251

  10. Long-Term Treatment and Transfusion of Normal Blood Components Following Tolerance Induction in Patients with Anti-IgA Anaphylactic Reactions

    PubMed Central

    Salama, Abdulgabar; Kardashi, Romina; Arbach, Olga

    2014-01-01

    Summary Background In general, patients with significant anti-Ig-A do not tolerate intravenous (i.v.) administration of normal blood products. Here, we present our experiences in the induction of immune tolerance (IIT) and long-term treatment in a series of such patients affected in such a way. The question whether blood components from IgA-deficient donors are required will be discussed. Methods Ten adult patients (4 females and 6 males; age ranging from 36 to 75 years) with anti-IgA were included in this study. All patients required long-term treatment with blood components. One patient had IgA deficiency and paroxysmal nocturnal hemoglobinuria (PNH), and all other patients had common variable immunodeficiency (CVID). The particle gel immunoassay was used for the detection of anti-IgA. Immune tolerance to IgA was induced by controlled subcutaneous (s.c.) and/or i.v. infusions of IgG preparations. Results Prior to IIT, anti-IgA was detectable in plasma samples of all patients and significantly diminished or abolished by controlled s.c. and/or i.v. infusions of IgG. Multiple transfusions with normal blood components could be repeatedly performed with the patient suffering from PNH without any complications. As long as i.v. IgG (IVIgG) infusions were consequently administered as individually required (intervals 2–8 weeks), none of the patients developed reactions during observation (up to 10 years). However, interruption of treatment and re-exposure to IVIgG resulted in adverse reactions. Conclusion Patients with significant anti-IgA can be safely desensitized and tolerate long-term IgG substitutions independent of the IgA concentration of the used blood component. PMID:25538541

  11. Is it Crohn's disease? A severe systemic granulomatous reaction to sulfasalazine in patient with rheumatoid arthritis

    Microsoft Academic Search

    Leonard G Quallich; Joel Greenson; Hilary M Haftel; Robert J Fontana

    2001-01-01

    BACKGROUND: Sulfasalazine is a widely used anti-inflammatory agent in the treatment of inflammatory bowel disease and several rheumatological disorders. Although as many as 20% of treated patients may experience reversible, dose-dependent side effects, less frequent but potentially severe, systemic reactions have also been reported. CASE PRESENTATION: A severe systemic reaction to sulfasalazine developed in a 21-year old female with rheumatoid

  12. Quality of life in patients with schizophrenia: the impact of socio-economic factors and adverse effects of atypical antipsychotics drugs.

    PubMed

    de Araújo, Aurigena Antunes; de Araújo Dantas, Diego; do Nascimento, Gemma Galgani; Ribeiro, Susana Barbosa; Chaves, Katarina Melo; de Lima Silva, Vanessa; de Araújo, Raimundo Fernandes; de Souza, Dyego Leandro Bezerra; de Medeiros, Caroline Addison Carvalho Xavier

    2014-09-01

    This cross-sectional study compared the effects of treatment with atypical antipsychotic drugs on quality of life (QoL) and side effects in 218 patients with schizophrenia attending the ambulatory services of psychiatric in Rio Grande do Norte, Brazil. Socio-economic variables were compared. The five-dimension EuroQoL (EQ-5D) was used to evaluate QoL, and side effects were assessed using the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale and the Simpson-Angus Scale. Data were analysed using the ? (2) test and Student's t test, with a significance level of 5 %. Average monthly household incomes in the medication groups were 1.1-2.1 minimum wages ($339-$678). UKU Scale scores showed significant differences in side effects, mainly, clozapine, quetiapine and ziprasidone (p < 0.05). EQ-5D scores showed that all drugs except olanzapine significantly impacted mobility (p < 0.05), and proportions of individuals reporting problems in other dimensions were high: 63.6 % of clozapine users reported mobility problems, 63.7 and 56.3 % of clozapine and ziprasidone users, respectively, had difficulties with usual activities, 68.8 and 54.5 % of ziprasidone and clozapine users, respectively, experienced pain and/or discomfort, and 72.8 % of clozapine users reported anxiety and/or depression. Psychiatric, neurological, and autonomous adverse effects, as well as other side effects, were prevalent in users of atypical antipsychotic drugs, especially clozapine and ziprasidone. Olanzapine had the least side effects. QoL was impacted by side effects and economic conditions in all groups. Thus, the effects of these antipsychotic agents appear to have been masked by aggravating social and economic situations. PMID:24789610

  13. Anaphylactic reaction to phuk-waan-ban in a patient with latex allergy.

    PubMed

    Stirapongsasuti, Patnarin; Tanglertsampan, Chuchai; Aunhachoke, Kobkul; Sangasapaviliya, Atik

    2010-05-01

    Phuk-waan-ban, Euphorbiaceae Sauropus androgynus (Linn) Merr, belongs to the family Euphorbiaceae, which is the same as the rubber tree, Euphorbiaceae Hevea brasiliensis. The young leaves are edible. To the best of the authors knowledge, this is the first report of anaphylactic reaction to Phuk-waan-ban in latex allergic patients. Contact urticaria and anaphylactic reactions to latex-containing rubber products are being recognized with increasing frequency in all kinds of medical disciplines. The prevalence and incidence are both increasing. Recently, a number of reports have been published describing anaphylactic reactions to food items in patients with latex allergy. The authors present a patient with occupational natural rubber allergy who developed an anaphylactic reaction with urticarial rash 20-30 minutes after ingestion of phuk-waan-ban. The diagnostic work up showed specific IgE to latex (CAP class 3). Positive skin prick tests to latex and cooked and raw phuk-waan-ban crude extract confirmed allergic reactions. Moreover, the cross-reaction between phuk-waan-ban and latex can be confirmed by using IgE inhibition test. PMID:20524450

  14. Dystonic reaction associated with ondansetron administration in a patient with normal pressure hydrocephalus.

    PubMed

    Diaz-Parlet, Jay; Subramani, Sudhakar

    2015-08-01

    A 77-year-old female with normal pressure hydrocephalus underwent urgent revision of the abdominal component of a ventriculoperitoneal shunt. Upon emergence from an uneventful general anesthetic, the patient exhibited cogwheel rigidity with decerebrate posturing and a markedly irregular respiratory rate. This prohibited extubation and prompted an unplanned intensive care unit admission. Ondansetron was the only medication administered that had previously been associated with dystonic reactions. In a previous procedure, the patient had been given ondansetron without a similar reaction. This presentation may have been provoked by existing pathology such as her underlying normal pressure hydrocephalus and small increases in intracranial pressure. PMID:25935832

  15. Patient reactions to personalized medicine vignettes: An experimental design

    PubMed Central

    Butrick, Morgan; Roter, Debra; Kaphingst, Kimberly; Erby, Lori H.; Haywood, Carlton; Beach, Mary Catherine; Levy, Howard P.

    2011-01-01

    Purpose Translational investigation on personalized medicine is in its infancy. Exploratory studies reveal attitudinal barriers to “race-based medicine” and cautious optimism regarding genetically personalized medicine. This study describes patient responses to hypothetical conventional, race-based, or genetically personalized medicine prescriptions. Methods Three hundred eighty-seven participants (mean age = 47 years; 46% white) recruited from a Baltimore outpatient center were randomized to this vignette-based experimental study. They were asked to imagine a doctor diagnosing a condition and prescribing them one of three medications. The outcomes are emotional response to vignette, belief in vignette medication efficacy, experience of respect, trust in the vignette physician, and adherence intention. Results Race-based medicine vignettes were appraised more negatively than conventional vignettes across the board (Cohen’s d = ?0.51?0.57?0.64, P < 0.001). Participants rated genetically personalized comparably with conventional medicine (? 0.14?0.15?0.17, P = 0.47), with the exception of reduced adherence intention to genetically personalized medicine (Cohen’s d = ?0.38?0.41?0.44, P = 0.009). This relative reluctance to take genetically personalized medicine was pronounced for racial minorities (Cohen’s d =?0.38?0.31?0.25, P = 0.02) and was related to trust in the vignette physician (change in R2 = 0.23, P < 0.001). Conclusions This study demonstrates a relative reluctance to embrace personalized medicine technology, especially among racial minorities, and highlights enhancement of adherence through improved doctor-patient relationships. PMID:21270639

  16. Oscillococcinum leading to angioedema, a rare adverse event.

    PubMed

    Azmi, Yusra; Rao, Mana; Verma, Isha; Agrawal, Abhinav

    2015-01-01

    Oscillococcinum is an alternative medicine prepared by serial dilution of wild duck heart and liver extracts. This preparation has been labelled as a 'non drowsy, homoeopathic medicine' that 'reduces the duration and severity of flu and flu-like symptoms'. Clinical evidence exists to support this claim and the product has not previously been reported to cause any serious adverse drug reactions. We bring to light, however, a case of angioedema in our patient who was using oscillococcinum for flu-like symptoms. Consumers must therefore exercise caution at the outset of allergy symptoms. PMID:26038386

  17. Long-lasting allergic patch test reactions: a study of patients with positive standard patch tests.

    PubMed

    Mancuso, G; Berdondini, R M; Cavrini, G

    1999-07-01

    The purpose of this study was to determine the duration of patch test reactions and the frequency of long-lasting allergic patch test reactions (LLAPTR), and to identify the possible factors related to the development of the LLAPTR. For this purpose, a group of 263 patients positive to 1 or more allergens in the GIRDCA standard series was recruited. Readings were made for each patient 2 and 3 days after patch test application and continued every 2nd and 3rd day until the disappearance of all palpable erythema. The % of LLAPTR out of the total of reactions was high: 17.9%). Kathon CG was the hapten that caused LLAPTR most frequently, with 16 cases, a frequency of 76.1%), and a mean duration of the patch test reactions of 25.4 days. Risk factors investigated were age, sex, atopy, intensity of the patch test reaction and sensitivity to some allergens with the greatest number of positive patch tests. The relative importance of each risk factor was calculated by multivariate stepwise logistic regression analysis. It was found that a Kathon CG sensitivity was the most important risk factor for LLAPTR. 2nd was atopy, followed by strong patch test reaction. Rejected risk factors were sex, age and sensitivity to nickel sulfate, potassium dichromate, Disperse Blue 124, fragrance mix and p-phenylenediamine. PMID:10416706

  18. FUNGAL SPECIATION USING QUANTITATIVE POLYMERASE CHAIN REACTION (QPCR) IN PATIENTS WITH AND WITHOUT CHRONIC RHINOSINUSITIS

    EPA Science Inventory

    Objectives/Hypothesis: 1. to determine the mycology of the middle meatus using an endoscopically guided brush sampling technique and polymerase chain reaction laboratory processing of nasal mucous. 2. To compare the mycology of the middle meatus in patients with sinus disease to...

  19. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study

    Microsoft Academic Search

    Caroline Sabin; Rainer Weber; Peter Reiss; W. El-Sadr; Francois Dabis; Stephane De Wit; Matthew Law; N. Friis-Møller; Ole Kirk; Eric Fontas; Ian Weller; Andrew Phillips; Jens Lundgren

    2010-01-01

    BACKGROUND. The risk of myocardial infarction (MI) in patients with human immunodeficiency virus (HIV) infection has been assessed in 13 anti-HIV drugs in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. METHODS. Poisson regression models were adjusted for cardiovascular risk factors, cohort, calendar year, and use of other antiretroviral drugs and assessed the association between MI risk

  20. Fatal delayed transfusion reaction in a sickle cell anemia patient with Serratia marcescens sepsis.

    PubMed

    Seeyave, Desiree; Desai, Ninad; Miller, Scott; Rao, Sreedhar P; Piecuch, Steve

    2006-10-01

    Patients with sickle cell anemia may require repeated red cell transfusion, putting them at risk for minor blood group alloimmunization and the development of delayed hemolytic transfusion reactions. Although Streptococcus pneumoniae is the most common cause of life-threatening infection in patients with sickle cell anemia, those who have been recently hospitalized are at risk for infection with resistant hospital-associated organisms, and blood transfusion may put the patient at risk of infection with transfusion-associated organisms such as Serratia marcescens and Yersinic enterocolitica. We recently cared for an adolescent with sickle cell anemia who presented to the emergency department with a severe, delayed hemolytic transfusion reaction and Serratia marcescens infection. The patient had been discharged from the hospital five days previously, and had been transfused and treated with antibiotics while hospitalized. In addition to demonstrating the potential severity of delayed hemolytic transfusion reactions, our case illustrates the importance of providing relatively broad-spectrum antibiotic coverage to patients with sickle cell anemia and possible infection who have recently been hospitalized. PMID:17052065

  1. Fatal delayed transfusion reaction in a sickle cell anemia patient with Serratia marcescens sepsis.

    PubMed Central

    Seeyave, Desiree; Desai, Ninad; Miller, Scott; Rao, Sreedhar P.; Piecuch, Steve

    2006-01-01

    Patients with sickle cell anemia may require repeated red cell transfusion, putting them at risk for minor blood group alloimmunization and the development of delayed hemolytic transfusion reactions. Although Streptococcus pneumoniae is the most common cause of life-threatening infection in patients with sickle cell anemia, those who have been recently hospitalized are at risk for infection with resistant hospital-associated organisms, and blood transfusion may put the patient at risk of infection with transfusion-associated organisms such as Serratia marcescens and Yersinic enterocolitica. We recently cared for an adolescent with sickle cell anemia who presented to the emergency department with a severe, delayed hemolytic transfusion reaction and Serratia marcescens infection. The patient had been discharged from the hospital five days previously, and had been transfused and treated with antibiotics while hospitalized. In addition to demonstrating the potential severity of delayed hemolytic transfusion reactions, our case illustrates the importance of providing relatively broad-spectrum antibiotic coverage to patients with sickle cell anemia and possible infection who have recently been hospitalized. PMID:17052065

  2. Reactions of psychiatric patients to the Three Mile Island nuclear accident.

    PubMed

    Bromet, E; Schulberg, H C; Dunn, L

    1982-06-01

    The reaction of patients in the community mental health system to the nuclear accident at Three Mile Island (TMI), Middletown, Pa, were assessed. The sample was composed of 151 patients from the TMI area and 64 patients from a comparison site where a similar nuclear plant is located. Mental health status was determined for the period immediately after the accident, nine to ten months later, and one year later. No significant differences were found between the TMI group and the comparison group. To isolate risk factors within the TMI group, patients who were most distressed were compared with patients with the least distress. The results showed that quality of network support and viewing TMI as dangerous were significantly associated with mental health. PMID:7092506

  3. Opposite effects of sleep deprivation on the continuous reaction times in patients with liver cirrhosis and normal persons.

