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1

Adverse drug reaction cards carried by patients.  

PubMed

Five hundred patients were asked whether they were allergic to any medicines. The description given of any stated reaction was assessed to see whether an important adverse drug reaction was likely to have occurred. The patients' records were also examined for collaborative evidence. Poor documentation often made it difficult to confirm the patient's claim of drug sensitivity. A total of 89 patients may have suffered from important adverse reactions to 113 drugs. Full documentation of adverse reactions is important, but only eight patients carried any information to warn others of their sensitivities. Patients should be asked about any drug sensitivities and, if appropriate, given written confirmation of them. A quick, simple method of doing this would be to provide patients' with a plastic card, similar to a credit card, with instructions and details of the reaction written on it with an indelible pen. PMID:3084023

Hannaford, P C

1986-04-26

2

Subjective adverse reactions to metronidazole in patients with amebiasis.  

PubMed

Subjective adverse reactions to metronidazole were analyzed in 111 patients with amebiasis. Metronidazole was administered to 36 patients at a daily dose of 2250mg and 75 patients at daily doses lower than 2250mg. The reactions reported included nausea without vomiting in 11 (9.9%) patients, nausea with vomiting in 2 (1.8%), dysgeusia in 2 (1.8%), diarrhea in 1 (0.9%), headache in 1 (0.9%), numbness in 1 (0.9%), dizziness in 1 (0.9%), urticaria in 1 (0.9%), exanthema in 1 (0.9%), and discomfort in 1 (0.9%). Nausea was reported by 28% (10/36) of the patients receiving metronidazole at a daily dose of 2250mg and 4% (3/75) of the patients receiving lower daily doses. The duration of the metronidazole administration in days was not associated with the appearance of nausea. No life-threatening adverse reactions were identified, and good clinical therapeutic effects were observed in 96% (107/111) of the patients. While metronidazole appears to be a safe anti-protozoal agent for patients with amebiasis, our results indicate that a daily metronidazole dose of 2250mg is excessive for amebiasis, as it often induces nausea. PMID:24929036

Ohnishi, Kenji; Sakamoto, Naoya; Kobayashi, Ken-Ichiro; Iwabuchi, Sentaro; Nakamura-Uchiyama, Fukumi; Ajisawa, Atsushi; Yamauchi, Yuko; Takeshita, Nozomi; Yamamoto, Yasuyuki; Tsunoda, Takafumi; Yoshimura, Yukihiro; Tachikawa, Natsuo; Uehira, Tomoko

2014-10-01

3

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

Microsoft Academic Search

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

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

2002-01-01

4

Contribution of adverse drug reactions to hospital admission of older patients  

Microsoft Academic Search

OBJECTIVE: To describe the severity of adverse drug reactions as a factor\\u000a in hospital admission of older patients, and to identify risk indicators\\u000a for severe adverse drug reactions in these patients. DESIGN: Observational\\u000a cross-sectional study. SETTING: Five wards in a university hospital in The\\u000a Netherlands. SUBJECTS: Patients aged 70 and over admitted to general\\u000a medical wards. METHODS: Use of statistical

C. K. Mannesse; F. H. M. Derkx; Ridder de M. A. J; A. J. Man in't Veld; Cammen van der T. J. M

2000-01-01

5

[Adverse reactions to vaccines].  

PubMed

Adverse reactions to vaccines are highly varied, ranging from mild local reactions to fatal outcomes. In the last few years many adverse reactions have been attributed to vaccines, often without justification. In agreement with the World Health Organization, these reactions can be classified as follows, depending on the cause: vaccination-induced reactions (due to an effect of the vaccine itself or to an idiosyncrasy); reactions due to errors in storage, manipulation and/or administration; and coincidental reactions (no causal relationship with the vaccine). Hypersensitivity reactions fall into six categories, depending on the causative agent: reactions due to some component of the infectious agent or one of its products; reactions due to adjuvants: aluminium hydroxide; reactions due to stabilizers: gelatin; reactions due to preservatives: thiomersal; reactions due to antibiotics: neomycin; and reactions due to a biological culture medium: chicken embryo cells. Allergic children should not be excluded from the normal vaccine calendar. Immunologically, allergic individuals are more susceptible to infection and to microbial and viral diseases, which often play an aggravating role. Rubella, whooping cough, and influenza usually exacerbate respiratory allergies. Non-vaccination carries a marked risk of contracting serious diseases such as poliomyelitis, tetanus, and diphtheria, etc. In a not too distant future, the techniques of genetic recombination and monoclonal antibody production will allow the creation of vaccines from organisms that cannot be cultivated in the laboratory or that produce small quantities of antigen. These techniques will also lead to identification of the antigens with the greatest immunogenic power and, consequently, to extremely pure vaccines. The adverse reactions to vaccines referred to our service account for between 0.59 % and 1.27 % of first visits in the last three years. We recorded a total of 48 adverse reactions to vaccines. Of these, 44 were attributed to the tetanus vaccine (92 %), 2 to the measles-mumps-rubella vaccine (4 %) and 2 to the meningitis A and C vaccine (4 %). Clinical features consisted of urticaria (11 cases), urticaria with angioedema (7 cases), pseudo-shock (5 cases), fever and urticaria (4 cases), local reactions (4 cases), persistent crying with exanthema (3 cases), giant local reactions with angioedema of the limb (3 cases), anaphylaxis (3 cases), fever > 39.5 C (2 cases), bronchospasm (1 case), and severe atopic dermatitis (1 case).A regimen of hyposensitization to tetanus toxoid was required in 20 patients (45 %); in three, this could not be completed due to generalized urticaria but all the patients presented protective titers with diluted vaccine. PMID:12783762

Eseverri, J L; Ranea, S; Marin, A

2003-01-01

6

Predisposing Factors in Adverse Reactions to Drugs  

Microsoft Academic Search

Predisposing factors were sought in 118 patients who developed adverse drug reactions in hospital. Significantly more patients of 60 years and over, and more women than men, developed adverse drug reactions. Patients with reactions had more drugs before the development of the reaction than patients who did not develop reactions. A previous adverse drug reaction and a history of allergic

Natalie Hurwitz

1969-01-01

7

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension  

PubMed Central

Purpose To prospectively investigate adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. We also examined patient attitudes to adverse reactions via a questionnaire. Methods Fifty-two Japanese patients with glaucoma or ocular hypertension were enrolled. Iridial, eyelid, and eyelash photographs were taken before and at 6 months after bimatoprost treatment. Increase in eyelid pigmentation, iridial pigmentation, eyelash growth and bristle, and vellus hair of the lid was assessed from the photographs. Questionnaires completed by patients provided insight into their subjective judgment of adverse reactions. Results Increase in eyelash bristle (53.8%), iris pigmentation (50.0%), eyelash growth (46.2%), vellus hair of the lid (40.4%), and eyelid pigmentation (7.7%) was evident after bimatoprost treatment. The objective and subjective assessments were in agreement in terms of increase in eyelash bristle, eyelash growth, and increase in vellus hair of the lid. Conclusion Most patients were conscious of these adverse reactions. Before administering bimatoprost, sufficient explanation of potential adverse reactions should be provided; after initiating treatment, careful observation is required.

Inoue, Kenji; Shiokawa, Minako; Sugahara, Michitaka; Higa, Risako; Wakakura, Masato; Tomita, Goji

2012-01-01

8

Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients  

Microsoft Academic Search

Objective To ascertain the current burden of adverse drug reactions (ADRs) through a prospective analysis of all admissions to hospital. Design Prospective observational study. Setting Two large general hospitals in Merseyside, England. Participants 18 820 patients aged > 16 years admitted over six months and assessed for cause of admission. Main outcome measures Prevalence of admissions due to an ADR,

Munir Pirmohamed; Sally James; Shaun Meakin; Chris Green; Andrew K Scott; Thomas J Walley; Keith Farrar; B Kevin Park; Alasdair M Breckenridge; Alasdair M

2006-01-01

9

Adverse reactions to vaccines.  

PubMed

(The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.) Immunization healthcare is becoming increasingly complex as the number and types of vaccines have continued to expand. Like all prescription drugs, vaccines may be associated with adverse events. The majority of these reactions are self-limited and not associated with prolonged disability. The media, Internet and public advocacy groups have focused on potentially serious vaccine-associated adverse events with questions raised about causal linkages to increasing frequencies of diseases such as autism and asthma. Despite a lack of evidence of a causal relationship to a variety of vaccine safety concerns, including extensive reviews by the Institute of Medicine, questions regarding vaccine safety continue to threaten the success of immunization programs. Risk communication arid individual risk assessment is further challenged by the public health success of vaccine programs creating the perception that certain vaccines are no longer necessary or justified because of the rare reaction risk. There is a need for improved understanding of true vaccine contraindications and precautions as well as host factors and disease threat in order to develop a patient specific balanced risk communication intervention. When they occur, vaccine related adverse events must be treated, documented and reported through the VAERS system. The increasing complexity of vaccination health care has led the Center of Disease Control and Prevention (CDC) to identify Vaccine Safety Assessment and Evaluation as a potential new specialty. PMID:12721397

Martin, Bryan L; Nelson, Michael R; Hershey, Joyce N; Engler, Renata J M

2003-06-01

10

Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes  

PubMed Central

Adverse drug reactions (ADRs) are a major cause of hospital admissions, but recent data on the incidence and clinical characteristics of ADRs which occur following hospital admission, are lacking. Patients admitted to twelve wards over a six-month period in 2005 were assessed for ADRs throughout their admission. Suspected ADRs were recorded and analysed for causality, severity and avoidability and whether they increased the length of stay. Multivariable analysis was undertaken to identify the risk factors for ADRs. The 5% significance level was used when assessing factors for inclusion in multivariable models. Out of the 3695 patient episodes assessed for ADRs, 545 (14.7%, 95% CI 13.6–15.9%) experienced one or more ADRs. Half of ADRs were definitely or possibly avoidable. The patients experiencing ADRs were more likely to be older, female, taking a larger number of medicines, and had a longer length of stay than those without ADRs. However, the only significant predictor of ADRs, from the multivariable analysis of a representative sample of patients, was the number of medicines taken by the patient with each additional medication multiplying the hazard of an ADR episode by 1.14 (95% CI 1.09, 1.20). ADRs directly increased length of stay in 147 (26.8%) patients. The drugs most frequently associated with ADRs were diuretics, opioid analgesics, and anticoagulants. In conclusion, approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode. The overall burden of ADRs on hospitals is high, and effective intervention strategies are urgently needed to reduce this burden.

Davies, Emma C.; Green, Christopher F.; Taylor, Stephen; Williamson, Paula R.; Mottram, David R.; Pirmohamed, Munir

2009-01-01

11

Cutaneous Adverse Reactions to Highly Antiretroviral Therapy in HIV-Positive Patients  

PubMed Central

Adverse drug reactions to highly antiretroviral therapy (HAART) are major obstacles in its success. Although overall mortality from HIV has dramatically declined owing to HAART, these antiretroviral regimens have been associated with a wide spectrum of severe cutaneous reactions. The severity of cutaneous adverse reactions varies greatly, and some may be difficult to manage. To optimize adherence and efficacy of antiretroviral treatment, clinicians must focus on preventing adverse effects whenever possible, and distinguish those that are self-limited from those that are potentially serious. This paper presents the case of a serious cutaneous adverse reaction to Atripla in a HIV-positive 50-year-old Caucasian woman.

Pistone, G.; Pistone, A.; Sorbello, D.; Viviano, E.; Bongiorno, M.R.

2014-01-01

12

Adverse reactions to food additives  

Microsoft Academic Search

There are thousands of additives used by the food industry for a variety of purposes in the foods we eat. However, only a\\u000a small number have been implicated in causing adverse reactions in humans. Although there are reported cases of individuals\\u000a who have reactions to single additives, most of the medical literature involves patients with asthma or chronic idiopathic\\u000a urticaria\\/angioedema

Ronald A. Simon

2003-01-01

13

ISMP Adverse Drug Reactions  

PubMed Central

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration’s (FDA’s) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@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.

2013-01-01

14

Adverse drug reactions in older patients: an Italian observational prospective hospital study  

PubMed Central

Background In adults over 65 years of age, the frequency of adverse drug reaction (ADRs) related hospital admissions is higher than in younger adults, and the frequency of ADRs occurring during hospital stay highly ranges. The review was designed to evaluate the frequency of ADRs, both resulting in hospital admission and occurring during the hospital stay of older patients, while identifying the types of reactions and the associated drugs. Methods Age, sex, date, and diagnosis of admission of all patients aged 65 and over admitted in three geriatric wards of University Hospital of Verona, Italy, from February to July 2009 were registered by nurses on a special form. In the specific cases of admissions caused by an ADR as well as in the cases of an ADR occurring during the hospital stay, the type of reactions and the suspected drugs were also registered by nurses and physicians involved in the study. Results During the six months of the study, 1023 patients matched the inclusion criteria and were included in the study. One hundred fourteen hospital admissions (11.1%) were caused by ADRs, while 256 patients (25.0%) had an ADR during their hospital stay. The duration of hospital stay was significantly longer in patients who developed an ADR during their time in hospital, 18.7 (95% CI: 17.2–20.1) days versus 12.6 (95% CI: 11.9–13.3) days. Electrolyte disorders, gastrointestinal disorders, anemia, and International Normalized Ratio increase were the more frequent observed ADRs, with diuretics, antithrombotic agents, and antibacterials as the main involved drugs. Our study confirms that ADRs are an important cause of hospitalization in older patients. In addition, the frequency of ADRs occurring during hospital stay is high and causes prolonged hospitalization.

Conforti, Anita; Costantini, Davide; Zanetti, Francesca; Moretti, Ugo; Grezzana, Matteo; Leone, Roberto

2012-01-01

15

HRQoL questionnaire evaluation in lactose intolerant patients with adverse reactions to foods.  

PubMed

The occurrence of patients with gastrointestinal symptoms attributed either to food allergy or intolerance has significantly increased. Nevertheless, an accurate and detailed case history, a systematic evaluation and the outcomes of specific allergy tests to identify the offending foods, including "in vivo" and "in vitro" allergy tests, are often negative for food allergy and may indicate a lactose intolerance, which is a recurrent condition affecting about 50% of adults. The aims of our study were the following: (1) What is the real incidence of the food hypersensitivity and the primary lactose intolerance in patients with gastrointestinal symptoms, initially referred to allergy or food intolerance? (2) Does lactose intolerance affect the quality of life and compliance to the therapy program? We investigated 262 consecutive patients, 72 men and 190 women. An accurate and detailed history and clinical examination were completed to investigate the offending foods. The evaluation in each patient included: allergy tests, lactose H2 breath test (LHBT) and the HRQoL questionnaire. Five years after the diagnosis of lactose intolerance, a questionnaire on the persistence of gastrointestinal symptoms after lactose ingestion and the diet compliance was distributed. Our results demonstrate an high prevalence of lactose intolerance, more frequent in women; in these patients, bloating and diarrhea are the most reported symptoms. We observe only a significant positive correlation between adverse drug reaction (ADR) and LHBT+ patients, but not an augmented prevalence of food allergy and a negative impact on the HRQoL questionnaire of lactose intolerance. PMID:21614464

Erminia, Ridolo; Ilaria, Baiardini; Tiziana, Meschi; Silvia, Peveri; Antonio, Nouvenne; Pierpaolo, Dall'Aglio; Loris, Borghi

2013-09-01

16

Motives for reporting adverse drug reactions by patient-reporters in the Netherlands  

PubMed Central

Aim The aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre. Method A web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were analysed using descriptive statistics, ?2 tests and Spearman’s correlation coefficients. Results The response rate was 76.5% after one reminder. The main reasons for patients to report ADRs were to share their experiences (89% agreed or strongly agreed), the severity of the reaction (86% agreed or strongly agreed to the statement), worries about their own situation (63.2% agreed or strongly agreed) and the fact the ADR was not mentioned in the patient information leaflet (57.6% agreed or strongly agreed). Of the patient-responders, 93.8% shared the opinion that reporting an ADR can prevent harm to other people, 97.9% believed that reporting contributes to research and knowledge, 90.7% stated that they felt responsible for reporting an ADR and 92.5% stated that they will report a possible ADR once again in the future. Conclusion The main motives for patients to report their ADRs to a pharmacovigilance centre were the severity of the ADR and their need to share experiences. The high level of response to the questionnaire shows that patients are involved when it comes to ADRs and that they are also willing to share their motivations for and opinions about the reporting of ADRs with a pharmacovigilance centre.

van der Welle, Christine; Passier, Anneke; van Puijenbroek, Eugene; van Grootheest, Kees

2010-01-01

17

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

PubMed Central

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

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

2014-01-01

18

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

PubMed Central

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

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

2013-01-01

19

[Novel oral anticancer drugs: a review of adverse drug reactions, interactions and patient adherence].  

PubMed

Each aspect of oncological care is widely affected by the spread of oral anticancer agents, which raises several questions in terms of safe medication use and patient adherence. Over the past decade targeted therapies have appeared in clinical practice and revolutionized the pharmacological treatment of malignancies. Regular patient - doctor visits and proper patient education is crucial in order to comply with the therapy previously agreed upon with the oncologist, to increase patient adherence, to detect and to treat adverse effects in early stages. Since the information on the new medicines in Hungarian language is sparse it is the intention of the authors to give an overview of the basic knowledge, patient safety issues, adverse effects and interactions. Official drug information summaries and data on pharmacokinetics, interactions and adverse effects from the literature are reviewed as the basis for this overview. PMID:22217686

Bartal, Alexandra; Mátrai, Zoltán; Szucs, Attila; Belinszkaja, Galina; Langmár, Zoltán; Rosta, András

2012-01-15

20

Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study  

PubMed Central

Background More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China. Methods A prospective population-based cohort study was performed during 2007–2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration. Results A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44–2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43–4.68). Conclusions The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.

Lv, Xiaozhen; Tang, Shaowen; Xia, Yinyin; Wang, Xiaomeng; Yuan, Yanli; Hu, Daiyu; Liu, Feiying; Wu, Shanshan; Zhang, Yuan; Yang, Zhirong; Tu, Dehua; Chen, Yixin; Deng, Peiyuan; Ma, Yu; Chen, Ru; Zhan, Siyan

2013-01-01

21

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

PubMed Central

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

Abbasinazari, Mohammad; Sahraee, Zahra; Mirahmadi, Maryam

2013-01-01

22

Immunogenicity and adverse reactions of influenza vaccination in elderly patients given acetaminophen or placebo.  

PubMed

The objective was to examine the antibody responses to influenza immunization in an elderly population and the effect of prophylactic acetaminophen on adverse responses due to inactivated whole virus vaccine containing influenza A (H3N2 and H1N1) and B antigens. During the autumn of 1990, 100 patients 65 years or older were immunized and randomly allocated to receive placebo or 1,950 mg (2 x 975 mg) of acetaminophen. They recorded any local and systemic side effects over a 3-day period. Serology was performed on pre- and post (4-6 weeks) -vaccination sera. Age and gender distribution in the study were: 47% who were 75 years or older, and 61% of the patients were female. Most of the patients (97%) had pre-existing antibodies to Influenza A or B. Average peak preimmunization antibody titers were 40 to B Yamagata and A Taiwan (H1N1) and 80 for A Shanghai (H3N2). Half of each treatment group had a 4-fold or greater rise in antibody titer in response to the vaccine. Only 30% of patients immunized the previous year but 80% of those never vaccinated previously demonstrated a 4-fold or greater serological response to the vaccine. However, measurement of protection rates (HI >/= 40) before and after vaccination indicated 81.1-100% protection for the 3 viruses not influenced by treatment, gender or a history of previous vaccination. Both treatment groups had equally small numbers of patients who recorded systemic symptoms of drowsiness, myalgia, fever and chills and about 50% had arm soreness. Although about 80% of previously unimmunized adults mounted a 4-fold antibody rise to influenza vaccine antigens whereas booster effects were seen in only 30% of those immunized the previous year, protection rates were high (81-100%) after immunization and were not affected by acetaminophen treatment. Adverse effects (15% systemic and 50% local) were not ameliorated by 1950 mg of acetaminophen in these elderly patients. PMID:15566726

Chernesky, M; O'Neill, D; Pickard, L; Castriciano, S; Kraftcheck, D; Sellors, J; McLean, D; Flett, N; Mahony, J

1993-07-01

23

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

PubMed Central

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

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

2014-01-01

24

[Adverse drug reactions on hair].  

PubMed

Adverse drug reactions on the hair are common side effects. The spectrum of loss of hair reaches from diffuse telogen effluvium up to circumscribed or diffuse alopecia on the scalp, sometimes also including other body areas. Other side effects observed are the stimulation of hair growth with hypertrichosis and induction or worsening of hirsutism, as well as changes of the structure or color of the hair. In most cases--other than those treated with cytostatics, androgens, or hormonal contraceptives with some androgenic effect--it is rather difficult to determine the time of onset and primary cause, since the diffuse types often start subclinically, and other factors may play an additional part. As a rule, adverse drug reactions are reversible provided the causative drug is avoided. PMID:2087842

Gollnick, H; Blume, U; Orfanos, C E

1990-12-01

25

Chlorhexidine: uses and adverse reactions.  

PubMed

Chlorhexidine is increasingly being used not only as an antiseptic to prevent hospital infections and an adjuvant in oral hygiene but also as a preservative in personal care products. As exposure to the agent becomes more widespread, reports of adverse reactions to it are increasing. Complications range from mild irritant contact dermatitis to life-threatening anaphylaxis. Allergic contact dermatitis in some cases precedes anaphylaxis. It is imperative that physicians be aware of the many possible sources of contact with this antiseptic and be alert to recognize the potentially debilitating and catastrophic reactions that may occur because of chlorhexidine sensitization. PMID:23665831

Silvestri, Dianne L; McEnery-Stonelake, Melissa

2013-01-01

26

How good are articles on adverse drug reactions?  

PubMed Central

A study was carried out of the quality and completeness of articles on adverse drug reactions: 5737 articles from 80 countries published between 1972 and 1979 were studied. Only 61% of the articles included information on the number of patients treated and the number with adverse drug reactions, yet these are essential for calculating the incidence of adverse reactions. In only 55% could the incidence of a particular adverse reaction be calculated. Great importance is placed on articles on adverse reactions, particularly those that report on many patients. Authors and editors should ensure that articles include the following information: drug regimens, numbers of patients treated, numbers of patients developing adverse reactions, and nature and incidence of adverse reactions.

Venulet, J; Blattner, R; von Bulow, J; Berneker, G C

1982-01-01

27

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

Microsoft Academic Search

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

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

28

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

PubMed

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

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

2012-01-01

29

Adverse reactions to injectable soft tissue fillers.  

PubMed

In recent years, injections with filler agents are often used for wrinkle-treatment and soft tissue augmentation by dermatologists and plastic surgeons. Unfortunately, the ideal filler has not yet been discovered and all of them may induce adverse reactions. Quickly biodegradable or resorbable agents may induce severe complications, but they will normally disappear spontaneously in a few months. Slowly biodegradable or nonresorbable fillers may give rise to severe reactions that show little or no tendency to spontaneous improvement. They may appear several years after the injection, when the patient does not remember which product was injected, and treatment is often insufficient. In this review, we discuss the most commonly used fillers, their most frequent adverse reactions as well as the characteristic histopathologic findings that allow the identification of the injected filler agent. In conclusion, histopathologic study remains as the gold standard technique to identify the responsible filler. PMID:21167403

Requena, Luis; Requena, Celia; Christensen, Lise; Zimmermann, Ute S; Kutzner, Heinz; Cerroni, Lorenzo

2011-01-01

30

Mechanisms of Adverse Drug Reactions to Biologics  

Microsoft Academic Search

Biologics encompass a broad range of therapeutics that include proteins and other products derived from living systems. Although\\u000a the multiplicity of target organs often seen with new chemical entities is generally not seen with biologics, they can produce\\u000a significant adverse reactions. Examples include IL-12 and an anti-CD28 antibody that resulted in patient deaths and\\/or long\\u000a stays in intensive care units.

Janet B. Clarke

31

HRQoL questionnaire evaluation in lactose intolerant patients with adverse reactions to foods  

Microsoft Academic Search

The occurrence of patients with gastrointestinal symptoms attributed either to food allergy or intolerance has significantly\\u000a increased. Nevertheless, an accurate and detailed case history, a systematic evaluation and the outcomes of specific allergy\\u000a tests to identify the offending foods, including “in vivo” and “in vitro” allergy tests, are often negative for food allergy\\u000a and may indicate a lactose intolerance, which

Ridolo Erminia; Baiardini Ilaria; Meschi Tiziana; Peveri Silvia; Nouvenne Antonio; Dall’Aglio Pierpaolo; Borghi Loris

32

Adverse Reactions: Structure, Philosophy, and Outcomes of the Patient Protection and Affordable Care Act  

Microsoft Academic Search

On March 24th, 2010, President Obama signed the Patient Protection and Affordable Care Act, declaring “everybody should have some basic security when it comes to their health care.” This Note provides legal scholarship’s first comprehensive examination of this complex legislation. Second, it reframes the bill by proposing that its miscellaneous-seeming provisions are designed to protect a single, central provision: the

Lee Michael A Jr

2010-01-01

33

Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy  

PubMed Central

To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/?l were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ?250 cells/mm3 with comorbid conditions.

Srikanth, B. Akshaya; Babu, S. Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar

2012-01-01

34

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

Microsoft Academic Search

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,

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

2002-01-01

35

[Study on adverse drug reaction in Yuixngcao injection literatures].  

PubMed

Yuxingcao injection was suspended by China State Food and Drug Administration in 2006 for its severe adverse reaction in clinical practice. Althoug there are many real factors resulted in Yuxingcao injection's adverse reaction, some confounding factors should not be ignored. This study searched different kinds of related literatures and found out irregularity in defining dosage, disuses courses, indications and administration approach, which were the potential factors that caused the reported adverse drug reaction for Yuxingcao injection. And 97.8% adverse drug reaction in Yuxingcao injection happened 30 minutes after patients received administion, hence, observing patients'reaction in the first 30 minutes should be very important to prevent severe adverse drug reaction. PMID:22292386

Wang, Zhifei; Xie, Yanming; Wang, Yongyan

2011-10-01

36

Adverse drug reactions induced by valproic acid.  

PubMed

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

Nanau, Radu M; Neuman, Manuela G

2013-10-01

37

Adverse drug reactions caused by methotrexate in Saudi population  

PubMed Central

Aim The aim of this study is to document adverse drug reactions (ARDs) of methotrexate (MTX) in Saudi patients. Methods Cross sectional study of adult patients on MTX, attending rheumatology drug monitoring clinics in a university hospital, over a period of 24 weeks. Adverse drug reactions were sought by patient interview, files review and laboratory abnormalities. Results Data collected included patients’ demographics, diagnoses, co-morbidities, MTX dose and duration, other medications, laboratory abnormalities and adverse reactions, their severity, preventability, and outcome. Out of a total of 593 patients screened, 186 (31.4%) using MTX were interviewed. Most of the patients were female (88.5%). Adverse drug reactions (ADRs) were detected in 61 patients (32.8%). Patients with ADRs took a mean dose of 12.9 mg (2.5–22.5 mg). Ten ADRs (16.4% of total reactions) were preventable; they ranged between severe, moderate and mild. The most common ADRs were gastrointestinal (GI) (52.5%), followed by anemia (8.2%) and chest tightness (6.6%). The duration of the reaction ranged from few hours to 4 years. Conclusion In conclusion our patients with adverse reactions were younger, took less medications and had less co-morbidities. Our results were different from those published in the literature relating MTX toxicity.

Al-Malaq, Haya M.; Al-Arfaj, Hussein F.; Al-Arfaj, Abdurhman S.

2012-01-01

38

Validating Adverse Drug Reaction Cases.  

National Technical Information Service (NTIS)

Difficulties in evaluating drug-reaction cases have arisen from failure to study time relationships between drugs and disease makers, failure to rule out other-than-drug causes, failure to use clinical-laboratory data, and lack of communication between cl...

N. S. Irey

1973-01-01

39

Idiosyncratic Adverse Drug Reactions: Current Concepts  

PubMed Central

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

Naisbitt, Dean J.

2013-01-01

40

Mechanisms underlying adverse reactions to vaccines.  

PubMed

A broad spectrum of adverse events is reported following human vaccination but such reactions are considered to be relatively rare. A variety of mechanisms has been proposed to account for such adverse events. These most commonly relate to the actual process of vaccination and range from the vagal reaction associated with anxiety about needle injection, to use of an inappropriate site of administration, or infection of the healthcare worker by accidental injection during needle-capping. Other adverse events directly associated with the vaccine include reversion to virulence of attenuated vaccine strains of organisms, or contamination of the vaccine product. Adverse events may involve immune-mediated phenomena triggered by exposure to the microbial or other components of vaccines. These include: classical IgE-mediated type I hypersensitivity reactions, and immune-complex type III hypersensitivity (Arthus) reactions. Such reactions may be localized or systemic in nature. A variety of autoimmune reactions has been suggested to be triggered by vaccination, but in general the evidence for such associations remains largely anecdotal. Finally, many reported adverse events are simply chance instances of infection or disease onset around the time of vaccination and are not causally associated with administration of vaccine. PMID:17559869

Siegrist, C-A

2007-07-01

41

[Injectable fillers: adverse reactions and their management].  