    PubMed

    Lauridsen, Mette Munk; Frøjk, Jesper; de Muckadell, Ove B Schaffalitzky; Vilstrup, Hendrik

    2014-09-01

    The continuous reaction times (CRT) method describes arousal functions. Reaction time instability in a patient with liver disease indicates covert hepatic encephalopathy (cHE). The effects of sleep deprivation are unknown although cirrhosis patients frequently suffer from sleep disorders. The aim of this study was to determine if sleep deprivation influences the CRT test. Eighteen cirrhosis patients and 27 healthy persons were tested when rested and after one night's sleep deprivation. The patients filled out validated sleep quality questionnaires. Seven patients (38%) had unstable reaction times (a CRTindex?patients, the wakefulness improved or normalized their reaction speed and CRTindex (p?=?0.01). There was no change in the other patients' reaction speed or stability. Seven patients (38%) reported poor sleep that was not related to their CRT tests before or after the sleep deprivation. In the healthy participants, the sleep deprivation slowed their reaction times by 11% (p?reaction time stability of the patients with a CRTindex below 1.9 and had no effect in the patients with a CRTindex above 1.9. There was no relation between reported sleep quality and reaction time results. Thus, in cirrhosis patients, sleep disturbances do not lead to 'falsely' slowed and unstable reaction times. In contrast, the acute sleep deprivation slowed and destabilized the reaction times of the healthy participants. This may have negative consequences for decision-making. PMID:25008562

  4. Is it Crohn's disease? A severe systemic granulomatous reaction to sulfasalazine in patient with rheumatoid arthritis

    PubMed Central

    Quallich, Leonard G; Greenson, Joel; Haftel, Hilary M; Fontana, Robert J

    2001-01-01

    Background Sulfasalazine is a widely used anti-inflammatory agent in the treatment of inflammatory bowel disease and several rheumatological disorders. Although as many as 20% of treated patients may experience reversible, dose-dependent side effects, less frequent but potentially severe, systemic reactions have also been reported. Case Presentation A severe systemic reaction to sulfasalazine developed in a 21-year old female with rheumatoid arthritis characterized by eosinophilia, granulomatous enteritis and myelotoxicity, cholestatic hepatitis, and seizures. The clinical course and management of this patient are presented as well as a review of the incidence and outcome of severe systemic reactions to sulfasalazine. Conclusions Granulomatous myelotoxicity and enteritis developed in a 21 year old female within 3 weeks of initiating sulfasalazine for rheumatoid arthritis. Following a short course of corticosteroids, the patient had resolution of her cholestatic hepatitis, rash, eosinophilia, and gastrointestinal symptoms with no residual manifestations at 7 months follow-up. Although severe reactions to sulfasalazine are rare and unpredictable, practicing physicians should be aware of unusual clinical presentations of toxicity when prescribing sulfasalazine. PMID:11570976

  5. Large-scale deployment of the Global Trigger Tool across a large hospital system: refinements for the characterisation of adverse events to support patient safety learning opportunities

    Microsoft Academic Search

    V S Good; M Saldaña; R Gilder; D Nicewander; D A Kennerly

    2011-01-01

    BackgroundThe Institute for Healthcare Improvement encourages use of the Global Trigger Tool to objectively determine and monitor adverse events (AEs).SettingBaylor Health Care System (BHCS) is an integrated healthcare delivery system in North Texas. The Global Trigger Tool was applied to BHCS's eight general acute care hospitals, two inpatient cardiovascular hospitals and two rehabilitation\\/long-term acute care hospitals.StrategyData were collected from a

  6. Pharmacotherapeutics for the AIDS Patient.

    ERIC Educational Resources Information Center

    Fife, Kenneth H.

    1991-01-01

    Anticipated shifts in the demographics of the Acquired Immune Deficiency Syndrome (AIDS) epidemic are examined, current state-of-the-art AIDS patient management is summarized, and some unique facets of drug therapy in the AIDS patient are discussed, including adverse reactions, complex drug interactions, use of investigational drugs, and…

  7. Detection of the cytomegalovirus by the polymerase chain reaction DNA amplification in a kidney transplanted patient.

    PubMed

    Ergazaki, M; Liloglou, T; Koffa, M; Kostakis, A; Haliassos, A; Spandidos, D A

    1993-01-01

    Cytomegalovirus injection is common in kidney transplanted patients. Viremia is the only marker of active CMV infection, but the use of cell culture for the direct detection of the virus is time-consuming and not very sensitive, while the detection of CMV by measuring the titre of antibodies is difficult due to the immunosuppression these patients undergo. Thus the ability to amplify CMV DNA by the polymerase chain reaction from blood or urine samples of the patients becomes a valuable diagnostic tool for the detection of CMV in the early stages of the infection. Using a set of primers specific for the amplification of a 435 bp region of the IE-1 gene, we detected CMV DNA in blood leucocytes of a kidney transplanted patient who received the transplant from a CMV-seropositive donor, 45 days after the operation, while the antibody titre showed no evidence of active CMV infection. PMID:8193272

  8. Identification of a 27 kDa protein in patients with anaphylactic reactions to mango.

    PubMed

    Renner, R; Hipler, C; Treudler, R; Harth, W; Süss, A; Simon, J C

    2008-01-01

    Mango fruit has become increasingly popular in recent years. We report on 2 patients who developed anaphylactic reactions after the ingestion of fresh mango. Allergy to mango was confirmed by a positive skin prick test result and positive cellular allergen stimulation test results. Neither of the patients had detectable mango-specific immunoglobulin (Ig) E levels. Results were validated by sodium dodecyl sulfate polyacrylamide gel electrophoresis immunoblotting and analyzed using Quantiscan.We identified 2 major allergens with a molecular weight of 27 kDa in both patients, in addition to a 15 kDa allergen in 1 patient and a 32 kDa allergen in the other. Currently available IgE systems seem to be lacking these mango allergens and as such are probably unsuitable for diagnosing type 1 sensitization to mango. Skin prick testing with fresh mango fruit therefore seems to be a much more reliable test method for clinical practice. PMID:19123442

  9. Increased risk of adverse events when changing intravenous immunoglobulin preparations

    PubMed Central

    AMERATUNGA, R; SINCLAIR, J; KOLBE, J

    2004-01-01

    Intravenous immunoglobulin (IVIG) therapy has represented a major advance in the treatment of patients with primary immune deficiency disorders. In September 2000 a new IVIG formulation, Intragam P, was introduced into clinical use. Intragam P is prepared by delipidation of pooled plasma followed by an ion exchange chromatography step to eliminate immunoglobulin aggregates. It is then pasteurized for 10 h at 60°C for viral inactivation before storage at pH 4·25 in 10% maltose. We report initial clinical experience with this new preparation. The details of adverse reactions of patients who received the new preparation were gathered shortly after it became apparent there was a change in IVIG formulation. Seven of 49 patients receiving Intragam P spontaneously reported adverse effects, which were temporally related to infusions. Subsequently, all seven patients have been able to tolerate the product with prophylactic use of antihistamines and paracetamol. This case series indicates that long-term tolerance of an older IVIG product does not necessarily equate to tolerance to a newer product, even if technically superior. Caution should be exercised when changing IVIG products, as they are not biologically equivalent. PMID:15030521

  10. Acute radiation reaction and local control in breast cancer patients treated with postmastectomy radiotherapy

    Microsoft Academic Search

    Thomas Kuhnt; Christine Richter; Helmut Enke; Jürgen Dunst

    1998-01-01

    Background  We have investigated the variation of acute radiation reactions in medium-risk patients with postmastectomy radiotherapy with\\u000a regard to a possible correlation between radiation oeaction of normal tissues and local tumor control.\\u000a \\u000a \\u000a \\u000a Material and Methods  From 1985 through 1991, a total number of 194 patients received postmastectomy radiotherapy for breast cancer pT1-2pN0-2M0\\u000a at the University of Halle-Wittenberg. The lymphatics were irradiated by

  11. [Group allergies and multiple reactions in patients with allergy to hydroxyquinoline derivatives].

    PubMed

    Pevny, I; Hutzler, D

    1988-01-01

    We carried out patch testing with a chinoline block comprising 25 substances in 316 patients with a suspected allergy to chinoline derivatives in the period from February 1969 to December 1983. 110 patients reacted to 2 or more substances. The reactions were totaled and tabulated in a list indicating frequency of sensitisation as decreasing in the order of Cl-F-Br-I halogens. The most frequent reactions observed were with Chlorisept, Sterosan, Vio-form, Chinosol, Ondron, and Broxychinolin, for all of which primary sensitisations are also possible. Concomitant reactions to chinaldol, chinaldine, aminochinaldine and chinoline are considered to be group allergies since contact is hardly possible with these substances in everyday life. Due to the lack of appropriate history, reactions to Resochin and the isoquinoline compounds Papaverine and Eupaverine may also be regarded as group allergies. Accordingly, non-hydroxylized chinoline derivatives are also viewed as group allergies in cases of sensitisation to hydroxy-chinoline derivatives. The group spectrum of hydroxy-chinoline allergy seems to be more far-reaching than was assumed. Five cases of a quinine allergy identified by appropriate history and confirmed epicutaneously are presented with a group allergy to various chinoline derivatives, including two cases with quinidine. PMID:2970377

  12. Evaluation of Systemic Provocation Tests in Patients with Suspected Allergic and Pseudoallergic Drug Reactions

    Microsoft Academic Search

    ULRICH R. HEIN; SIBYLLA CHANTRAINE-HESS; MARGITTA WORM; TORSTEN ZUBERBIER; BEATE M. HENZ

    1999-01-01

    In order to examine the diagnostic value of systemic provoca- tion tests, we studied 56 inpatients hospitalized for identi¢ca- tion of the agent eliciting previous severe allergic or pseudoallergic reactions to non-steroidal anti-in£ammatory drugs, local anaesthetics or antibiotics. Skin tests were posi- tive in only 4 patients reacting to antibiotics and propyphena- zone and were always negative for local anaesthetics

  13. Urticaria and angiedema-like skin reactions in a patient treated with adalimumab

    Microsoft Academic Search

    S. N. Nikas; P. V. Voulgari; A. A. Drosos

    2007-01-01

    Specific inhibition of the cytokine tumor necrosis factor alpha has resulted in significant clinical and laboratory improvement\\u000a of patients with chronic inflammatory diseases of Th1 phenotype. Etanercept is a recombinant fusion protein of two p75 soluble\\u000a receptors, while infliximab is a chimeric monoclonal antibody. Both have been considered to be immunogenic and cause various\\u000a immune-mediated skin reactions. On the other

  14. Drug-induced skin reactions: a 2-year study

    PubMed Central

    Farshchian, Mahmood; Ansar, Akram; Zamanian, Abbas; Rahmatpour-Rokni, Ghasem; Kimyai-Asadi, Arash; Farshchian, Mehdi

    2015-01-01

    Background The aim of this study was to analyze the clinical characteristics of patients with adverse cutaneous drug reactions, which occur when a medicinal product results in cutaneous morbidity. Methods The study included 308 patients who were diagnosed as having an adverse cutaneous drug reaction during the study period (2007–2009). In 84 cases, histopathologic examination of skin biopsies were also performed. Results Patients with drug reactions were found to be more commonly female (63%) than male (37%). Beta-lactam antibiotics were found to be the most frequent cause of adverse cutaneous drug reactions (42.7%), followed by non-steroidal anti-inflammatory drugs (16.5%). Acute urticaria was the most common clinical presentation (59.2%) followed by fixed drug eruptions (18.5%), and maculopapular eruptions (14.9%). Conclusion Adverse cutaneous drug reactions in our study population were mainly induced by beta-lactam antibiotics and non-steroidal anti-inflammatory drugs. The most common forms of cutaneous adverse drug reactions were found to be acute urticaria, fixed drug eruptions, and maculopapular rashes. PMID:25709487

  15. Minimizing perioperative adverse events in the elderlydagger

    Microsoft Academic Search

    F. Jin; F. Chung

    2001-01-01

    Elderly patients still have the highest postoperative mortality and morbidity rate in the adult surgical population. Preoperative clinical assessment to detect patients at high risk of post- operative events, and specific intraoperative and postoperative anaesthesia management are important to minimize postoperative adverse events in the elderly. Br J Anaesth 2001; 87: 608-24

  16. Polymerase chain reaction-based active surveillance of MRSA in emergency department patients

    PubMed Central

    Seki, Masafumi; Takahashi, Hiroki; Yamamoto, Norihisa; Hamaguchi, Shigeto; Ojima, Masahiro; Hirose, Tomoya; Yoshiya, Kazuhisa; Ogura, Hiroshi; Shimazu, Takeshi; Tomono, Kazunori

    2015-01-01

    Conventional culture methods to detect methicillin-resistant Staphylococcus aureus (MRSA) take a few days, and their sensitivity and usefulness also need to be improved. In this study, active screening was performed using the polymerase chain reaction (PCR) for colonization with MRSA on admission and follow-up surveillance after admission to an emergency department between June 2012 and August 2012, and the backgrounds of PCR and/or culture-method-positive patients were compared. Among 95 patients, 15 (15.8%) patients were positive for MRSA on PCR and/or culture; 6.3% (6/95) of patients were positive on admission, and 9.5% (9/95) became positive during the stay after admission. The major primary diagnoses in MRSA-positive patients were trauma and cerebrovascular diseases. Nine (60%) of 15 patients were MRSA-positive on both PCR and culture, compared with three (20%) of 15 who were PCR-positive but culture-negative. The other three (20%) of 15 patients were PCR-negative but culture-positive. Furthermore, there was a tendency for younger age and shorter stay to be associated with PCR-positive but culture-negative results. These findings suggest that active surveillance with PCR may be highly sensitive and useful for the early diagnosis of MRSA colonization to prevent nosocomial transmission from the emergency department to the regular inpatient wards of the hospital. PMID:25999747

  17. Recovery of visual fields in brain-lesioned patients by reaction perimetry treatment

    PubMed Central

    Schmielau, Fritz; Wong, Edward K

    2007-01-01

    Background The efficacy of treatment in hemianopic patients to restore missing vision is controversial. So far, successful techniques require laborious stimulus presentation or restrict improvements to selected visual field areas. Due to the large number of brain-damaged patients suffering from visual field defects, there is a need for an efficient automated treatment of the total visual field. Methods A customized treatment was developed for the reaction perimeter, permitting a time-saving adaptive-stimulus presentation under conditions of maximum attention. Twenty hemianopic patients, without visual neglect, were treated twice weekly for an average of 8.2 months starting 24.2 months after the insult. Each treatment session averaged 45 min in duration. Results In 17 out of 20 patients a significant and stable increase of the visual field size (average 11.3° ± 8.1) was observed as well as improvement of the detection rate in the defective visual field (average 18.6% ± 13.5). A two-factor cluster analysis demonstrated that binocular treatment was in general more effective in augmenting the visual detection rate than monocular. Four out of five patients with a visual field increase larger than 10° suffered from hemorrhage, whereas all seven patients with an increase of 5° or less suffered from infarction. Most patients reported that visual field restoration correlated with improvement of visual-related activities of daily living. Conclusion Rehabilitation treatment with the Lubeck Reaction Perimeter is a new and efficient method to restore part of the visual field in hemianopia. Since successful transfer of treatment effects to the occluded eye is achieved under monocular treatment conditions, it is hypothesized that the damaged visual cortex itself is the structure in which recovery takes place. PMID:17705848

  18. New drugs: watch out for unexpected adverse effects.

    PubMed

    2002-10-01

    (1) Some serious adverse drug reactions only emerge once a drug has been released on to the market. (2) 10% of the new drugs marketed in the United States over the last 25 years were subsequently withdrawn or were the subject of major warnings about serious or life-threatening side effects. The number of patients affected is unknown. (3) Patients must not be placed at risk because doctors prescribe a new drug when a reliable alternative is available or when the condition treated is mild. (4) Prevention should be based on improved quality of clinical trials and on upgraded procedures for marketing approval. Other measures include encouraging the correct use of recently marketed drugs; closer monitoring of these drugs; better notification of side effects; and improved quality and transparency of pharmacovigilance data. PMID:12378747

  19. Sensitization and cross-reaction patterns in Danish Compositae-allergic patients.

    PubMed

    Paulsen, E; Andersen, K E; Hausen, B M

    2001-10-01

    Results of aimed patch testing with constituents of sesquiterpene lactone (SL) mix, Compositae mix (CM) and other Compositae extracts and allergens in 190 Compositae-allergic patients detected in an 8-year period are presented. Feverfew of CM elicited positive reactions most frequently, followed by tansy, wild chamomile, yarrow and arnica, whereas dehydrocostus lactone of SL was the most frequent elicitor of positive reactions, followed by alantolactone and costunolide. Chrysanthemum (Dendranthema) and marguerite (Argyranthemum frutescens) were the most important suspected sensitizers in both occupationally and nonoccupationally exposed, and cross-reactions between chrysanthemum and feverfew/tansy/chamomile may partly explain the high prevalence of positive reactions to the 3 last mentioned. In the nonoccupationally sensitized group, garden plants such as feverfew, blanket flower (Gaillardia), elecampane (Inula helenium), large yellow ox-eye (Telekia speciosa) and cosmea (Cosmos) were additional important allergenic plants. The 3 last mentioned were picked up by SL mix. Most of the lettuce-sensitized persons were CM-positive. 19% of the occupationally sensitized group were negative to both SL and CM, making very aimed patch testing necessary, notably when suspecting rare sensitizers such as Gerbera and star of the veldt (Osteospermum). The significance of the weeds dandelion, dog fennel and ox-eye daisy as sensitizers is not clarified, but they are probably less important than cultivated plants. PMID:11683829

  20. Impact of diabetes on hospital adverse cardiovascular outcomes in acute coronary syndrome patients: Data from the Saudi project of acute coronary events

    PubMed Central

    AlNemer, Khalid A.; AlFaleh, Hussam F.; AlHabib, Khalid F.; Ullah, Anhar; Hersi, Ahmad; AlSaif, Shukri; Taraben, Amir; Hussein, Gamal; Butt, Modather

    2012-01-01

    Background Diabetes mellitus (DM) is a major public health problem in Saudi Arabia. DM patients who present with acute coronary syndrome (ACS) have worse cardiovascular outcomes. We characterized clinical features and hospital outcomes of diabetic patients with ACS in Saudi Arabia. Methods ACS patients enrolled in the Saudi Project for Assessment of Acute Coronary Syndrome (SPACE) study from December 2005 to December 2007, either with DM or newly diagnosed during hospitalization were eligible. Baseline demographics, clinical presentation, therapies, and in-hospital outcomes were compared with non-diabetic patients. Results Of the 5055 ACS patients enrolled in SPACE, 2929 (58.1%) had DM (mean age 60.2 ± 11.5, 71.6% male, and 87.6% Saudi nationals). Diabetic patients had higher risk-factor (e.g., hypertension, hyperlipidemia) prevalences and were more likely to present with non–ST-elevation myocardial infarction (40.2% vs. 31.4%, p < 0.001), heart failure (25.4% vs. 13.9%, p < 0.001), significant left ventricular systolic dysfunction and multi-vessel disease. Diabetic patients had higher in-hospital heart failure, cardiogenic shock, and re-infarction rates. Adjusted odds ratio for in-hospital mortality in diabetic patients was 1.83 (95% CI, 1.02–3.30, p = 0.042). Conclusions A substantial proportion of Saudi patients presenting with ACS have DM and a significantly worse prognosis. These data highlight the importance of cardiovascular preventative interventions in the general population. PMID:24174830

  1. An analysis of skin prick test reactions in 656 asthmatic patients.

    PubMed Central

    Hendrick, D J; Davies, R J; D'Souza, M F; Pepys, J

    1975-01-01

    Of 656 asthmatic patients referred specifically for allergy assessments, 544 (84 percent) gave positive immediate skin prick tests to at least one of 22 common allergens used routinely. Comparison of these skin test positive patients with the 102 (16 percent) who were skin test negative showed a number of significant differences. The majority of the skin test positive patients (52 percent) were less than 10 years old at the time of onset of the asthma, whereas, of the skin test negative patients, 56 percent were aged over 30 years at the time of onset. Seventy per cent report rhinitis compared with 48 per cent of the skin test negative patients, and 29 per cent reported infantile eczema compared with 9 per cent. Symptoms attributed to house dust, pollens, and animals were noted two to three times more frequently by the skin test positive patients, while corticosteroid drugs had been used more commonly by the skin test negative patients (45 percent compared with 35 percent). No significant differences were observed with the other factors studied, namely, history of urticaria or angio-oedema, family history of "allergic" disease, and awareness of sensitivity to foods, aspirin or penicillin. Prick test reactions in the skin test positive patients were most commonly seen to house dust or the acarine mite, Dermatophagoides farinae (82 percent), followed by pollens (66 percent), animal danders (38 percent), foods (16 percent), Aspergillus fumigatus (16 percent), and other moulds (21 percent). There was a highly significant association of positive history with positive prick test for all allergens studied. Images PMID:1168378

  2. Analysis of Vertical Ground Reaction Force Variables Using Foot Scans in Hemiplegic Patients

    PubMed Central

    Kim, Hyun Dong; Jeon, Dong-Min; Shin, Min-Ha; Han, Nami; Eom, Mi-Ja; Jo, Geun-Yeol

    2015-01-01

    Objective To analyze the differences in the vertical ground reaction force (GRF) variables of hemiplegic patients compared with a control group, and between the affected and unaffected limbs of hemiplegic patients using foot scans. Methods Patients (n=20) with hemiplegia and healthy volunteers (n=20) underwent vertical force analysis. We measured the following: the first and second peak forces (F1, F2) and the percent stances at which they occurred (T1, T2); the vertical force impulse (VFI) and stance times. The GRF results were compared between the hemiplegic patients and control individuals, and between the affected and unaffected limbs of hemiplegic patients. Additionally, we analyzed the impulse of the unaffected limb according to the motor assessment scale (MAS), Brunnstrom stage, and a Timed Up and Go Test. Results The F1s and F2s of the affected and unaffected limbs were significantly less than those of the normal control individuals (p<0.05). The T1s of both the affected and unaffected limbs of the patients were greater than control individuals, whilst the T2s were lower (p<0.05). Greater impulses and stance times were recorded on both sides of the patients than in the limbs of the control individuals (p<0.05). The MAS, Brunnstrom stage and Timed Up and Go Test results were significantly correlated with the VFI of the unaffected limbs (p<0.05). Conclusion The high impulse values of the unaffected limb were associated with complications during gait rehabilitation. Therefore, these results suggest that unaffected limbs should also be taken into consideration in these patients. PMID:26161347

  3. Isn't This Just Bedtime Snacking?: The potential adverse effects of night-eating symptoms on treatment adherence and outcomes in patients with diabetes

    Microsoft Academic Search

    SHEREEN A. MORSE; PAUL S. CIECHANOWSKI; WAYNE J. KATON; IRL B. HIRSCH

    2006-01-01

    OBJECTIVE — Night-eating syndrome is characterized by excessive eating in the evening and nocturnal awakening with ingestion of food. Psychosocial variables and emotional triggers may be associated with these behaviors. In patients with diabetes, such behaviors may lead to glucose dysregulation and contribute to obesity and complications. RESEARCH DESIGN AND METHODS — In 714 tertiary care patients with type 1

  4. Simple and choice reaction time in patients with human immunodeficiency virus infection.

    PubMed

    Perdices, M; Cooper, D A

    1989-05-01

    The performance of 56 homosexual men infected with human immunodeficiency virus (HIV) was compared to that of 23 HIV antibody-seronegative controls on simple (SRT) and choice (CRT) reaction time tasks. Patients were classified into 3 groups according to Centers for Disease Control clinical criteria. There were 18 patients who had acquired immunodeficiency syndrome (AIDS), 18 who had AIDS-related complex (ARC), and 20 who were HIV antibody-seropositive but otherwise asymptomatic (HIV-Ab+). The SRT task consisted of 5 trials, each containing 10 target stimuli. The CRT task consisted of 10 trials, each containing 5 target stimuli randomly interspersed with 5 nontarget stimuli. The mean response latency of each of the patient groups on the SRT task was not significantly different from that of controls. However, the performance of patients with AIDS or ARC on the CRT task was significantly lower than that of controls, whereas that of HIV-Ab+ patients was not. Analysis of the quality of RT task performance also indicated that the impairment of processing efficiency at higher levels of task difficulty reflected a disruption of processing prior to the response selection stage. PMID:2774486

  5. [Alternative diagnoses among suspected herpes simplex encephalitis patients with negative polymerase chain reaction].