PubMed

Injectable fillers are one of the corner stones of aesthetic medicine. In general they are safe to use. However, adverse reactions may occur. These reactions may be acute, subacute or delayed, e.g. after decades. It is important to know these reactions and to be prepared so that they can be adequately treated, in view of the clinical symptoms, the injected material and if applicable other diseases/treatments that might trigger these reactions. Last but not least, all reactions should be reported either to specialized registries or regulatory agencies. Only then we are able to learn more about these reactions and their best possible treatment. PMID:23407758

Rzany, B; Bachmann, F; Nast, A

2013-02-01

42

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

PubMed Central

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

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

2013-01-01

43

Adverse cutaneous reactions to imatinib (STI571) in Philadelphia chromosome-positive leukemias: A prospective study of 54 patients  

Microsoft Academic Search

Background: Imatinib is a new major treatment in chronic myeloid leukemia. Objective: To study the cutaneous reactions induced by imatinib. Methods: All inpatients and outpatients with Philadelphia chromosome-positive leukemia treated by imatinib were included in this prospective study. Clinical features, pathologic findings, evolution of each case, and analysis of potential risk factors were recorded. Results: A total of 54 patients

Laurence Valeyrie; Sylvie Bastuji-Garin; Jean Revuz; Nicolas Bachot; Janine Wechsler; Patrice Berthaud; Michel Tulliez; Stéphane Giraudier

2003-01-01

44

[Pharmacotherapy of hyperthyreosis--adverse drug reactions].  

PubMed

The antithyroid drugs mainly include thioimidazole (carbimazole, methimazole=thiamazole) and propylthiouracil. After absorption, carbimazole is rapidly metabolized to methimazole and thus switching between these two drugs should not be considered in case of side effects. Furthermore, in case of side effects, sometimes even cross reactions between thioimidazoles and propylthiouracil occur. Common and typical adverse reactions of antithyroid drugs include dose dependent hypothyroidism and thus thyroid function should be repeatedly checked while the patient is on antithyroid drugs. Furthermore, pruritus and rash may develop. In this case, one might try to switch from thioimidazoles to propylthiouracil or vice versa. Antithyroid drugs may cause mild dose dependent neutropenia or severe allergy-mediated agranulocytosis, which typically occurs during the first three months of treatment, has an incidence of 3 per 10,000 patients and cross reactivity between thioimidazoles to propylthiouracil may occur. Rarely, antithyroid drugs can cause aplastic anemia. Mainly propylthiouracil, but sometimes also methimazole may lead to an asymptomatic transient increase in liver enzymes or to severe, even lethal liver injury of cholestatic or hepatocellular pattern. Since propylthiouracil associated liver injury was observed increasingly among children and adolescent, it has been suggested to prefer thioimidazoles for these patients. Because of these potential serious adverse effects, physicians should advise patients to immediately seek medical help if they get a fever or sore throat or malaise, abdominal complaints or jaundice, respectively. Furthermore, arthralgias may develop in 1-5% of patients under both antithyroid drugs. Since arthralgias may be the first symptom of more serious immunologic side effects, it is recommended to stop the antithyroid drug in this case. Drug induced polyarthritis mainly develops during the first month of therapy, whereas ANCA-positive vasculitis is generally observed only after long term exposure to propylthiouracil or very rarely with the thioimidazoles. The teratogenic risk of the thioimidazoles is somewhat higher (Aplasia cutis congenita), that is why one generally recommends preferring propylthiouracil during pregnancy. During breast feeding both, thioimidazoles or propylthiouracil, may be administered. Nowadays, perchlorate is only used short term in case of latent hyperthyroidism before administering iodine-containing contrast agents. Therefore, the known side effects, which usually are only observed after long term treatment, are not an issue any more. PMID:21656488

Perger, Ludwig; Bürgi, Ulrich; Fattinger, Karin

2011-06-01

45

Intensive Hospital Monitoring of Adverse Reactions to Drugs  

Microsoft Academic Search

A total of 1,268 patients admitted to hospital wards were kept under surveillance by one observer throughout their stay in hospital. All drugs given to them and the occurrence of adverse reactions were recorded.Drug reactions were found in 10·2% of the 1,160 patients who received drug therapy. Most reactions were due to known pharmacological actions of the drugs. Though only

Natalie Hurwitz; O. L. Wade

1969-01-01

46

A Summary of Adverse Reactions Reported to FDA. Volume I. Drug to Adverse Reaction. Volume II. Adverse Reaction to Drug.  

National Technical Information Service (NTIS)

This summary reflects cases of adverse drug reactions reported to FDA which have an occurrence of two or more relative relationships of probable or definite for the period covered by the report. These reports were received through the FDA Voluntary Report...

1980-01-01

47

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

PubMed

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

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

2014-03-01

48

Adverse Drug Reactions Causing Admission to a Paediatric Hospital  

PubMed Central

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.

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

49

Pharmacogenetics of Idiosyncratic Adverse Drug Reactions  

Microsoft Academic Search

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

Munir Pirmohamed

50

Molecular mechanisms of adverse drug reactions  

Microsoft Academic Search

Background: Other than alkylating agents used in cancer chemotherapy, most drugs that cause adverse reactions require metabolism to structures that can react with constituents of our cellular environment to form products that initiate a chain of chemical and biochemical events leading to cellular damage. The mechanisms of formation of reactive metabolites that can cause cellular injury, the nature of the

Sidney D. Nelson

2001-01-01

51

Annual Adverse Drug Reaction Report: 1989.  

National Technical Information Service (NTIS)

The review provides a descriptive overview of the adverse drug reaction (ADR) reports received by the US Food and Drug Administration during 1989. As well as general information, the ADR reports are profiled by types of reports, outcomes, body systems, de...

D. E. Knapp Z. A. Perry A. L. Britt

1990-01-01

52

[Adverse reaction to fillers. Diagnosis and management].  

PubMed

Injectable fillers are an established component of aesthetic medicine. In general they are safe to use. However, adverse reactions are possible for the whole spectrum of products. These reactions can occur immediately, subacute or delayed, e.g. after years. Erythema, edema, abscesses, nodule formation or even ulcerations can be observed. A correct diagnoses of these reactions is important to allow an appropriate treatment, taking into consideration the clinic, the injected material and if applicable other diseases/treatments that might contribute to these reactions. All of these reactions should be reported either to specialized registries and/or to the appropriate national agencies. Only then will we be able to learn more about these reactions and the best possible treatment. PMID:23443639

Rzany, B; Bachmann, F; Nast, A

2013-03-01

53

Pharmacogenomics and adverse drug reactions in children  

PubMed Central

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

Rieder, Michael J.; Carleton, Bruce

2014-01-01

54

Adverse drug reaction, patent blue V dye and anaesthesia  

PubMed Central

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

Tripathy, Swagata; Nair, Priya V

2012-01-01

55

Genetic susceptibility to adverse drug reactions  

Microsoft Academic Search

Adverse drug reactions (ADRs) are a major clinical problem. Genetic factors can determine individual susceptibility to both dose-dependent and dose-independent ADRs. Determinants of susceptibility include kinetic factors, such as gene polymorphisms in cytochrome P450 enzymes, and dynamic factors, such as polymorphisms in drug targets. The relative importance of these factors will depend on the nature of the ADR; however, it

Munir Pirmohamed; B. Kevin Park

2001-01-01

56

Outbreak of Adverse Reactions Associated with Contaminated Heparin  

PubMed Central

BACKGROUND In January 2008, the Centers for Disease Control and Prevention began a nationwide investigation of severe adverse reactions that were first detected in a single hemodialysis facility. Preliminary findings suggested that heparin was a possible cause of the reactions. METHODS Information on clinical manifestations and on exposure was collected for patients who had signs and symptoms that were consistent with an allergic-type reaction after November 1, 2007. Twenty-one dialysis facilities that reported reactions and 23 facilities that reported no reactions were included in a case–control study to identify facility-level risk factors. Unopened heparin vials from facilities that reported reactions were tested for contaminants. RESULTS A total of 152 adverse reactions associated with heparin were identified in 113 patients from 13 states from November 19, 2007, through January 31, 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100.0% of case facilities vs. 4.3% of control facilities, P<0.001). Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate (OSCS). Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. Of 130 reactions for which information on the heparin lot was available, 128 (98.5%) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3%) occurred after the administration of OSCS-contaminated heparin. CONCLUSIONS Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.

Blossom, David B.; Kallen, Alexander J.; Patel, Priti R.; Elward, Alexis; Robinson, Luke; Gao, Ganpan; Langer, Robert; Perkins, Kiran M.; Jaeger, Jennifer L.; Kurkjian, Katie M.; Jones, Marilyn; Schillie, Sarah F.; Shehab, Nadine; Ketterer, Daniel; Venkataraman, Ganesh; Kishimoto, Takashi Kei; Shriver, Zachary; McMahon, Ann W.; Austen, K. Frank; Kozlowski, Steven; Srinivasan, Arjun; Turabelidze, George; Gould, Carolyn V.; Arduino, Matthew J.; Sasisekharan, Ram

2013-01-01

57

In Vivo Diagnostic Tests in Adverse Reactions to Quinolones  

Microsoft Academic Search

? Abstract Background and objective: Contradictory reports of the sensitivity of skin tests in quinolone allergy have been reported. Our objectives were to describe the outcome of quinolone skin and challenge tests in patients consulting because of a history of adverse reaction to quinolone and to compare the outcome of quinolone skin tests and challenge tests in the subsample of

M Venturini Díaz; T Lobera Labairu; I González Mahave

58

Antimicrobial agents, drug adverse reactions and interactions, and cancer.  

PubMed

The intent of this chapter is to review the types of adverse drug reactions and interactions associated with antimicrobial agents, specifically in the setting of patients with malignancies. The initial sections will discuss categorizing and describing the mechanisms of adverse reactions and interactions. The later sections include a detailed discussion about adverse reactions and drug interactions associated with commonly used antibacterial, antiviral, and antifungal agents in this subpopulation. Where relevant, the clinical use and indication for the drugs will be reviewed. The antibacterial section will specifically address the emergence of antimicrobial resistance and drugs of last resort (newer agents, such as linezolid and daptomycin and novel uses of older previously retired agents, such as polymyxin B). The antifungal section will address the ramification of pharmacokinetic interactions and the need to measure drug levels. The chapter is not meant to be exhaustive and as such will not extensively address all antimicrobials or all interactions for each of these agents. PMID:24706233

Millan, Ximena; Muggia, Victoria; Ostrowsky, Belinda

2014-01-01

59

Adverse drug reactions in the elderly  

PubMed Central

Medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population. Age-related changes in drug disposition and pharmacodynamic responses have significant clinical implications; increased use of a number of medications raises the risk that medicine-related problems may occur. The relationship between increased use of drugs including the prescription medication and elderly is well established. Majority of ADRs (80%) causing admission or occurring in hospital are type A reactions. Although less common occurring in elderly, type B ADRs may sometimes cause serious toxicity. Studies have correlated the integral association between old age and increased rate of adverse drug reactions arising out of confounding association between age and polypharmacy contributed by age-related changes in pharmacodynamics and pharmacokinetics at least for some medical conditions. A drug combination may sometimes cause synergistic toxicity which is greater than the sum of the risks of toxicity of either agent used alone. But, strategies to increase opportunities for identifying ADRs and related problems have not been emphasised in current international policy responses especially in India to the increase in elderly population and chronic conditions. Careful epidemiological studies that encompass large numbers of elderly drug users are required to obtain this information as increased knowledge of the frequency and cost of adverse drug reactions is important in enabling both more rational therapeutic decisions by individual clinicians and more optimal social policy.

Brahma, Dhriti K.; Wahlang, Julie B.; Marak, Maxilline D.; Ch. Sangma, Marlina

2013-01-01

60

Adverse drug reactions in the elderly.  

PubMed

Medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population. Age-related changes in drug disposition and pharmacodynamic responses have significant clinical implications; increased use of a number of medications raises the risk that medicine-related problems may occur. The relationship between increased use of drugs including the prescription medication and elderly is well established. Majority of ADRs (80%) causing admission or occurring in hospital are type A reactions. Although less common occurring in elderly, type B ADRs may sometimes cause serious toxicity. Studies have correlated the integral association between old age and increased rate of adverse drug reactions arising out of confounding association between age and polypharmacy contributed by age-related changes in pharmacodynamics and pharmacokinetics at least for some medical conditions. A drug combination may sometimes cause synergistic toxicity which is greater than the sum of the risks of toxicity of either agent used alone. But, strategies to increase opportunities for identifying ADRs and related problems have not been emphasised in current international policy responses especially in India to the increase in elderly population and chronic conditions. Careful epidemiological studies that encompass large numbers of elderly drug users are required to obtain this information as increased knowledge of the frequency and cost of adverse drug reactions is important in enabling both more rational therapeutic decisions by individual clinicians and more optimal social policy. PMID:23761706

Brahma, Dhriti K; Wahlang, Julie B; Marak, Maxilline D; Ch Sangma, Marlina

2013-04-01

61

The ambiguity of adverse drug reactions  

Microsoft Academic Search

Three clinical pharmacologists independently evaluated 500 untoward clinical events reported by physicians as adverse drug reactions (ADRs). They often disagreed with the reporting physicians and with each other. They judged 14.4–28.2% of the events to be definite, 26.4–38.0% probable, 21.4–31.0% possible and 15.8–28.2% unlikely ADRs. In their opinion 19.1–32.4% of the drugs blamed were definitely, 29.8–34.4% probably, 24.9–36.7% possibly and

J. Koch-Weser; E. M. Sellers; R. Zacest

1977-01-01

62

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

PubMed Central

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

2014-01-01

63

Adverse allergic reaction to Technetium-99m methylene diphosphonate  

SciTech Connect

Adverse allergic reactions to radiopharmaceuticals are rare but have been documented in the literature. This report presents data consistent with a definite adverse reaction to the radiopharmaceutical (/sup 99m/Tc)MDP.

Spicer, J.A.; Preston, D.F.; Stephens, R.L.

1985-04-01

64

Adverse reactions to the sulphite additives  

PubMed Central

Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. Most studies report a prevalence of sulphite sensitivity of 3 to 10% among asthmatic subjects who ingest these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. Although a number of potential mechanisms have been proposed, the precise mechanisms underlying sulphite sensitivity remain unclear.

Misso, Neil LA

2012-01-01

65

21 CFR 606.170 - Adverse reaction file.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2010-04-01 true Adverse reaction file. 606.170 Section...and Reports § 606.170 Adverse reaction file. (a) Records shall...any reports of complaints of adverse reactions regarding each unit of...

2011-04-01

66

21 CFR 606.170 - Adverse reaction file.  

Code of Federal Regulations, 2010 CFR

...2009-04-01 2009-04-01 false Adverse reaction file. 606.170 Section...and Reports § 606.170 Adverse reaction file. (a) Records shall...any reports of complaints of adverse reactions regarding each unit of...

2009-04-01

67

21 CFR 606.170 - Adverse reaction file.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section...and Reports § 606.170 Adverse reaction file. (a) Records shall...any reports of complaints of adverse reactions regarding each unit of...

2010-04-01

68

Finding the Genetic Determinants of Adverse Reactions to Radiotherapy.  

PubMed

Individual variation in radiosensitivity is thought to be at least partly determined by genetic factors. The remaining difference between individuals is caused by comorbidities, variation in treatment, body habitus and stochastic factors. Evidence for the heritability of radiosensitivity comes from rare genetic disorders and from cell-based studies. To what extent common and rare genetic variants might explain the genetic component of radiosensitivity has not been fully elucidated. If the genetic variants accounting for this heritability were to be determined, they could be incorporated into any future predictive statistical model of adverse reactions to radiotherapy. With the evolution of DNA sequencing and bioinformatics, radiogenomics has emerged as a new research field with the aim of finding the genetic determinants of adverse reactions to radiotherapy. Similar to the investigation of other complex genetic disease traits, early studies in radiogenomics involved candidate gene association studies - many plagued by false associations caused by low sample sizes and problematic experimental design. More recently, some promising genetic associations (e.g. with tumour necrosis factor) have emerged from large multi-institutional cohorts with built-in replication. At the same time, several small- to medium-sized genome-wide association studies (GWAS) have been or are about to be published. These studies will probably lead to an increasing number of genetic polymorphisms that may predict adverse reactions to radiotherapy. The future of the field is to create large patient cohorts for multiple cancer types, to validate the genetic loci and build reliable predictive models. For example, the REQUITE project involves multiple groups in Europe and North America. For further discovery studies, larger GWAS will be necessary to include rare sequence variants through next generation sequencing. Ultimately, radiogenomics seeks to predict which cancer patients will show radiosensitivity or radioresistance, so oncologists and surgeons can alter treatment accordingly to lower adverse reactions or increase the efficacy of radiotherapy. PMID:24702740

Rattay, T; Talbot, C J

2014-05-01

69

Association of UGT2B7 and ABCB1 genotypes with morphine-induced adverse drug reactions in Japanese patients with cancer  

Microsoft Academic Search

Purpose  To investigate the effects of genetic polymorphisms on morphine-induced adverse events in cancer patients.\\u000a \\u000a \\u000a \\u000a Methods  We examined the relation of morphine-related adverse events to polymorphisms in UDP-glucuronosyltransferase (UGT) 2B7, ATP-binding cassette, sub-family B, number 1 (ABCB1), and ?-opioid receptor 1 genes in 32 Japanese cancer patients receiving oral controlled-release morphine sulfate tablets.\\u000a \\u000a \\u000a \\u000a Results  The T\\/T genotype at 1236 or TT\\/TT diplotype at

Ken-ichi Fujita; Yuichi Ando; Wataru Yamamoto; Toshimichi Miya; Hisashi Endo; Yu Sunakawa; Kazuhiro Araki; Keiji Kodama; Fumio Nagashima; Wataru Ichikawa; Masaru Narabayashi; Yuko Akiyama; Kaori Kawara; Mari Shiomi; Hiroyasu Ogata; Hiroyasu Iwasa; Yasushi Okazaki; Takashi Hirose; Yasutsuna Sasaki

2010-01-01

70

Adverse Drug Reactions and Death: A Review of 827 Cases.  

National Technical Information Service (NTIS)

A study of 827 cases of adverse drug reactions (ADRs) in which autopsies were done was carried out to determine the relative frequency of drugs that caused adverse reactions, their sites of action, and the variety of pathologic processes induced by them. ...

N. S. Irey

1976-01-01

71

Precautions and Adverse Reactions during Blood Transfusion  

MedlinePLUS

... leukocyte reduction), allergic reactions are less common. Fluid overload: Transfusion recipients can receive more fluid than their ... Special Blood Donation Procedures Next: Overview of Iron Overload

72

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

Microsoft Academic Search

BACKGROUNDAdverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed.METHODSA total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance

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

2001-01-01

73

Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment  

PubMed Central

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.

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

2013-01-01

74

Adverse events in surgical patients in Australia  

Microsoft Academic Search

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

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

2002-01-01

75

A prospective study of adverse drug reactions in hospitalized children  

PubMed Central

Aims There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. Methods An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. Results A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR = 1.66, 95% CI 1.03–2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. Conclusions Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.

Martinez-Mir, Inocencia; Garcia-Lopez, Mercedes; Palop, Vicente; Ferrer, Jose M; Rubio, Elena; Morales-Olivas, Francisco J

1999-01-01

76

Adverse drug reactions: oral and dental manifestations and complications.  

PubMed

Adverse, that is unintended untoward effects of medications, are increasing in incidence and their severity, given the aging of the Australian and New Zealand population and associated drug use. Not only are the number of agents that our patients are using increasing, including the increased use of "alternate" or "complimentary" medications, but also their complexity, with the advent of potent, targeted, biological agents. The result is an increasing number of our patients will be at greater risk of adverse effects from their medications. These adverse effects include the impeding of the safe delivery of dental treatment and the adverse oral and dental manifestations and complications related to the use of medications. PMID:24783838

Schifter, M

2012-04-01

77

Hospital admissions due to adverse drug reactions: A comparative study from Jerusalem and Berlin  

Microsoft Academic Search

A comparative study of adverse drug reactions (ADR) leading to hospital admission showed that 103 (4.1%) out of 2499 medical admissions in Jerusalem and 167 (5.7%) out of 2933 admissions in Berlin were due to such reactions. Sex distribution in the two patient — populations was almost equal but the Jerusalem patients were younger. The most frequent ADRs were digitalis

M. Levy; H. Kewitz; W. Altwein; J. Hillebrand; M. Eliakim

1980-01-01

78

Severe cutaneous adverse reactions related to systemic antibiotics.  

PubMed

Background.?Systemic antibiotics are a major cause of severe cutaneous adverse reactions (SCARs). The selection of alternative antibiotics and management for SCARs patients with underlying infections can be challenging. Methods.?We retrospectively analyzed 74 cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), related to use of systemic antibiotics in Taiwan from January 2006 to January 2012. We analyzed the causative antibiotics, clinical features, organ involvements, and mortality. We also assessed patient tolerability to alternative antibiotics after the development of antibiotic-related SCARs. Results.?The most common causes of SCARs were penicillins and cephalosporins for SJS/TEN and AGEP; glycopeptides for DRESS. Fatality was more frequent in the SJS/TEN group. In patients with SJS/TEN, higher mortality was associated with old age and underlying sepsis before the development of SCARs. The majority of patients with penicillin- or cephalosporin-related SCARs were able to tolerate quinolones, glycopeptides, and carbapenems. Conclusions.?Complicated underlying conditions and infections may increase mortality in patients with antibiotic-related SCARs. The selection of structurally different alternative drugs is important to avoid recurrence. PMID:24599767

Lin, Ying-Fang; Yang, Chih-Hsun; Sindy, Hu; Lin, Jing-Yi; Rosaline Hui, Chung-Yee; Tsai, Yun-Chen; Wu, Ting-Shu; Huang, Ching-Tai; Kao, Kuo-Chin; Hu, Han-Chung; Chiu, Cheng-Hsun; Hung, Shuen-Iu; Chung, Wen-Hung

2014-05-01

79

Adverse reactions to acetylcysteine and effects of overdose  

Microsoft Academic Search

Since the introduction in 1979 of intravenous acetylcysteine (Parvolex) as an antidote for overdosage of paracetamol the National Poisons Information Service and the manufacturer have been notified of 38 adverse reactions that were anaphylactoid in nature and 19 accidental overdoses. The most common feature of the anaphylactoid reaction to normal dosage was rash; other features reported included angioedema, hypotension, and

T G Mant; J H Tempowski; G N Volans; J C Talbot

1984-01-01

80

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

Code of Federal Regulations, 2010 CFR

...2009-07-01 false Significant adverse reactions that must be recorded. 717...SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT...Provisions § 717.12 Significant adverse reactions that must be recorded....

2009-07-01

81

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

Code of Federal Regulations, 2010 CFR

...2010-07-01 false Significant adverse reactions that must be recorded. 717...SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT...Provisions § 717.12 Significant adverse reactions that must be recorded....

2010-07-01

82

A method for estimating the probability of adverse drug reactions  

Microsoft Academic Search

The estimation of the probability that a drug caused an adverse clinical event is usually based on clinical judgment. Lack of a method for establishing causality generates large between-raters and within-raters variability in assessment. Using the conventional categories and definitions of definite, probable, possible, and doubtful adverse drug reactions (ADRs), the between-raters agreement of two physicians and four pharmacists who

C A Naranjo; U Busto; E M Sellers; P Sandor; I Ruiz; E A Roberts; E Janecek; C Domecq; D J Greenblatt

1981-01-01

83

Improving reporting of adverse drug reactions: Systematic review  

PubMed Central

Background: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, with many being identified post-marketing. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Objectives: To evaluate methods to improve ADR reporting via a systematic literature review. Methods: Data sources were Medline, Embase, Cochrane Library and National Library for health searches on ADR reporting (January 1997 to August 2007) including cross-referenced articles. Twenty-four out of 260 eligible studies were identified and critically assessed. Studies were grouped as follows: i) spontaneous reporting (11); ii) medical chart/note review (2); iii) patient interviews/questionnaires (3); and iv) combination methods including computer-assisted methods (8). Results: Using computerized monitoring systems (CMS) to generate signals associated with changes in laboratory results with other methods can improve ADR reporting. Educational interventions combined with reminders and/or prescription card reports can improve hospital-based ADR reporting, and showed short to medium term improvement. Conclusions: The use of electronic health data combined with other methods for ADR reporting can improve efficiency and accuracy for detecting ADRs and can be extended to other health care settings. Although methods with educational intervention appear to be effective, few studies have reviewed long-term effects to assess if the improvements can be sustained.

Molokhia, Mariam; Tanna, Shivani; Bell, Derek

2009-01-01

84

Clinical and economic burden of adverse drug reactions  

PubMed Central

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

Sultana, Janet; Cutroneo, Paola; Trifiro, Gianluca

2013-01-01

85

Adverse reaction to an adrenergic herbal extract ( Citrus aurantium)  

Microsoft Academic Search

We report the case of a 52 year old woman that had an adverse reaction after taking a dry herbal extract of an unripe fruit of Citrus aurantium L. var. amara, as dietary supplement for weight loosing. The fruit is also known as zhi shi (in traditional Chinese Medicine) or bitter orange in other parts of the world.

F. Firenzuoli; L. Gori; C. Galapai

2005-01-01

86

Are Migraineurs at Increased Risk of Adverse Drug Responses?: A Meta-Analytic Comparison of Topiramate-Related Adverse Drug Reactions in Epilepsy and Migraine  

Microsoft Academic Search

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

J Luykx; M Mason; J Carpay

2009-01-01

87

iADRs: towards online adverse drug reaction analysis.  

PubMed

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

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

2012-12-01

88

Physician access to drug profiles to reduce adverse reactions  

NASA Astrophysics Data System (ADS)

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

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

1995-10-01

89

Patient perspectives of patient-provider communication after adverse events  

Microsoft Academic Search

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

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

2005-01-01

90

Pharmacoepidemiological characterization of drug-induced adverse reaction clusters towards understanding of their mechanisms.  

PubMed

A big challenge in pharmacology is the understanding of the underlying mechanisms that cause drug-induced adverse reactions (ADRs), which are in some cases similar to each other regardless of different drug indications, and are in other cases different regardless of same drug indications. The FDA Adverse Event Reporting System (FAERS) provides a valuable resource for pharmacoepidemiology, the study of the uses and the effects of drugs in large human population. However, FAERS is a spontaneous reporting system that inevitably contains noise that deviates the application of conventional clustering approaches. By performing a biclustering analysis on the FAERS data we identified 163 biclusters of drug-induced adverse reactions, counting for 691ADRs and 240 drugs in total, where the number of ADR occurrences are consistently high across the associated drugs. Medically similar ADRs are derived from several distinct indications for use in the majority (145/163=88%) of the biclusters, which enabled us to interpret the underlying mechanisms that lead to similar ADRs. Furthermore, we compared the biclusters that contain same drugs but different ADRs, finding the cases where the populations of the patients were different in terms of age, sex, and body weight. We applied a biclustering approach to catalogue the relationship between drugs and adverse reactions from a large FAERS data set, and demonstrated a systematic way to uncover the cases different drug administrations resulted in similar adverse reactions, and the same drug can cause different reactions dependent on the patients' conditions. PMID:24534381

Mizutani, Sayaka; Noro, Yousuke; Kotera, Masaaki; Goto, Susumu

2014-06-01

91

Cytotoxic Proteins and Therapeutic Targets in Severe Cutaneous Adverse Reactions  

PubMed Central

Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrosis (TEN), are rare but life-threatening conditions induced mainly by a variety of drugs. Until now, an effective treatment for SJS/TEN still remains unavailable. Current studies have suggested that the pathobiology of drug-mediated SJS and TEN involves major histocompatibility class (MHC) I-restricted activation of cytotoxic T lymphocytes (CTLs) response. This CTLs response requires several cytotoxic signals or mediators, including granulysin, perforin/granzyme B, and Fas/Fas ligand, to trigger extensive keratinocyte death. In this article, we will discuss the cytotoxic mechanisms of severe cutaneous adverse reactions and their potential applications on therapeutics for this disease.

Su, Shih-Chi; Chung, Wen-Hung

2014-01-01

92

Cutaneous adverse reactions to therapeutic monoclonal antibodies for cancer  

Microsoft Academic Search

Advances in molecular biology have led to the successful development of targeted monoclonal antibodies to several types of\\u000a malignancies. By June 2007, nine therapeutic monoclonal antibodies had been approved by the US Food and Drug Administration\\u000a to treat various human cancers. In general, the adverse reactions of these agents have been milder than their cytotoxic chemotherapy\\u000a counterparts, but side effects

Patricia L. Myskowski; Allan C. Halpern

2008-01-01

93

Cutaneous adverse reactions to therapeutic monoclonal antibodies for cancer  

Microsoft Academic Search

Advances in molecular biology have led to the successful development of targeted monoclonal antibodies to several types of\\u000a malignancies. By June 2007, nine therapeutic monoclonal antibodies had been approved by the US Food and Drug Administration\\u000a to treat various human cancers. In general, the adverse reactions of these agents have been milder than their cytotoxic chemotherapy\\u000a counterparts, but side effects

Patricia L. Myskowski; Allan C. Halpern

2009-01-01

94

Pathogenic mechanisms underlying adverse reactions induced by intravenous administration of snake antivenoms.  

PubMed

Snake antivenoms are formulations of immunoglobulins, or immunoglobulin fragments, purified from the plasma of animals immunized with snake venoms. Their therapeutic success lies in their ability to mitigate the progress of toxic effects induced by snake venom components, when administered intravenously. However, due to diverse factors, such as deficient manufacturing practices, physicochemical characteristics of formulations, or inherent properties of heterologous immunoglobulins, antivenoms can induce undesirable adverse reactions. Based on the time lapse between antivenom administration and the onset of clinical manifestations, the World Health Organization has classified these adverse reactions as: 1 - Early reactions, if they occur within the first hours after antivenom infusion, or 2 - late reactions, when occurring between 5 and 20 days after treatment. While all late reactions are mediated by IgM or IgG antibodies raised in the patient against antivenom proteins, and the consequent formation of immune complexes, several mechanisms may be responsible for the early reactions, such as pyrogenic reactions, IgE-mediated reactions, or non IgE-mediated reactions. This work reviews the hypotheses that have been proposed to explain the mechanisms involved in these adverse reactions to antivenoms. The understanding of these pathogenic mechanisms is necessary for the development of safer products and for the improvement of snakebite envenomation treatment. PMID:24055551

León, Guillermo; Herrera, María; Segura, Álvaro; Villalta, Mauren; Vargas, Mariángela; Gutiérrez, José María

2013-12-15

95

Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges  

Microsoft Academic Search

Serious adverse drug reactions (SADRs) are a major cause of morbidity and mortality worldwide. Some SADRs may be predictable, based upon a drug's pharmacodynamic and pharmacokinetic properties. Many, however, appear to be idiosyncratic. Genetic factors may underlie susceptibility to SADRs and the identification of predisposing genotypes may improve patient management through the prospective selection of appropriate candidates. Here we discuss

Russell A. Wilke; Debbie W. Lin; Dan M. Roden; Paul B. Watkins; David Flockhart; Issam Zineh; Kathleen M. Giacomini; Ronald M. Krauss

2007-01-01

96

[Cutaneous adverse reaction to Bio-Alcamid implant].  