    PubMed

    Domingues, R B; Pannuti, C S; Fink, M C; Tsanaclis, A M

    2000-12-01

    The aim of this study was to analyze the diagnosis found in a series of patients in which the diagnosis of Herpes simplex encephalitis (HSE) was ruled out by a negative polymerase chain reaction (PCR) result for HSV DNA in cerebrospinal fluid (CSF) samples. Forty three out of 61 HSE suspected patients had negative PCR. An alternative diagnosis was established in 41.9% of these patients. These patients were diagnosed as having viral (2 cases-11.1%) and non viral (5 cases-27.2%) CNS infections, vascular (4 cases-22.2%) and demyelinating diseases (3 cases-16.7%), metabolic disturbances (3 cases-16.7%), and CNS tumor (1 case-5.6%). The non specific clinical presentation of this disease and the availability of an efficient treatment for HSE explain why several patients with other diseases were initially treated with acyclovir. The early use of PCR in CSF was considered essential for the evaluation of the acute encephalitis cases in this study. PMID:11105075

  6. [Complications, adverse events and errors in medical treatment with the emphasis on transfusion treatment with blood components].

    PubMed

    Grgicevi?, Damir; Cikes, Nada

    2006-06-01

    Adverse events and errors are relatively frequent in patients treatment and occur in all medical departments. In most cases they do not cause medical complications and they are seldom the cause of serious reactions and patients morbidity or mortality. Although adverse events and errors are almost always brought about by individual persons, their cause in the majority of cases is inadequate organization or bad working conditions. The frequency and serious consequences of errors and adverse events were not recognized until to the recent past and they were not analyzed enough mostly due to subjective or organizational reasons. The patient has to be informed about the error that has caused damage or harmed him. The decrease of harm done by errors and adverse reactions and their prevention can be achieved only by an organizational change with the introduction of quality management, specifically risk management, and the acceptance of the culture of quality and open dialogue by all. The errors that have already been made should be used for the improvement of health service and the patient's benefit. Full truth and genuine sincerity are the prerequisites for the protection against legal proceedings. PMID:16933830

  7. Detection of Borrelia burgdorferi in patients with Lyme disease by the polymerase chain reaction.

    PubMed Central

    Guy, E C; Stanek, G

    1991-01-01

    Borrelia burgdorferi, the causative agent of Lyme disease, was detected in patients' serum by DNA amplification using the polymerase chain reaction (PCR). B burgdorferi was pelleted from serum samples by centrifugation (10,000 x g for 10 minutes) and lysed by treatment with ammonium hydroxide (100 degrees C for 15 minutes). Two pairs of "nested" PCR primers complementary to the gene encoding a major outer surface protein (OSP A) of B burgdorferi were used in DNA amplification under standard PCR conditions (Perkin-Elmer Cetus). Two out of five patients with erythema migrans, the characteristic primary skin lesion associated with early Lyme disease, were positive by the PCR. This method could form the basis of a useful routine laboratory test in those cases of early Lyme disease where conventional serological testing commonly yields equivocal or false negative results. PMID:1856296

  8. Probabilistic learning and reversal deficits in patients with Parkinson's disease or frontal or temporal lobe lesions: possible adverse effects of dopaminergic medication.

    PubMed

    Swainson, R; Rogers, R D; Sahakian, B J; Summers, B A; Polkey, C E; Robbins, T W

    2000-01-01

    Three groups of patients with Parkinson's disease (PD) - mild, unmedicated (UPD), mild, medicated (MPD) and severe, medicated (SPD) - and patients with lesions of the frontal lobe (FLL) or temporal lobe (TLL) were compared with matched controls on the learning and reversal of probabilistic and two-pair concurrent colour discriminations. Both of the cortical lesion groups showed reversal deficits, with no increase in perseverative responding. The UPD group, although impaired on a spatial recognition task, showed intact discrimination learning and reversal; the MPD and SPD patients showed non-perseverative reversal impairments on both reversal tasks. Two hypotheses - based on disease severity and possible deleterious effects of medication - are offered to explain the reversal impairments of the PD patients and the results are discussed in terms of the role of dopamine in reward-based learning. PMID:10689037

  9. Tracing of Helicobacter Pylori in Patients of Otitis Media with Effusion by Polymerase Chain Reaction

    PubMed Central

    Shishegar, Mahmood; Motamedi-Far, Mohammad; Hashemi, Seyed Basir; Bigham-Sadegh, Abbas; Emami, Amir

    2015-01-01

    Otitis media with effusion (OME) is one of the most common causes of hearing loss (HL) in children. It has been reported that several factors such as eustachian tube dysfunction, insufficiencies in the aeration of the mastoid cells, allergies, immunity, and infections play an important role in the etiology of the disease. Little is known about the role of Helicobacter pylori (H. pylori) in extragastric diseases. Because of the near location of the nose, sinuses, tonsils, and adenoids to the eustachian tube and middle ear, we believe it is possible to have H. pylori in the middle ear. The present study was designed to investigate the presence of H. pylori by polymerase chain reaction (PCR) in the middle ear effusion of patients with OME. The study was performed on 21 patients, 19 patients were affected bilaterally, and 2 patients were affected unilaterally, from which 40 specimens were collected. OME was diagnosed through findings by otoscopic examination and tympanogram. The middle ear fluid samples were collected under sterile conditions. A total of 40 samples was stored at -80°C until analyzed by PCR assay. From 40 specimens, 2 specimens were serosal and 38 specimens were mucoid. PCR results of the study in assays for Helicobacter pylori were not positive in all collected specimens. Overall, probably there was no H. pylori organism in free-floating form and thus could not be detected by PCR. PMID:25999629

  10. Endoscopic retrograde cholangiopancreatography-related adverse events: general overview.

    PubMed

    Rustagi, Tarun; Jamidar, Priya A

    2015-01-01

    Endoscopic retrograde cholangiopancreatography (ERCP) represents a monumental advance in the management of patients with pancreaticobiliary diseases, but is a complex and technically demanding procedure with the highest inherent risk of adverse events of all routine endoscopic procedures. Overall adverse event rates for ERCP are typically reported as 5-10%. The most commonly reported adverse events include post-ERCP pancreatitis, bleeding, perforation, infection (cholangitis), and cardiopulomary or "sedation related" events. This article evaluates patient-related and procedure-related risk factors for ERCP-related adverse events, and discusses strategies for the prevention, diagnosis and management of these events. PMID:25442961

  11. SMARTS (Systematic Monitoring of Adverse events Related to TreatmentS): The development of a pragmatic patient-completed checklist to assess antipsychotic drug side effects

    PubMed Central

    Fleischhacker, W Wolfgang; Peuskens, Joseph; Cavallaro, Roberto; Lean, Michael EJ; Morozova, Margarita; Reynolds, Gavin; Azorin, Jean-Michel; Thomas, Pierre; Möller, Hans-Jürgen

    2014-01-01

    Objectives: Antipsychotic drug side effects are common and can cause stigmatisation, decreased quality of life, poor adherence, and secondary morbidity and mortality. Systematic assessment of anticipated side effects is recommended as part of good clinical care, but is uncommon in practice and patients may not spontaneously report side effects. We aimed to develop a simple patient-completed checklist to screen systematically for potential antipsychotic side effects. Methods: The SMARTS checklist was developed over a series of group meetings by an international faculty of 12 experts (including psychiatrists, a general physician and a psychopharmacologist) based on their clinical experience and knowledge of the literature. The emphasis is on tolerability (i.e. assessment of side effects that ‘trouble’ the patient) as subjective impact of side effects is most relevant to medication adherence. The development took account of feedback from practising psychiatrists in Europe, the Middle East and Africa, a process that contributed to face validity. Results: The SMARTS checklist assesses whether patients are currently ‘troubled’ by 11 well-established potential antipsychotic side effects. Patients provide their responses to these questions by circling relevant side effects. An additional open question enquires about any other possible side effects. The checklist has been translated into Italian and Turkish. Conclusions: The SMARTS checklist aims to strike a balance between brevity and capturing the most common and important antipsychotic side effects. It is appropriate for completion by patients prior to a clinical consultation, for example, in the waiting room. It can then form the focus for a more detailed clinical discussion about side effects. It can be used alone or form part of a more comprehensive assessment of antipsychotic side effects including blood tests and a physical examination when appropriate. The checklist assesses current problems and can be used longitudinally to assess change. PMID:24490026

  12. Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial

    PubMed Central

    2010-01-01

    Background Neck pain of a mechanical nature is a common complaint seen by practitioners of manual medicine, who use a multitude of methods to treat the condition. It is not known, however, if any of these methods are superior in treatment effectiveness. This trial was stopped due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, (2) to report on the data obtained from subjects who completed the study, (3) to discuss the problems we encountered in conducting this study. Methods A pragmatic randomised clinical trial was undertaken. Patients who met eligibility criteria were randomised into three groups. One group was treated using specific segmental high velocity low amplitude manipulation (diversified), another by specific segmental mobilisation, and a third group by the Activator instrument. All three groups were also treated for any myofascial distortions and given appropriate exercises and advice. Participants were treated six times over a three-week period or until they reported being pain free. The primary outcome measure for the study was Patient Global Impression of Change (PGIC); secondary outcome measures included the Short-Form Health Survey (SF-36v2), the neck Bournemouth Questionnaire, and the numerical rating scale for pain intensity. Participants also kept a diary of any pain medication taken and noted any perceived adverse effects of treatment. Outcomes were measured at four points: end of treatment, and 3, 6, and 12 months thereafter. Results Between January 2007 and March 2008, 123 patients were assessed for eligibility, of these 47 were considered eligible, of which 16 were allocated to manipulation, 16 to the Activator instrument and 15 to the mobilisation group. Comparison between the groups on the PGIC adjusted for baseline covariants did not show a significant difference for any of the endpoints. Within group analyses for change from baseline to the 12-month follow up for secondary outcomes were significant for all groups on the Bournemouth Questionnaire and for pain, while the mobilisation group had a significant improvement on the PCS and MCS subscales of the SF-36v2. Finally, there were no moderate, severe, or long-lasting adverse effects reported by any participant in any group. Conclusions Although the small sample size must be taken into consideration, it appears that all three methods of treating mechanical neck pain had a long-term benefit for subacute neck pain, without moderate or serious adverse events associated with any of the treatment methods. There were difficulties in recruiting subjects to this trial. This pragmatic trial should be repeated with a larger sample size. PMID:20618936

  13. Osteonecrosis of the jaw as an adverse bisphosphonate event: Three cases of bone metastatic prostate cancer patients treated with zoledronic acid

    Microsoft Academic Search

    Jose Angel; García Sáenz; Sara López Tarruella; Beatriz García Paredes; Laura Rodríguez Lajusticia; Laura Villalobos; Eduardo Díaz Rubio; José Ángel García-Sáenz

    Bisphosphonates offer a significant improvement in the quality of life for cancer patients; these potent inhibitors of bone resorption have been shown to markedly reduce the morbidity frequently resulting from bone metastases. Despite the success of bisphosphonates as therapeutic agents, however, toxicity in the form of osteonecrosis of the jaw (ONJ) is a rare complication whose incidence rate has climbed

  14. Psychometric properties of a modified version of the Caregiver Reaction Assessment Scale measuring caregiving and post-caregiving reactions of caregivers of cancer patients.

    PubMed

    Bachner, Yaacov G; O'Rourke, Norm; Carmel, Sara

    2007-01-01

    Most care received by cancer patients is provided in the community by informal or unpaid caregivers. The unrelenting care demands can lead to physical, emotional, social, and financial reactions; furthermore, studies indicate that the effects of caregiving may endure after the patient's death. A need therefore exists for instruments measuring both caregiving and post-caregiving reactions. Among available instruments, the Caregiver Reaction Assessment (CRA) is a multidimensional, 5-factor measure designed to assess the negative and positive aspects of caregiving. The current study examined the psychometric properties and factor structure of responses to a modified Hebrew version of the CRA aimed at measuring caregiving and post-caregiving reactions. Although the scale was modified, it was assumed that, similar to the original CRA, a 5-factor structure would be supported by means of confirmatory factor analysis. A total of 236 bereaved primary caregivers of cancer patients from central and southern regions of Israel were recruited over a period of 18 months. As hypothesized, results provide support for a 5-factor structure of responses to this modified version of the CRA. The concurrent validity of responses to the scale was also supported. Replication of the findings with randomly derived and larger sample sizes is needed. PMID:17853843

  15. Adverse effects and drug interactions of clinical importance with antiviral drugs.

    PubMed

    Morris, D J

    1994-04-01

    Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclovir). Their adverse effects mostly involve bone marrow depression (e.g. granulocytopenia with ganciclovir, anaemia with zidovudine) or neurotoxicity (e.g. seizures with interferon-alpha, peripheral neuropathy with zalcitabine), although gastrointestinal effects are also seen. Idiosyncratic reactions include didanosine-induced acute pancreatitis. Only inosine pranobex is largely free from toxicity. Idoxuridine must be administered topically, given the severity of its systemic adverse effects. Drug interactions involving antiviral agents mostly reflect shared toxicity with other agents (e.g. neutropenia with ganciclovir and zidovudine, pancreatitis with didanosine and alcohol), although renal excretion or hepatic metabolism may be implicated. Given the possibility of severe adverse reactions and drug interactions, antiviral chemotherapy should only be used for potentially serious virus infections. Topical administration avoids systemic adverse effects but not mutagenic risks, and may result in exposure of individuals other than the patient (e.g. aerosolised ribavirin). PMID:8018300

  16. Factors influencing polymerase chain reaction outcomes in patients with clinically suspected ocular tuberculosis

    PubMed Central

    2014-01-01

    Background Polymerase chain reaction (PCR) assay can be a useful method for definitive diagnosis in paucibacillary infections such as ocular tuberculosis (TB). In this study, we have evaluated factors affecting PCR outcomes in patients with clinically suspected ocular TB. Patients with clinically suspected ocular TB were investigated by PCR of aqueous or vitreous samples. Three control groups were also tested: group 1 included culture-proven non-tuberculous endophthalmitis, group 2 culture-negative non-tuberculous endophthalmitis, and group 3 patients undergoing surgery for uncomplicated cataract. PCR targeted one or more of following targets: IS6110, MPB64, and protein b genes of Mycobacterium tuberculosis complex. Multiple regression analysis (5% level of significance) was done to evaluate the associations between positive PCR outcome and laterality of disease, tuberculin skin test (TST)/interferon-gamma release assay (IGRA), chest radiography, and type of sample (aqueous or vitreous). The main outcome measures were positive PCR by one or more gene targets, and factors influencing positive PCR outcomes. Results All 114 samples were tested for MPB64, 110 for protein b, and 88 for IS6110. MPB64 was positive in 70.2% (n?=?80) of tested samples, protein b in 40.0% (n?=?44), and IS6110 in only 9.1% (n?=?8). DNA sequencing of amplicons from four randomly chosen PCR reactions showed homology for M. tuberculosis complex. Of the 80 PCR-positive patients, 71 completed a full course of antitubercular therapy, of which 65 patients (91.5%) had complete resolution of inflammation at final follow-up. Among controls, 12.5% (3 out of 24) in group 1 and 18.7% (6 out of 32) in group 2 also tested positive by PCR. No PCR-positive outcome was observed in control group 3 (n?=?25). Multiple regression analysis revealed significant association of positive PCR outcome with bilateral presentation, but not with a positive TST/IGRA, chest radiography, or type of sample (aqueous/vitreous) used. Conclusions Careful selection of gene targets can yield high PCR positivity in clinically suspected ocular TB. Bilateral disease presentation but not any evidence of latent systemic TB influences PCR outcomes. False-positive results may be seen in ocular inflammation unrelated to ocular TB. PMID:24661354

  17. [Delayed hemolytic transfusion reaction in sicle cell disease patients: a new challenge for the Hemovigilance network].

    PubMed

    Rieux, C; De Meyer, E; Boudjedir, K

    2015-03-01

    Delayed hemolytic reaction transfusion in patients with sickle cell disease (SCD) is a serious and still under diagnosed event. Clinical and biological presentation mimics an acute SCD complication. It is a life-threatening event, especially in hyperhemolysis syndrome (HS) characterized by a massive destruction of both the donor's and patient's red blood cells. The main cause is related to the presence of alloantibodies directed against red blood cell antigens, more rarely autoantibodies. In approximately a third of the cases, no new antibody is highlighted. Pathophysiological hypotheses are still under debate but most of the authors agree on the role played by the SCD inflammatory state. Several therapeutic approaches are used but the data are still insufficient to estimate their efficiency. It is admitted that a new transfusion may exacerbate the phenomenon and the benefit-risk of any transfusion must be carefully evaluated. Measures limiting alloimmunization and rigorous follow-up of SCD patients and their immunohematologic status can prevent some of these accidents. The Hemovigilance network has a role to play in the recognition and the description of this risk. A first analysis realized on the French national Hemovigilance database of the French National Agency for Medicines and Health Products Safety (ANSM) over the period 2000-2013, shows us interesting information but some inadequacies, described here, must be taken into account to strengthen these data and insure in the future a better reporting quality. PMID:25441454

  18. Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five European countries

    PubMed Central

    Porta, Camillo; Levy, Antonin; Hawkins, Robert; Castellano, Daniel; Bellmunt, Joaquim; Nathan, Paul; McDermott, Ray; Wagstaff, John; Donnellan, Paul; McCaffrey, John; Vekeman, Francis; Neary, Maureen P; Diaz, Jose; Mehmud, Faisal; Duh, Mei Sheng

    2014-01-01

    Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients ?18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity. PMID:25045157

  19. Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five European countries.

    PubMed

    Porta, Camillo; Levy, Antonin; Hawkins, Robert; Castellano, Daniel; Bellmunt, Joaquim; Nathan, Paul; McDermott, Ray; Wagstaff, John; Donnellan, Paul; McCaffrey, John; Vekeman, Francis; Neary, Maureen P; Diaz, Jose; Mehmud, Faisal; Duh, Mei Sheng

    2014-12-01

    Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients ? 18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity. PMID:25045157

  20. Peak and fixed-time high-sensitive troponin for prediction of infarct size, impaired left ventricular function, and adverse outcomes in patients with first ST-segment elevation myocardial infarction receiving percutaneous coronary intervention.

    PubMed

    Boden, Helèn; Ahmed, Tarek A N; Velders, Matthijs A; van der Hoeven, Bas L; Hoogslag, Georgette E; Bootsma, Marianne; le Cessie, Saskia; Cobbaert, Christa M; Delgado, Victoria; van der Laarse, Arnoud; Schalij, Martin J

    2013-05-15

    The clinical use of advanced imaging modalities for early determination of infarct size and prognosis is limited. As a specific indicator of myocardial necrosis, cardiac troponin T (cTnT) can be used as a surrogate measure for this purpose. The present study sought to investigate the use of peak and serial 6-hour fixed-time high-sensitive (hs) cTnT for estimation of infarct size, left ventricular (LV) function, and prognosis in consecutive patients with ST-segment elevation myocardial infarction. The infarct size was expressed as the 48-hour cumulative creatine kinase release. LV function at 3 months was assessed using the echocardiographic wall motion score index and LV ejection fraction using radionuclide ventriculography. Adverse outcomes, comprising all-cause death, implantable cardioverter-defibrillator implantation, or hospitalization for heart failure, were recorded at 1 year of follow-up. In 188 patients, the peak and all fixed-time values correlated significantly with the 48-hour cumulative creatine kinase release, wall motion score index, and LV ejection fraction. The hs-cTnT value at 24 hours demonstrated the greatest correlation (r = 0.86, r = 0.47, and r = -0.59, respectively; p <0.001 for all). In the multivariate regression models adjusted for the clinical parameters, almost all were independently associated with the 48-hour cumulative creatine kinase release, wall motion score index, and LV ejection fraction, with the hs-cTnT value at 24 hours having the largest effect. Moreover, all cTnT values independently predicted adverse outcomes, again, with the hs-cTnT value at 24 hours showing the largest influence (hazard ratio 3.77, 95% confidence interval 2.12 to 6.73, p <0.001). In conclusion, not only peak, but all fixed-time hs-cTnT values were associated with infarct size, LV function at 3 months, and adverse outcomes 1 year after ST-segment elevation myocardial infarction. The value 24 hours after the onset of symptoms had the closest associations with all outcomes. Therefore, serial sampling for a peak value might be redundant. PMID:23465094

  1. Leprosy Reactions in Patients Coinfected with HIV: Clinical Aspects and Outcomes in Two Comparative Cohorts in the Amazon Region, Brazil

    PubMed Central

    Pires, Carla Andréa Avelar; Jucá Neto, Fernando Octávio Machado; de Albuquerque, Nahima Castelo; Macedo, Geraldo Mariano Moraes; Batista, Keila de Nazaré Madureira; Xavier, Marília Brasil

    2015-01-01

    Background Leprosy, caused by Mycobacterium leprae, can lead to scarring and deformities. Human immunodeficiency virus (HIV), a lymphotropic virus with high rates of replication, leads to cell death in various stages of infection. These diseases have major social and quality of life costs, and although the relevance of their comorbidity is recognized, several aspects are still not fully understood. Methodology/Principal Findings Two cohorts of patients with leprosy in an endemic region of the Amazon were observed. We compared 40 patients with leprosy and HIV (Group 1) and 107 leprosy patients with no comorbidity (Group 2) for a minimum of 2 years. Group 1 predominantly experienced the paucibacillary classification, accounting for 70% of cases, whereas Group 2 primarily experienced the multibacillary classification (80.4% of cases). There was no significant difference in the prevalence of leprosy reactions among the two groups (37.5% for Group 1 vs. 56.1% for Group 2), and the most frequent reaction was Type 1. The appearance of Group 1 patients’ reversal reaction skin lesions was consistent with each clinical form: typically erythematous and infiltrated, with similar progression as those patients without HIV, which responded to prednisone. Patients in both groups primarily experienced a single episode (73.3% in Group 1 and 75% in Group 2), and Group 1 had shorter reaction periods (?3 months; 93.3%), moderate severity (80%), with 93.3% of the patients in the state of acquired immune deficiency syndrome, and 46.7% presenting the reaction at the time of the immune reconstitution inflammatory syndrome. Conclusions/Significance This study used a large sample and makes a significant contribution to the clinical outcomes of patients in the reactive state with comorbid HIV and leprosy. The data indicate that these diseases, although concurrent, have independent courses. PMID:26029928

  2. Analysis of the Cytokine Pattern Expressed In Situ in Inhalant Allergen Patch Test Reactions of Atopic Dermatitis Patients

    Microsoft Academic Search

    Markus Grewe; Stefan Walther; Karin Gyufko; Wolfgang Czech; Erwin Schöpf; Jean Krutmann

    1995-01-01

    In the present study, we examined the cytokine pattern expressed in situ during the development of eczematous reactions that had been provoked in atopic dermatitis patients by patch testing with house dust mite allergen. In 24-h house dust mite allergen patch test reactions, expression of interleukin (IL)-4 mRNA and IL-2 mRNA increased, but interferon (IFN)-? mRNA did not, as compared

  3. Evaluation of IgE Antibodies to Recombinant Peanut Allergens in Patients with Reported Reactions to Peanut

    Microsoft Academic Search

    Robert Movérare; Staffan Ahlstedt; Ulf Bengtsson; Magnus P. Borres; Marianne van Hage; Maryam Poorafshar; Sigrid Sjölander; Johanna Åkerström; Jenny van Odijk

    2011-01-01

    Background: Peanut may cause severe reactions in allergic individuals. The objective was to evaluate IgE antibodies to various recombinant (r) peanut and birch pollen allergens in relation to IgE levels to whole peanut extract and severe allergic reactions to peanut. Methods: Seventy-four Swedish peanut-allergic patients (age: 14–61 years) reported previous peanut exposure and associated symptoms using a questionnaire. Their IgE

  4. Prescription-medication sharing among family members: an unrecognized cause of a serious drug adverse event in a patient with impaired renal function.

    PubMed

    Makówka, Agnieszka; Zawiasa, Anna; Nowicki, Michal

    2015-03-01

    Many medications need to be avoided in chronic kidney disease (CKD) because of increased toxicity. Metformin - an oral hypoglycemic drug universally recommended as the first-line treatment for type 2 diabetes mellitus (T2DM) - undergoes significant accumulation in advanced CKD that may ultimately lead to lactic acidosis. Recently, it has been found that side effects of the therapy may occasionally neither be linked to improper prescription nor lack of dose adjustment by the physician, but can result from borrowing and sharing of drugs with relatives and friends. This poorly recognized problem has never been studied in renal patients. This work contains a discussion on the diagnostic problems associated with proper diagnosis of the etiology of severe acidosis in an elderly woman with advanced CKD and diabetes. The patient developed severe lactic acidosis by taking metformin that was prescribed by another doctor to her son, who was also diabetic. The diagnosis of lactic acidosis was delayed since the initial laboratory assessments had focused mostly on dehydration and substance abuse. PMID:24691009

  5. The Ontology of Vaccine Adverse Events (OVAE) and its usage in representing and analyzing adverse events associated with US-licensed human vaccines

    PubMed Central

    2013-01-01

    Background Licensed human vaccines can induce various adverse events (AE) in vaccinated patients. Due to the involvement of the whole immune system and complex immunological reactions after vaccination, it is difficult to identify the relations among vaccines, adverse events, and human populations in different age groups. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of US-licensed commercial vaccine products. To better represent and analyze VAEs, we developed the Ontology of Vaccine Adverse Events (OVAE) as an extension of the Ontology of Adverse Events (OAE) and the Vaccine Ontology (VO). Results Like OAE and VO, OVAE is aligned with the Basic Formal Ontology (BFO). The commercial vaccines and adverse events in OVAE are imported from VO and OAE, respectively. A new population term ‘human vaccinee population’ is generated and used to define VAE occurrence. An OVAE design pattern is developed to link vaccine, adverse event, vaccinee population, age range, and VAE occurrence. OVAE has been used to represent and classify the adverse events recorded in package insert documents of commercial vaccines licensed by the USA Food and Drug Administration (FDA). OVAE currently includes over 1,300 terms, including 87 distinct types of VAEs associated with 63 human vaccines licensed in the USA. For each vaccine, occurrence rates for every VAE in different age groups have been logically represented in OVAE. SPARQL scripts were developed to query and analyze the OVAE knowledge base data. To demonstrate the usage of OVAE, the top 10 vaccines accompanying with the highest numbers of VAEs and the top 10 VAEs most frequently observed among vaccines were identified and analyzed. Asserted and inferred ontology hierarchies classify VAEs in different levels of AE groups. Different VAE occurrences in different age groups were also analyzed. Conclusions The ontology-based data representation and integration using the FDA-approved information from the vaccine package insert documents enables the identification of adverse events from vaccination in relation to predefined parts of the population (age groups) and certain groups of vaccines. The resulting ontology-based VAE knowledge base classifies vaccine-specific VAEs and supports better VAE understanding and future rational AE prevention and treatment. PMID:24279920