PubMed

In the last years new and numerous materials for the correction of defects and wrinkles have been developed. One of these materials is Bio-Alcamid, a non reabsorbable gel polymer constituted by meshes of poly-alkyl-imide, without known adverse effects. We report a 34-year-old woman that had Bio-Alcamid implants for acne scars and several months after presented nodular lesions together with a painful inflammatory nodule. The nodule was drained and culture of the purulent material yielded Streptococcus viridans. A cytology and a cellular block of that material showed a granulomatous inflammatory reaction together with a foreign body. The different types of reactions to implants and their pathogenic mechanism are discussed. It is important to know these possible reactions to filler materials given their increasing use and the potential medico-legal consequences. PMID:17506960

Gómez-de la Fuente, E; Alvarez-Fernández, J G; Pinedo, F; Naz, E; Gamo, R; Vicente-Martín, F J; López-Estebaranz, J L

2007-05-01

97

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

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.

Maxwell, Whitney D.; Bennett, Charles L.

2014-01-01

98

Genetic Variants of NPAT-ATM and AURKA are Associated With an Early Adverse Reaction in the Gastrointestinal Tract of Patients With Cervical Cancer Treated With Pelvic Radiation Therapy  

SciTech Connect

Purpose: This study sought to associate polymorphisms in genes related to cell cycle regulation or genome maintenance with radiotherapy (RT)-induced an early adverse reaction (EAR) in patients with cervical cancer. Methods and Materials: This study enrolled 243 cervical cancer patients who were treated with pelvic RT. An early gastrointestinal reaction was graded using the National Cancer Institute Common Toxicity Criteria, version 2. Clinical factors of the enrolled patients were analyzed, and 208 patients were grouped for genetic analysis according to their EAR (Grade {<=}1, n = 150; Grade {>=}2, n = 58). Genomic DNA was genotyped, and association with the risk of EAR for 44 functional single-nucleotide polymorphisms (SNPs) of 19 candidate genes was assessed by single-locus, haplotype, and multilocus analyses. Results: Our analysis revealed two haplotypes to be associated with an increased risk of EAR. The first, comprising rs625120C, rs189037T, rs228589A, and rs183460G, is located between the 5' ends of NPAT and ATM (OR = 1.86; 95% CI, 1.21-2.87), whereas the second is located in the AURKA gene and comprises rs2273535A and rs1047972G (OR = 1.75; 95% CI, 1.10-2.78). A third haplotype, rs2273535T and rs1047972A in AURKA, was associated with a reduced EAR risk (OR = 0.42; 95% CI, 0.20-0.89). The risk of EAR was significantly higher among patients with both risk diplotypes than in those possessing the other diplotypes (OR = 3.24; 95% CI, 1.52-6.92). Conclusions: Individual radiosensitivity of intestine may be determined by haplotypes in the NPAT-ATM and AURKA genes. These variants should be explored in larger association studies in cervical cancer patients.

Ishikawa, Atsuko; Suga, Tomo; Shoji, Yoshimi [RadGenomics Project, National Institute of Radiological Sciences, Chiba (Japan); Kato, Shingo; Ohno, Tatsuya; Ishikawa, Hitoshi [Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba (Japan); Yoshinaga, Shinji [Research Center for Radiation Protection, National Institute of Radiological Sciences, Chiba (Japan); Ohara, Kiyoshi [Tsukuba University Hospital, Tsukuba (Japan); Ariga, Hisanori [Tohoku University Hospital, Miyagi (Japan); Nomura, Kuninori [Toyama University Hospital, Toyama (Japan); Shibamoto, Yuta [Nagoya City University Hospital, Aichi (Japan); Ishikawa, Ken-Ichi; Moritake, Takashi; Michikawa, Yuichi; Iwakawa, Mayumi [RadGenomics Project, National Institute of Radiological Sciences, Chiba (Japan); Imai, Takashi, E-mail: imait@nirs.go.jp [RadGenomics Project, National Institute of Radiological Sciences, Chiba (Japan)

2011-11-15

99

The sensitivity, specificity and predictive values of raised plasma metal ion levels in the diagnosis of adverse reaction to metal debris in symptomatic patients with a metal-on-metal arthroplasty of the hip.  

PubMed

Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties. There was wide variation in plasma cobalt and chromium levels, and MARS-MRI scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%). There was a significant difference in the median plasma cobalt and chromium levels between those with positive and negative MARS-MRI scans (p < 0.001). Compared with MARS-MRI as the potential reference standard for the diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt or chromium with a cut-off of > 7 µg/l was 57%. The specificity was 65%, positive predictive value was 52% and the negative predictive value was 69% in symptomatic patients. A lowered threshold of > 3.5 µg/l for cobalt and chromium ion levels improved the sensitivity and negative predictive value to 86% and 74% but at the expense of specificity (27%) and positive predictive value (44%). Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels. PMID:22844044

Malek, I A; King, A; Sharma, H; Malek, S; Lyons, K; Jones, S; John, A

2012-08-01

100

Potential Adverse and Allergic Reactions from Complementary and Alternative Medicine and Dietary Supplements  

PubMed Central

Complementary and alternative medicine and dietary supplements are often used by patients. A detailed examination of each preparation used by four patients was carried out. Seven such preparations with the potential to cause bleeding, cardiovascular and central nervous system side effects, and allergic food reactions are described. They were taken by both Asian and Caucasian patients, were purchased locally, and were used for allergic and nonallergic disorders. Inquiry into their use is important to prevent potential adverse and allergic reactions. There should be a higher standard of regulation for such products.

2006-01-01

101

Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi  

PubMed Central

Aim To monitor the adverse drug reactions (ADRs) caused by antihypertensive medicines prescribed in a university teaching hospital. Methods The present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO), Government of India. Results A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40?years in age, and females experienced more ADRs (n = 14, 7.29%) than males, 7 (3.64%). Combination therapy was associated with more number of adverse drug reactions (66.7%) as against monotherapy (33.3%). Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7), followed by diuretics (n = 5), and ?-blockers (n = 4). Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7), followed by torasemide (n = 3). Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8%) followed by musculo-skeletal complaints (23.8%) and gastro-intestinal disorders (14.3%). Conclusions The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.

2012-01-01

102

COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms. Fifth Edition.  

National Technical Information Service (NTIS)

The Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration for the coding, filing and retrieving of postmarketing adverse reaction reports. It provided a method to deal ...

1995-01-01

103

Rotigotine adverse effects affecting patient's sexual partner.  

PubMed

Somnolence is one of the most common adverse effects of a dopaminergic agonist, rotigotine. We report putative adverse effects experienced by a spouse of a man treated with this compound because of advanced Parkinson disease. We propose the exposure to rotigotine through the seminal fluid because protected sexual intercourse eliminated her postcoital symptoms. This previously unrecognized mechanism may be more common and associated with other psychoactive compounds penetrating the blood-testis barrier, and it may account for otherwise unexplained postcoital somnolence or fatigue. PMID:20124785

Hedera, Peter

2010-01-01

104

Attitudinal survey of voluntary reporting of adverse drug reactions  

PubMed Central

Aims Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. Methods A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. Results One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34%vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. Conclusions There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.

Eland, I A; Belton, K J; van Grootheest, A C; Meiners, A P; Rawlins, M D; Stricker, B H Ch

1999-01-01

105

Enhancing Communication about Paediatric Medicines: Lessons from a Qualitative Study of Parents' Experiences of Their Child's Suspected Adverse Drug Reaction  

PubMed Central

Background There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. Objective To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Methods Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Results Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Conclusion Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for linking children's symptoms to medicines could be a starting point for improved communication.

Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J.; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L.

2012-01-01

106

An EAACI "European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)": the methodology  

PubMed Central

At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a “harmonised terminology” according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective pilot survey to be conducted in three European countries (France, Germany and Spain). A designated “national coordinator” was responsible for following ethics requirements relative to each country and to select at least 30 doctors per country. Patients were recruited the same day they received their first dose of either SCIT or SLIT. Patient inclusion criteria were: adults and children, with IgE mediated pollen, house dust mite, Alternaria, and/or animal dander respiratory allergies who will initiate AIT. A list of 31 symptoms terms were extracted from the MedDRA (Medical Dictionary for Regulatory Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database. Three questionnaires were generated: i) the Doctor Questionnaire, ii) the Patient Questionnaire and iii) the Adverse Reaction Questionnaire. A handbook and a mistake report form were given to each doctor. In this paper, we describe the methodology followed.

2014-01-01

107

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

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,

R A J Ransford; M J S Langman

2002-01-01

108

Severe cutaneous adverse drug reaction to leflunomide: a report of five cases.  

PubMed

Medications used to treat human ailments are known to cause cutaneous reactions which may vary in their severity. Leflunomide, an immunomodulating agent recently introduced to treat rheumatoid arthritis, is reported to cause severe cutaneous reactions. We are reporting five such cases. All our patients were started on leflunomide for rheumatoid arthritis, 4-6 weeks before the onset of cutaneous reaction and were admitted to the hospital with the common complaints of fever, skin rash and generalized weakness. All of them had characteristic pattern of events such as delayed onset of reaction, widespread and long lasting skin rash and internal organ involvement. These features suggest a possibility of drug hypersensitivity syndrome to leflunomide. Careful dosing and periodic monitoring of patients treated with leflunomide for possible adverse drug reaction is recommended. PMID:16880575

Shastri, Veeranna; Betkerur, Jyayadev; Kushalappa, P A; Savita, T G; Parthasarathi, G

2006-01-01

109

Oral adverse reactions after injection of cosmetic fillers: report of three cases.  

PubMed

The use of injectable cosmetic fillers in orofacial tissues has increased in the past few years. Although a wide variety of agents are available on the market and satisfactory results have been achieved, adverse reactions can be observed. The authors report three new cases of oral reactions in three women who received injections of different cosmetic fillers in the perioral area. In two cases, the lesions presented as nodules on the lip mucosa, and in the last case, as an intraoral ulcer with submental swelling. Considering the concern of patients about malignancies in these lesions, clinicians and pathologists should be aware of these adverse reactions and a detailed history should be made to diagnose these conditions. PMID:22749542

Feio, P S Q; Gouvêa, A F; Jorge, J; Lopes, M A

2013-04-01

110

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

PubMed Central

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

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

2013-01-01

111

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

PubMed

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

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

2013-12-01

112

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

PubMed

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

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

2013-08-01

113

Adverse reactions to cosmetics and methods of testing.  

PubMed

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

Nigam, P K

2009-01-01

114

[Pharmacogenomic research for avoiding adverse reactions by anti-cancer drugs].  

PubMed

Anti-cancer drugs have relatively low effective rates and high frequencies of adverse reactions, occasionally leading to cessation of their treatments. Use of pharmacogenomic (PGx) information could be able to select the patients with high-response and less-adverse reactions, resulting in increase of patients' QOL and proper use of drugs. We have been collaborating with National Cancer Center for PGx analysis of anti-cancer drugs including irinotecan and gemcitabine in Japanese cancer patients. Irinotecan, now used for treatments of many cancers, is metabolically activated to SN-38 and then inactivated to SN-38 glucuronide by a UDP-glucuronosyltransferase UGT1A1. In the UGT1A1 gene, two representative genetic polymorphisms, *28 and *6, were detected at 0.138 and 0.167, respectively in 177 Japanese cancer patients. When the patients were homozygotes of *28 or *6, or compound heterozygotes of them, statistically significant decreases were observed in the SN-38 glucuronidation activity and increases in the rate of severe neutropenia, compared to those in the patients without *28 or *6. Our results and papers were cited in the Japanese package inserts of irinotecan. Gemcitabine was inactivated by cytidine deaminase (CDA) into 2'-2'-difluorodeoxyuridine. A CDA polymorphism 208G>A (Ala70Thr) was detected at 0.037 frequency in 256 Japanese cancer patients and associated with reduced gemcitabine clearance as well as increased frequency of severe neutropenia. In the 4 patients suffered from very severe bone marrow toxicities, 3 patients were homozygous CDA*3, suggesting that this polymorphism is exquisite for predicting severe adverse reactions by gemcitabine in Japanese. PMID:21297369

Saito, Yoshiro

2011-02-01

115

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

PubMed Central

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

Gabrilovich, Evgeniy

2013-01-01

116

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

PubMed Central

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

Bertulyte, Ilma; Schwan, Sofie; Hallberg, Par

2014-01-01

117

[Adverse reaction induced by licorice preparations: clinical analysis of 93 cases].  

PubMed

Licorice is a traditional Chinese medicine commonly used in clinic. The products,what contain licorice or licorice extract, has early been involved in the field of cosmetics except for the field of pharmaceuticals and food. Consequently, the reporting on adverse reactions induced by licorice preparations are more frequent. Based on the clinical data of licorice preparations adverse reactions, we described the characteristics of the licorice-related adverse reactions, and proposed specific measures to reduce the incidence of adverse reactions, provided a reference for the rational use of licorice preparations. PMID:24494570

Mao, Min; Li, Wei; Wang, Wei; Wang, Shu-Xia; Lu, Jin; Chang, Zhang-Fu

2013-11-01

118

Hematopoietic SCT with cryopreserved grafts: adverse reactions after transplantation and cryoprotectant removal before infusion.  

PubMed

Transplantation of hematopoietic stem cells (HSCs) has been successfully developed as a part of treatment protocols for a large number of clinical indications, and cryopreservation of both autologous and allogeneic sources of HSC grafts is increasingly being used to facilitate logistical challenges in coordinating the collection, processing, preparation, quality control testing and release of the final HSC product with delivery to the patient. Direct infusion of cryopreserved cell products into patients has been associated with the development of adverse reactions, ranging from relatively mild symptoms to much more serious, life-threatening complications, including allergic/gastrointestinal/cardiovascular/neurological complications, renal/hepatic dysfunctions, and so on. In many cases, the cryoprotective agent (CPA) used-which is typically dimethyl sulfoxide (DMSO)-is believed to be the main causal agent of these adverse reactions and thus many studies recommend depletion of DMSO before cell infusion. In this paper, we will briefly review the history of HSC cryopreservation, the side effects reported after transplantation, along with advances in strategies for reducing the adverse reactions, including methods and devices for removal of DMSO. Strategies to minimize adverse effects include medication before and after transplantation, optimizing the infusion procedure, reducing the DMSO concentration or using alternative CPAs for cryopreservation and removing DMSO before infusion. For DMSO removal, besides the traditional and widely applied method of centrifugation, new approaches have been explored in the past decade, such as filtration by spinning membrane, stepwise dilution-centrifugation using rotating syringe, diffusion-based DMSO extraction in microfluidic channels, dialysis and dilution-filtration through hollow-fiber dialyzers and some instruments (CytoMate, Sepax S-100, Cobe 2991, microfluidic channels, dilution-filtration system, etc.) as well. However, challenges still remain: development of the optimal (fast, safe, simple, automated, controllable, effective and low cost) methods and devices for CPA removal with minimum cell loss and damage remains an unfilled need. PMID:24076548

Shu, Z; Heimfeld, S; Gao, D

2014-04-01

119

Adverse reactions to food additives in children with atopic symptoms.  

PubMed

In a multicenter study conducted at four Danish hospital pediatric departments, the parents of 472 consecutive children were informed of this project to determine the incidence of intolerance of food additives among children referred to an allergy clinic with symptoms of asthma, atopic dermatitis, rhinitis, or urticaria. After a 2-week period on an additive-free diet, the children were challenged with the eliminated additives. The food additives investigated were coloring agents, preservatives, citric acid, and flavoring agents. Carbonated "lemonade" containing the dissolved additives was used for the open challenge. Two doses were used: a low dose and a 10-fold higher dose. Gelatin capsules were used for a double-blind challenge. The children were 4-15 years old, and they were attending an outpatient pediatric clinic for the first time. Of the 379 patients who entered the study, 44 were excluded and 335 were subjected to open challenge. A total of 23 children developed positive reactions after the open challenge. Sixteen of these patients accepted the double-blind challenge, and six showed a positive reaction to preservatives (atopic dermatitis, asthma, rhinitis), coloring agents (atopic dermatitis, asthma, urticaria, gastrointestinal symptoms), and citric acid (atopic dermatitis, gastrointestinal symptoms). The incidence of intolerance of food additives was 2% (6/335), as based on the double-blind challenge, and 7% (23/335), as based on the open challenge with lemonade. Children with atopic skin symptoms had a statistically increased risk of a positive reaction. This may have consequences for the future clinical investigation of children with atopic cutaneous symptoms. PMID:8198237

Fuglsang, G; Madsen, G; Halken, S; Jørgensen, S; Ostergaard, P A; Osterballe, O

1994-01-01

120

Is inappropriate medication use a major cause of adverse drug reactions in the elderly?  

PubMed Central

What is already known about this subject Several studies have shown that inappropriate medications induce adverse health outcomes in the elderly. The hypothesis of Beers et al. that these inappropriate medications increase the likelihood of adverse drug reactions is debated and checked in patients admitted to hospital. What this study adds Inappropriate medications do not seem to be the major cause of adverse drug reactions in the elderly. More than the inappropriateness of the drugs themselves, it is the inappropriate use of drugs that is to be tackled when treating the elderly. The main preventable factor is the reduction in the number of drugs given. Aim To study the occurrence of adverse drug reactions (ADRs) linked to inappropriate medication (IM) use in elderly people admitted to an acute medical geriatric unit. Methods All the elderly people aged ? 70 years admitted to the acute medical geriatric unit of Limoges University hospital (France) over a 49-month period were included, whatever their medical condition. For all the patients, clinical pharmacologists listed the medications given before admission and identified the possible ADRs. The appropriateness of these medications and the causal relationship between drugs (either appropriate or not) and ADRs were evaluated. Results Two thousand and eighteen patients were included. The number of drugs taken was 7.3 ± 3.0 in the patients with ADRs and 6.0 ± 3.0 in those without ADRs (P < 0.0001). Sixty-six percent of the patients were given at least one IM prior to admission. ADR prevalence was 20.4% among the 1331 patients using IMs and 16.4% among those using only appropriate drugs (P < 0.03). In only 79 of the 1331 IM users (5.9%) were ADRs directly attributable to IMs. The IMs most often involved in patients with ADRs were: anticholinergic antidepressants, cerebral vasodilators, long-acting benzodiazepines and concomitant use of two or more psychotropic drugs from the same therapeutic class. Using multivariate analysis, after adjusting for confounding factors, IM use was not associated with a significant increased risk of ADRs (odds ratio 1.0, 95% confidence interval 0.8, 1.3). Conclusion Besides a reduction in the number of drugs given to the elderly, a good prescription should involve a reduction in the proportion of IMs and should take into consideration the frailty of these patients.

Laroche, Marie-Laure; Charmes, Jean-Pierre; Nouaille, Yves; Picard, Nicolas; Merle, Louis

2007-01-01

121

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

Microsoft Academic Search

Allopurinol, a commonly prescribed medication for gout and hyperuricemia, is a frequent cause of severe cutaneous adverse reactions (SCAR), which include the drug hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The adverse events are unpredictable and carry significant morbidity and mortality. To identify genetic markers for allopurinol-SCAR, we carried out a case-control association study. We enrolled 51 patients with

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

2005-01-01

122

Adverse drug reaction profile of anti-snake venom in a rural tertiary care teaching hospital  

PubMed Central

Objectives The study was carried out with the aim of evaluation of the adverse drug reaction profile of anti-snake venom serum (ASV) in a rural tertiary care hospital. Methods An observational study was conducted in SRTR Medical College, Ambajogai, Maharashtra, India. A total number of 296 indoor case papers of snake bite from February to September 2011 and June to August 2012 were retrieved from the record section and the antivenom reactions were assessed. In addition, basic epidemiological data and prescribing practices of ASV were also analyzed. Results Vasculotoxic snake bites were more common (50.61%) than neuroparalytic ones (22.56%). Mild envenomation was the commonest presentation. A total of 92 (56.10%) patients who received ASV suffered from antivenom reactions. The most common nature of reaction was chills, rigors (69.56%) followed by nausea and vomiting (34.8%). 10-15% patients suffered from moderate to severe reactions like hypotension and sudden respiratory arrest. We did not find any dose response relationship of ASV to risk of reactions (odds ratio 0.37). Intradermal sensitivity test was performed in about 72% cases. Conclusion Our study showed a higher incidence of reactions to ASV at our institute.

Deshpande, Rushikesh Prabhakar; Motghare, Vijay Motiram; Padwal, Sudhir Laxman; Pore, Rakesh Ramkrishna; Bhamare, Chetanraj Ghanshyam; Deshmukh, Vinod Shivaji; Pise, Harshal Nutan

2013-01-01

123

Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series  

PubMed Central

Medical burden of fatal adverse drug reactions (FADRs) is significant. The epidemiological data on FADR do exist from the western world, but there is scanty from India. We hereby report a case series of FADRs recorded in a 2 years period. Point prevalence of FADRs was 0.223%. Point prevalence of all cause death in the hospital was 1.20%. The drugs causing FADRs were injection bupivacaine, amphotericin B, directly observed treatment short-course Category-1, injection streptokinase, and tablet ferrous sulfate. All these FADR were labeled as possible expect one case as probable. All FADR were labeled as type A. In three out of five the central nervous system was involved, while the hepatic system and multiorgan failure accounted for one case each. Two cases each were acute and subacute, while one was latent in nature. Reporting of FADRs shall go a long way in patient safety.

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

2014-01-01

124

Adverse Reactions to Iodinated Contrast Media Administered at the Time of Endoscopic Retrograde Cholangiopancreatography (ERCP)  

Microsoft Academic Search

Adverse reactions after intravascular administration of iodine contrast media are common and prophylactic regiments consisting of the use of steroids and low osmolality contrast media are highly effective in significantly decreas- ing the adverse reactions rate. The same type of contrast media are also used for opacification of the biliary tree and the pancreatic duct at the time of endoscopic

Jen-Jung Pan; Peter V. Draganov

2009-01-01

125

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

ERIC Educational Resources Information Center

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

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

2008-01-01

126

COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms. Third Edition.  

National Technical Information Service (NTIS)

The coding symbols for a thesaurus of adverse reaction terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for coding, filing and retrieving of post-marketing adverse reaction reports. It provides a method to de...

1989-01-01

127

Cost of adverse drug reactions in a South Indian tertiary care teaching hospital.  

PubMed

In India, very few reports on the cost of adverse drug reactions (ADRs) are available. There is a need to study this aspect of health care in order to understand the economic burden imposed by ADRs. The aim of the current work was to study the costs associated with documented ADRs in a tertiary care teaching hospital. This study was conducted in medical wards of a south Indian tertiary care teaching hospital over a 6-month period. The study protocol was assessed and approved by the institutional ethics committee. A total of 317 ADRs from 246 patients were identified during the study period. The present study used an intensive monitoring method to detect ADRs and assessed an incidence of 32.7% adverse reactions in the monitored group. The causality, severity, predictability, and preventability of the documented ADRs were assessed. The total cost to the hospital due to ADRs was found to be Rs. 1,567,397 (US$36 451). The average cost per patient hospitalized with an ADR was Rs. 4,945 (US$115). The cost per reaction was found to be higher in the Indian context, as the per capita annual expenditure on health in this country is around US$109. PMID:21505086

Rajakannan, Thiyagu; Mallayasamy, Surulivelrajan; Guddattu, Vasudeva; Kamath, Asha; Vilakkthala, Rajesh; Rao, Padma G M; Bairy, Laxminarayana K

2012-04-01

128

Adverse Events Associated with Azathioprine Treatment in Korean Pediatric Inflammatory Bowel Disease Patients  

PubMed Central

Purpose This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease. Methods Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received azathioprine in order to maintain remission at Samsung Medical Center (Seoul, Korea) from January 2002 through December 2012 were included in this study. Medical records of these subjects were retrospectively reviewed regarding the development of adverse events associated with azathioprine treatment. Results Ninety-eight patients (56.3%) of 174 patients experienced 136 episodes of adverse events, requiring dose reduction in 31 patients (17.8%), and discontinuation in 18 patients (10.3%). The mean dose of azathioprine that had been initially administered was 1.32±0.42 mg/kg/day. Among the adverse reactions, bone marrow suppression developed in 47 patients (27.0%), requiring dose reduction in 22 patients (12.6%) and discontinuation in 8 patients (4.6%). Other adverse events that occurred were gastrointestinal disturbance (15.5%), hair loss (12.1%), pancreatitis (7.5%), arthralgia (6.9%), hepatotoxicity (2.9%), skin rash/allergic reactions (2.9%), headache/dizziness (2.3%), sepsis (0.6%), and oral mucositis (0.6%). Conclusion Bone marrow suppression, especially leukopenia was most commonly associated with azathioprine treatment in Korean pediatric inflammatory bowel disease patients. Close observation for possible adverse events is required in this population with inflammatory bowel diseases who are under treatment with azathioprine.

Chun, Ji Young; Kang, Ben; Lee, Yoo Min; Lee, Soo Youn; Kim, Mi Jin

2013-01-01

129

Role of viral infections in the induction of adverse drug reactions.  

PubMed

A spectrum of adverse drug reactions that are caused by the combined action of drugs and viruses has been described: ampicillin rash in acute infectious mononucleosis; Reye's syndrome; hypersensitivity reactions to sulphonamides in patients with HIV infection; drug-induced agranulocytosis; paracetamol (acetaminophen) hepatotoxicity; aspirin (acetylsalicyclic acid)-induced asthma; Epstein-Barr virus-associated lymphoma and methotrexate; and AIDS-related Kaposi's sarcoma and nitrite use. Changes in pharmacokinetics have been reported for: caffeine, sulfamethoxazole and fluconazole in patients with HIV infection; theophylline, following influenza and influenza vaccination; and recently, dipyrone metabolites in carriers of the hepatitis B virus. In addition increased drug- and drug metabolite-related toxicity has been observed in virally infected cells. Pathogenetic mechanisms for the interaction between drugs and viruses are varied, and include biological mechanisms (often immunological) and changes in drug metabolism. The combined effects of chemical and biological exposure provide a unique model for the study of disease induction. PMID:9010640

Levy, M

1997-01-01

130

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

PubMed

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

Scala, G; Ciccarelli, A; Calabrò, C

2014-05-01

131

One-component revision of failed hip resurfacing from adverse reaction to metal wear debris.  

PubMed

This study assessed the results of 90 one-component revisions for failed hip resurfacing due to adverse reaction to metal wear debris (76 acetabular, 14 femoral). Patients with a femoral head size 40-45 mm (n=33) received a two-piece titanium meshed shell with a cross-linked polyethylene liner and patients with femoral head size 46-54 mm (n=43) received metal-on-metal components. Patients with femoral head size>45 mm who wished a metal-polyethylene bearing received a dual mobility femoral prosthesis. The mean follow-up was 61 months and the procedure was successful in 97% of the patients. Three failures required re-revision; there was one deep infection. There were no dislocations. One-component revision is a reasonable alternative to revision to total hip arthroplasty. PMID:23680501

Pritchett, James W

2014-01-01

132

Adverse drug reactions during lymphatic mapping and sentinel lymph node biopsy for solid neoplasms.  

PubMed

Currently, 1 per cent isosulfan blue dye and technetium-99-labeled sulfur colloid (SC) are used in lymphatic mapping (LM). Several reports have suggested that the incidence of adverse drug reactions (ADRs) during LM is high. We report our experience with LM for solid neoplasms in order to determine the incidence and risk factors for development of ADRs. Seven hundred fifty-three patients (90% women, mean age 57) underwent LM with blue dye alone or in combination with SC from 1998 to 2004. The most common malignancy was breast cancer (83%). One hundred ten patients (14%) had injection of both mapping agents. Most patients (87%) underwent intraparenchymal injection of LM agent. Eight patients (1.1%) had an ADR during LM; none had prior exposure to LM. Of these, 7 had limited reactions (mostly blue hives) that quickly resolved. One patient (0.1%) developed anaphylaxis. The ADR incidence in patients with a sulfa allergy was not significantly different than that in patients without a sulfa allergy (3.4 vs 1%, P = 0.12). No risk factors for development of ADR were identified. Overall, the incidence of ADR during LM is low. Patients with sulfa allergies and prior exposure to LM did not demonstrate an increased incidence of ADR. Anaphylaxis, though rare, can occur during LM. PMID:16468505

Amr, Dena; Broderick-Villa, Gregory; Haigh, Philip I; Guenther, J Michael; DiFronzo, L Andrew

2005-09-01

133

Prevalence of adverse drug reactions at a private tertiary care hospital in south India  

PubMed Central

BACKGROUND: Adverse Drug Reactions (ADRs) constitute an enormous burden for the society. The aim of the present study was to detect, document, assess and report the suspected ADRs and preparation of guidelines to minimize the incidence of ADRs. METHODS: A prospective-observational study was conducted in the Department of General Medicine of a tertiary care hospital for 12 months from April 2008 to March 2009. Detected and suspected ADRs were analyzed for causality, severity and preventability using appropriate validated scales and were reported. ADR alert card was prepared and given to patients. Therapeutic guidelines were prepared and given to the relevant departments. RESULTS: A total of 57 ADRs were detected, documented, assessed and reported during the study period the incidence was found to be 1.8%. Assessment of severity of the suspected ADRs revealed that 12% of suspected ADRs were severe and 49% of ADRs were moderate in severity. Causality assessment was done which revealed 63% of ADRs were possibly drug-related. The majority of patients who had suffered from ADRs were above 60 years (56%). Gastrointestinal system was most commonly affected (37%) and the drug class mostly associated with ADRs was antibiotics (23%). Preventability of ADRs was assessed; and the results revealed that 28% of ADRs were definitely preventable. CONCLUSIONS: Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient's safety. In this way, hospital/clinical pharmacists play the cornerstone role.