  6. Aspirin reduces adverse effects of gefitinib.

    PubMed

    Kanazawa, Shigenori; Yamaguchi, Kazuyuki; Kinoshita, Yoshimi; Muramatsu, Mikiko; Komiyama, Yutaka; Nomura, Shosaku

    2006-04-01

    We measured serum levels of soluble (s) P-selectin and thromboxane B2 (TxB2) in patients with lung cancer treated with gefitinib, and investigated the effect of low-dose aspirin on some adverse effects of gefitinib. The serum levels of sP-selectin and TxB2 increased significantly in all patients who received gefitinib for 2 weeks. Forty patients were recruited, and 28 received gefitinib without low-dose aspirin (Group 1) and 12 were co-administered low-dose aspirin (Group 2). In Group 2, the frequency of adverse events, skin rash and diarrhea was evidently reduced by the low-dose aspirin therapy, despite having shown no remarkable change in gefitinib responsiveness between both groups. In one of the 12 patients in Group 2, aspirin therapy was suspended due to the occurrence of nasal bleeding. Four days after treatment suspension, she developed a skin lesion in her finger. However, the skin lesion improved after re-administration of aspirin without any other medications. After treatment, TxB2 significantly decreased, but not sP-selectin. These results suggest that one of the mechanisms causing gefitinib-related adverse effects depends on platelet activation. Administration of gefitinib with low-dose aspirin to lung cancer patients may prevent the development of gefitinib-related complications. PMID:16550000

  7. Airway bacteria measured by quantitative polymerase chain reaction and culture in patients with stable COPD: relationship with neutrophilic airway inflammation, exacerbation frequency, and lung function

    PubMed Central

    Bafadhel, Mona; Haldar, Koirobi; Barker, Bethan; Patel, Hemu; Mistry, Vijay; Barer, Michael R; Pavord, Ian D; Brightling, Christopher E

    2015-01-01

    Background Potentially pathogenic microorganisms can be detected by quantitative real-time polymerase chain reaction (qPCR) in sputum from patients with COPD, although how this technique relates to culture and clinical measures of disease is unclear. We used cross-sectional and longitudinal data to test the hypotheses that qPCR is a more sensitive measure of bacterial presence and is associated with neutrophilic airway inflammation and adverse clinical outcomes. Methods Sputum was collected from 174 stable COPD subjects longitudinally over 12 months. Microbial sampling using culture and qPCR was performed. Spirometry and sputum measures of airway inflammation were assessed. Findings Sputum was qPCR-positive (>106 copies/mL) in 77/152 samples (Haemophilus influenzae [n=52], Moraxella catarrhalis [n=24], Streptococcus pneumoniae [n=19], and Staphylococcus aureus [n=7]). Sputum was culture-positive in 50/174 samples, with 49 out of 50 culture-positive samples having pathogen-specific qPCR bacterial loads >106 copies/mL. Samples that had qPCR copy numbers >106/mL, whether culture-positive or not, had increased sputum neutrophil counts. H. influenzae qPCR copy numbers correlated with sputum neutrophil counts (r=0.37, P<0.001), were repeatable within subjects, and were >106/mL three or more times in 19 patients, eight of whom were repeatedly sputum culture-positive. Persistence, whether defined by culture, qPCR, or both, was associated with a higher sputum neutrophil count, lower forced expiratory volume in 1 second (FEV1), and worsened quality of life. Interpretation qPCR identifies a significant number of patients with potentially bacteria-associated neutrophilic airway inflammation and disease that are not identified by traditional culture-based methods.

  8. Dermatological reactions to the multitargeted tyrosine kinase inhibitor sunitinib

    Microsoft Academic Search

    S. E. Rosenbaum; S. Wu; M. A. Newman; D. P. West; T. Kuzel; M. E. Lacouture

    2008-01-01

    Background  The multikinase inhibitor sunitinib has enhanced the treatment of renal cell carcinoma and gastrointestinal stromal tumor\\u000a through an improved clinical response with decreased systemic toxicities. However, sunitinib is frequently associated with\\u000a dermatological adverse reactions. The physical and psychosocial impact of frequent dermatological toxicities can affect consistent\\u000a antineoplastic therapy and quality of life.\\u000a \\u000a \\u000a \\u000a Patients and methods  Dermatological adverse reaction information was compiled

  9. Tissue Inhibitor Metalloproteinase-2 (TIMP-2)?IGF-Binding Protein-7 (IGFBP7) Levels Are Associated with Adverse Long-Term Outcomes in Patients with AKI.

    PubMed

    Koyner, Jay L; Shaw, Andrew D; Chawla, Lakhmir S; Hoste, Eric A J; Bihorac, Azra; Kashani, Kianoush; Haase, Michael; Shi, Jing; Kellum, John A

    2015-07-01

    Tissue inhibitor metalloproteinase-2 (TIMP-2) and IGF-binding protein-7 (IGFBP7) have been validated for risk stratification in AKI. However, the association of urinary TIMP-2 and IGFBP7 with long-term outcomes is unknown. We evaluated the 9-month incidence of a composite end point of all-cause mortality or the need for RRT in a secondary analysis of a prospective observational international study of critically ill adults. Two predefined [TIMP-2]?[IGFBP7] cutoffs (0.3 for high sensitivity and 2.0 for high specificity) for the development of AKI were evaluated. Cox proportional hazards models were used to determine risk for the composite end point. Baseline [TIMP-2]?[IGFBP7] values were available for 692 subjects, of whom 382 (55.2%) subjects developed stage 1 AKI (defined by Kidney Disease Improving Global Outcomes guidelines) within 72 hours of enrollment and 217 (31.4%) subjects met the composite end point. Univariate analysis showed that [TIMP-2]?[IGFBP7]>2.0 was associated with increased risk of the composite end point (hazard ratio [HR], 2.11; 95% confidence interval [95% CI], 1.37 to 3.23; P<0.001). In a multivariate analysis adjusted for the clinical model, [TIMP-2]?[IGFBP7] levels>0.3 were associated with death or RRT only in subjects who developed AKI (compared with levels?0.3: HR, 1.44; 95% CI, 1.00 to 2.06 for levels>0.3 to ?2.0; P=0.05 and HR, 2.16; 95% CI, 1.32 to 3.53 for levels>2.0; P=0.002). In conclusion, [TIMP-2]?[IGFBP7] measured early in the setting of critical illness may identify patients with AKI at increased risk for mortality or receipt of RRT over the next 9 months. PMID:25535301

  10. Quantitation of herpes simplex virus DNA in cerebrospinal fluid of patients with herpes simplex encephalitis by the polymerase chain reaction

    Microsoft Academic Search

    M. Grazia Revello; Fausto Baldanti; Antonella Sarasini; Davide Zella; Maurizio Zavattoni; Giuseppe Gerna

    1997-01-01

    Background: Previous studies have shown the diagnostic utility of qualitative detection of herpes simplex virus (HSV) DNA by the polymerase chain reaction (PCR) in cerebrospinal fluid samples (CSF) from patients with herpes simplex encephalitis (HSE).Objectives: To determine whether quantitation of HSV DNA in CSF could be useful for monitoring efficacy of antiviral therapy and provide prognostic indications.Study design: A quantitative

  11. Do fibromyalgia patients display hypervigilance for innocuous somatosensory stimuli? Application of a body scanning reaction time paradigm

    Microsoft Academic Search

    Madelon L Peters; Johan W. S Vlaeyen; Chantal van Drunen

    2000-01-01

    This study tested the hypothesis that fibromyalgia patients display hypervigilance for somatosensory signals. Hypervigilance was operationalized as the detection of weak electrocutaneous stimuli. Innocuous electrical stimuli gradually increasing in strength were administered to one of four different body locations. A reaction time paradigm was used in which subjects had to respond as fast as possible to stimulus detection by pressing

  12. An Investigation of Nursing Staff Attitudes and Emotional Reactions towards Patients with Intellectual Disability in a General Hospital Setting

    ERIC Educational Resources Information Center

    Lewis, Sharna; Stenfert-Kroese, Biza

    2010-01-01

    Background: It has been suggested that inequalities in health care for people with intellectual disabilities may be partly explained by negative attitudes of health professionals. This study aimed to investigate the attitudes and emotional reactions reported by nursing staff working in general hospitals towards caring for patients with…

  13. Language proficiency and adverse events in US hospitals: a pilot study

    Microsoft Academic Search

    CHANDRIKA DIVI; RICHARD G. KOSS; STEPHEN P. SCHMALTZ; JEROD M. LOEB

    2007-01-01

    Objective. To examine differences in the characteristics of adverse events between English speaking patients and patients with limited English proficiency in US hospitals. Setting. Six Joint Commission accredited hospitals in the USA. Method. Adverse event data on English speaking patients and patients with limited English proficiency were collected from six hospitals over 7 months in 2005 and classified using the

  14. Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol

    PubMed Central

    2014-01-01

    Background Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR). The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. Methods All iodinated and gadolinium contrast-enhanced radiologic examinations between August 2011 and February 2013 for which the premedication protocol was applied in our institution were assessed for BTRs. Results The protocol was applied to a total of 252 examinations (153 patients, ages 15–87 years; 63 males, 90 females). Of these, 152 were for prior acute adverse reactions to contrast media, 85 were for a history of bronchial asthma, and 15 were for other reasons. There were 198 contrast enhanced CTs and 54 contrast enhanced MRIs. There were nine BTR (4.5%) for iodinated contrast media, and only one BTR (1.9%) for gadolinium contrast media: eight were mild and one was moderate. No patient who had a mild index reaction (IR) had a severe BTR. Conclusion Incidence of BTRs when following the premedication protocol was low. This study by no means proves the efficacy of premedication, but provides some support for following a premedication protocol to improve safety of contrast-enhanced examinations when prior adverse reactions are mild, or when there is a history of asthma. PMID:25287952

  15. Spondylarthritis presenting with an allergic immediate systemic reaction to adalimumab in a woman: a case report

    Microsoft Academic Search

    Maurizio Benucci; Mariangela Manfredi; Sergio Testi; Maria L Iorno; Maurizio Valentini; Francesca Soldaini; Paolo Campi

    2011-01-01

    Introduction  The efficacy of adalimumab, a fully human anti-tumor necrosis factor ? recombinant antibody, has dramatically improved the\\u000a quality of life of patients with rheumatoid and psoriatic arthritis and Crohn's disease. Because it is fully human, one should\\u000a not expect immune reactions to this molecule. Adverse reactions to adalimumab are limited mainly to injection site reactions\\u000a and are very common. Immediate

  16. Paradoxical Reaction to Golimumab: Tumor Necrosis Factor ? Inhibitor Inducing Psoriasis Pustulosa

    PubMed Central

    Soto Lopes, Marien Siqueira; Trope, Beatriz Moritz; Rochedo Rodriguez, Maria Paula Rua; Grynszpan, Rachel Lima; Cuzzi, Tullia; Ramos-e-Silva, Marcia

    2013-01-01

    Importance Golimumab is a human monoclonal antibody, used for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Adverse reactions are increasing with this class of medication (tumor necrosis factor ? inhibitors). Observations The authors present a case of a female patient who presented with psoriasis pustulosa after the use of golimumab for rheumatoid arthritis. Conclusions and Relevance Paradoxically, in this case, golimumab, which is used for psoriasis, induced the pustular form of this disease. We are observing an increasing number of patients who develop collateral effects with tumor necrosis factor ? inhibitors, and the understanding of the mechanism of action and how these adverse reactions occur may contribute to avoid these sometimes severe situations. PMID:24348382

  17. Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study

    PubMed Central

    Matlow, Anne G.; Baker, G. Ross; Flintoft, Virginia; Cochrane, Douglas; Coffey, Maitreya; Cohen, Eyal; Cronin, Catherine M.G.; Damignani, Rita; Dubé, Robert; Galbraith, Roger; Hartfield, Dawn; Newhook, Leigh Anne; Nijssen-Jordan, Cheri

    2012-01-01

    Background: Limited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada. Methods: We performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events. Results: A total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65–5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08–9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0–3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2–0.9). Interpretation: More children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error. PMID:22847964

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

    PubMed Central

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

    2013-01-01

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

  19. 43-kilodalton glycoprotein from Paracoccidioides brasiliensis: immunochemical reactions with sera from patients with paracoccidioidomycosis, histoplasmosis, or Jorge Lobo's disease.

    PubMed Central

    Puccia, R; Travassos, L R

    1991-01-01

    Sera from patients with paracoccidioidomycosis (PCM), histoplasmosis (HP), or Jorge Lobo's disease (JL) were titrated against purified gp43 from Paracoccidioides brasiliensis by using both enzyme-linked immunosorbent assay (ELISA) and immunoprecipitation (IPP) reactions with 125I-labeled antigens. In IPP, PCM sera and other sera could be distinguished on the basis of serum titers, whereas in ELISA, 53% of the HP sera and 29% of the JL sera reacted similarly to the PCM sera. To investigate the possible role of the carbohydrate epitopes in these reactions, we compared the reactivities of sera from several patients with native and deglycosylated gp43. Competition experiments were carried out with monosaccharides as inhibitors. The results suggest that greater than 85% of the reactions of the PCM sera with gp43 involved peptide epitopes. Cross-reactions with HP and JL sera in ELISA were predominantly attributed to periodate-sensitive carbohydrate epitopes containing galactosyl residues. HP and JL sera which reacted strongly with gp43 in ELISA were only weakly reactive or did not react in IPP with labeled antigens in solution. Moreover, ELISA reactions could be significantly inhibited either by monosaccharides or by periodate treatment. Apparently, carbohydrate epitopes in gp43 are more accessible to the antibodies when the molecule is bound to a plastic substrate than when it is in solution. Structural changes in the gp43 antigen arising by N deglycosylation abolish reactivity with PCM sera and support the existence of conformational peptide epitopes. Images PMID:1722220

  20. Vitamin D receptor expression levels determine the severity and complexity of disease progression among leprosy reaction patients

    PubMed Central

    Mandal, D.; Reja, A.H.H.; Biswas, N.; Bhattacharyya, P.; Patra, P.K.; Bhattacharya, B.

    2015-01-01

    We studied the roles of vitamin D and its receptor, VDR, in the progression of leprosy. The majority of individuals with leprosy from Kolkata, India, with a type 1 or type 2 reaction have low levels of vitamin D3 in serum samples. Interestingly, individuals with a type 2 reaction associated with neuritis/erythema nodosum leprosum had very low VDR mRNA expression levels, ranging from 5% to 10%, compared to that of healthy control subjects; these patients also had a high bacilli index, ranging from 3+ to 5+. This is the first report to indicate that VDR expression levels may determine the complexity and severity of the progression of leprosy.

  1. A retrospective study on the incidences of adverse drug events and analysis of the contributing trigger factors

    PubMed Central

    Sam, Aaseer Thamby; Lian Jessica, Looi Li; Parasuraman, Subramani

    2015-01-01

    Objectives: To retrospectively determine the extent and types of adverse drug events (ADEs) from the patient cases sheets and identify the contributing factors of medication errors. To assess causality and severity using the World Health Organization (WHO) probability scale and Hartwig's scale, respectively. Methods: Hundred patient case sheets were randomly selected, modified version of the Institute for Healthcare Improvement (IHI) Global Trigger Tool was utilized to identify the ADEs; causality and severity were calculated utilizing the WHO probability scale and Hartwig's severity assessment scale, respectively. Results: In total, 153 adverse events (AEs) were identified using the IHI Global Trigger Tool. Majority of the AEs are due to medication errors (46.41%) followed by 60 adverse drug reactions (ADRs), 15 therapeutic failure incidents, and 7 over-dose cases. Out of the 153 AEs, 60 are due to ADRs such as rashes, nausea, and vomiting. Therapeutic failure contributes 9.80% of the AEs, while overdose contributes to 4.58% of the total 153 AEs. Using the trigger tools, we were able to detect 45 positive triggers in 36 patient records. Among it, 19 AEs were identified in 15 patient records. The percentage of AE/100 patients is 17%. The average ADEs/1000 doses is 2.03% (calculated). Conclusion: The IHI Global Trigger Tool is an effective method to aid provisionally-registered pharmacists to identify ADEs quicker. PMID:25767366

  2. Adverse drug events in hospital: pilot study with trigger tool

    PubMed Central

    Rozenfeld, Suely; Giordani, Fabiola; Coelho, Sonia

    2013-01-01

    OBJECTIVE To estimate the frequency of and to characterize the adverse drug events at a terciary care hospital. METHODS A retrospective review was carried out of 128 medical records from a hospital in Rio de Janeiro in 2007, representing 2,092 patients. The instrument used was a list of triggers, such as antidotes, abnormal laboratory analysis results and sudden suspension of treatment, among others. A simple random sample of patients aged 15 and over was extracted. Oncologic and obstetric patients were excluded as were those hospitalized for less than 48 hours or in the emergency room. Social and demographic characteristics and those of the disease of patients who underwent adverse events were compared with those of patients who did not in order to test for differences between the groups. RESULTS Around 70.0% of the medical records assessed showed at least one trigger. Adverse drug events triggers had an overall positive predictive value of 14.4%. The incidence of adverse drug events was 26.6 per 100 patients and 15.6% patients suffered one or more event. The median length of stay for patients suffering an adverse drug event was 35.2 days as against 10.7 days for those who did not (p < 0.01). The pharmacological classes most commonly associated with an adverse drug event were related to the cardiovascular system, nervous system and alimentary tract and metabolism. The most common active substances associated with an adverse drug event were tramadol, dypirone, glibenclamide and furosemide. Over 80.0% of events provoked or contributed to temporary harm to the patient and required intervention and 6.0% may have contributed to the death of the patient. It was estimated that in the hospital, 131 events involving drowsiness or fainting 33 involving falls, and 33 episodes of hemorrhage related to adverse drug effects occur annually. CONCLUSIONS Almost one-sixth of in-patients (16,0%) suffered an adverse drug event. The instrument used may prove useful as a technique for monitoring and evaluating patient care results. Psycothropic therapy should be critically appraised given the frequency of associated events, such as excessive sedation, lethargy, and hypotension. PMID:24626548

  3. Allergy to lentils in Mediterranean pediatric patients

    Microsoft Academic Search

    Cristina Y. Pascual; Jesus Fernandez-Crespo; Sofia Sanchez-Pastor; M. Antonia Padial; Jose Maria Diaz-Pena; Flora Martin-Muñoz; Manuel Martin-Esteban

    1999-01-01

    Background: Peanuts and soybeans are the major legumes involved in human food allergy; however, scarce data exist on adverse reactions to other temperate legumes, such as lentils. Objective: The purpose of this study was to identify patients who are allergic to lentils, to assess clinical features and other associated food allergies, and to characterize allergens in lentil extract. Methods: Twenty-two

  4. Psychiatric adverse effects of pediatric corticosteroid use.

    PubMed

    Drozdowicz, Linda B; Bostwick, J Michael

    2014-06-01

    Corticosteroids, highly effective drugs for myriad disease states, have considerable neuropsychiatric adverse effects that can manifest in cognitive disorders, behavioral changes, and frank psychiatric disease. Recent reviews have summarized these effects in adults, but a comprehensive review on corticosteroid effects in children has not been published since 2005. Here, we systematically review articles published since then that, we find, naturally divide into 3 main areas: (1) chronic effects of acute prenatal and neonatal exposure associated with prematurity and congenital conditions; (2) immediate behavioral effects of acute exposure via oncological protocols; and (3) acute behavioral effects of sporadic use in children and adolescents with other conditions. PsycInfo, MEDLINE, Embase, and Scopus were queried to identify articles reporting psychiatric adverse effects of corticosteroids in pediatric patients. Search terms included corticosteroids, adrenal cortex hormones, steroid psychosis, substance-induced psychoses, glucocorticoids, dexamethasone, hydrocortisone, prednisone, adverse effects, mood disorders, mental disorders, psychosis, psychotic, psychoses, side effect, chemically induced, emotions, affective symptoms, toxicity, behavior, behavioral symptoms, infant, child, adolescent, pediatric, paediatric, neonatal, children, teen, and teenager. Following guidelines for systematic reviews from the Potsdam Consultation on Meta-Analysis, we have found it difficult to draw specific conclusions that are more than general impressions owing to the quality of the available studies. We find a mixed picture with neonates exposed to dexamethasone, with some articles reporting eventual deficits in neuropsychiatric functioning and others reporting no effect. In pediatric patients with acute lymphoblastic leukemia, corticosteroid use appears to correlate with negative psychiatric and behavioral effects. In children treated with corticosteroids for noncancer conditions, adverse effects have been observed both during treatment and after cessation, although the data from article to article are not consistent enough to establish dose relationships. By and large, inhaled corticosteroids are considered safe and free of severe neuropsychiatric effects. Although both antipsychotic medications and benzodiazepines have been used to treat corticosteroid-induced mania and psychosis, no unified management strategy has emerged. Large-scale standardized investigations are needed to clarify the psychiatric effect of corticosteroids on children in all these conditions. Meanwhile, there is general agreement that patients as well as caregivers should be warned of the potential for behavioral adverse effects when patients receive these drugs. PMID:24943696

  5. Delayed-type hypersensitivity reaction to piperacillin/tazobactam in a patient with an infected total knee replacement.

    PubMed

    Song, E K; Seon, J K; Jeong, M S

    2010-11-01

    We describe a patient who developed a delayed-type hypersensitivity reaction to piperacillin/tazobactam in the cement beads and a spacer inserted at revision of total replacement of the left knee. We believe that this is the first report of such a problem. Our experience suggests that a delayed-type hypersensitivity reaction should be considered when a mixture of antibiotics such as piperacillin/tazobactam has been used in the bone cement, beads or spacer and the patient develops delayed symptoms of pain or painful paraesthesiae, fever, rash and abnormal laboratory findings in the absence of infection. The diagnosis was made when identical symptoms were induced by a provocation challenge test. PMID:21037360

  6. Psychiatric considerations in patients with decreased levels of consciousness.

    PubMed

    Young, James L; Rund, Douglas

    2010-08-01

    When patients present to the emergency department with changes in behavior and levels of consciousness, psychiatric causes often move to the top of the list of diagnostic considerations. It is important to thoroughly assess such patients for medical causes. Although it is not common for primary psychiatric conditions to present with altered levels of consciousness, severe cases may present in this fashion. Altered mental states may also be caused by adverse reactions to psychiatric medications. In this article, the authors review some of the psychiatric causes of decreased levels of consciousness, as well as certain adverse drug reactions to psychotropic medications. PMID:20709245

  7. Adverse Events of Monoclonal Antibodies Used for Cancer Therapy

    PubMed Central

    Guan, Mei; Zhou, Yan-Ping; Sun, Jin-Lu; Chen, Shu-Chang

    2015-01-01

    In 1997, the first monoclonal antibody (MoAb), the chimeric anti-CD20 molecule rituximab, was approved by the US Food and Drug administration for use in cancer patients. Since then, the panel of MoAbs that are approved by international regulatory agencies for the treatment of hematopoietic and solid malignancies has continued to expand, currently encompassing a stunning amount of 20 distinct molecules for 11 targets. We provide a brief scientific background on the use of MoAbs in cancer therapy, review all types of monoclonal antibodies-related adverse events (e.g., allergy, immune-related adverse events, cardiovascular adverse events, and pulmonary adverse events), and discuss the mechanism and treatment of adverse events.

  8. Adverse possession of subsurface minerals

    SciTech Connect

    Bowles, P.N.

    1983-01-01

    Concepts applicable to adverse possession of subsurface minerals are generally the same as those that apply to adverse possession of all real estate. However, special requirements must be satisfied in order to perfect title to subsurface minerals by adverse possession, particularly when there has been a severance of the true title between surface and subsurface minerals. In those jurisdictions where senior and junior grants came from the state or commonwealth covering the same or some of the same land and in those areas where descriptions of land were vague or not carefully drawn, adverse possession serves to solidify land and mineral ownership. There may be some public, social, and economic justification in rewarding, with good title, those who take possession and use real estate for its intended use, including the extraction of subsurface minerals. 96 refernces.

  9. Anti-EGFR mechanism of action: antitumor effect and underlying cause of adverse events.

    PubMed

    Lenz, Heinz-Josef

    2006-04-01

    Overexpression of the epidermal growth factor receptor (EGFR) is correlated with poor prognosis in many human cancers. Two main classes of anticancer agents affect the EGFR: those targeting the extracellular ligand-binding domain and those that block the intracellular tyrosine kinase (TK) domain. Cetuximab (Erbitux) is a mouse/human chimeric monoclonal antibody that targets the ligand-binding domain of the EGFR, whereas erlotinib (Tarceva) and gefitinib (Iressa) are small-molecule TK inhibitors. Common toxicities of agents targeting the EGFR differ from those associated with traditional chemotherapy. Given the common pathway through which these agents work, some adverse events are similar. Many patients treated with these agents develop an acne-like rash on the face and upper body, most likely related to keratinocyte alterations and hair follicle proliferation and maturation. Although clinical manifestation of this reaction closely resembles acne vulgaris, the histology is more similar to infectious folliculitis. Other adverse events appear to be related to a drug class or individual agent. For example, interstitial lung disease is a rare but potentially fatal reaction that has been reported with gefitinib. Hypomagnesemia reported in association with cetuximab may be related to EGFR blockade in the kidney. Anaphylactic or anaphylactoid infusion reactions are also seen with cetuximab, as with other monoclonal antibodies. PMID:16736978

  10. Des-Arg 9-bradykinin metabolism in patients who presented hypersensitivity reactions during hemodialysis: role of serum ACE and aminopeptidase P

    Microsoft Academic Search

    Charles Blais; William H Simmons; Guy Loute; Pierre Thibault; Randal A Skidgel; Albert Adam

    1999-01-01

    Bradykinin (BK) has been proposed as the principal mediator of hypersensitivity reactions (HSR) in patients dialyzed using negatively charged membranes and concomitantly treated with angiotensin-converting enzyme (ACE) inhibitors. We investigated the metabolism of exogenous BK added to the sera of 13 patients dialyzed on an AN69 membrane with a history of HSR (HSR+ patients) and 10 others who did not

  11. Cross-reactions to desoximetasone and mometasone furoate in a patient with multiple topical corticosteroid allergies.