Sriram, Shanmugam; Ghasemi, Ali; Ramasamy, Rajeswari; Devi, Manjula; Balasubramanian, Rajalingam; Ravi, Thengungal Kochupapy; Sabzghabaee, Ali Mohammad

2011-01-01

134

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

PubMed

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

Kaniwa, Nahoko; Saito, Yoshiro

2013-06-01

135

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

NASA Astrophysics Data System (ADS)

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.

Hirsch, Michael J.; Meneses, Claudio N.; Pardalos, Panos M.; Ragle, Michelle; Resende, Mauricio G. C.

2007-11-01

136

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

SciTech Connect

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.

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

137

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

Microsoft Academic Search

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

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

2010-01-01

138

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

Microsoft Academic Search

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

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

2010-01-01

139

Adverse Drug Reactions in Clinical Practice: a Causality Assessment of a Case of Drug-Induced Pancreatitis  

Microsoft Academic Search

Modern therapy has changed the way diseases are controlled and has brought significant benefits. In spite of all the benefits, adverse drug reactions are a common, often preventable, cause of illness, disability and even death. Besides the intrinsic danger associated with the drug, patients might have a particular, unpredictable hypersensitivity to certain drugs, which requires careful monitoring. Different studies have

Andreea Farcas; Marius Bojita

140

A replicated association between polymorphisms near TNF? and risk for adverse reactions to radiotherapy  

PubMed Central

Background: Response to radiotherapy varies between individuals both in terms of efficacy and adverse reactions. Finding genetic determinants of radiation response would allow the tailoring of the treatment, either by altering the radiation dose or by surgery. Despite a growing number of studies in radiogenomics, there are no well-replicated genetic association results. Methods: We carried out a candidate gene association study and replicated the result using three additional large cohorts, a total of 2036 women scored for adverse reactions to radiotherapy for breast cancer. Results: Genetic variation near the tumour necrosis factor alpha gene is shown to affect several clinical endpoints including breast induration, telangiectasia and overall toxicity. In the combined analysis homozygosity for the rare allele increases overall toxicity (P=0.001) and chance of being in the upper quartile of risk with odds ratio of 2.46 (95% confidence interval 1.52–3.98). Conclusion: We have identified that alleles of the class III major histocompatibility complex region associate with overall radiotherapy toxicity in breast cancer patients by using internal replication through a staged design. This is the first well-replicated report of a genetic predictor for radiotherapy reactions.

Talbot, C J; Tanteles, G A; Barnett, G C; Burnet, N G; Chang-Claude, J; Coles, C E; Davidson, S; Dunning, A M; Mills, J; Murray, R J S; Popanda, O; Seibold, P; West, C M L; Yarnold, J R; Symonds, R P

2012-01-01

141

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

PubMed

Abstract 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

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

2014-06-01

142

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

PubMed

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

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

2012-04-01

143

Genetics and the potential for predictive tests in adverse drug reactions.  

PubMed

Drug hypersensitivity reactions are an immune-mediated reaction to otherwise innocuous antigens derived from drugs. These reactions can affect many different organs, with the skin being the commonest. Skin involvement can range in severity with hypersensitivity syndrome (or DRESS) and the blistering reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), also termed serious cutaneous adverse drug reactions, being the most severe and most feared. There is increasing evidence for the role of the immune system in the pathogenesis of these reactions, with drug-specific T cells having been identified in many patients. Until recently, very little was known about the predisposition to these reactions. However, the availability of more accurate molecular typing methods, and the ability to analyse the whole genome in an unbiased fashion, has led to some remarkable findings of the role of the HLA genes as genomic biomarkers of predisposition. The 'revolution' started with abacavir where the predisposition to hypersensitivity was linked to HLA-B*57:01, which was confirmed in a clinical trial, and where its implementation has shown to reduce the incidence of hypersensitivity in a cost-effective manner. Since then, associations have also been shown for allopurinol (HLA-B*58:01)- and carbamazepine (HLA-B*1502 and HLA-A*3101)-induced serious cutaneous adverse drug reactions. The latter is interesting since the association with HLA-B*1502 is present in certain South-Eastern Asian populations, and the predisposition is phenotype specific (only for SJS/TEN). The utility of this biomarker has been shown in a prospective cohort study performed in Taiwan. By contrast, the association with HLA-A*3101 is seen in more diverse ethnic groups, and predisposes to mild as well more severe cutaneous reactions associated with carbamazepine. It is important to note that strong HLA associations have also been shown with a number of drugs that cause liver injury including flucloxacillin, lumiracoxib, lapatinib and ximelagatran, indicating that the immune system is also important in the pathogenesis of other forms of drug-induced organ toxicity. The crucial question as to whether these HLA alleles are truly causative or acting as surrogate markers of predisposition, however, is still unclear, and will require further investigations in larger patient cohorts, through the use of bioinformatic techniques, fine mapping using next generation sequencing technologies and functional studies. PMID:22613851

Pirmohamed, Munir

2012-01-01

144

[Review of the literature on adverse reactions to sunscreens 1947 to 1989].  

PubMed

Sunscreens in cosmetics may trigger off photoallergic contact dermatitis. In addition, they can induce allergic, irritant, or phototoxic dermatitis. Adverse reactions may also be caused by fragrances, preservatives, and other ingredients in light-protective cosmetics. We give a survey on 87 publications dealing with this issue, which appeared from 1947 through 1989. The survey comprises information on the nature of the sunscreen or other ingredient as well as the type of reaction observed in 357 patients. We also refer to the sex distribution and summarize the reasons for using products absorbing UV light. Aside from commercial preparations, all UV filters currently in use should be tested in photopatch tests in order to improve the diagnostic tools. PMID:2150456

Schauder, S

1990-11-01

145

Evaluation of an indirect method of detecting adverse reactions to anticoagulants.  

PubMed

An indirect system of adverse-drug-reaction (ADR) surveillance was evaluated by determining the number of "alerting orders" for suspected ADRs in patients on anticoagulant therapy that were reported by staff pharmacists compared with those detected by an on-floor pharmacist observer. Physicians' orders for patients receiving warfarin or continuous-infusion heparin therapy were monitored during a five-week period to detect "alerting orders" that appeared to indicate the presence of bleeding or excessive hypoprothrombinemia during warfarin therapy or bleeding or thrombocytopenia during continuous-infusion heparin therapy. Alerting orders were classified as antidote, laboratory-test, and dosage-reduction orders, including "hold warfarin" orders; staff pharmacists were taught to detect these orders through inservice-education programs and the use of a training manual. The on-floor observer detected alerting orders through daily monitoring of all study patients' charts and evaluated suspected ADRs using predefined criteria. A total of 1622 physicians' orders were written for 79 patients. Staff pharmacists detected significantly fewer alerting orders than did the on-floor observer (76 versus 273). Also, staff pharmacists reported as alerting orders 21 physicians' orders that did not meet alerting-order criteria. Staff pharmacists reported at least one alerting order for 52 of the 75 patients who had alerting orders identified by the on-floor observer. The use by staff pharmacists of "alerting orders" was not an effective method of detecting anticoagulant-drug adverse reactions when compared with the performance of an on-floor concurrent monitor. PMID:3565412

Swanson, C N; Keys, P W

1987-03-01

146

The genetics of pro-arrhythmic adverse drug reactions.  

PubMed

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

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

2014-04-01

147

Pattern of Angiotensin-Converting Enzyme Inhibitors Induced Adverse Drug Reactions in South Indian Teaching Hospital  

PubMed Central

Background: Adverse drug reactions (ADRs) occur frequently with cardiovascular drugs leading to change in therapy, increasing morbidity, and mortality. Aim: The study was conducted to evaluate the incidence of ADRs due to angiotensin-converting enzyme Inhibitors in cardiology department. Materials and Methods: A cross-sectional observational study was carried out for a period of 6 months. The data were assessed for the pattern of the ADRs with respect to patient demographics, nature of the reaction, outcome of the reactions, causality, severity, and preventability. Results: Among 692 patients, 51 (7.36%) had developed 60 ADRs, and majority of cases (56.66%) were in the age group of >61 years and most of them were developed in female (80%). The common ADRs observed were cough, hypotension, hyperkalemia, and acute renal failure. In 21.66% cases the dose of the suspected drug was altered and in 78.33% cases the drug was withdrawn. Considering the outcome, 93.33% of cases recovered from ADRs, whereas in 6.66% cases were continuing. Causality assessment showed that majority of ADRs was probable and were found to be moderately severe. Conclusion: Our study concludes geriatrics and female patients have higher incidence of ADRs. So early identification and management of ADRs are essential for this population.

Mateti, Uday Venkat; Nekkanti, Haritha; Vilakkathala, Rajesh; Rajakannan, Thiyagu; Mallayasamy, Surulivelrajan; Ramachandran, Padmakumar

2012-01-01

148

Adverse reactions to ultrasound contrast agents: Is the risk worth the benefit?  

Microsoft Academic Search

The introduction of ultrasound contrast agents has led to a marked improvement in diagnostic capabilities in echocardiography. As no serious adverse events were seen during the preclinical development phase, ultrasound contrast agents were thought to be safe. Recently, three fatal and 19 severe, non-fatal adverse reactions were reported in a post marketing analysis of more than 150,000 studies of Sonovue,

P. A. Dijkmans; C. A. Visser; O. Kamp

2005-01-01

149

Adverse Reaction to Poetry Therapy: A Case Report.  

ERIC Educational Resources Information Center

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)

Pies, Ronald

1993-01-01

150

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

Code of Federal Regulations, 2011 CFR

...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...

2011-07-01

151

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

Code of Federal Regulations, 2012 CFR

...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...

2012-07-01

152

Evaluation of Adverse Reactions in Hemophiliacs from Long-Term Exposure to Blood and Blood Products.  

National Technical Information Service (NTIS)

This study assesses current therapeutic efficacy and adverse reactions in hemophiliacs. Approximately 50 percent of hemophiliacs showed long term (greater than 6 months) abnormalities of liver function. A significant increase in diastolic blood pressure w...

S. S. Shapiro

1976-01-01

153

Design of the Antituberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)  

Microsoft Academic Search

BACKGROUND: More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts

Yin Yin Xia; Dai Yu Hu; Fei Ying Liu; Xiao Meng Wang; Yan Li Yuan; De Hua Tu; Yi Xin Chen; Lin Zhou; Li Zhen Zhu; Wei Wei Gao; Hong Yuan Wang; Da Fang Chen; Li Yang; Ping Ping He; Xiao Ting Li; Ying Jian He; Feng Sun; Si Yan Zhan

2010-01-01

154

Non-steroidal Anti-inflammatory Drugs with Adverse Psychiatric Reactions: Five Case Reports  

Microsoft Academic Search

:   Adverse drug reactions of non-steroidal anti-inflammatory drugs (NSAIDs) are quite prevalent, but there are few reports about\\u000a possible adverse psychiatric reactions, which may be ignored or underestimated. We describe here five psychiatric outpatients,\\u000a two with major depressive disorders, one bipolar disorder, one schizophrenic disorder and one anxiety disorder, who were treated\\u000a with NSAIDs for pain due to rheumatoid arthritis,

Hann-Kuang Jiang; Deh-Ming Chang

1999-01-01

155

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

PubMed Central

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 (cases) or placebo (controls) immediately before infusion of antivenom serum. Interventions Adrenaline 0.25?ml (1:1000). Main outcome measures Development of acute adverse reactions to serum and side effects attributable to adrenaline. Results 56 patients (cases) received adrenaline and 49 (controls) received placebo as pretreatment. Six (11%) adrenaline patients and 21 (43%) control patients developed acute adverse reactions to antivenom serum (P=0.0002). Significant reductions in acute adverse reactions to serum were also seen in the adrenaline patients for each category of mild, moderate, and severe reactions. There were no significant adverse effects attributable to adrenaline. Conclusions Use of 0.25?ml of 1:1000 adrenaline given subcutaneously immediately before administration of antivenom serum to patients with envenomation after snake bite reduces the incidence of acute adverse reactions to serum. Key messagesAntivenom serum is the only effective treatment for envenomation after snake biteAcute adverse reactions to the serum are common and include anaphylactic shockThe prophylactic use of 1:1000 adrenaline in a dose of 0.25?ml given subcutaneously immediately before infusion of antivenom serum significantly reduces the risk of acute adverse reactions

Premawardhena, A P; de Silva, C E; Fonseka, M M D; Gunatilake, S B; de Silva, H J

1999-01-01

156

[Suggestions for prevention of adverse reactions after intravasal administration of iodinated contrast media].  

PubMed

Iodinated contrast media are widely used in computed tomography and angiography. Adverse reactions such as contrast-medium induced nephropathy (CIN), anaphylactoid reactions and iodine-induced thyrotoxicosis are associated with intravasal administration of contrast agents. Iodinated contrast agents are generally considered to be safe, but in rare cases they can cause severe life threatening situations. In this review we present an overview about the incidence, pathways, and risk factors of adverse reactions. Simple schemes including hydration protocols for prevention of CIN, medication for prophylaxis of iodine-induced thyrotoxicosis with thyreostatics and anaphylactoid reactions with histamine antagonists and corticosteroids are suggested. PMID:19294866

Kuefner, Michael A; Heinrich, Marc; Bautz, Werner; Uder, Michael

2008-01-01

157

Natural Inhibitors of Cholinesterases: Implications for Adverse Drug Reactions  

PubMed Central

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

Krasowski, Matthew D.; McGehee, Daniel S.

2010-01-01

158

Adverse drug reactions related to the use of non-steroidal anti-inflammatory drugs: results of spontaneous reporting from central India.  

PubMed

To assess the adverse drug reactions to non-steroidal anti-inflammatory drugs through spontaneous reporting system in IGGMC&H, Nagpur and to analyse them using WHO assessment scales, an observational, prospective study was conducted in patients attending outpatient department, inpatient department and casualty of IGGMC and H Nagpur from 1st June 2005 to 31st May 2009. Data were collected by spontaneous adverse drug reactions reporting system. Among 2639 total adverse drug reactions reported, 336 (12.7%) were due to non-steroidal anti-inflammatory drugs. The non-steroidal anti-inflammatory drugs most frequently implicated with adverse drug reactions were ibuprofen (51.19%) followed by diclofenac (27.08%), paracetamol (6.55%), nimesulide (6.25%), aspirin (5.95%). The most commonly affected organ systems were skin and appendages and gastro-intestinal system. Maculopapular rashes were the most frequent skin Involvement. Non-steroidal anti-inflammatory drugs are the most frequently used drugs. As they are commonly associated with adverse drug reactions, their limited and careful use is needed. Considering their prominent role in therapeutics, close clinical observations are very important in minimising adverse drug reactions and demands need for vigilant surveillance of adverse drug reactions in patients, receiving established as well as newer non-steroidal anti-inflammatory drugs. PMID:24003566

Shrivastava, Meena Pramendra; Chaudhari, Harshal Vikas; Dakhale, Ganesh Nathuji; Hiware, Sachin Keshavrao; Solanke, Bhupendra Prakash; Shinde, Abhijit

2013-02-01

159

Adverse drug reaction monitoring in a secondary care hospital in South India  

PubMed Central

Aims To ascertain the current burden of ADRs at a Government hospital in Ooty and to assess the severity of reported ADRs and the additional financial burden associated with ADRs. Methods A prospective, spontaneous reporting study was conducted over a period of 9 months of inpatient admissions to the medical wards, co-ordinated by clinical pharmacists. The WHO definition of an ADR was adopted. The Naranjo algorithm scale was used for causality assessment. Confirmed ADRs were classified according to the Wills & Brown [7] method and assessed for severity and patient outcomes. The average cost incurred in treating the ADRs was calculated. Results Of the total of 187 adverse drug events (ADEs) reported, 164 reports from 121 patients were confirmed as ADRs, giving an overall incidence of 9.8%. This included 58 (3.4%) ADR related admissions and 63 (3.7%) ADRs occurring during the hospital stay. About two thirds of the reactions (102, 62.2%) were classified as probable. The majority of the reactions (88, 53.7%) were mild. Most patients (119, 72.6%) recovered from the incidence. The majority of the reactions were of type H (100, 61%) which indicates that they were not predictable and not potentially preventable. An average cost of 481 rupees (£6) was spent on each patient to manage ADRs. Conclusions The incidence and severity of ADRs documented in our study are lower than those reported in comparable populations in Western studies but more than those reported in India. What is already known about this subject The benefits of adverse drug reaction (ADR) monitoring are well-known.Poor awareness and nonavailability of a central co-ordinating body resulted in lack of ADR monitoring in India.The National Pharmacovigilance Programme was recently initiated, encouraging ADR monitoring in selected centres, including our centre. What this study adds This is the first study of its kind at GHQH, Ootacamund that has provided insight into the burden of ADRs here.The incidence and severity of ADRs documented in our study is lower than those reported in comparable populations in Western studies but more than those reported in India.

Arulmani, R; Rajendran, SD; Suresh, B

2008-01-01

160

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

PubMed Central

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.

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

2007-01-01

161

Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges  

PubMed Central

Serious adverse drug reactions (SADRs) are a major cause of morbidity and mortality worldwide. Some SADRs may be predictable, based upon a drug's pharmacodynamic and pharmacokinetic properties. Many, however, appear to be idiosyncratic. Genetic factors may underlie susceptibility to SADRs and the identification of predisposing genotypes may improve patient management through the prospective selection of appropriate candidates. Here we discuss three specific SADRs with an emphasis on genetic risk factors. These SADRs, selected based on wide-sweeping clinical interest, are drug-induced liver injury, statin-induced myotoxicity and drug-induced long QT and torsades de pointes. Key challenges for the discovery of predictive risk alleles for these SADRs are also considered.

Wilke, Russell A.; Lin, Debbie W.; Roden, Dan M.; Watkins, Paul B.; Flockhart, David; Zineh, Issam; Giacomini, Kathleen M.; Krauss, Ronald M.

2009-01-01

162

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

PubMed Central

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

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

163

Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review.  

PubMed

Case reports of adverse reactions with psychotropic drugs can be useful in raising hypotheses, to be tested with more rigorous study designs. However such reports have significant methodological drawbacks, making it hard to determine causality. We undertook a systematic assessment of the quality of case reports and small case series published within Human Psychopharmacology over 25 years. For reports of adverse drug reactions, modified Bradford Hill criteria for causality (for consistency, strength, specificity, temporal relationship and plausibility) were used to ascertain the quality of the account. Reports which had been cited at least 10 times by December 2010 were examined in detail, to assess their overall contribution in extending understanding and influencing clinical practice. Of 40 reports of adverse drug reactions, only seven were sufficiently robust for confidence in probable or possible causality. Nine reports had been cited more than 10 times: the five most frequently cited reports of adverse drug reactions described movement disorders, suicidal thoughts and discontinuation symptoms with SSRIs: clinical relevance was high, but their quality was not markedly greater than less frequently cited reports. Nearly all reports of adverse drug reactions, published in a single journal over 25 years, were insufficiently robust to demonstrate probable causality. Reports that are cited frequently become influential because of their potential clinical relevance, rather than due to their methodological quality. PMID:23754771

Talat, Bilal; Mayers, Andrew; Baldwin, David S

2013-09-01

164

Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction  

PubMed Central

Background Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. Methods A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed. Results A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication. Conclusion Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials.

Betancourt, Blas Y; Marrero-Miragaya, Maria A; Jimenez-Lopez, Giset; Valenzuela-Silva, Carmen; Garcia-Iglesias, Elizeth; Hernandez-Bernal, Francisco; Debesa-Garcia, Francisco; Gonzalez-Lopez, Tania; Alvarez-Falcon, Leovaldo; Lopez-Saura, Pedro A

2005-01-01

165

Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India.  

PubMed

Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, anti-tubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were 'Mild' followed by 'Moderate' and 'Severe' reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality. PMID:24170978

Patidar, Dindayal; Rajput, Mithun S; Nirmal, Nilesh P; Savitri, Wenny

2013-03-01

166

Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India  

PubMed Central

Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, anti-tubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were ‘Mild’ followed by ‘Moderate’ and ‘Severe’ reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality.

Rajput, Mithun S.; Nirmal, Nilesh P.; Savitri, Wenny

2013-01-01

167

Comparison of radiographic quality and adverse reactions in myelography with iopamidol and metrizamide.  

PubMed

A randomized double-blind study was conducted to compare the radiographic quality and adverse reactions in myelography of the two nonionic water-soluble contrast media, iopamidol and metrizamide. A total of 46 myelograms were obtained, 28 with iopamidol and 18 with metrizamide. Untoward reactions consisted of nausea, headaches, back and leg pain, neuropsychiatric findings, and urinary retention. Iopamidol caused no reactions in 20 of the 28 cases, while metrizamide caused no reactions in only three of 18 cases. Film quality evaluation showed 22 of the 28 studies with iopamidol were judged excellent, whereas only 11 of the 18 metrizamide studies were judged excellent. The results of this study suggest that iopamidol produces better quality studies with fewer and milder adverse reactions than metrizamide. PMID:6410730

Bannon, K R; Braun, I F; Pinto, R S; Manuell, M; Sudilovsky, A; Kricheff, I I

1983-01-01

168

Anti-tuberculosis drugs adverse reactions: a review of the Iranian literature.  

PubMed

Introduction: Tuberculosis (TB) treatment, in particular therapy for multidrug-resistant TB (MDR-TB), is associated with toxicities and adverse drug reactions (ADRs). Areas covered: This paper reviews Iranian literature reporting ADRs which occurred during tuberculosis treatment. English language papers were sourced from PubMed, ScienceDirect, Wiley, Ovid and Proquest, with Google Scholar searched for Persian language articles. Reported ADRs, proportion of patients with ADRs, risk factors and determinants, as well as the characteristics of the studies were reviewed. 21 articles were included; about 60% of them were in English and three included patients with MDR-TB. The ratio of ADR per capita was 1.9 (in 6 studies) and 33.63% of patients developed an ADR (in 7 studies). Hepatitis (2.5 - 45.3%) was reported in nearly all of the studies. The mean time from initiation of medication to development of hepatitis ranged from 4.67 to 25.25 days (in 6 studies). Most cases of mortality were due to hepatotoxicity. Except for comorbidities and female gender, other risk factors such as HIV and length of hospitalization were only reported in one article. Expert opinion: The pattern of ADRs in Iranian articles was found to be similar to many other studies in the present review. We suggest that future studies resolve the confounding factors in this area that are mentioned in this review. PMID:24935479

Kargar, Mona; Mansouri, Ava; Hadjibabaie, Molouk; Javadi, Mohammadreza; Radfar, Mania; Gholami, Kheirollah

2014-07-01

169

Preventability analysis of adverse drug reactions detected in two internal medicine departments in Romania.  

PubMed

In order to improve patient safety, systematic analysis of common and repetitive patterns of preventable adverse drug reactions (pADRs) in the clinical setting should be performed regularly in order to propose adequate prevention strategies. Our aim is to evaluate the preventability of all ADRs collected in a drug information research center database, by spontaneous reporting and clinical surveillance in two internal medicine departments. One reviewer systematically reevaluated all the cases stored in the database. ADRs were deemed preventable if they were due to: a contraindication, an inadequate dose, a drug interaction, an inappropriate prescribing decision for the patient's condition, inadequate monitoring, self-medication, or non-adherence to therapy. Out of 251 ADRs evaluated, 103 (41 %) were considered preventable. Out of the total pADRs, 86.4 % were serious. The most frequent adverse outcomes affected the gastrointestinal system (21.4 %), followed by the renal (11.6 %), metabolic (10.7 %), vascular (10.7 %) and hepatic (6.8 %) systems. Acenocoumarol (28 %), diclofenac (12.6 %), digoxin and furosemide accounted for more than 50 % of all preventable reports. One of up to three factors was involved in the preventability of the analyzed reports. Drug-drug interactions were the cause of 49.5 % of the pADRs. Inappropriate dose accounted for 17.5 % reports out of the total pADRs, inappropriate monitoring for 9.7 % reports, history of allergy to drug or drug class for 5.8 % reports and administration of a contraindicated drug for 4.8 % reports. Identifying prevalent pADRs in this study indicates a clear target for prevention strategies: drug prescription, with a special emphasis on drug interactions. PMID:22907809

Farcas, Andreea; Bucsa, Camelia; Sinpetrean, Aura; Leucuta, Daniel; Mogosan, Cristina; Dumitrascu, Dan; Achimas, Andrei Cadariu; Bojita, Marius

2014-03-01

170

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

PubMed Central

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.

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

2014-01-01

171

Adverse drug reaction profile of oseltamivir in Indian population: A prospective observational study  

PubMed Central

Objectives: To analyze the pattern of adverse drug reactions (ADRs) of oseltamivir and its comparison with available data. Materials and Methods: Suspected or confirmed cases of H1N1 influenza A on therapeutic regimen and close contacts of cases H1N1 influenza A on prophylactic regimen of oseltamivir were included. Data were collected by personal interview after obtaining written informed consent. Causality, severity, and preventability assessments were done by using Naranjo's scale, modified Hartwig and Siegel's scale, and modified Schumock and Thornton Scale, respectively. Data were expressed in proportions. Frequency of ADRs in therapeutic and prophylactic groups were compared with phase III trial of oseltamivir by using Chi-square test. Results: Total 294 patients were interviewed. In prophylactic group, 107 of 257 (41.63%) and in therapeutic, group 23 of 37 (62.16%) developed ADRs. ADRs reported in therapeutic group was significantly (P = 0.029) higher as compared with prophylactic group. Frequently observed ADRs in both the groups were gastritis, nausea, vomiting, diarrhea weakness, sedation, loneliness, sadness, headache, and abdominal pain. Naranjo's algorithm showed all ADRs in probable category in prophylactic group, 27.78% probable and 72.22% possible reactions in therapeutic group. Severity assessment showed 76% mild and 24% moderate reactions in therapeutic group, 89% mild and 11% moderate reactions in prophylactic group. Severity of ADRs was significantly higher in therapeutic group. Most of ADRs were in nonpreventable category, except gastritis, nausea and vomiting were in definitely preventable category. Conclusion: Oseltamivir is well tolerated in Indian population. Gastrointestinal side effects are most common and preventable.

Anovadiya, Ashish P.; Barvaliya, Manish J.; Shah, Rajesh A.; Ghori, Vishal M.; Sanmukhani, Jayesh J.; Patel, Tejas K.; Tripathi, C. B.

2011-01-01

172

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

PubMed Central

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.

Ho, Maria Y; Mackey, John R

2014-01-01

173

An algorithm to detect adverse drug reactions in the neonatal intensive care unit.  

PubMed

Critically ill newborns in neonatal intensive care units (NICUs) are at greater risk of developing adverse drug reactions (ADRs). Differentiation of ADRs from reactions associated with organ dysfunction/immaturity is difficult. Current ADR algorithm scoring was established arbitrarily without validation in infants. The study objective was to develop a valid and reliable algorithm to identify ADRs in the NICU. Algorithm development began with a 24-item questionnaire for data collection on 100 previously suspected ADRs. Five pediatric pharmacologists independently rated cases as definite, probable, possible, and unlikely ADRs. Consensus "gold standard" was reached via teleconference. Logistic regression and iterative C programs were used to derive the scoring system. For validation, 50 prospectively collected ADR cases were assessed by 3 clinicians using the new algorithm and the Naranjo algorithm. Weighted kappa and intraclass correlation coefficient (ICC) were used to compare validity and reliability of algorithms. The new algorithm consists of 13 items. Kappa and ICC of the new algorithm were 0.76 and 0.62 versus 0.31 and 0.43 for the Naranjo algorithm. The new algorithm developed using actual patient data is more valid and reliable than the Naranjo algorithm for identifying ADRs in the NICU population. Because of the relatively small and nonrandom samples, further refinement and additional testing are needed. PMID:23400748

Du, Wei; Lehr, Victoria Tutag; Lieh-Lai, Mary; Koo, Winston; Ward, Robert M; Rieder, Michael J; Van Den Anker, John N; Reeves, Jaxk H; Mathew, Merene; Lulic-Botica, Mirjana; Aranda, Jacob V

2013-01-01

174

Agomelatine and hepatotoxicity: implications of cumulated data derived from spontaneous reports of adverse drug reactions.  

PubMed

Considering the antidepressant agomelatine (AGM) there is a discrepancy between the widespread knowledge of the potential of AGM to cause hepatotoxic adverse drug reactions (ADR) and the availability of corresponding published data. This impedes an adequate assessment of the hepatotoxicity profile of AGM. We conducted a query of the database of a German Medical Regulatory Body (BfArM) and analyzed spontaneous reports of hepatotoxic ADR. We identified n=58 cases of AGM-related hepatotoxic ADR. Most frequent ADR was asymptomatic increase of liver enzymes (79%); n=6 patients (10%) with AGM-related toxic hepatitis were reported. Characteristics of patients: female sex (69%), age > 50 years (mean 54 years), polypharmacy (57%), and presence of cardiovascular risk factors (58.5%). Most of the hepatotoxic ADR (90%) were reported to have improved/recovered after discontinuation of AGM. Our evaluation suggests that AGM features a potential to cause severe forms of hepatotoxicity and emphasizes that a pre-existing liver disease is a contraindication for treatment with AGM. Secondly, increased age, female sex and polypharmacy may be risk factors for the development of AGM-related hepatotoxic ADR. PMID:23966266

Gahr, M; Freudenmann, R W; Connemann, B J; Hiemke, C; Schönfeldt-Lecuona, C

2013-09-01

175

A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation  

Microsoft Academic Search

Reporting and investigation of serious adverse events and reactions associated with tissue and cell transplantation is a fundamental\\u000a aspect of ensuring adequate levels of safety and quality and is a requirement of the European Union Directives on tissues\\u000a and cells. In the UK, a system for the reporting and analysis of events and reactions associated with ocular tissue transplantation\\u000a is

Stephen Kaye; Andrew Baddon; Mark Jones; W. John Armitage; Deirdre Fehily; Ruth M. Warwick

2010-01-01

176

Perception on Adverse Drug Reaction Reporting by Physicians Working in Southern Romania  

PubMed Central

ABSTRACT Aim: The purpose of our study was to investigate and to assess the perceptions of Romanian doctors towards adverse drug reactions (ADRs) reporting. Method: A questionnaire with 20 items accompanied by a letter presenting the study was circulated using Internet and face to face interviews to 532 doctors in Bucharest and two neighboring regions from Romania (Muntenia and Oltenia). Results: 204 (56.2%) of the total number of responders expressed their opinion that the daily number of ADRs observed to be under 5 309 (58%) of responders were never informed about ADRs reporting, 439 (82.52%) did not know that the Romanian College of Physicians is scoring this activity under the "Continuous medical education program". Factors that might encourage voluntary reporting of adverse reactions were identified to be: the easiness of reporting, their periodic information and the training about all adverse reactions reported by doctors and the measures taken. Factors discouraging voluntary reporting of an adverse drug reaction were: the lack of information on where, when and how to report ADRs, the uncertain causality. Conclusion: Currently, the pharmacovigilance activities including reporting of ADRs in Romania are more of an accidental nature, doctors are less or not at all informed about this activity. Doctors have a favorable attitude towards reporting ADRs – as the majority believes that the reporting should be either voluntary or mandatory as opposed to a small number that would expect to be paid for this activity.

PAVELIU, Marian Sorin; BENGEA-LUCULESCU, Simona; TOMA, Mihai; PAVELIU, Silvia Fraga

2013-01-01

177

Intensive monitoring of adverse drug reactions in infants and preschool children  

Microsoft Academic Search

Intensive monitoring of adverse drug reactions (ADR) in infants and preschool children in the paediatric outpatient unit covering the town of Karlovac (150000 inhabitants) was performed over a period of three months. Data were obtained by physical examination of children and the history given by their parents. In all 2359 children were examined. ADR were recorded in 63 children and

A. ?irko-Begovi?; B. Vrhovac; I. Bakran

1989-01-01

178

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

Microsoft Academic Search

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

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

2004-01-01

179

COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms (Second Edition). Documentation.  

National Technical Information Service (NTIS)

The primary purpose of COSTART is to provide a basis for vocabulary control of adverse reactions associated with drugs received from a diversity of sources and a multitude of reporters. Such control is a necessary first step in the effective use of the co...

1985-01-01

180

Severe adverse reaction risks during mass treatment with ivermectin in loiasis-endemic areas  

Microsoft Academic Search

The control of onchocerciasis remains a priority in sub-Saharan Africa. Jean-Philippe Chippaux, Michel Boussinesq, Jacques Gardon, Nathalie Gardon-Wendel and Jean-Christophe Ernould here outline studies concerning possible severe adverse reactions to ivermectin used to control onchocerciasis in areas where loiasis is also endemic, and discuss precautions that may be advisable during the implementation of such programmes.

Jean-Philippe Chippaux; Michel Boussinesq; Jacques Gardon; Nathalie Gardon-Wendel; Jean-Christophe Ernould

1996-01-01

181

Reported paediatric adverse drug reactions in the UK 2000-2009  

PubMed Central

AIMS The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect ‘suspected’ adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients. METHODS Data on all ADRs reported to the MHRA in patients <17 years from the years 2000–9 were supplied in two datasets, inclusive and exclusive of vaccines. RESULTS Of 222 755 ADR reports received by the MHRA from 2000–9, 31 726 (14.2%) were in children <17 years. The number of reports in 2000 was greater than in subsequent years (12 035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001–2009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22 102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12 106 reports) and headache the commonest symptom (3163). Excluding vaccines, methylphenidate (653 reports) and atomoxetine (491) were the most commonly reported medications, and the most commonly reported symptom was vomiting (374). Reporting by nurses increased from 396 in 2001 to 1295 in 2009 (41.8% of all reports); reporting by doctors stayed constant. Reports from patients, parents or carers more than doubled but remained infrequent (1.5% in 2005, 4.0% in 2009). CONCLUSIONS Although under-reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients <17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.

Hawcutt, Daniel B; Mainie, Pramod; Riordan, Andrew; Smyth, Rosalind L; Pirmohamed, Munir

2012-01-01

182

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

PubMed

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

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

2012-12-01

183

Treatment of Brugia timori and Wuchereria bancrofti infections in Indonesia using DEC or a combination of DEC and albendazole: adverse reactions and short-term effects on microfilariae.  

PubMed

Filariasis caused by Brugia timori and Wuchereria bancrofti is an important public health problem on Alor island, East Nusa Tenggara, Indonesia. To implement a control programme, adverse reactions and short-term effects on the microfilaria (mf) density were studied following a divided dose of diethylcarbamazine (DEC, 6 mg/kg body weight - 100 mg on day 1 and the rest on day 3) or a single dose of DEC (6 mg/kg body weight on day 3) and albendazole (Alb, 400 mg). In order to define the most appropriate regimen, 30 persons infected with B. timori were treated in the hospital and results were compared with those obtained from the treatment of 27 persons infected with W. bancrofti. Adverse reactions consisted of systemic reactions such as fever, headache, myalgia, itching and local reactions such as adenolymphangitis. Fever experienced by a number of patients in both treatment groups generally occurred 12-24 h after drug administration and lasted up to 2 days. Adenolymphangitis tended to occur later and was resolved within 4 days. The number of W. bancrofti patients suffering from adverse reactions was lower and the reactions were milder than those of the B. timori patients. There was no difference in adverse reactions between DEC alone and DEC-Alb treatment for either infection. The geometric mean mf count decreased on day 7 in the B. timori infected patients from 234 mf/ml in the DEC group and from 257 mf/ml in the DEC-Alb group to 7 and 8 mf/ml, respectively. The mf densities of the W. bancrofti infected patients decreased on day 7 from 214 mf/ml in the DEC group and from 559 mf/ml in the DEC-Alb group to 15 and 14 mf/ml, respectively. Our data indicate that the microfilaricidal effect of the drugs is achieved more rapidly for B. timori, which is associated with more adverse reactions than W. bancrofti. In addition, 111 B. timori infected persons were treated in the community with DEC-Alb in one selected village. The adverse reactions and the reduction of mf density was similar to the findings of the hospital-based study. In this group, there was a strong correlation of mf density with the frequency and severity of adverse reactions. The addition of Alb resulted in no additional adverse reactions compared with DEC treatment alone and can also be used for the treatment of B. timori infection. In Indonesia, where the prevalence of intestinal helminths is high, the use of a combination of DEC and Alb to control lymphatic filariasis may also have impact on the control of intestinal helminths. PMID:12358626

Supali, Taniawati; Ismid, Is Suhariah; Rückert, Paul; Fischer, Peter

2002-10-01

184

Community-based treatment of onchocerciasis with ivermectin: acceptability and early adverse reactions.  

PubMed Central

A study of community-based treatment of onchocerciasis with ivermectin was undertaken in a rain forest area of Liberia to investigate the possible occurrence of serious adverse effects. The total population was 13,704, the microfilarial load was 5.35 mf/mg skin, and the prevalence of Onchocerca volvulus infection was 50% at 9 years of age and over 80% among those aged 15 years and older. Certain groups (like pregnant women and young children) were excluded from treatment. Out of the 7956 people eligible for treatment, 7699 (97%) accepted the ivermectin. Data on possible adverse reactions were collected by four different methods, including systematic house-by-house follow-up visits three days after treatment, biweekly population surveillance, and monitoring of both mobile clinic records and hospital records. No severe adverse reactions were noted, and no deaths could be related to ivermectin treatment; only 1.3% of the persons treated had a moderate adverse reaction of the Mazzotti type, presumably related to the killing of microfilariae. The study showed good acceptance by the population, and that mass treatment campaigns with ivermectin are feasible.

Pacque, M. C.; Dukuly, Z.; Greene, B. M.; Munoz, B.; Keyvan-Larijani, E.; Williams, P. N.; Taylor, H. R.

1989-01-01

185

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

PubMed Central

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

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

2014-01-01

186

Fear of needles and vasovagal reactions among phlebotomy patients  

Microsoft Academic Search

Anxiety associated with blood and injections is a common problem in medical settings and, in severe cases, affects sufferers’ ability to receive medically essential treatment. The present study was conducted to examine incidence of adverse reactions to venipunctures among phlebotomy patients, as well as to understand the demographic and psychological characteristics associated with such reactions. A large sample of participants

Brett Deacon; Jonathan Abramowitz

2006-01-01

187

Spontaneous Reporting of Adverse Drug Reactions through Electronic Submission from Regional Society Healthcare Professionals in Korea  

PubMed Central

Purpose Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals. Materials and Methods Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed e-sub ADR cases and matters to determine common culprits and organ specified ADR matters. Results There were 3,049 matters in 933 ADR cases for 1 year, and 3.3 matters per case were reported. In organ specific ADR classification, skin reactions which took the first place in 866 matters (28%) included urticaria and rash. The next cases were neurologic symptom (624 matters, 21%) and gastrointestinal symptom (581 matters, 19%). Doctor (53%) and pharmacist (31%) were the most important participants in e-sub spontaneous reporting system, and 3% of ADR cases were reported by patients or their guardians. WHO-Uppsala Monitoring Center causality assessment results showed certain 10.6%, probable 37.7%, possible 41.7% and below unlikely 10.0%. Culprit drugs were antibiotics (23.4%), neurologic agents (14.7%) and non-steroidal anti-inflammatory drugs (9.4%). Conclusion In our study, antibiotic was most common culprit drug, and skin manifestation was most common symptom in e-sub ADRs collected from regional healthcare practitioners in Korea.

Lee, Jae-Hyun; Park, Kyung Hee; Moon, Hyun Joo; Lee, Yong Won; Park, Jung-Won

2012-01-01

188

COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms, 4th Edition, (3 1/2 inch version) (for Microcomputers).  

National Technical Information Service (NTIS)

Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to de...

1993-01-01

189

COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms, 5th Edition (3 1/2 Inch Version) (for Microcomputers).  

National Technical Information Service (NTIS)

Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to de...

1995-01-01

190

COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms, 4th Edition (5 1/4 inch version) (for Microcomputers).  

National Technical Information Service (NTIS)

Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to de...

1993-01-01

191

Gd-DOTA administration at MRI in children younger than 18 months of age: immediate adverse reactions  

Microsoft Academic Search

Background  There is a paucity of evidence with regard to the safety of contrast medium administration at MRI in neonates and infants.\\u000a \\u000a \\u000a \\u000a Purpose  To assess immediate adverse reactions in children younger than 18 months of age during routine clinical utilization of gadoteric\\u000a acid (Gd-DOTA) in a cohort of patients with nonselected indications.\\u000a \\u000a \\u000a \\u000a \\u000a Materials and methods  One hundred and four neonates and infants were

Sophie Emond; Francis Brunelle

192

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

Microsoft Academic Search

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

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

2006-01-01

193

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

Microsoft Academic Search

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

A Clavenna; M Bonati

2009-01-01

194

A Bayesian neural network method for adverse drug reaction signal generation  

Microsoft Academic Search

Objective: The database of adverse drug reactions (ADRs) held by the Uppsala Monitoring Centre on behalf of the 47 countries of the\\u000a World Health Organization (WHO) Collaborating Programme for International Drug Monitoring contains nearly two million reports.\\u000a It is the largest database of this sort in the world, and about 35 000 new reports are added quarterly. The task of

A. Bate; M. Lindquist; I. R. Edwards; S. Olsson; R. Orre; A. Lansner; R. M. De Freitas

1998-01-01

195

Metal ion levels not sufficient as a screening measure for adverse reactions in metal-on-metal hip arthroplasties.  

PubMed

This study aims to assess the accuracy of metal ion analysis in the diagnosis of adverse reaction to metal debris (ARMD) in patients with metal-on-metal hip arthroplasties by comparing the cobalt and chromium levels in 57 patients (62 hips) to findings on metal artifact reduction magnetic resonance imaging (MRI). An ARMD was detected using MRI in 18 (29%) of the hips. Forty patients had cobalt levels less than 7 ?g/L, and 33 had chromium levels less than 7 ?g/L, but 8 of these had an ARMD on MRI and only minimal symptoms (Oxford Hip Score ? 44/48). The incidence of ARMD was significantly higher when chromium concentration was above 7 ?g/L (P = .02), but normal metal ion levels can be misleading and metal artifact reduction MRI imaging is advised in all patients. PMID:22771092

Macnair, Rory D; Wynn-Jones, Henry; Wimhurst, James A; Toms, Andoni; Cahir, John

2013-01-01

196

Cilostazol eliminates adverse smoking outcome in patients with drug-eluting stent implantation.  

PubMed

Background:?The present study investigated whether cilostazol can eliminate adverse smoking outcome after percutaneous coronary intervention (PCI). Methods and Results:?A total of 914 patients with successful drug-eluting stent (DES) implantation were randomly assigned to dual antiplatelet therapy (DAT; aspirin and clopidogrel, n=457) or to triple antiplatelet therapy (TAT; DAT with cilostazol, n=457). The effect of smoking on 2-year major adverse cardio/cerebrovascular events (MACCE) in both the TAT and DAT groups was evaluated. Total MACCE were not significantly different between the 2 anti-platelet regimens (9.8% in TAT vs. 11.4% in DAT groups, P=0.45), but the adverse effects of smoking on clinical outcome were different between DAT vs. TAT. Current smokers had a higher prevalence of MACCE than non-smokers in the DAT group (16.7% vs. 9.5%, P=0.04). In the TAT group, however, the adverse effect of smoking was abolished (9.2% vs. 10.1%, P=0.85). Regarding the effects of smoking on the antiplatelet effects of DAT or TAT, post-treatment platelet reactivity (in P2Y12 reaction units; PRU) in current smokers was not significantly lower than that in non-smokers in the DAT group, whereas, in the TAT group, it was significantly lower than that of non-smokers (189±88 vs. 216±89 PRU, P=0.01). Conclusions:?Adverse clinical effects of smoking may be eliminated by the addition of cilostazol to DAT after DES implantation. This may be due to the stimulation of cilostazol's antiplatelet effects by smoking.??(Circ J?2014; 78: 1420-1427). PMID:24694769

Kim, Hack-Lyoung; Suh, Jung-Won; Lee, Seung-Pyo; Kang, Hyun-Jae; Koo, Bon-Kwon; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho; Choi, Dong-Ju; Rha, Seung-Woon; Bae, Jang-Ho; Kwon, Taek-Geun; Bae, Jang-Whan; Cho, Myeong-Chan; Kim, Hyo-Soo

2014-05-23

197

Evaluation of adverse reactions in dogs following intravenous mesenchymal stem cell transplantation  

PubMed Central

Background Recent studies have assessed the therapeutic potential and drawbacks of mesenchymal stem cells (MSCs). The adverse reactions of intravenous transplantation of bone marrow (BM)-derived MSCs were examined at varying doses and frequencies of administration. Nine healthy beagle dogs were purchased from a commercial laboratory. The dogs were distributed equally (n?=?3 per group) and randomly into three groups. All dogs received allogeneic BM-derived MSCs: 2?×?106 once (group A), 2?×?107 once (group B), and 2?×?106 for three consecutive days (group C). Various laboratory examinations, multi-detector computed tomography features and histopathology were evaluated to clarify the clinical and diagnostic features of adverse reactions of MSCs administration, prior to receiving MSCs (pre procedure) and on days 1, 3, and 7 post transplantation. Results Only one dog had clinical signs during and after MSCs transplantation. Dogs receiving 2?×?106 MSCs showed increased numbers of lymphocytes but the total white blood cell counts were not elevated (P?adverse reactions after intravenous MSCs transplantation; however these results should be cautiously interpreted.

2014-01-01

198

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

PubMed Central

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

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

2012-01-01

199

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

PubMed Central

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

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

2012-01-01

200

Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records  

PubMed Central

Objective Medication  safety requires that each drug be monitored throughout its market life as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient harm. Recently, electronic medical records (EMRs) have emerged as a valuable resource for pharmacovigilance. This study examines the use of retrospective medication orders and inpatient laboratory results documented in the EMR to identify ADRs. Methods Using 12?years of EMR data from Vanderbilt University Medical Center (VUMC), we designed a study to correlate abnormal laboratory results with specific drug administrations by comparing the outcomes of a drug-exposed group and a matched unexposed group. We assessed the relative merits of six pharmacovigilance measures used in spontaneous reporting systems (SRSs): proportional reporting ratio (PRR), reporting OR (ROR), Yule's Q (YULE), the ?2 test (CHI), Bayesian confidence propagation neural networks (BCPNN), and a gamma Poisson shrinker (GPS). Results We systematically evaluated the methods on two independently constructed reference standard datasets of drug–event pairs. The dataset of Yoon et al contained 470 drug–event pairs (10 drugs and 47 laboratory abnormalities). Using VUMC's EMR, we created another dataset of 378 drug–event pairs (nine drugs and 42 laboratory abnormalities). Evaluation on our reference standard showed that CHI, ROR, PRR, and YULE all had the same F score (62%). When the reference standard of Yoon et al was used, ROR had the best F score of 68%, with 77% precision and 61% recall. Conclusions Results suggest that EMR-derived laboratory measurements and medication orders can help to validate previously reported ADRs, and detect new ADRs.

Liu, Mei; McPeek Hinz, Eugenia Renne; Matheny, Michael Edwin; Denny, Joshua C; Schildcrout, Jonathan Scott; Miller, Randolph A; Xu, Hua

2013-01-01

201

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

PubMed Central

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.

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

2012-01-01

202

Impact of patient knowledge, patient-pharmacist relationship, and drug perceptions on adverse drug therapy outcomes.  

PubMed

The purpose of this project was to determine the relationship between adverse drug outcomes and knowledge of drugs, quality of a counseling relationship, and perceptions about drugs in an ambulatory clinic population. The presence of these three factors and other indicators of adverse outcomes were identified through a structured interview of 78 patients. Medical records were reviewed 3, 6, and 12 months after the initial interview to determine the presence of adverse drug outcomes. Four outcomes-hospitalizations, unscheduled clinic visits, emergency room visits, and changes in drug regimen-were assessed and categorized according to drug-related problem. Demographics of the group were recorded. Responses to the interview were analyzed to determine differences in counseling relationships between pharmacists and other health professionals. Logistic regression analysis was performed to determine the influence of independent variables on outcome. Relative risks for developing adverse outcomes given the presence of certain independent variables were calculated for significant associations. Significant relationships between predictor variables and adverse drug outcomes were identified for the following independent variables: female gender (RR = 5.2, CI 1.11, 24.31), three or more diseases (RR = 3.3, CI 1.13, 9.75), more drug knowledge and better perceptions (RR = 0.29, CI 0.10, 0.84), perception of no or low drug interference (RR = 0.18, CI 0.044, 0.745), and inadequate data collection by nurses and physicians as perceived by the patient (RR = 3.08, CI 1.09, 8.70). More knowledge and better perceptions about drugs were associated with a reduced risk of therapy changes due to drug-related problems. No association was found between the quality of the pharmacist-patient counseling relationship and adverse drug outcomes. PMID:9545152

O'Neil, C K; Poirer, T I

1998-01-01

203

A Review of Safety, Efficacy, and Utilization of Erythropoietin, Darbepoetin, and Peginesatide for Patients with Cancer or Chronic Kidney Disease: A Report from the Southern Network on Adverse Reactions (SONAR)  

PubMed Central

The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin prevent transfusions among chemotherapy-associated anemia patients. Clinical trials, meta-analyses, and guidelines identify mortality, tumor progression, and venous thromboembolism (VTE) risks with ESA administration in this setting. Product labels advise against administering ESAs with potentially curative chemotherapy (United States) or to conduct risk–benefit assessments (Europe/Canada). Since 2007, fewer chemotherapy-associated anemia patients in the United States and Europe receive ESAs. ESAs and the erythropoietin receptor agonist peginesatide prevent transfusions among chronic kidney disease (CKD) patients; clinical trials, guidelines, and meta-analyses demonstrate myocardial infarction, stroke, VTE, or mortality risks with ESAs targeting high hemoglobin levels. U.S. labels recommend administering ESAs or peginesatide at doses sufficient to prevent transfusions among dialysis CKD patients. For dialysis CKD patients, Canadian and European labels recommend targeting hemoglobin levels of 10 to 12 g/dL and 11 to 12 g/dL, respectively, with ESAs. ESA utilization for dialysis CKD patients has decreased in the United States.

Bennett, Charles L.; Spiegel, David M.; Macdougall, Iain C.; Norris, LeAnn; Qureshi, Zaina P.; Sartor, Oliver; Lai, Stephen Y.; Tallman, Martin S.; Raisch, Dennis W.; Smith, Sheila Weiss; Silver, Samuel; Murday, Alanna S.; Armitage, James O.; Goldsmith, David

2014-01-01

204

Dermatological adverse reactions during anti-TNF treatments: focus on inflammatory bowel disease.  

PubMed

The clinical introduction of tumour necrosis factor (TNF) inhibitors has deeply changed the treatment of inflammatory bowel diseases (IBD). It has demonstrated impressive efficacy as compared to alternative treatments, allowing for the chance to achieve near-remission and long-term improvement in function and quality of life and to alter the natural history of Crohn's disease (CD) and ulcerative colitis (UC). As a consequence of longer follow-up periods the number of side effects which may be attributed to treatment with biologics is growing significantly. Cutaneous reactions are among the most common adverse reactions. These complications include injection site reactions, cutaneous infections, immune-mediated complications such as psoriasis and lupus-like syndrome and rarely skin cancers. We review the recent literature and draw attention to dermatological side effects of anti-TNF therapy of inflammatory bowel disease. PMID:23453887

Mocci, Giammarco; Marzo, Manuela; Papa, Alfredo; Armuzzi, Alessandro; Guidi, Luisa

2013-11-01

205

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

PubMed

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

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

2014-04-01

206

Histamine in foods: its possible role in non-allergic adverse reactions to ingestants.  

PubMed

Histamine is well recognized as a product of both mast cells and basophils. Its release from these sources in IgE-mediated reactions unquestionably contributes to the allergic response. It is often stated that ingestion of foods rich in histamine can result in absorption of sufficient histamine to provoke signs and symptoms reminiscent of an allergic reaction. A review of literature relevant to this issue suggests that certain foods do indeed contain histamine as measured by current methodology. Further, histamine ingestion in excess of 36 to 250 mg may or may not result in a clinical response which includes abdominal complaints, feelings of warmth, flushing and headache. Taken together, this evidence supports the hypothesis that ingestion of large amounts of histamine-containing foods or foods which contain the histamine precursor, histidine, under some circumstances can result in adverse reactions. PMID:3302658

Malone, M H; Metcalfe, D D

1986-01-01

207

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

Microsoft Academic Search

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

Eric J Thomas; Troyen A Brennan

2000-01-01

208

Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions  

PubMed Central

Objective Data-mining algorithms that can produce accurate signals of potentially novel adverse drug reactions (ADRs) are a central component of pharmacovigilance. We propose a signal-detection strategy that combines the adverse event reporting system (AERS) of the Food and Drug Administration and electronic health records (EHRs) by requiring signaling in both sources. We claim that this approach leads to improved accuracy of signal detection when the goal is to produce a highly selective ranked set of candidate ADRs. Materials and methods Our investigation was based on over 4 million AERS reports and information extracted from 1.2 million EHR narratives. Well-established methodologies were used to generate signals from each source. The study focused on ADRs related to three high-profile serious adverse reactions. A reference standard of over 600 established and plausible ADRs was created and used to evaluate the proposed approach against a comparator. Results The combined signaling system achieved a statistically significant large improvement over AERS (baseline) in the precision of top ranked signals. The average improvement ranged from 31% to almost threefold for different evaluation categories. Using this system, we identified a new association between the agent, rasburicase, and the adverse event, acute pancreatitis, which was supported by clinical review. Conclusions The results provide promising initial evidence that combining AERS with EHRs via the framework of replicated signaling can improve the accuracy of signal detection for certain operating scenarios. The use of additional EHR data is required to further evaluate the capacity and limits of this system and to extend the generalizability of these results.

Harpaz, Rave; Vilar, Santiago; DuMouchel, William; Salmasian, Hojjat; Haerian, Krystl; Shah, Nigam H; Chase, Herbert S; Friedman, Carol

2013-01-01

209

Effects of the Serotonin Type 2A, 3A and 3B Receptor and the Serotonin Transporter Genes on Paroxetine and Fluvoxamine Efficacy and Adverse Drug Reactions in Depressed Japanese Patients  

Microsoft Academic Search

In this study, we tested the influence of the serotonin type 2A, 3A and 3B receptor genes (HTR2A, HTR3A, HTR3B) in addition to a polymorphism in the promoter region of the serotonin transporter (SERTPR), and investigated the different characteristics of clinical responses to paroxetine and fluvoxamine. A total of 100 Japanese patients affected by major recurrent depression were enrolled in

Masaki Kato; Tsuyoshi Fukuda; Masataka Wakeno; Kazuhiro Fukuda; Gaku Okugawa; Yuka Ikenaga; Megumi Yamashita; Yoshiteru Takekita; Kenji Nobuhara; Junichi Azuma; Toshihiko Kinoshita

2006-01-01

210

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

PubMed Central

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

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

2013-01-01

211

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

PubMed Central

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.

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

2013-01-01

212

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

PubMed

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

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

2013-03-01

213

An overview of Canadian and U.S. approaches to drug regulation and responses to postmarket adverse drug reactions.  

PubMed

Over the years, drug products, including those indicated for diabetes, have been withdrawn from the marketplace because of quality concerns and/or severe adverse drug reactions. While the drug regulatory process is designed to detect, among other things, adverse drug reactions before a drug receives marketing authorization, for various reasons, premarket detection of all potential adverse reactions associated with a drug may not be possible. As such, regulatory authorities must also react to and manage adverse reactions identified at the postmarket stage. In this article, we provide a general overview of drug regulation in Canada and the United States and consider an example of a drug indicated for the treatment of diabetes and how newly identified potential safety concerns were managed in the postmarket environment. PMID:23566987

Cheung, Richard Y; Goodwin, Sarah H

2013-01-01

214

Incidence of and Risk Factors for Adverse Drug Reactions in a Prospective Cohort of HIV?Infected Adults Initiating Protease Inhibitor–Containing Therapy  

Microsoft Academic Search

8 Unite ´ de Maladies Infectieuses et Tropicales, Hotel-Dieu, Nantes, France Risk factors associated with the occurrence of protease inhibitor (PI)-related severe and serious adverse drug reactions (SADRs) were analyzed in a prospective cohort of 1155 patients who initiated PI-containing therapy. During a total follow-up of 2037 patient-years, 169 SADRs were reported, yielding a rate of 8 incidents per 100

Xavier Duval; Valerie Journot; Catherine Leport; Genevieve Chene; Michel Dupon; Lise Cuzin; Thierry May; Philippe Morlat; Anne Waldner; Roger Salamon; Francois Raffi

2004-01-01

215

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

Microsoft Academic Search

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

Dan NORBACK; Greta SMEDJE; Gunilla WIESLANDER

216

Communication regarding adverse drug reactions between secondary and primary care: a postal questionnaire survey of general practitioners.  

PubMed

GPs are not always informed that their patient suffered an adverse drug reaction (ADR) while in hospital. We have conducted a postal questionnaire survey of 270 GPs in order to elicit their views regarding provision of information from secondary care regarding ADRs. Of the 141 (52.2%) GPs that replied, 127 (90.1%) saw patients that had experienced an ADR in hospital. Of these GPs, 113 (89%) stated that they encountered instances where no record of the ADR existed in patients' discharge documentation. Where written information was absent, GPs are reliant on information given to them by patients. Of those responding, none were 'very confident' of this information, while 92 (78.6%) were 'uncertain' or 'very uncertain' of this information. A sample notification form was developed. GPs were generally satisfied with its content and 110 (82.7%) thought that patients should receive a copy. Almost all GPs (135 (97.8%)) felt that it would be appropriate to provide patients with ADR warning cards. Ensuring that patients and their carers are aware of drugs to which they may be allergic or intolerant through verbal and written methods should minimize the unnecessary risks of inadvertent re-exposure. PMID:10380065

Green, C F; Mottram, D R; Pirmohamed, M; Horner, R; Rowe, P H

1999-04-01

217

What can hospitalized patients tell us about adverse events? Learning from patient-reported incidents  

Microsoft Academic Search

PURPOSE: Little is known about how well hospitalized patients can identify errors or injuries in their care. Accordingly, the purpose\\u000a of this study was to elicit incident reports from hospital inpatients in order to identify and characterize adverse events\\u000a and near-miss errors.\\u000a \\u000a \\u000a SUBJECTS: We conducted a prospective cohort study of 228 adult inpatients on a medicine unit of a Boston

Saul N. Weingart; Odelya Pagovich; Daniel Z. Sands; Joseph M. Li; Mark D. Aronson; Roger B. Davis; David W. Bates; Russell S. Phillips

2005-01-01

218

Adverse effects of antipsychotic drugs: survey of doctors’ versus patients’ perspective  

Microsoft Academic Search

Aims  Almost no data are available on whether patients and doctors have similar or dissimilar opinions on the presence and level\\u000a of distress due to antipsychotic adverse effects. The aim of this survey is to compare doctors’ versus patients’ perspective\\u000a on the presence and level of distress due to antipsychotic adverse effects in a sample of patients under the care of

Maria Angela Mazzi; Eleonora Esposito; Marco Bianchini; Paola Petrosemolo; Giovanni Ostuzzi; Michele Tansella; Corrado Barbui

219

Effect of ketotifen premedication on adverse reactions during peanut oral immunotherapy  

PubMed Central

Background Oral immunotherapy (OIT) has shown promise in inducing desensitization for food allergy. However, there are safety concerns regarding the frequency and severity of adverse events during food OIT. Objective To evaluate the effect of Ketotifen premedication on adverse reactions during peanut OIT. Methods A randomized single blind placebo controlled pilot study was performed. Peanut OIT was performed using a previously published protocol. Ketotifen was up-titrated to 2 mg twice daily over two weeks (week -2 to 0), followed by a peanut OIT initial escalation day (day 1). Ketotifen was administered from week 0–4 of peanut OIT; reactions to peanut OIT doses were recorded by clinic staff and subject diary. Results Six subjects (median age 10 years, peanut IgE >100kUA/L) were enrolled, 4 randomized to Ketotifen, 2 to placebo. The most common side effect of Ketotifen was fatigue (9% during up-titration). The rate of reaction per peanut OIT dose was lower for subjects on ketotifen (K) compared to placebo (P) during initial escalation on day 1 (K: 22% (8/36) vs. P: 67% (12/18)); week 0–4 build-up doses (K: 75% (3/4) vs. P: 100% (2/2)); and week 0–4 home doses (K: 50% (54/108) vs. P: 82% (27/33)). The rate of gastrointestinal symptoms per peanut OIT dose was also lower for subjects on ketotifen during initial escalation on day 1 (K: 17% (6/36) vs. P: 61% (11/18)); week 0–4 build-up doses (K: 75% (3/4) vs P: 100% (2/2)); and week 0–4 home doses (K: 46% (50/108) vs. P: 82% (27/33)). Conclusions Ketotifen premedication is well tolerated and reduces the rate of gastrointestinal symptoms during peanut OIT. These findings require confirmation in a larger study of Ketotifen premedication used throughout peanut OIT. Trial registration Clinical Trials number: NCT0162515

2014-01-01

220

Intensive monitoring of adverse drug reactions in infants and preschool children.  