    PubMed

    Donovan, Jeffrey C H; Dekoven, Joel G

    2006-09-01

    A 60-year-old man developed a bullous contact dermatitis after topical corticosteroid treatment of dermatitis on his lower leg. Subsequent patch testing showed cross-reactions to numerous group B and group D corticosteroids as well as cross-reactions to group C desoximetasone and group D1 mometasone furoate. His patch-test result was negative for the group A corticosteroids hydrocortisone and tixocortol pivalate. We discuss the uncommon finding of cross-reactions to desoximetasone and mometasone furoate. PMID:16956468

  12. Severe hemolytic transfusion reaction due to anti-D in a D+ patient with sickle cell disease.

    PubMed

    Ipe, Tina S; Wilkes, Jennifer J; Hartung, Helge D; Westhoff, Connie M; Chou, Stella T; Friedman, David F

    2015-03-01

    A 5-year-old male with sickle cell disease presented with pain, dark urine, and fatigue 10 days after a red blood cell (RBC) transfusion. Laboratory evaluation demonstrated severe anemia, blood type O+, and anti-D in the serum. Anti-D in a D+ patient led to RH genotyping, which revealed homozygosity for RHD*DAU4 that encodes partial D antigen. Anti-D in this patient whose RBCs exclusively express partial D caused a delayed hemolytic transfusion reaction after exposure to D+ RBCs. The finding of anti-D in a D+patient should be investigated by molecular methods to help distinguish an alloantibody from an autoantibody. PMID:25171447

  13. Liposomal amphotericin B in the treatment of fungal infections in neutropenic patients: a single-centre experience of 133 episodes in 116 patients

    Microsoft Academic Search

    W. Mills; R. Chopra; D. C. Linch; A. H. Goldstone

    1994-01-01

    Summary. Liposomal amphotericin B ( AmBisome) was used for suspected or confirmed fungal infection complicating 13 3 neutropenic episodes in 116 patients not tolerating, or not responding to, conventional amphotericin. Adverse effects were infrequent and no significant renal impairment resulted. Acute reactions occurred in five patients, reversible hepatic dysfunction in 23, and hypernatraemia in 17. The putative mycosis resolved with

  14. Highly Frequent and Enhanced Injection Site Reaction Induced by Peripheral Venous Injection of Fosaprepitant in Anthracycline-Treated Patients

    PubMed Central

    Sato, Yumiko; Kondo, Masahiro; Inagaki, Atsushi; Komatsu, Hirokazu; Okada, Chika; Naruse, Kumi; Sahashi, Tomoyo; Kuroda, Junko; Ogura, Hiroka; Uegaki, Shiori; Yoshida, Tatsuya; Mori, Yoshinori; Sawada, Hiroo; Watanabe, Shoichi; Sugiura, Hiroshi; Endo, Yumi; Yoshimoto, Nobuyasu; Toyama, Tatsuya; Iida, Shinsuke; Yamada, Koichi; Kimura, Kazunori; Wakita, Atsushi

    2014-01-01

    Background: Fosaprepitant-associated injection site reaction (ISR) has been reported in patients treated with cisplatin, an irritant drug. We conducted this retrospective study to clarify the incidence and symptoms of fosaprepitant-associated ISR in patients treated with anthracycline. Patients and methods: Fifty six patients receiving 159 injections administering doxorubicin/cyclophosphamide (AC), fluorouracil/epirubicin/cyclophosphamide (FEC), or rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone (R-)CHOP regimen through a peripheral vein at ambulatory treatment centers reviewed for this study from patients' medical records. Incidence of ISR was compared between 24 patients with fosaprepitant injection (fosaprepitant group) and 32 patients without fosaprepitant (control group). Frequency and symptoms of ISR per injection were also compared between 61 injections with fosaprepitant and 98 injections without fosaprepitant. Results: Both the ISR incidence rate per patient and per injection were significantly higher in the fosaprepitant group than in the control group (67% vs. 16%; P=0.0002, 34% vs. 8.2%; P<0.0001, respectively). By multivariate analysis, fosaprepitant injection was found to be a significant independent variable correlated with ISR risk. Symptoms observed in 61 injections of fosaprepitant were pain (n=14, 23%), erythema (n=10, 16%), swelling (n=6, 10%), and delayed drip infusion (n=6, 10%). After the observation period, no ISR occurred when the administration route was changed to central venous injection or oral aprepitant was administered despite the continuation of chemotherapy. Conclusion: ISR occurred more frequently and severely when fosaprepitant was injected through the peripheral vein in patients treated with anthracyclines compared to those without fosaprepitant. PMID:24799957

  15. Herbal remedies: adverse effects and drug interactions.

    PubMed

    Cupp, M J

    1999-03-01

    A growing number of Americans are using herbal products for preventive and therapeutic purposes. The manufacturers of these products are not required to submit proof of safety and efficacy to the U.S. Food and Drug Administration before marketing. For this reason, the adverse effects and drug interactions associated with herbal remedies are largely unknown. Ginkgo biloba extract, advertised as improving cognitive functioning, has been reported to cause spontaneous bleeding, and it may interact with anticoagulants and antiplatelet agents. St. John's wort, promoted as a treatment for depression, may have monoamine oxidase-inhibiting effects or may cause increased levels of serotonin, dopamine and norepinephrine. Although St. John's wort probably does not interact with foods that contain tyramine, it should not be used with prescription antidepressants. Ephedrine-containing herbal products have been associated with adverse cardiovascular events, seizures and even death. Ginseng, widely used for its purported physical and mental effects, is generally well tolerated, but it has been implicated as a cause of decreased response to warfarin. Physicians must be alert for adverse effects and drug interactions associated with herbal remedies, and they should ask all patients about the use of these products. PMID:10088878

  16. Adversomics: The Emerging Field of Vaccine Adverse Event Immunogenetics

    Microsoft Academic Search

    Gregory A. Poland; Inna G. Ovsyannikova; Robert M. Jacobson

    2009-01-01

    genetic basis for adverse events after smallpox vaccination. 9 The hypothesis was that subjects experiencing AEs exhibited unique genetic polymorphisms associated with AE reactions in response to smallpox vaccination. To test the hypothesis 346 smallpox (Dryvax) immunized individuals were genotyped for single-nucleotide polymorphisms (SNPs) in 19 candidate genes and assessed for the development of fever associated with the receipt of

  17. Comparison of Allergic Adverse Effects and Contrast Enhancement Between Iodixanol and Iopromide

    PubMed Central

    Gharekhanloo, Farideh; Torabian, Saadat

    2012-01-01

    Background Iodinated X-ray contrast media are the most commonly used contrast agents in the world with an annual application of 40-50 million. New non-ionic contrast agents are subdivided into low osmolar agents such as iopromide and iso-osmolar agents such as iodixanol. Regarding different biochemical characteristics, these agents are different in the allergic reactions and contrast enhancement and final lesion conspicuity. Objectives This study was carried out to compare allergic adverse effects and contrast enhancement between iodixanol and iopromide. Patients and Methods One-hundred and twenty patients who were referred for abdominal CT scan to Besat Hospital were included in this study. Patients were randomly divided into two groups (A and B). Group A received 100 cc iodixanol (300 mgI/mL) and group B received 100 cc iopromide (300 mgI/ml) by power injector. CT examination was performed using Helical CT Scanner (Somatom, Siemens, Germany). Sixty seconds after injection, images were obtained and enhancement of port, liver and aorta were determined. Allergic adverse effects were recorded one hour and up to one week after injection. Results Iodixanol produced a significantly greater enhancement of the hepatic, aorta and portal vein than iopromide (P < 0.01). Sixty seconds after injection, associated pain and heat sensation were less frequent in iodixanol in comparison with iopromide (P = 0.03). Immediate reactions such as nausea and vomiting were less frequent in iodixanol (P = 0.01). Late skin reactions such as rash was more frequent in iodixanol (P < 0.01). Conclusions Iodixanol is safe and is better tolerated in the early phase of injection with better contrast enhancement and lesion conspicuity. Mild late skin rash is its disadvantage. PMID:23329965

  18. Acute Normal Tissue Reactions in Head-and-Neck Cancer Patients Treated With IMRT: Influence of Dose and Association With Genetic Polymorphisms in DNA DSB Repair Genes

    SciTech Connect

    Werbrouck, Joke [Department of Basic Medical Sciences, Ghent University, Ghent (Belgium)], E-mail: joke.werbrouck@ugent.be; Ruyck, Kim de [Department of Basic Medical Sciences, Ghent University, Ghent (Belgium); Duprez, Frederic; Veldeman, Liv [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Claes, Kathleen [Center for Medical Genetics, Ghent University Hospital, Ghent (Belgium); Eijkeren, Marc van; Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Willems, Petra; Vral, Anne [Department of Basic Medical Sciences, Ghent University, Ghent (Belgium); Neve, Wilfried de [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Thierens, Hubert [Department of Basic Medical Sciences, Ghent University, Ghent (Belgium)

    2009-03-15

    Purpose: To investigate the association between dose-related parameters and polymorphisms in DNA DSB repair genes XRCC3 (c.-1843A>G, c.562-14A>G, c.722C>T), Rad51 (c.-3429G>C, c.-3392G>T), Lig4 (c.26C>T, c.1704T>C), Ku70 (c.-1310C>G), and Ku80 (c.2110-2408G>A) and the occurrence of acute reactions after radiotherapy. Materials and Methods: The study population consisted of 88 intensity-modulated radiation therapy (IMRT)-treated head-and-neck cancer patients. Mucositis, dermatitis, and dysphagia were scored using the Common Terminology Criteria (CTC) for Adverse Events v.3.0 scale. The population was divided into a CTC0-2 and CTC3+ group for the analysis of each acute effect. The influence of the dose on critical structures was analyzed using dose-volume histograms. Genotypes were determined by polymerase chain reaction (PCR) combined with restriction fragment length polymorphism or PCR-single base extension assays. Results: The mean dose (D{sub mean}) to the oral cavity and constrictor pharyngeus (PC) muscles was significantly associated with the development of mucositis and dysphagia, respectively. These parameters were considered confounding factors in the radiogenomics analyses. The XRCC3c.722CT/TT and Ku70c.-1310CG/GG genotypes were significantly associated with the development of severe dysphagia (CTC3+). No association was found between the investigated polymorphisms and the development of mucositis or dermatitis. A risk analysis model for severe dysphagia, which was developed based on the XRCC3c.722CT/TT and Ku70c.-1310CG/GG genotypes and the PC dose, showed a sensitivity of 78.6% and a specificity of 77.6%. Conclusions: The XRCC3c.722C>T and Ku70c.-1310C>G polymorphisms as well as the D{sub mean} to the PC muscles were highly associated with the development of severe dysphagia after IMRT. The prediction model developed using these parameters showed a high sensitivity and specificity.

  19. Adverse effects of cocaine abuse.

    PubMed

    Washton, A M; Tatarsky, A

    1984-03-01

    Specific consequences of cocaine abuse on health and psycho-social functioning were assessed in 55 cocaine-abusing subjects who called a telephone "helpline." REsults showed a high incidence and wide range of adverse consequences including: impairment of job functioning, interpersonal relationships, and financial status; disturbances of mood and cognitive functioning; psychiatric symptoms of depression, paranoia, and increased suicidal/violent tendencies; and physical symptoms of exhaustion, weight loss, sleep problems, and seizures. Cocaine-related automobile accidents, suicide attempts, and violent acts, including a cocaine-related homicide, were also reported. Intranasal users reported no fewer and no less severe adverse consequences than free-base smokers or intravenous users. Our findings challenge popular notions that cocaine is a benign "recreational" drug and that the intranasal route of administration guarantees protection against addictive patterns of use and adverse effects. PMID:6434968

  20. Detection of herpesvirus DNA by the polymerase chain reaction (PCR) in vitreous samples from patients with necrotising retinitis

    PubMed Central

    Nogueira, M; Siqueira, R; Freitas, N; Amorim, J; Bonjardim, C; Ferreira, P; Orefice, F; Kroon, E

    2001-01-01

    Aims—Viral uveitis and retinitis, usually caused by herpesviruses, are common in immunosuppressed patients. The diagnosis of viral anterior uveitis and retinitis is usually clinical. The polymerase chain reaction (PCR) has been used for the diagnosis of some viral infections, especially those caused by herpesviruses. This paper reports the use of PCR in the diagnosis of viral retinitis in vitreous samples from Brazilian patients. Methods—PCR was used for the diagnosis of necrotising retinitis in vitreous samples from patients from the Hospital São Geraldo, Universidade Federal de Minas Gerais, Brazil. The vitreous samples were collected by paracentesis and stored until analysis. Samples were analysed by PCR using specific primers designed to amplify herpes simplex virus 1 (HSV-1), varicella zoster virus (VZV), or human cytomegalovirus (HCMV). In a case of anterior uveitis, PCR was performed with a sample from the anterior chamber. Results—Herpesvirus DNA was amplified in 11 of 17 samples. HCVM DNA was detected in nine samples but DNA from HSV-1 and VZV were detected only once each. Conclusion—These results strongly suggest that PCR could be used for a rapid complementary diagnosis of viral uveitis and retinitis. A prospective study to evaluate the PCR results, clinical evolution, and treatment is imperative to corroborate the real value of PCR in diagnosis and how it could help the clinicians' approach. Key Words: polymerase chain reaction • uveitis • retinitis PMID:11215276