PubMed

Intensive monitoring of adverse drug reactions (ADR) in infants and preschool children in the paediatric outpatient unit covering the town of Karlovac (150,000 inhabitants) was performed over a period of three months. Data were obtained by physical examination of children and the history given by their parents. In all 2359 children were examined. ADR were recorded in 63 children and were reported to the National ADR monitoring centre in Zagreb. Using the algorithm of Hutchinson et al. (1979), all ADR were classified as "definite", "probable", "possible" and "unlikely". Drugs were prescribed in 97.3% of children, 60.24% received an antimicrobial agent (43% of them on the basis of a sensitivity test), and an antipyretic was given to 1878 children, mostly paracetamol. ADR were most frequently caused by antibiotics (49 reactions to penicillin V, and 15 to amoxycillin) and secretolytics (7 reactions). ADR were followed by complete recovery and not a single child was hospitalized because of an ADR. The results, when compared with the very small number of broadly comparable studies, indicate that the incidence of ADR in this population is rather small and of minor importance. PMID:2917590

Cirko-Begovi?, A; Vrhovac, B; Bakran, I

1989-01-01

221

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

PubMed Central

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.

Watanabe, Hitoshi; Kubosawa, Hitoshi

2014-01-01

222

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

PubMed Central

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

Chung, Wen-Hung

2014-01-01

223

Two case reports of cutaneous adverse reactions following hepatitis B vaccine: lichen planus and granuloma annulare.  

PubMed

We report two cases of adverse cutaneous reactions following hepatitis B vaccination. The first case occurred 3 weeks after the first dose of hepatitis B vaccine in a 16-year-old white girl with the onset of lichen planus lesions on her thighs and abdomen. After the second dose a disseminated lichen planus developed within 2 weeks. The second case concerns to the development of papular and patch granuloma annulare in a 58-year-old white woman 2 months after the second dose of hepatitis B vaccine. To the best of our knowledge, only a few paediatric and adult cases of lichen planus as a complication of hepatitis B vaccination have been reported in medical literature so far. This is the second case of granuloma annulare following hepatitis B vaccine. Our report, similar to earlier papers, appears to support the onset of lichen planus and granuloma annulare as a possible rare complication of hepatitis B immunization. PMID:15324406

Criado, P R; de Oliveira Ramos, R; Vasconcellos, C; Jardim Criado, R F; Valente, N Y S

2004-09-01

224

Analysis of spontaneous adverse drug reaction (ADR) reports using supplementary information.  

PubMed

Assessment of safety of newly marketed drugs is an important public health issue. Once the drug is in the market, clinicians and/or health professionals are responsible for recognizing and reporting suspected side effects known as adverse drug reaction (ADR). Such reports are collected in a so-called spontaneous reporting (SR) system. The primary purpose of spontaneous ADR reporting is to provide early warnings or suspicions, which have not been recognized prior to marketing of a drug because of limitations of clinical trials. We shall discuss the existing work to analyze the SR database and their drawbacks and also suggest methodologies to tackle these drawbacks by defining a source population and considering the problem of under-reporting, with the help of supplementary data. Unbiased estimate of population odds-ratio has been obtained and the corresponding asymptotic results are derived. PMID:21544847

Ghosh, Palash; Dewanji, Anup

2011-07-20

225

Community pharmacists' knowledge and perceptions about adverse drug reactions and barriers towards their reporting in Eastern region, Alahsa, Saudi Arabia  

PubMed Central

Objective: The present study aims to analyze community pharmacists’ current knowledge and perceived barriers to adverse drug reaction (ADR) reporting systems in the Eastern region, Alahsa, Saudi Arabia. Method: A cross-sectional study was planned from 1 June 2012 to 15 July 2012 among the community pharmacies in the Eastern region, Alahsa. A total of 70 community pharmacists were approached using a cluster sampling method. A self-administered, 28-item questionnaire was used to attain the objectives of the study. Data analysis was done using Statistical Package for Social Science version 13. Relative index ranking was used to identify the top five barriers to the ADR reporting process. Results: Response to the survey was 71.43%. In terms of knowledge about ADRs, very few (four, 8.0%) pharmacists were unable to differentiate between the right and wrong definition of ADRs. About 42 (84.0%) pharmacists mentioned that patients often report adverse events. However, 45 (90.0%) were not aware of the ADR reporting system in Saudi Arabia. A deficient professional environment was the main barrier to the ADR reporting process. In addition, unavailability of the reporting forms and poor understanding of the reporting process were common barriers to the reporting process. Conclusion: Most of the community pharmacists were unaware of the ADR reporting system in Saudi Arabia. Logistic issues were the main barriers to the ADR reporting process.

2013-01-01

226

Possible pathogenic pathways in the adverse clinical events seen following ivermectin administration to onchocerciasis patients.  

PubMed Central

Background Reactions are commonly associated with the chemotherapy of onchocerciasis. However unmanageable reactions are uncommon when ivermectin (Mectizan®) is used for the treatment of this infection, and this drug has proved to be a great improvement over previously used agents. Serious adverse events (SAE) nevertheless have occurred, and there is considerable concern about the negative effect such events may have on mass drug administration programs. This paper reviews the basic pathogenic mechanisms that can be involved in the destruction of microfilaria by chemotherapeutic agents. A central challenge to filarial chemotherapy is the need to remove parasites from biologically sensitive tissues, a more difficult medical challenge than eliminating nematodes from the gastrointestinal tract. Explanations for the etiology of the serious adverse reactions occurring with ivermectin treatment in specific geographic areas where there is coincident heavy Loa loa infections are hampered by a lack of specific pathological case material. Ways to investigate these possibilities are reviewed. Possible pathogenic mechanisms include embolic vascular pathology accompanied by local inflammation, blood brain barrier mdr1 abnormalities, and genetic predisposition to excessive inflammatory responses. Conclusion It is important to keep ivermectin, and all its associated adverse clinical events, in perspective with the many other chemotherapeutic agents in general use – many of which produce serious adverse events even more frequently than does ivermectin. Currently available evidence indicates that the pathogenesis of the Loa-associated adverse reactions are probably related to inflammatory responses to microfilariae in specific tissues. However, the possibility of genetic predispositions to pathology should also be considered.

Mackenzie, Charles D; Geary, Timothy G; Gerlach, John A

2003-01-01

227

Adverse events and potentially preventable deaths in Dutch hospitals: results of a retrospective patient record review  

Microsoft Academic Search

OBJECTIVE: This study determined the incidence, type, nature, preventability and impact of adverse events (AEs) among hospitalised patients and potentially preventable deaths in Dutch hospitals. METHODS: Using a three-stage retrospective record review process, trained nurses and doctors reviewed 7926 admissions: 3983 admissions of deceased hospital patients and 3943 admissions of discharged patients in 2004, in a random sample of 21

H. W. M. Zegers; M. C. de Bruijne; C. Wagner; L. H. F. Hoonhout; R. Waaijman; M. Smits; P. P. Groenewegen; L. Zwaan; I. Christiaans-Dingelhoff; D. R. M. Timmermans; G. van der Wal

2009-01-01

228

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

PubMed

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

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

2014-06-01

229

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

Microsoft Academic Search

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

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

2011-01-01

230

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

PubMed

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

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

2014-05-01

231

Adverse systemic arterial function in patients with selenium deficiency  

Microsoft Academic Search

Background  Experimental studies have shown that selenium is involved in the synthesis of selenoproteins which might contribute to cardiovascular\\u000a protection. However, the relationship between selenium deficiency and vascular function in clinical context remains unknown.\\u000a \\u000a \\u000a \\u000a \\u000a Objective  To investigate for any relationship between selenium deficiency and systemic arterial function in patients with high risk\\u000a of vascular events.\\u000a \\u000a \\u000a \\u000a \\u000a Design  Cross-sectional study.\\u000a \\u000a \\u000a \\u000a Setting and Participants  306 consecutive patients

Y.-H. Chan; C.-W. Siu; K.-H. Yiu; H.-T. Chan; S.-W. Li; S. Tam; B. M. Cheung; C.-P. Lau; T. H. Lam; Hung-Fat Tse

232

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

PubMed Central

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

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

2014-01-01

233

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

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.

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

2014-01-01

234

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

SciTech Connect

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

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

2010-06-15

235

Summary of: Preaching to the converted - optimising adverse drug reaction reporting by dentists.  

PubMed

Objective To assess the level of knowledge and reporting of adverse drug reactions (ADRs) of dentists at different stages of their careers and conduct a training need analysis.Design Structured questionnaires were distributed to final year dental students (DSs), foundation year one students (DF1s) and general dental practitioners (GDPs).Setting Opportunity samples of DSs from Kings College London, DF1s from the postgraduate deaneries of Kent, Surrey and Sussex, and Oxford and GDPs in Hampshire and the Isle of Wight. The study was conducted from November 2012 to February 2013.Main outcome measures Relative knowledge and awareness of ADRs and ADR reporting, and performance in an assessment of these aspects.Results Thirty-one DSs, 35 DF1s and 98 GDPs took part in the study. Awareness of the Yellow Card Scheme varied between groups (30.8%, 48.6% and 88.8% respectively). Reported use of the scheme was uniformly low (2.6%, 5.7% and 5.1% respectively). There were no differences in knowledge about ADRs and ADR reporting between the three groups of dentists as indicated by median scores achieved in the questionnaire test (54%, 73% and 62% for DSs, DF1s and GDPs respectively; p = 0.638). All of the DSs, 91.4% of DF1s and 91.8% of GDPs said that they would welcome further training. Key topics included training on ADRs to medicines commonly used in their dental practice and deciding what ADRs needed to be reported. The most popular format for delivery of this training was formal lectures for DF1s and GDPs, but workshops for DSs. Postgraduate deaneries were the most popular provider choice for DF1s and GDPs.Conclusions Dentists at different stages of their careers showed variable awareness and knowledge of the UK Yellow Card Scheme and what to report. Training should be tailored to fit the needs of the different groups. A questionnaire survey incorporating a summative knowledge assessment demonstrated variable levels of knowledge about adverse drug reactions and what to report. Large majorities of all groups (>90%) expressed a desire for training in these areas and in the case of graduate and practising dentists, indicated that this should be organised by the postgraduate deaneries. PMID:25060459

Wray, David

2014-07-25

236

Preaching to the converted - optimising adverse drug reaction reporting by dentists.  

PubMed

Objective To assess the level of knowledge and reporting of adverse drug reactions (ADRs) of dentists at different stages of their careers and conduct a training need analysis.Design Structured questionnaires were distributed to final year dental students (DSs), foundation year one students (DF1s) and general dental practitioners (GDPs).Setting Opportunity samples of DSs from Kings College London, DF1s from the postgraduate deaneries of Kent, Surrey and Sussex, and Oxford and GDPs in Hampshire and the Isle of Wight. The study was conducted from November 2012 to February 2013.Main outcome measures Relative knowledge and awareness of ADRs and ADR reporting, and performance in an assessment of these aspects.Results Thirty-one DSs, 35 DF1s and 98 GDPs took part in the study. Awareness of the Yellow Card Scheme varied between groups (30.8%, 48.6% and 88.8% respectively). Reported use of the scheme was uniformly low (2.6%, 5.7% and 5.1% respectively). There were no differences in knowledge about ADRs and ADR reporting between the three groups of dentists as indicated by median scores achieved in the questionnaire test (54%, 73% and 62% for DSs, DF1s and GDPs respectively; p = 0.638). All of the DSs, 91.4% of DF1s and 91.8% of GDPs said that they would welcome further training. Key topics included training on ADRs to medicines commonly used in their dental practice and deciding what ADRs needed to be reported. The most popular format for delivery of this training was formal lectures for DF1s and GDPs, but workshops for DSs. Postgraduate deaneries were the most popular provider choice for DF1s and GDPs.Conclusions Dentists at different stages of their careers showed variable awareness and knowledge of the UK Yellow Card Scheme and what to report. Training should be tailored to fit the needs of the different groups. A questionnaire survey incorporating a summative knowledge assessment demonstrated variable levels of knowledge about adverse drug reactions and what to report. Large majorities of all groups (>90%) expressed a desire for training in these areas and in the case of graduate and practising dentists, indicated that this should be organised by the postgraduate deaneries. PMID:25060479

Patel, M M; Radford, D R; Brown, D

2014-07-25

237

Adjuvant Chemotherapy Use and Adverse Events among Older Patients with Stage III Colon Cancer  

PubMed Central

Context Randomized trials suggest adjuvant chemotherapy is effective for elderly patients with stage III colon cancer. However, the elderly are less likely to receive this therapy than younger patients, perhaps because of concern about adverse effects. Objective To evaluate adjuvant chemotherapy use and outcomes for older patients with stage III colon cancer from well-defined population-based settings and healthcare systems. Design Observational study of adjuvant chemotherapy use and outcomes by age, using Poisson regression to estimate the number of adverse events adjusted for demographic and clinical factors, including comorbid illness and specific elements of chemotherapy regimens documented with clinically detailed medical record reviews and patient and surrogate surveys. Setting Five geographically defined regions (Alabama, Iowa, Los Angeles County, Northern California, and North Carolina), five integrated health-care delivery systems, and 15 Veterans hospitals. Patients All 675 patients diagnosed with stage III colon cancer during 2003-2005 who underwent surgical resection were followed up to 15 months post-diagnosis. Main outcome measures Chemotherapy regimen, dose, duration and annualized mean number of adverse events stratified by age. Results Half of the 202 patients >=75 years received adjuvant chemotherapy compared with 87% of 473 younger patients (diff 37%, 95% CI 30%-45%). Among adjuvant chemotherapy users, 14 (14%) of patients >=75 years and 178 (44%) of younger patients received a regimen containing oxaliplatin (diff 30%, 95% CI 21%-38%). Older patients were less likely to continue. By 150 days, 99 (40%) patients >= 65 years and 68 (25%) younger patients had discontinued chemotherapy (diff 15%, 95% CI 7%-23%). Overall, 162 (24%) patients had at least one adverse clinical event, with more events among patients treated with vs. without adjuvant chemotherapy (mean 0.394 vs. 0.160, diff 0.234, 95% CI 0.11-0.36, p<0.001). Among adjuvant chemotherapy users, adjusted rates of late clinical adverse events show a reverse U-distribution with lower rates for patients >= 75 years (0.277) versus for younger patients (0.345 for 18-54, 0.519 for 55-64, and 0.446 for 65-75 years, p=0.008 for any age effect). Conclusions Older patients in the community receive less toxic and shorter chemotherapy regimens, and those treated had fewer adverse events than younger patients. The effect of these differences on clinical outcomes is not clear.

Kahn, Katherine L.; Adams, John L.; Weeks, Jane C.; Chrischilles, Elizabeth A.; Schrag, Deborah; Ayanian, John Z.; Kiefe, Catarina I.; Ganz, Patricia A.; Bhoopalam, Nirmala; Potosky, Arnold L.; Harrington, David P.; Fletcher, Robert H.

2010-01-01

238

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

ERIC Educational Resources Information Center

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

Bisgaier, Joanna; Rhodes, Karin V.

2011-01-01

239

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

Microsoft Academic Search

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

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

240

Managing adverse effects of glaucoma medications  

PubMed Central

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

Inoue, Kenji

2014-01-01

241

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

PubMed Central

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

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

242

An educational intervention to improve nurses' knowledge, attitude, and practice toward reporting of adverse drug reactions  

PubMed Central

Background: The reporting of adverse drug reactions (ADRs) by nurses in hospitals is very important. Aims: This study was aimed at investigating the impact of an educational intervention to improve ADR reporting and whether trained nurses had better knowledge, attitude, and practice toward ADR reporting. Materials and Methods: A total of 300 nurses in a tertiary care teaching hospital in Tehran, Iran were evaluated with a knowledge, attitude, and practice (KAP) questionnaire regarding ADR reporting in March 2010. After this, an educational program about ADR was provided to nurses. Then the nurses were re-evaluated by the same questionnaire. Comparisons were made of the attitude and knowledge within nurses, before and after education. Data were analyzed using SPSS software. P < 0.05 was considered as significant level. Independent-sample t-test was used to measure the intervention effect. Results: The response rate was 61.3% (N = 184). Knowledge of nurses before the intervention was significantly less than the knowledge after the intervention (P = 0.001). Also, there was a significant effect on attitude (P = 0.002). During the follow-up period of 4 months after the intervention, 26 spontaneous reports were received. Conclusion: Continuous ADR educational program, training, and integration of ADRs’ reporting into the activities of the nurses would likely improve ADR reporting.

Hanafi, Somayeh; Torkamandi, Hassan; Hayatshahi, Alireza; Gholami, Kheirollah; Shahmirzadi, Nikinaz Ashrafi; Javadi, Mohammad Reza

2014-01-01

243

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

PubMed

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

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

2014-06-01

244

Consensus List of Signals to Detect Potential Adverse Drug Reactions in Nursing Homes  

PubMed Central

OBJECTIVES To develop a consensus list of agreed upon laboratory, pharmacy, and Minimum Data Set signals that can be used by a computer system in the nursing home to detect potential adverse drug reactions (ADRs). DESIGN AND SETTING Literature search for potential ADR signals, followed by an Internet-based, two-round, modified Delphi survey of experts in geriatrics. PARTICIPANTS Panel of 13 physicians, 10 pharmacists, and 13 advanced practitioners. MEASUREMENTS Mean score and 95% confidence interval (CI) for each of 80 signals rated on a 5-point Likert scale (5=strong agreement with likelihood of indicating potential ADRs). Consensus agreement indicated by a lower-limit 95% CI of ?4.0. RESULTS Panelists reached consensus agreement on 40 signals: 15 laboratory/medication combinations, 12 medication concentrations, 10 antidotes, and 3 Resident Assessment Protocols (RAPs). Highest consensus scores (4.6; 95% CI, 4.4–4.9 or 4.4–4.8) were for naloxone when taking opioid analgesics; phytonadione when taking warfarin; dextrose, glucagon, or liquid glucose when taking hypoglycemic agents; medication-induced hypoglycemia; supratherapeutic international normalized ratio when taking warfarin; and triggering the Falls RAP when taking certain medications. CONCLUSION A multidisciplinary expert panel was able to reach consensus agreement on a list of signals to detect potential ADRs in nursing home residents. The results of this study can be used to prioritize an initial list of signals to be included in paper or computer-based methods for potential ADR detection.

Handler, Steven M.; Hanlon, Joseph T.; Perera, Subashan; Roumani, Yazan F.; Nace, David A.; Fridsma, Douglas B.; Saul, Melissa I.; Castle, Nicholas G.; Studenski, Stephanie A.

2009-01-01

245

Analysis of the adverse reactions induced by natural product-derived drugs  

PubMed Central

Compared with the therapeutic effects of established medicinal drugs, it is often considered that natural product-derived drugs are of a more benign nature in side-effects, which has made natural medicines become a popular form of therapy. Traditional Chinese medicine (TCM) is generally considered as being natural and harmless. TCM has been paid much more attention than before and widely used for the treatment nowadays. However, with the increasing cases of adverse drug reactions (ADRs), the ADRs induced by TCM are becoming more widely recognized. Some ADRs are sometimes even life-threatening. This article reviews literatures on ADRs induced by TCM which was published in the past 10 years. A total of 3122 cases including complete data are selected for the present analysis. From the data of the 3122 cases, statistics is carried out to the distribution of administration routes and time of the occurrence of ADRs, the prognosis of ADRs, sex and age factors, types and clinical symptoms of ADRs, and drugs involved in ADRs. In addition, occurrence and influencing factors of TCM-induced diseases are also analysed, which includes spices confusion, processing drugs improperly, toxic components, long-term medication, improper concerted application, interaction of TCM and Western medicine. It is concluded that the efficacy and toxicity of TCM, often using the compound prescription involving various plants and animals, resulted from a variety of chemical constituents, which lead to a comprehensive response in the human body. The ‘toxicity’ of TCM should be correctly recognized and reasonably utilized.

Zeng, Zhi-Ping; Jiang, Jian-Guo

2010-01-01

246

A comparison of disproportionality analysis methods in national adverse drug reaction databases of China.  

PubMed

Objective: Several disproportionality analysis methods are widely used for signal detection. The goal of this study was to compare the concordance of the performance characteristics of these methods in spontaneous reporting system of China. Methods: Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), a composite criterion previously used by Medicines and Healthcare Products Regulatory Agency (MHRA) were compared. Kappa coefficient was used as the gauge to test the concordance. Reports received in the year 2004 and 2005 were extracted for analysis in this study. Results: After data processing, 361,872 reports representing 52,769 combinations were analysed. The analysis generated 24,022, 22,646, 5637 and 5302 signals of disproportionality by PRR, ROR, MHRA and IC, respectively. The kappa coefficient increased with the threshold of number of drug-adverse drug reactions (ADR) combination, and the coefficient exceeded 0.7 when the number of suspected drug-ADR exceeded 2. Conclusion: This study shows that different measures used are broadly comparable in spontaneous reporting system in China when two or more cases per combination have been collected. PMID:24918197

Hou, Yongfang; Ye, Xiaofei; Wu, Guizhi; Cheng, Gang; Du, Xiaoxi; He, Jia

2014-07-01

247

Predicting adverse drug reaction profiles by integrating protein interaction networks with drug structures.  

PubMed

The prediction of adverse drug reactions (ADRs) has become increasingly important, due to the rising concern on serious ADRs that can cause drugs to fail to reach or stay in the market. We proposed a framework for predicting ADR profiles by integrating protein-protein interaction (PPI) networks with drug structures. We compared ADR prediction performances over 18 ADR categories through four feature groups-only drug targets, drug targets with PPI networks, drug structures, and drug targets with PPI networks plus drug structures. The results showed that the integration of PPI networks and drug structures can significantly improve the ADR prediction performance. The median AUC values for the four groups were 0.59, 0.61, 0.65, and 0.70. We used the protein features in the best two models, "Cardiac disorders" (median-AUC: 0.82) and "Psychiatric disorders" (median-AUC: 0.76), to build ADR-specific PPI networks with literature supports. For validation, we examined 30 drugs withdrawn from the U.S. market to see if our approach can predict their ADR profiles and explain why they were withdrawn. Except for three drugs having ADRs in the categories we did not predict, 25 out of 27 withdrawn drugs (92.6%) having severe ADRs were successfully predicted by our approach. PMID:23184540

Huang, Liang-Chin; Wu, Xiaogang; Chen, Jake Y

2013-01-01

248

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

PubMed Central

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.

Najam, Rahila; Mateen, Ahmed

2013-01-01

249

Multidisciplinary treatments, patient characteristics, context of care, and adverse incidents in older, hospitalized adults.  

PubMed

The purpose of this study was to examine factors that contribute to adverse incidents by creating a model that included patient characteristics, clinical conditions, nursing unit context of care variables, medical treatments, pharmaceutical treatments, and nursing treatments. Data were abstracted from electronic, administrative, and clinical data repositories. The sample included older adults hospitalized during a four-year period at one, academic medical facility in the Midwestern United States who were at risk for falling. Relational databases were built and a multistep, statistical model building analytic process was used. Total registered nurse (RN) hours per patient day (HPPD) and HPPDs dropping below the nursing unit average were significant explanatory variables for experiencing an adverse incident. The number of medical and pharmaceutical treatments that a patient received during hospitalization as well as many specific nursing treatments (e.g., restraint use, neurological monitoring) were also contributors to experiencing an adverse incident. PMID:22530112

Shever, Leah L; Titler, Marita G

2012-01-01

250

Multidisciplinary Treatments, Patient Characteristics, Context of Care, and Adverse Incidents in Older, Hospitalized Adults  

PubMed Central

The purpose of this study was to examine factors that contribute to adverse incidents by creating a model that included patient characteristics, clinical conditions, nursing unit context of care variables, medical treatments, pharmaceutical treatments, and nursing treatments. Data were abstracted from electronic, administrative, and clinical data repositories. The sample included older adults hospitalized during a four-year period at one, academic medical facility in the Midwestern United States who were at risk for falling. Relational databases were built and a multistep, statistical model building analytic process was used. Total registered nurse (RN) hours per patient day (HPPD) and HPPDs dropping below the nursing unit average were significant explanatory variables for experiencing an adverse incident. The number of medical and pharmaceutical treatments that a patient received during hospitalization as well as many specific nursing treatments (e.g., restraint use, neurological monitoring) were also contributors to experiencing an adverse incident.

Shever, Leah L.; Titler, Marita G.

2012-01-01

251

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

PubMed

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

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

2011-12-01

252

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

PubMed Central

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.

Salter, Mark D.

2013-01-01

253

FREQUENCY, SEVERITY, AND COSTS OF ADVERSE REACTIONS FOLLOWING MASS TREATMENT FOR LYMPHATIC FILARIASIS USING DIETHYLCARBAMAZINE AND ALBENDAZOLE IN LEOGANE, HAITI, 2000  

Microsoft Academic Search

In October 2000, 71,187 persons were treated for lymphatic filariasis using albendazole and diethylcar- bamazine (DEC) or DEC alone in Leogane, Haiti. We documented the frequency of adverse reactions, severity and cost of treatment. Adverse reactions were classified as minor, moderate, or severe. Overall, 24% (17,421) of the treated persons reported one or more adverse reactions. There were 15,916 (91%)

STEVEN I. MCLAUGHLIN; JEANNE RADDAY; MARIE CARMEL MICHEL; DAVID G. ADDISS; MICHAEL J. BEACH; PATRICK J. LAMMIE; JOHN LAMMIE; RICHARD RHEINGANS; JACK LAFONTANT

2003-01-01

254

Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003  

PubMed Central

What is already known about this subject Adverse drug reactions (ADRs) are a major cause of morbidity in older patients and represent a major burden on healthcare. The rate of ADR-related hospital stays in older people in Western Australia (WA) increased fivefold from 1981 to 2002. Little information is available regarding repeated ADRs in the elderly and the drugs most responsible. What this study adds Repeat ADR-related hospitalizations have consistently increased faster than first-time ADRs in the elderly in WA from 1980 and had reached 30.3% of all ADRs by 2003. The mean time interval declined with each successive repeat ADR and the most common repeat ADRs were nausea and vomiting, haemorrhage due to anticoagulants, drug-induce osteoporosis and poisoning by cardiovascular agents. Strategies to ensure the safer use cardiovascular agents, corticoids, nonsteroidal anti-inflammatory drugs, opioids and, in particular, anticoagulants, in this population are warranted. Aim To examine trends in the rate of repeat adverse drug reactions (ADRs) causing hospitalization in older Australians and to identify the most common ADRs and drugs most often implicated in repeat and first-time ADRs. Methods Analysis of routinely collected hospital record administrative data, with International Classification of Diseases external cause codes for ADRs extracted from the Western Australia (WA) Hospital Morbidity Data System and WA Death Register, for people aged ?60 years in 1980–2003. Results A total of 37 296 people aged ?60 years with an ADR-related hospitalization were identified. Among them, 6853 (18.4%) patients had 10 212 repeat ADRs. Repeat ADRs consistently increased from 1980 and reached 30.3% of all ADRs by 2003. The mean time interval declined with each successive repeat ADR (810, 606 and 299 days for the first, second and higher ranked repeat episodes, respectively). The most common repeat ADRs were nausea/vomiting (8.0%), haemorrhage due to anticoagulants (5.5%), drug-induced osteoporosis (4.8%) and poisoning by cardiovascular agents (3.9%). The drugs most often involved in repeat ADRs were cardiovascular agents (15.6%), antineoplastic drugs (11.0%), corticoids (10.1%), anticoagulants (8.6%), antirheumatics/nonsteroidal anti-inflammatory drugs (5.1%) and opioids (4.9%). The trends of anticoagulants and antineoplastic drugs implicated in repeat ADRs were still rising at the end of the study. The specific drug classes involved in repeat ADRs differed in relative importance from first-time ADRs. Conclusions Repeat ADR-related hospitalizations have consistently increased in elderly Australians from 1980 to 2003. Strategies to ensure the safer use of medicines, in particular anticoagulants, in this population are warranted.

Zhang, Min; Holman, C D'Arcy J; Preen, David B; Brameld, Kate

2007-01-01

255

Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011  

PubMed Central

Background Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications. Methods ADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR. Results We located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline. Conclusions The majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.

2013-01-01

256

Sex differences in cardiovascular drug-induced adverse reactions causing hospital admissions  

PubMed Central

AIMS Cardiovascular disease in women is often underestimated. The effects of cardiovascular drugs differ between the sexes because of pharmacokinetic and pharmacodynamic differences. Adverse drug reactions (ADRs) within these drug classes may have serious consequences, leading to hospital admission. We aimed to study differences between men and women in hospital admissions for ADRs due to cardiovascular drugs. METHODS We conducted a nationwide study of all hospital admissions between 2000 and 2005 with data from the Dutch National Medical Register. Relative risks were calculated of hospital admissions due to ADRs to the different cardiovascular drug groups for women compared with men. By an ecological design, risks were adjusted for the total number of Dutch inhabitants and the total number of prescriptions. RESULTS In total, 14 207 of the hospital admissions (34% of all ADR-related admissions) were attributed to cardiovascular drugs [7690 in women (54%; 95% confidence interval 53–55%)]. ‘Anticoagulants and salicylates’ (n= 8988), ‘high- and low-ceiling diuretics’ (n= 2242) and ‘cardiotonic glycosides’ (n= 932) were responsible for the majority of the ADR-related hospital admissions. The most pronounced sex differences were seen in users of low-ceiling diuretics (relative risk 4.02; 95% confidence interval 3.12–5.19), cardiotonic glycosides (relative risk 2.38; 95% confidence interval 2.06–2.74), high-ceiling diuretics (relative risk 2.10; 95% confidence interval 1.91–2.32) and coronary vasodilators (relative risk 0.77; 95% confidence interval 0.65–0.91). CONCLUSIONS Clear sex differences exist in ADRs requiring hospital admission for different cardiovascular drug groups. Sex differences should be taken into account in the prescription and evaluation of drugs.

Rodenburg, Eline M; Stricker, Bruno H; Visser, Loes E

2012-01-01

257

Disease progression and adverse events in patients listed for elective percutaneous coronary intervention  

PubMed Central

Objective: To record disease progression and the timing of adverse events in patients on a waiting list for elective percutaneous coronary intervention (PCI). Design: Observational prospective study. Settings: A UK tertiary cardiothoracic centre, at a time when waiting lists for PCI were up to 18 months. Patients: 145 patients (116 men, median age 59.5 years) placed on an elective waiting list for PCI between October 1998 and September 1999. Main outcome measures: Adverse events recorded were death, myocardial infarction, need for urgent hospital admission because of unstable angina, and need for emergency revascularisation while waiting for PCI. Results: During a median follow up of 10 months (range 1–18 months), nine (6.2%) patients experienced an adverse event. Eight (5.52%) patients were admitted with unstable angina as emergencies. One was admitted with a myocardial infarction. Twenty nine (20.0%) patients had significant disease progression at the time of the repeat angiogram before PCI. In 10 (7%), disease had progressed so that PCI was no longer feasible and patients were referred for coronary artery bypass graft. Sixteen (11%) were removed from the PCI waiting list because of almost complete resolution of their anginal symptoms. Conclusion: Adverse coronary events and clinically significant disease progression occur commonly in patients waiting for PCI. Despite the presence of severe coronary lesions, myocardial infarction was rare and no patients died while on the waiting list. Resolution of anginal symptoms was also comparatively common. The pathophysiology of disease progression frequently necessitates a change in the treatment of patients waiting for PCI.

Talwar, S; Karpha, M; Thomas, R; Vurwerk, C; Cox, I; Burrell, C; Motwani, J; Gilbert, T; Haywood, G

2005-01-01

258

The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department specialty  

PubMed Central

Background Adverse Drug Reactions (ADRs) have been regarded as a major public health problem since they represent a sizable percentage of admissions. Unfortunately, there is a wide variation of ADR related admissions among different studies. The aim of this study was to evaluate the frequency of ADR related admissions and its dependency on reporting and method of detection, urgency of admissions and included medical departments reflecting department/hospital type within one study. Methods The study team of internal medicine specialists retrospectively reviewed 520 randomly selected medical records (3%) of patients treated in the medical departments of the primary city and tertiary referral governmental hospital for certain ADRs causing admissions regarding WHO causality criteria. All medical records were checked for whether the treating physicians recognised and documented ADRs causing admissions. The hospital information system was checked to ensure ADR related diagnoses were properly coded and the database of a national spontaneous reporting system was searched for patients with ADRs included in this study. Results The established frequency of admissions due to certain ADRs recognised by the study team and documented in medical records by the treating physicians was the same and represented 5.8% of all patients (30/520). The frequency of ADR causing admissions detected by employing a computer-assisted approach using an ICD-10 coding system was 0.2% (1/520), and no patient admitted due to ADRs was reported to the national reporting system (0/520). The recognized frequency of ADR related admissions also depends on the department's specialty (p = 0.001) and acceptance of urgently admitted patients (p = 0.001). Patients admitted due to ADRs were significantly older compared to patients without ADRs (p = 0.025). Gastrointestinal bleeding due to NSAID, acetylsalicylic acid and warfarin was the most common ADR that resulted in admission and represented 40% of all certain ADRs (12/30) according to WHO causality criteria. Conclusion ADRs cause 5.8% of admissions in medical departments in the primary city and tertiary referral hospital. The physicians recognise certain ADR related admissions according to WHO causality criteria and note them in medical records, but they rarely code and report ADRs. The established frequency of ADR related admissions depends on the detection method, department specialty and frequency of urgently admitted patients.

Brvar, Miran; Fokter, Nina; Bunc, Matjaz; Mozina, Martin

2009-01-01

259

Adverse reactions to suxamethonium and other muscle relaxants under general anesthesia  

SciTech Connect

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

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

1983-06-01

260

Individualized Risks of First Adverse Events in Patients With Fanconi Anemia  

Cancer.gov

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

261

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

PubMed Central

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.

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

2013-01-01

262

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

PubMed Central

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

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

2013-01-01

263

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

PubMed

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

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

264

Design of a retrospective patient record study on the occurrence of adverse events among patients in Dutch hospitals  

Microsoft Academic Search

BACKGROUND: Various international studies have shown that a substantial number of patients suffer from injuries or even die as a result of care delivered in hospitals. The occurrence of injuries among patients caused by health care management in Dutch hospitals has never been studied systematically. Therefore, an epidemiological study was initiated to determine the incidence, type and impact of adverse

Marieke Zegers; Martine C de Bruijne; Cordula Wagner; Peter P Groenewegen; Roelof Waaijman; Gerrit van der Wal

2007-01-01

265

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)  

Cancer.gov

The purpose of the PRO-CTCAE project is to develop an electronic-based system for patient self-reporting of symptom adverse events (AEs) listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. The accurate reporting of AEs that occur to patients on clinical trials is a federal requirement that facilitates evaluation of new therapies.

266

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

Microsoft Academic Search

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

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

267

Medicare payment for selected adverse events: building the business case for investing in patient safety.  

PubMed

This study estimates that Medicare extra payments under the hospital prospective payment system (PPS) range from about $700 per case of decubitus ulcer to $9,000 per case of postoperative sepsis in the five types of adverse events identifiable in Medicare claims. Medicare extra payment for the five types of events totals more than $300 million per year, accounting for 0.27 percent of annual Medicare hospital spending. But these extra payments cover less than a third of the extra costs incurred by hospitals in treating these adverse events. We conclude that both Medicare and hospitals gain financially by improving patient safety. PMID:16966737

Zhan, Chunliu; Friedman, Bernard; Mosso, Andrew; Pronovost, Peter

2006-01-01

268

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

PubMed Central

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.

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

2013-01-01

269

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

PubMed

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

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

270

Do Geriatric Conditions Increase Risk of Adverse Drug Reactions in Ambulatory Elders? Results From the VA GEM Drug Study  

PubMed Central

Background. Many clinicians prescribe cautiously to older adults with common geriatric conditions for fear of causing adverse drug reactions (ADRs). However, little is known about the association between these conditions and risk of ADRs. Methods. Using data from the VA Geriatric Evaluation and Management Drug Study, we determined any, preventable, and serious ADRs in 808 elders for 12 months after hospital discharge using a validated process involving patient self-report and chart review adjudicated by two health care professionals. Eight common geriatric conditions (activities of daily living, dementia, incontinence, falls, difficulty ambulating, malnourishment, depression, and prolonged bed rest) were evaluated at study baseline through self-report and structured assessments. We used Poisson regression to model the relationship between these geriatric conditions and ADRs. Results. Participants had a mean of 2.9 ± 1.2 geriatric conditions. Over the 12-month follow-up period, 497 ADRs occurred in 269 participants, including 187 ADRs considered preventable and 127 considered severe. On multivariable analyses, participants with dependency in one or more activities of daily living were less likely to suffer ADRs than those who were fully independent (incidence rate ratio: 0.78, 95% confidence interval = 0.62–1.00). None of the other seven geriatric conditions assessed were associated with ADR risk. Results were similar for preventable and serious ADRs, although participants with a history of falls were more likely to develop serious ADRs (incidence rate ratio: 1.49, 95% confidence interval = 1.00–2.21). Conclusions. Many geriatric conditions were not associated with risk of ADRs. Although it is prudent to prescribe judiciously in patients with these conditions, excessive caution may not be warranted.

Hanlon, Joseph T.; Sloane, Richard J.; Boscardin, W. John; Schmader, Kenneth E.

2011-01-01

271

Psychiatric adverse effects of zonisamide in patients with epilepsy and mental disorder comorbidities.  

PubMed

Over the last few years, zonisamide has been proposed as a potentially useful medication for patients with focal seizures, with or without secondary generalization. Since psychiatric adverse effects, including mania, psychosis, and suicidal ideation, have been associated with its use, it was suggested that the presence of antecedent psychiatric disorders is an important factor associated with the discontinuation of zonisamide therapy in patients with epilepsy. We, therefore, set out to assess the tolerability profile of zonisamide in a retrospective chart review of 23 patients with epilepsy and comorbid mental disorders, recruited from two specialist pediatric (n=11) and adult (n=12) neuropsychiatry clinics. All patients had a clinical diagnosis of treatment-refractory epilepsy after extensive neurophysiological and neuroimaging investigations. The vast majority of patients (n=22/23, 95.7%) had tried previous antiepileptic medications, and most adult patients (n=9/11, 81.8%) were on concomitant medication for epilepsy. In the majority of cases, the psychiatric adverse effects of zonisamide were not severe. Four patients (17.4%) discontinued zonisamide because of lack of efficacy, whereas only one patient (4.3%) discontinued it because of the severity of psychiatric adverse effects (major depressive disorder). The low discontinuation rate of zonisamide in a selected population of patients with epilepsy and neuropsychiatric comorbidity suggests that this medication is safe and reasonably well-tolerated for use in patients with treatment-refractory epilepsy. Given the limitations of the present study, including the relatively small sample size, further research is warranted to confirm this finding. PMID:24070880

Cavanna, Andrea E; Seri, Stefano

2013-11-01

272

Vital sign abnormalities, rapid response, and adverse outcomes in hospitalized patients.  

PubMed

Rapid response activation (RRA), triggered chiefly by surpassing threshold vital sign abnormalities (TVSAs), is designed to intervene at the earliest point in a patient's deteriorating course. The authors aimed to quantify the incidence of TVSA among patients hospitalized on acute care units in a hospital that uses rapid response. During the course of 6 months, the authors compared adverse events (mortality, unexpected intensive care unit [ICU] transfers, and cardiopulmonary arrest) and TVSA among patients who triggered an RRA, patients with TVSAs and no RRA, and all other patients. At least 1 TVSA was recorded in 31.9% of stays and 12.2% of patient-days. RRA patients were more likely (22.5%) than other TVSA patients (7.9%) and other patients (1.8%) to have an adverse event (P < .01). Incidence varied by vital sign. During the investigation, only 2.5% of TVSA opportunities triggered an RRA. As systems engage electronic workflows, automatically triggering RRAs based solely on TVSAs could place a tremendous burden on systems. PMID:22378957

Fagan, Kate; Sabel, Allison; Mehler, Philip S; MacKenzie, Thomas D

2012-01-01

273

Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability  

Microsoft Academic Search

Objective: Adverse drug reactions (ADRs) are a major cause of hospital admission and in-hospital morbidity. Departments of internal\\u000a medicine are at the forefront of this problem. To increase the knowledge base, we did a study of the frequency, hazard function,\\u000a avoidability, and cost of ADRs as a cause for admission in internal medicine, or when occurring after admission.\\u000a \\u000a \\u000a \\u000a Methods: This

R. Lagnaoui; N. Moore; J. Fach; M. Longy-Boursier; B. Bégaud

2000-01-01

274

A comparison of measures of disproportionality for signal detection in spontaeous reporting systems for adverse drug reactions  

Microsoft Academic Search

Purpose: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to\\u000aa spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative\\u000aprocedures can be used to sift data in different ways. In various centres, different measures are used to quantify the\\u000aextent to which an ADR is

Andrew Bate; Hubert G. M. Leufkens; Marie Lindquist; Roland Orre; Antoine C. G. Egberts

2002-01-01

275

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

Microsoft Academic Search

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

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

2002-01-01

276

Acetaminophen prophylaxis of adverse reactions following vaccination of infants with diphtheria-pertussis-tetanus toxoids-polio vaccine.  

PubMed

The effect of acetaminophen on reducing the frequency and severity of adverse reactions following diphtheria-pertussis-tetanus toxoids-polio vaccine was studied in a randomized clinical trial involving 519 vaccinations in 383 infants 2 to 6 months of age and 70 infants 18 months of age. Significantly fewer local and systemic reactions were reported in acetaminophen-treated infants at 2 to 6 months of age. Acetaminophen also reduced the incidence of fever greater than 38.0 degrees C from 44% to 27%. Only 0.9% of acetaminophen-treated infants had overall behavioral changes rated as severe by parents compared to 13% of the placebo group. Infants vaccinated at 18 months of age had higher rates of systemic and local reactions than younger infants. Acetaminophen did not result in significant reductions in reaction rates after the booster at 18 months. We conclude that acetaminophen administered at the time of primary vaccination with diphtheria-pertussis-tetanus toxoids-polio can significantly reduce the frequency and severity of common adverse reactions. PMID:3313232

Ipp, M M; Gold, R; Greenberg, S; Goldbach, M; Kupfert, B B; Lloyd, D D; Maresky, D C; Saunders, N; Wise, S A

1987-08-01

277

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

PubMed

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

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

2014-08-01

278

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

Microsoft Academic Search

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

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

2007-01-01

279

A Potential Causal Association Mining Algorithm for Screening Adverse Drug Reactions in Postmarketing Surveillance  

Microsoft Academic Search

Early detection of unknown adverse drug reac- tions (ADRs) in postmarketing surveillance saves lives and pre- vents harmful consequences. We propose a novel data mining approach to signaling potential ADRs from electronic health databases. More specifically, we introduce potential causal as- sociation rules (PCARs) to represent the potential causal rela- tionship between a drug and ICD-9 (CDC. (2010). International Classification

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

2011-01-01

280

Major adverse reactions to yeast-derived hepatitis B vaccines—a review  

Microsoft Academic Search

Yeast-derived recombinant DNA hepatitis B vaccines usage became widely accepted since the early 1990s. Severe adverse events have been reported infrequently in adults and rarely in infants and children given hepatitis B vaccine in the ten years which have passed since the introduction of the vaccine. Some of the data were summarized in previous review articles. Our review of the

I. Grotto; Y. Mandel; M. Ephros; I. Ashkenazi; J. Shemer

1998-01-01

281

Quality of life and adverse effects of olanzapine versus risperidone therapy in patients with schizophrenia.  

PubMed

This cross-sectional study aimed to compare the effects of treatment with an atypical antipsychotic drug (olanzapine or risperidone) on quality of life (QoL) and to document adverse effects in 115 patients diagnosed with schizophrenia who attended the ambulatory service of Hospital Dr. João Machado, Natal, Rio Grande do Norte, Brazil. Socioeconomic, sociodemographic, and clinical variables were compared. The QoL Scale validated for Brazil (QLS-BR) was used to evaluate QoL, and adverse effects were assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. Data were analyzed using the ?(2) test and Student's t test, with a significance level of 5 %. Patients in both drug groups showed severe impairment in the occupational domain of the QLS-BR. Global QLS-BR scores indicated impairment among risperidone users and severe impairment among olanzapine users. The most significant side effects were associated with risperidone, including asthenia/lassitude/fatigue, somnolence/sedation, paresthesia, change in visual accommodation, increased salivation, diarrhea, orthostatic posture, palpitations/tachycardia, erythema, photosensitivity, weight loss, galactorrhea, decreased sexual desire, erectile/orgasmic dysfunction, vaginal dryness, headache, and physical dependence. QoL was impaired in patients using olanzapine and in those using risperidone. Risperidone use was associated with psychic, neurological, and autonomous adverse effects and other side effects. PMID:22806578

Chaves, Katarina Melo; Serrano-Blanco, Antoni; Ribeiro, Susana Barbosa; Soares, Luiz Alberto Lira; Guerra, Gerlane Coelho Bernardo; do Socorro Costa Feitosa Alves, Maria; de Araújo Júnior, Raimundo Fernandes; de Paula Soares Rachetti, Vanessa; Filgueira Júnior, Antônio; de Araújo, Aurigena Antunes

2013-03-01

282

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

PubMed

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

Siller-Matula, J M; Arbesu, I; Jilma, B; Maurer, G; Lang, I M; Mannhalter, C

2014-06-01

283

An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study  

PubMed Central

Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists’ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion: The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.

Ahmad, Akram; Patel, Isha; Balkrishnan, Rajesh; Mohanta, G. P.; Manna, P. K.

2013-01-01

284

Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck  

PubMed Central

Background: Femoral stems with dual-taper modularity were introduced to allow additional options for hip-center restoration independent of femoral fixation in total hip arthroplasty. Despite the increasing availability and use of these femoral stems, concerns exist about potential complications arising from the modular neck-body junction. Methods: This was a multicenter retrospective case series of twelve hips (eleven patients) with adverse local tissue reactions secondary to corrosion at the modular neck-body junction. The cohort included eight women and three men who together had an average age of 60.1 years (range, forty-three to seventy-seven years); all hips were implanted with a titanium-alloy stem and cobalt-chromium-alloy neck. Patients presented with new-onset and increasing pain at a mean of 7.9 months (range, five to thirteen months) following total hip arthroplasty. After serum metal-ion studies and metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) revealed abnormal results, the patients underwent hip revision at a mean of 15.2 months (range, ten to twenty-three months). Tissue specimens were examined by a single histopathologist, and the retrieved implants were studied with use of light and scanning electron microscopy. Results: Serum metal levels demonstrated greater elevation of cobalt (mean, 6.0 ng/mL) than chromium (mean, 0.6 ng/mL) or titanium (mean, 3.4 ng/mL). MRI with use of MARS demonstrated adverse tissue reactions in eight of nine patients in which it was performed. All hips showed large soft-tissue masses and surrounding tissue damage with visible corrosion at the modular femoral neck-body junction. Available histology demonstrated large areas of tissue necrosis in seven of ten cases, while remaining viable capsular tissue showed a dense lymphocytic infiltrate. Microscopic analysis was consistent with fretting and crevice corrosion at the modular neck-body interface. Conclusions: Corrosion at the modular neck-body junction in dual-tapered stems with a modular cobalt-chromium-alloy femoral neck can lead to release of metal ions and debris resulting in local soft-tissue destruction. Adverse local tissue reaction should be considered as a potential cause for new-onset pain in patients with these components, and early revision should be considered given the potentially destructive nature of these reactions. A workup including serologic studies (erythrocyte sedimentation rate and C-reactive protein), serum metal levels, and MARS MRI can be helpful in establishing this diagnosis. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Cooper, H. John; Urban, Robert M.; Wixson, Richard L.; Meneghini, R. Michael; Jacobs, Joshua J.

2013-01-01

285

Adverse reactions to Patent Blue V dye used in sentinel lymph node biopsy for Melanoma  

Microsoft Academic Search

Sentinel lymph node biopsy (SLNB) is an established investigation used in the management of melanoma, and contributes to disease\\u000a staging. In the UK, Patent Blue V is injected intra-operatively to help identify the sentinel node. However little is known\\u000a about the adverse effects associated with Patent Blue V in this technique. We performed a targeted survey of UK surgeons conducting

Milap G. Rughani; Marc C. Swan; Titus S. Adams; Mark R. Middleton; Oliver C. Cassell

2011-01-01

286

Adverse reactions following injection with a permanent facial filler polyacrylamide hydrogel (Aquamid): causes and treatment  

Microsoft Academic Search

Background  Polyacrylamide hydrogel (Aquamid), an atoxic non-immunogenic gel of the non-resorbable type, has gained widespread popularity as an injectable filler for facial augmentation. However, adverse events (AEs) have occurred, the nature of which seems obscure because of negative findings on culture and a pattern of foreign-body response on microscopy.Design  This is a prospective study of case reports provided by physicians injecting Aquamid

Lise Christensen; Vibeke Breiting; Jens Vuust; Estrid Hogdall

2006-01-01

287

Relationship of nimesulide safety to its pharmacokinetics: assessment of adverse reactions  

Microsoft Academic Search

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used drugs and their use is frequently associated with severe or even serious adverse events, which increase morbidity and mortality. The increase of toxic effects, primarily of the digestive system, due to treatment with NSAIDs, underlines a need for safer NSAIDs. Nimesulide (4-nitro-2-phenoxymethanesulphonanilide) is a chemically unique anti-inflammatory agent in that

K. D. Rainsford

1999-01-01

288

Adverse Drug Reactions in Hospitalised Children in Germany Are Decreasing: Results of a Nine Year Cohort-Based Comparison  

PubMed Central

Background In recent years, efforts have been made to improve paediatric drug therapy. The aim of this research was to investigate any changes regarding the frequency and nature of adverse drug reactions (ADRs) in hospitalized children in one paediatric general medical ward over a 9-year period. Methodology Two prospective observational cohort studies were conducted at a large University hospital in Germany in 1999 and 2008, respectively. Children aged 0–18 years admitted to the study ward during the study periods were included. ADRs were identified using intensive chart review. Uni- and multivariable regression has been used for data analysis. Results A total of 520 patients (574 admissions) were included [1999: n?=?144 (167); 2008: n?=?376 (407)]. Patients received a total of 2053 drugs [median 3, interquartile range (IQR) 2–5]. 19% of patients did not receive any medication. Median length of stay was 4 days (IQR 3–7; range 1–190 days) with a significantly longer length of stay in 1999. The overall ADR incidence was 13.1% (95% CI, 9.8–16.3) varying significantly between the two study cohorts [1999: 21.9%, 95% CI, 14.7–29.0; 2008: 9.2%, 95% CI, 5.9–12.5 (p<0.001)]. Antibacterials and corticosteroids for systemic use caused most of the ADRs in both cohorts (1999; 2008). Exposure to systemic antibacterials decreased from 62.9% to 43.5% whereas exposure to analgesics and anti-inflammatory drugs increased from 17.4% to 45.2%, respectively. The use of high risk drugs decreased from 75% to 62.2%. In 1999, 45.7% and in 2008 96.2% of ADRs were identified by treating clinicians (p<0.001). Conclusions Between 1999 and 2008, the incidence of ADRs decreased significantly. Improved treatment strategies and an increased awareness of ADRs by physicians are most likely to be the cause for this positive development. Nevertheless further research on ADRs particularly in primary care and the establishment of prospective pharmacovigilance systems are still needed.

Oehme, Ann-Kathrin; Rashed, Asia N.; Hefele, Barbara; Wong, Ian C. K.; Rascher, Wolfgang; Neubert, Antje

2012-01-01

289

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

PubMed

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

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

290

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

PubMed Central

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

2013-01-01

291

[Glucocorticoid-induced adverse events in patients with giant cell arteritis or polymyalgia rheumatica].  

PubMed

Giant cell arteritis and polymyalgia rheumatica are common reasons for prescribing long-term glucocorticoid therapy. Glucocorticoids efficacy in these patients is rapid and undeniable, but it is often overshadowed by adverse events, appearing more or less early during treatment course. These adverse events are usually minor but some of them may be life threatening. Because of the absence of randomized, controlled trials comparing glucocorticoids to placebo in this indication and in this aged population, it is difficult to precise the role of corticosteroids in the occurrence of some complications that can also be precipitated by the disease itself (e.g., vascular complications) or related to aging. In this context, analysis of the crude morbidity and mortality can help in anticipating the potential problems that these patients will encounter. In addition, the long duration of glucocorticoid exposure should prompt physicians to be particularly vigilant regarding some adverse events that are minimally symptomatic on the short term but have a major long-term impact. PMID:23743479

Fardet, L

2013-07-01

292

Management of common adverse events in patients treated with sorafenib: nurse and pharmacist perspective.  

PubMed

Sorafenib, a tyrosine kinase inhibitor, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC). Sorafenib is currently being evaluated in phase II and III trials in various malignancies as a single agent (locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer [DTC]), as part of multimodality care (HCC), and in combination with chemotherapies (metastatic breast cancer). Grade 1 and 2 adverse events (AEs) that commonly occur during treatment (ie, dermatologic manifestations, diarrhea, fatigue, and hypertension) should be proactively managed. The goal is to allow patients to remain on their full dose of sorafenib for as long as their treatment is indicated. A combination of early recognition of and intervention for AEs, patient education, and an open dialogue between patients and their multidisciplinary healthcare team, with timely reporting of AEs, will allow for effective management of AEs and minimize the need for sorafenib dose reduction or discontinuation. PMID:24576655

Walko, Christine M; Grande, Carolyn

2014-02-01

293

Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association  

PubMed Central

Background The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. Methods All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN’s Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments. Results Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their antidepressant treatment on their own. Conclusions The present study indicates that free text comments as often contained in case reports directly submitted by patients can be of value in pharmacovigilance and provide important information on how a drug may affect the person using it and influence his or her personal life.

2012-01-01

294

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

PubMed Central

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.

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

2009-01-01

295

Clinical benefit, survival and adverse events in patients with implantable cardioverter defibrillators: the initial Rotterdam experience  

PubMed Central

Background The implantable cardioverter defibrillator (ICD) has become a widely accepted therapy for patients with severe life-threatening ventricular tachyarrhythmias. The aim of this study was to illustrate the possible advantages of ICDs with respect to survival and clinical events. Methods and results Between 1998 and 2000, 92 patients (aged 58±15 years; ejection fraction 36±15%; coronary artery disease 71%) were treated with an ICD in combination with an endocardial lead system. Benefit of the ICD was estimated as the difference between total cardiac death and the projected death rate of fast ventricular tachyarrhythmias (>200 bpm), assuming that most fast ventricular tachyarrhythmias would have been fatal without termination by the ICD. Adverse events were classified according to European standards. The cardiac mortality rate was 5.5% and 9.8%, at one and two years respectively. The recurrence rate of fast VT (>200 bpm) was 22.4% and 30.2%, at one and two years respectively. The observed difference between cardiac death and projected death was very significant (p=0.002) and suggests a clear benefit from ICD implantation. Low ejection fraction (<35%) and NYHA class ?II correlated with a higher projected death. The most common adverse event was inappropriate therapy (18%). Conclusion The results from our small series support the existing data that especially patients with poor ejection fraction (<35%) benefit from ICD implantation. The adverse event rate was low. However, inappropriate therapy remains a matter of concern. Given the high workload of correct screening and follow-up, we expect that the actual number of centres in the Netherlands permitted to implant ICDs will be unable to cope with the widening spectrum of ICD indications.

Theuns, D.A.M.J.; Klootwijk, A.P.J.; Kimman, G.P.; Simoons, M.L.; Roelandt, J.R.T.C.; Jordaens, L.J.L.M.

2001-01-01

296

[Correlations between drug plasma concentration and adverse effects in patients treated with itraconazole for pulmonary aspergilloma].  

PubMed

We measured the plasma concentration of itraconazole (ITCZ) in 18 patients who received ITCZ for the treatment of pulmonary aspergilloma. Abnormal laboratory values were observed in 4 out of 10 patients who received 200 mg/day, 1 out of 3 patients who received 300 mg/day, and 2 out of 5 patients who received 400 mg/day. Four patients discontinued ITCZ therapy because of adverse effects following the administration of 200 mg/day or 400 mg/day. The mean plasma ITCZ concentration was 622 ng/ml in patients treated with less than 4 mg/kg, and 1,352 ng/ml in patients treated with more than 4 mg/kg of ITCZ. The sensitivity of Aspergillus species to ITCZ was measured with the NCCLS microdilution method, using alamar blue indicator. The MIC50 of ITCZ was 0.5 microg/ ml for 25 strains of A. fumigatus, 4 microg/ml for 15 strains of A. niger, and 0.25 microg/ml for 10 strains of A. flavus. In conclusion, this study underscored the necessity of monitoring the plasma concentration of ITCZ for effective treatment of patients with pulmonary aspergilloma. PMID:18217308

Maesaki, S; Hashiguchi, K; Tomiyama, Y; Sasaki, E; Miyazaki, H; Miyazaki, Y; Higashiyama, Y; Tomono, K; Tashiro, T; Kohno, S

1999-11-01

297

The Efficacy and Adverse Reaction of Bleeding of Clopidogrel plus Aspirin as Compared to Aspirin Alone after Stroke or TIA: A Systematic Review  

PubMed Central

Background and Purpose Given the high risk of stroke after TIA (transient ischemia attack) or stroke and the adverse reaction of bleeding of antiplatelets, we undertook a meta-analysis, reviewed randomized controlled trials (RCTs) comparing aspirin plus clopidogrel with aspirin alone to determine the efficacy and adverse reaction of bleeding of the two protocols in the prevention of stroke. Methods We analyzed the incidences of stroke, bleeding and severe bleeding by using fixed-effect model or random-effect model on the basis of the result of heterogeneity test. Results Five qualified RCTs satisfied the inclusion criteria. We found that treatment with aspirin plus clopidogrel was associated with lower incidence of stroke (Risk Ratio (RR), 0.66, 95% confidence interval (CI), 0.47 to 0.93), higher incidence of bleeding (RR, 1.75, 95% CI, 1.48 to 2.05) as compared with aspirin-alone treatment. In terms of severe bleeding, no statistical difference existed between them (RR, 2.21, 95% CI, 0.25 to 19.52). Conclusion The combined use of aspirin and clopidogrel is more effective than aspirin alone for patients with previous TIA or stroke for the prevention of stroke, with risk of bleeding being higher. No statistical difference was found in severe bleeding between the two treatment protocols.

Li, Jian-Yong; Li, Min; Xia, Yuan-Peng; Mao, Ling; Hu, Bo

2013-01-01

298

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

PubMed Central

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

Bruggeman, Richard; Balje-Volkers, Corine

2014-01-01

299

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

PubMed Central

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.

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

2012-01-01

300

Placental Growth Factor for the Prediction of Adverse Outcomes in Patients with Suspected Preeclampsia or Intrauterine Growth Restriction  

PubMed Central

Background The circulating concentration of PlGF is reported to be lower in patients experiencing preeclampsia and patients delivering a small for gestational age (SGA) neonate. To evaluate the predictive value of circulating PlGF for preeclampsia and adverse outcome in patients with suspected preeclampsia or intrauterine growth restriction (IUGR). Methodology/Principal Findings A double blind prospective study. We enrolled 96 women for suspected preeclampsia or IUGR, and measured plasma levels of PlGF (Triage®) at enrolment. We defined adverse outcome as severe preeclampsia, SGA neonate (<10th centile) or elective delivery for maternal or fetal complication. Severe adverse outcome was studied among patients included <34 weeks gestation (WG) and defined as eclampsia, HELLP syndrome, very SGA (<3rd centile) or elective delivery <34 WG. The mean logtransformed PlGF level was lower for women who experienced preeclampsia (2.9 vs 3.7, p?=?0.02), and was markedly lower for patients who experienced adverse outcome (2.9 vs 4.3, p<0.001). The odds of presenting an adverse outcome were higher for the lowest tertile of PlGF compared to the higher (OR?=?13 , 95% CI [3–50]). For severe adverse outcome, odds were respectively for the lowest and intermediate tertile as compared with the higher tertile : OR?=?216, 95% CI [18–2571]; and OR?=?17, 95% CI [3–94]. When included <34 WG, patients with a PlGF level <12 pg/ml experienced a severe adverse outcome in 96% of cases (24/25), and only 1 of 20 patients with a PlGF level >5th centile experienced a severe adverse outcome within 15 days (5%). Conclusions/Significance Among women with suspected preeclampsia or IUGR, PlGF helps identify women who will experience an adverse outcome and those who will not within a time period of 15 days.

Sibiude, Jeanne; Guibourdenche, Jean; Dionne, Marie-Danielle; Le Ray, Camille; Anselem, Olivia; Serreau, Raphael; Goffinet, Francois; Tsatsaris, Vassilis

2012-01-01

301

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

PubMed Central

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

2014-01-01

302

Effectiveness of relaxation training in reducing adverse reactions to cancer chemotherapy  

Microsoft Academic Search

Cancer patients who had developed negative conditioned responses to their chemotherapy either did (relaxation training) or did not (no relaxation training) receive progressive muscle relaxation training and guided relaxation imagery instructions immediately before and during their chemotherapy treatments. Physiological (blood pressure and pulse rate) measures of arousal, frequency of vomiting, and patient-reported and nurse-reported indices of negative affect and nausea

Thomas G. Burish; Jeanne Naramore Lyles

1981-01-01

303

Emergency Department Visits for Adverse Reactions Involving the Insomnia Medication Zolpidem  

MedlinePLUS

... The Drug Abuse Warning Network (DAWN) is a public health surveillance system that monitors drug-related ED visits ... drug safety is an important step toward improving public health and reducing health care costs. Patients can help ...

304

Incidence of adverse wear reactions in hip resurfacing arthroplasty: a single surgeon series of 2,600 cases.  

PubMed

A single surgeon performed 2,559 metal-on-metal hip resurfacing arthroplasties in ?2,109 patients. The Corin Cormet 2000 (393 cases) and Biomet Recap implants (2,166 cases) were used in our series. In this study, the adverse wear failure (AWF) rate was 0.27%. At 10 years postoperatively, our Kaplan-Meier cumulative revision rate for AWF was 1% for all patients, 0.2% for men, 2.6% for women, and 9% for patients with a diagnosis of dysplasia. All AWF failures had component sizes ?48 mm. All had metal ion levels above 15 ug/ml. All had acetabular inclination angles (AIA) ?50° on standing pelvis radiographs. All had severe metallosis found at the time of revision. Six of the seven AWF cases were in women. There were no failures from pseudotumours without AWF (metallosis) in this series. PMID:23760745

Gross, Thomas P; Liu, Fei

2013-01-01

305

Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I*  

PubMed Central

??Background: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. Methods: We reviewed 30 121 randomly selected records from 51 randomly selected acute care, non-psychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. Results: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test ?2 = 21.04, p<0.0001). Using weighted totals we estimated that among the 2 671 863 patients discharged from New York hospitals in 1984 there were 98 609 adverse events and 27 179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence. Conclusions: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Brennan, T; Leape, L; Laird, N; Hebert, L; Localio, A; Lawthers, A; Newhouse, J; Weiler, P; Hiatt, H

2004-01-01

306

[Adverse events associated with temsirolimus for patients with metastatic renal cell carcinoma].  

PubMed

Temsirolimus is an inhibitor of mammalian target of rapamycin, with proven efficacy against advanced renal cell carcinoma (RCC), particularly poor risk and/or non-clear cell RCC, in a randomized first-line phase III trial. In this trial, adverse events (AEs)?grade 3 occurred in 47.6% of patients treated with temsirolimus alone (n?208), and the common AEs included asthenia, anemia and hyperglycemia. During the observation period of this trial, drug-related pneumonitis was detected ; 4 patients developed temsirolimus-related pneumonitis, including 2 with ?grade 3. To date, there have not been any reports analyzing data from a large number of Japanese RCC patients treated with temsirolimus. However, judging from our experience, the severity as well as the frequency of AEs associated with temsirolimus in Japanese patients seem to be similar to those in the Western population. In this study, we summarize our clinical experience with the use of temsirolimus focusing on its AEs and try to clarify the characteristics of temsirolimus-related AEs in Japanese patients, and then present our data relevant to this point from our clinical studies in order to discuss the significance of the management of AEs encountered during treatment with temsirolimus. PMID:23254795

Miyake, Hideaki; Fujisawa, Masato

2012-11-01

307

Adverse Reactions to Isosulfan Blue During Selective Sentinel Lymph Node Dissection in Melanoma  

Microsoft Academic Search

Background: Selective sentinel lymph node (SLN) dissection can spare about 80% of patients with primary melanoma from radical lymph node dissection. This procedure identifies the SLN either visually by injecting isosulfan blue dye around the primary melanoma site or by handheld gamma probe after radiocolloid injection.Methods: During selective SLN mapping, 1 to 5 ml of isosulfan blue was injected intradermally

Stanley P. L. Leong; Elizabeth Donegan; Wanda Heffernon; Susan Dean; Jeffrey A. Katz

2000-01-01

308

Onset of palmoplantar pustular psoriasis while on adalimumab for psoriatic arthritis: a 'class effect' of TNF-alpha antagonists or simply an anti-psoriatic treatment adverse reaction?  

PubMed

Adalimumab is a human, recombinant IgG1 monoclonal antibody that specifically blocks the interaction of tumour necrosis factor (TNF)-alpha with the p55 and the p75 TNF-alpha cell surface receptors. We report the appearance of palmoplantar pustular psoriasis in a patient after 6 months of successful adalimumab administration for psoriatic arthritis. The development or worsening of psoriatic skin lesions is a known side effect of adalimumab and other TNF-alpha antagonists increasingly reported in the literature. Although it has been reported as a 'class-effect' of TNF-alpha antagonists, we believe that the deterioration or new onset of psoriasis is an adverse reaction seen mainly with drugs used for the treatment of psoriasis and not solely with anti-TNF agents. The latter is probably implying an existing gap in the understanding of the pathophysiology of psoriasis or of the anti-psoriatic drugs' mechanisms of action. PMID:19701844

Rallis, Efstathios; Korfitis, Chrysovalantis; Stavropoulou, Evgenia; Papaconstantis, Markos

2010-01-01

309

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

PubMed Central

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

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

2013-01-01

310

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

Microsoft Academic Search

\\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

Stephane Dalle; Sandra Knowles; Neil H. Shear

311

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

PubMed Central

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

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

2012-01-01

312

Predictors of first-line antiretroviral therapy discontinuation due to drug-related adverse events in HIV-infected patients: a retrospective cohort study  

PubMed Central

Background Drug-related toxicity has been one of the main causes of antiretroviral treatment discontinuation. However, its determinants are not fully understood. Aim of this study was to investigate predictors of first-line antiretroviral therapy discontinuation due to adverse events and their evolution in recent years. Methods Patients starting first-line antiretroviral therapy were retrospectively selected. Primary end-point was the time to discontinuation of therapy due to adverse events, estimating incidence, fitting Kaplan-Meier and multivariable Cox regression models upon clinical/demographic/chemical baseline patients’ markers. Results 1,096 patients were included: 302 discontinuations for adverse events were observed over 1,861 person years of follow-up between 1988 and 2010, corresponding to an incidence (95% CI) of 0.16 (0.14-0.18). By Kaplan-Meier estimation, the probabilities (95% CI) of being free from an adverse event at 90 days, 180 days, one year, two years, and five years were 0.88 (0.86-0.90), 0.85 (0.83-0.87), 0.79 (0.76-0.81), 0.70 (0.67-0.74), 0.55 (0.50-0.61), respectively. The most represented adverse events were gastrointestinal symptoms (28.5%), hematological (13.2%) or metabolic (lipid and glucose metabolism, lipodystrophy) (11.3%) toxicities and hypersensitivity reactions (9.3%). Factors associated with an increased hazard of adverse events were: older age, CDC stage C, female gender, homo/bisexual risk group (vs. heterosexual), HBsAg-positivity. Among drugs, zidovudine, stavudine, zalcitabine, didanosine, full-dose ritonavir, indinavir but also efavirenz (actually recommended for first-line regimens) were associated to an increased hazard of toxicity. Moreover, patients infected by HIV genotype F1 showed a trend for a higher risk of adverse events. Conclusions After starting antiretroviral therapy, the probability of remaining free from adverse events seems to decrease over time. Among drugs associated with increased toxicity, only one is currently recommended for first-line regimens but with improved drug formulation. Older age, CDC stage, MSM risk factor and gender are also associated with an increased hazard of toxicity and should be considered when designing a first-line regimen.

2012-01-01

313

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

PubMed

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

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

2011-03-01

314

Genetic variants of drug metabolizing enzymes and drug transporter (ABCB1) as possible biomarkers for adverse drug reactions in an HIV/AIDS cohort in Zimbabwe.  

PubMed

A study was conducted in an HIV/AIDS Zimbabwean cohort to assess possible associations of pharmacogenetic variants with common adverse drug reactions (ADRs) during anti-retroviral treatment (ART) and/or tuberculosis (TB) treatment. Genotype and allele frequencies for CYP2B6 G516T, CYP2B6 T983C, CYP2A6*17, ABCB1 rs10276036 C>T, NAT2*5 and NAT2*14 were similar to those reported in literature for other African populations. The CYP2B6 516TT genotype and male gender were significantly associated with occurrence of Efavirenz induced central nervous system disorders (OR 20.58, p=0.004) and the ABCB1 rs10276036TT genotype with Nevirapine induced skin hypersensitivity (OR 4.01, p=0.04). For Stavudine, time on treatment was the main factor in development of lipodystrophy (OR 1.06, p<0.0001). For isoniazid, increasing patient age was associated with peripheral neuropathy (OR 1.05, p=0.001). Although genetic polymorphisms may play a role in predicting occurrence of ADRs, this study also indicates that other factors (gender, age, treatment time) are crucial in predicting drug-induced adverse effects. PMID:24517233

Dhoro, Milcah; Ngara, Bernard; Kadzirange, Gerald; Nhachi, Charles; Masimirembwa, Collen

2013-09-01

315

Adverse outcomes in surgical patients: implementation of a nationwide reporting system  

PubMed Central

Problem Lack of comparable data on adverse outcomes in hospitalised surgical patients. Design A Plan?Do?Study?Act (PDSA) cycle to implement and evaluate nationwide uniform reporting of adverse outcomes in surgical patients. Evaluation was done within the Reach Efficacy?Adoption Implementation Maintenance (RE?AIM) framework. Setting All 109 surgical departments in The Netherlands. Key measures for improvement Increase in the number of departments implementing the reporting system and exporting data to the national database. Strategies for change The intervention included (1) a coordinator who could mediate in case of problems; (2) participation of an opinion leader; (3) a predefined plan of action communicated to all departments (including feedback of results during implementation); (4) connection with existing hospital databases; (5) provision of software and a helpdesk; and (6) an instrument based on nationwide standards. Effects of change Implementation increased from 18% to 34% in 1.5?years. The main reason for not implementing the system was that the Information Computer Technology (ICT) department did not link data with the hospital information system (lack of time, finances, low priority). Only 5% of the departments exported data to the national database. Export of data was hindered mainly by slow implementation of the reporting system (so that departments did not have data to export) and by concerns regarding data quality and public availability of data from individual hospitals. Lessons learned Hospitals need incentives to realise implementation. Important factors are financial support, sufficient manpower, adequate ICT linkage of data, and clarity with respect to public availability of data.

de Mheen, P J Marang-van; Stadlander, M C; Kievit, J

2006-01-01

316

Increased cerebrospinal fluid concentrations of asymmetric dimethylarginine correlate with adverse clinical outcome in subarachnoid hemorrhage patients.  

PubMed

Elevated cerebrospinal fluid (CSF) concentrations of asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthase, have been found in patients with subarachnoid hemorrhage (SAH). In addition, CSF levels of ADMA are associated with the severity of vasospasm. However, the relation between CSF ADMA levels and the clinical outcome of SAH patients is still unclear. We hypothesized that elevated ADMA levels in CSF might be related to the clinical outcome of SAH patients. CSF ADMA levels were measured in 20 SAH patients at days 3-5, days 7-9 and days 12-14 after SAH onset using high-performance liquid chromatography. Cerebral vasospasm was assessed by transcranial Doppler ultra sonography. Clinical outcome at 2year follow-up was evaluated using the Karnofsky Performance Status scale (KPS). CSF ADMA concentrations in all SAH patients were significantly increased at days 3-5 (p=0.002) after SAH, peaked on days 7-9 (p<0.001) and remained elevated until days 12-14 (p<0.001). In subgroup analysis, significant increases of CSF ADMA levels were found in patients both with and without vasospasm. The KPS scores significantly correlated with CSF levels of ADMA at days 7-9 (correlation coefficient=-0.55, p=0.012; 95% confidence interval -0.80 to -0.14). Binary logistic regression analysis indicated that higher ADMA level at days 7-9 predicted a poor clinical outcome at 2year follow-up after SAH (odds ratio=1.722, p=0.039, 95% confidence interval 1.029 to 2.882). ADMA may be directly involved in the pathological process and future adverse prognosis of SAH. PMID:24814854

Li, Hua; Wu, Wei; Liu, Ming; Zhang, Xin; Zhang, Qing-Rong; Ni, Li; Hang, Chun-Hua

2014-08-01

317

Risk factors for serious adverse effects of thiopurines in patients with Crohn's disease.  

PubMed

Purpose: Thiopurines are effective in attaining and maintaining remission in patients with inflammatory bowel diseases (IBD). The major drawback of these drugs are their serious adverse effects (SAE), highlighting the importance of preemptive identification of patients at risk. We aimed to examine whether gene polymorphisms in GSTM1, GSTT1 and TPMT, combined with various clinical parameters, can predict thiopurine induced SAE. Methods: A retrospective cohort of 176 Crohn's Disease (CD) patients treated with thiopurines (131 with 6MP and 45 with azathioprine) was genotyped for common polymorphisms in GSTM1, GSTT1 and TPMT. Clinical data including SAE, age, ethnicity, gender and smoking status were extracted from patient charts. SAEs evaluated were myelosuppression, hepatotoxicity and pancreatitis. Associations between demographic, clinical, and genetic variables and thiopurine induced SAE were assessed. Results: Twenty-four patients (14%) developed SAE, revealing a significant association between thiopurine induced SAE and GSTM1-null genotype (P=0.05), older age (P=0.016) and active smoking status (P=0.043) and SAE. On multi-variant analysis, past or current smokers were at increased risk for developing thiopurine related SAE (OR 2.915, CI 95%: 1.199- 7.084), specifically pancreatitis (p<0.001). No association was found between TPMT or GSTT1 polymorphisms and the development of SAE. Conclusions: Active smoking and GSTM1-null genotype appear to be risk factors for thiopurine induced SAEs (i.e. myelosuppression, hepatotoxicity and pancreatitis) in patients with CD. Corroboration of these associations in larger cohorts is warranted. PMID:23845145

Mazor, Yoav; Koifman, Eduard; Elkin, Hela; Chowers, Yehuda; Krivoy, Norberto; Karban, Amir; Efrati, Edna

2013-07-01

318

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

PubMed Central

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.

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

319

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

PubMed

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

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

2013-12-01

320

Effect of childhood adversity on health related quality of life in patients with upper abdominal or chest pain  

PubMed Central

Background and aims: This study assessed whether childhood and current adversities: (a) were more prevalent in patients with functional dyspepsia (FD) or non-cardiac chest pain (NCCP) than in patients with gastro-oesophageal reflux disease (GORD) or ischaemic heart disease (IHD); and (b) predicted health related quality of life in these disorders. Patients: Cohort study of consecutive attenders to gastroenterology and cardiology clinics in a secondary/tertiary referral centre. Methods: Patients were interviewed using the childhood experience of care and abuse and life events and difficulties schedules. Distress was assessed by questionnaire. Outcome was assessed using SF36 at the index clinic visit and six months later. Results: A total of 133 patients were included (40 NCCP, 43 FD, 29 GORD, and 21 IHD) (67% response rate). The diagnostic groups did not differ significantly in the proportion reporting childhood adversity (30%), ongoing social stress (40%), lack of a close confidant (14%), or level of psychological distress. Reported childhood adversity was associated with poor outcome at the index visit (SF36 physical component score: 36.6 (SEM 1.8) v 42.3 (SEM 1.2) for the remainder; p?=?0.014). In multiple regression analysis, childhood adversity was a significant independent predictor for patients with functional disorders (NCCP and FD) but not organic disorders (GORD or IHD). Change in SF36 score at six months was determined by age and distress score at the index visit in both groups. Conclusion: Childhood adversity was common among this consecutive sample but was associated directly with poor outcome only in patients with functional gastrointestinal syndromes. Distress is an important predictor of outcome in all patients. Greatest impairment occurs when lack of social support accompanies reported childhood adversity.

Biggs, A-M; Aziz, Q; Tomenson, B; Creed, F

2004-01-01

321

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

ERIC Educational Resources Information Center

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

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

2010-01-01

322

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

Microsoft Academic Search

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;

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

2005-01-01

323

Prevalence of Unplanned Hospitalizations Caused by Adverse Drug Reactions Among Older Veterans  

PubMed Central

Objectives To describe the prevalence of unplanned hospitalizations caused by ADRs among older Veterans and examine the association between this outcome and polypharmacy after controlling for comorbidities and other patient characteristics. Design Retrospective cohort. Setting Veterans Affairs Medical Centers (VAMC). Participants 678 randomly selected unplanned hospitalizations of older (age ? 65 years) Veterans between 10/01/03 and 09/30/06. Measurements Naranjo ADR algorithm, ADR preventability, and polypharmacy (0–4, 5–8, and ? 9 scheduled medications). Results Seventy ADRs involving 113 drugs were determined in 68 (10%) older Veterans’ hospitalizations, of which 36.8% (25/68) were preventable. Extrapolating to the population of over 2.4 million older Veterans receiving care during the study period, 8,000 hospitalizations may have been unnecessary. The most common ADRs that occurred were bradycardia (n=6; beta blockers, digoxin), hypoglycemia (n=6; sulfonylureas, insulin), falls (n=6; antidepressants, ACE-inhibitors), and mental status changes (n=6; anticonvulsants, benzodiazepines). Overall, 44.8% of Veterans took ? 9 outpatient medications and 35.4% took 5–8. Using multivariable logistic regression and controlling for demographic, health status, and access to care variables, polypharmacy (? 9 and 5–8) was associated with an increased risk of ADR-related hospitalization (AOR 3.90, 95% CI 1.43–10.61 and AOR 2.85, 95% CI 1.03–7.85, respectively). Conclusion ADRs determined by a validated causality algorithm are a common cause of unplanned hospitalization among older Veterans, are frequently preventable, and are associated with polypharmacy.

Marcum, Zachary A.; Amuan, Megan E.; Hanlon, Joseph T.; Aspinall, Sherrie L.; Handler, Steven M.; Ruby, Christine M.; Pugh, Mary Jo V.

2011-01-01

324

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

PubMed Central

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

Chen, Zhibin; Liew, Danny; Kwan, Patrick

2014-01-01

325

Knowledge, Practices and Attitudes Towards Adverse Drug Reaction Reporting by Private Practitioners from Klang Valley in Malaysia  

PubMed Central

Background: The study aimed to determine current status of knowledge, practices, and attitudes towards adverse drug reaction (ADR) reporting among private practitioners in Klang region of Malaysia. Methods: A total of 238 private practitioners in Klang valley were distributed a questionnaire consisting of seven questions, two knowledge-related, two practice-related and three attitude-related. Each favourable and unfavourable response was given a score of 1 and 0 respectively. Total score of 70% or more for each domain was considered “satisfactory” whereas less than 70% as “unsatisfactory”. Results: One hundred forty-five participants completed questionnaire. Knowledge assessment showed 83.4% responses stating that ADR reporting helps to identify safe drugs and 91.7% responded that it measures ADR incidence. Regarding practices, 76.6% respondents were willing to report only if confident that reaction is an ADR. Regarding attitudes, 81.9%, 66.9% and 23.5% participants showed complacency, ignorance, and indifference respectively. Unsatisfactory knowledge, practices, and attitudes were observed in 57.2%, 56.6%, and 73.1% respondents respectively. Satisfactory knowledge was significantly higher in respondent with higher qualification with odds ratio of 2.96 with 95% confidence interval of 1.48–5.93. Conclusion: The study showed unsatisfactory level of knowledge, practices, and attitudes towards ADR reporting among high proportion of private practitioners in Klang valley, Malaysia.

Agarwal, Renu; Daher, Aqil Mohammad; Mohd Ismail, Nafeeza

2013-01-01

326

Preoperative HO-1 Levels as Prognostic Factor for Adverse Cardiac Events in Elder Patients Undergoing Non-Cardiac Surgery  

PubMed Central

Background Hypoxia-inducible factor-1? (HIF-1?) and heme oxygenase-1(HO-1) are involved in the tissue hypoxic response. Hypothesis HIF-1? and HO-1 levels may predict cardiac ischemia and adverse cardiac events during non-cardiac surgery. Methods HIF-1? and HO-1 levels were determined in elderly patients undergoing non-cardiac surgery preoperatively and at 30 minutes, 48 and 72 hours postoperatively. Results were analyzed with respect to the occurrence of adverse cardiac events. Results A total of 380 patients with a mean age of 65.3 years were included, and 54 (14.2%) who had adverse cardiac events during or after the surgery. HIF-1? and HO-1 levels in the adverse cardiac event group were significantly higher than in the group without adverse cardiac events at each time point (all, P<0.05). In multivariates regression analysis, the odds of an adverse cardiac event was increased by every 1-year increase in age (odd ratio [OR] 1.39, P<0.001), abnormal ECG at baseline (OR 2.27, P?=?0.048), myocardial infarction history (OR 3.18, P?=?0.015), and positive baseline cTnI level were associated with an increased likelihood of an adverse cardiac event (OR 8.78, P?=?0.019), and for every 1 unit increase of HO-1, the odds of an adverse cardiac event increased by 1.30 (P?=?0.002). Conclusion Determination of preoperative HO-1 levels may aid in identifying patients at risk of developing ischemic cardiac events.

Zheng, Hong; Ma, Hai-Ping; Wang, Jiang; Ma, Ming

2013-01-01

327

ToxAlerts: a Web server of structural alerts for toxic chemicals and compounds with potential adverse reactions.  

PubMed

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

Sushko, Iurii; Salmina, Elena; Potemkin, Vladimir A; Poda, Gennadiy; Tetko, Igor V

2012-08-27

328

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

PubMed Central

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

2012-01-01

329

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

PubMed Central

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.

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

330

Adverse reactions to vaccines  

Microsoft Academic Search

(The opinions or assertions contained herein are the private views of the authors and are not to be construed as official\\u000a or as reflecting the views of the Department of the Army or the Department of Defense.)\\u000a \\u000a Immunization healthcare is becoming increasingly complex as the number and types of vaccines have continued to expand. Like\\u000a all prescription drugs, vaccines may

Bryan L. Martin; Michael R. Nelson; Joyce N. Hershey; Renata J. M. Engler

2003-01-01

331

Profiling of Childhood Adversity-Associated DNA Methylation Changes in Alcoholic Patients and Healthy Controls  

PubMed Central

The increased vulnerability to alcohol dependence (AD) seen in individuals with childhood adversity (CA) may result in part from CA-induced epigenetic changes. To examine CA-associated DNA methylation changes in AD patients, we examined peripheral blood DNA methylation levels of 384 CpGs in promoter regions of 82 candidate genes in 279 African Americans [AAs; 88 with CA (70.5% with AD) and 191 without CA (38.2% with AD)] and 239 European Americans [EAs; 61 with CA (86.9% with AD) and 178 without CA (46.6% with AD)] using Illumina GoldenGate Methylation Array assays. The effect of CA on methylation of individual CpGs and overall methylation in promoter regions of genes was evaluated using a linear regression analysis (with consideration of sex, age, and ancestry proportion of subjects) and a principal components-based analysis, respectively. In EAs, hypermethylation of 10 CpGs in seven genes (ALDH1A1, CART, CHRNA5, HTR1B, OPRL1, PENK, and RGS19) were cross validated in AD patients and healthy controls who were exposed to CA. P values of two CpGs survived Bonferroni correction when all EA samples were analyzed together to increase statistical power [CHRNA5_cg17108064: Padjust?=?2.54×10?5; HTR1B_cg06031989: Padjust?=?8.98×10?5]. Moreover, overall methylation levels in the promoter regions of three genes (ALDH1A1, OPRL1 and RGS19) were elevated in both EA case and control subjects who were exposed to CA. However, in AAs, CA-associated DNA methylation changes in AD patients were not validated in healthy controls. Our findings suggest that CA could induce population-specific methylation alterations in the promoter regions of specific genes, thus leading to changes in gene transcription and an increased risk for AD and other disorders.

Zhang, Huiping; Wang, Fan; Kranzler, Henry R.; Zhao, Hongyu; Gelernter, Joel

2013-01-01

332

FGF-23 Levels in Patients with AKI and Risk of Adverse Outcomes  

PubMed Central

Summary Background and objectives Fibroblast growth factor 23 plays an important role in regulating phosphate and vitamin D homeostasis. Elevated levels of fibroblast growth factor 23 are independently associated with mortality in patients with CKD and ESRD. Whether fibroblast growth factor 23 levels are elevated and associated with adverse outcomes in patients with AKI has not been studied. Design, setting, participants, & measurements This study had 30 participants with AKI, which was defined as an increase in serum creatinine?0.3 mg/dl or ?50% from baseline, and 30 controls from the general hospital wards and intensive care units. Plasma levels of C-terminal fibroblast growth factor 23 and vitamin D metabolites were measured within 24 hours of AKI onset and 5 days later. The composite endpoint was death or need for renal replacement therapy. Results Enrollment fibroblast growth factor 23 levels were significantly higher among participants with AKI than controls (median [interquartile range]=1471 [224–2534] versus 263 [96–574] RU/ml, P=0.003). Enrollment fibroblast growth factor 23 correlated negatively with 25-hydroxyvitamin D (r=?0.43, P<0.001) and 1,25-dihydroxyvitamin D (r=?0.39, P=0.003) and positively with phosphate (r=0.32, P=0.02) and parathyroid hormone (r=0.37, P=0.005). Among participants with AKI, enrollment fibroblast growth factor 23 (but not other serum parameters) was significantly associated with the composite endpoint, even after adjusting for age and enrollment serum creatinine (11 events; adjusted odds ratio per 1 SD higher ln[fibroblast growth factor 23]=13.73, 95% confidence interval=1.75–107.50). Conclusions Among patients with AKI, fibroblast growth factor 23 levels are elevated and associated with greater risk of death or need for renal replacement therapy.

Wolf, Myles; Waikar, Sushrut S.; Chase, Herbert; Christov, Marta; Cremers, Serge; Stern, Leonard

2012-01-01

333

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

PubMed Central

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.

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

2013-01-01

334

Genetics or environment in drug transport: the case of organic anion transporting polypeptides and adverse drug reactions  

PubMed Central

Introduction Organic anion transporting polypeptide (OATP) uptake transporters are important for the disposition of many drugs and perturbed OATP activity can contribute to adverse drug reactions (ADRs). It is well documented that both genetic and environmental factors can alter OATP expression and activity. Genetic factors include single nucleotide polymorphisms (SNPs) that change OATP activity and epigenetic regulation that modify OATP expression levels. SNPs in OATPs contribute to ADRs. Environmental factors include the pharmacological context of drug--drug interactions and the physiological context of liver diseases. Liver diseases such as non-alcoholic fatty liver disease, cholestasis and hepatocellular carcinoma change the expression of multiple OATP isoforms. The role of liver diseases in the occurrence of ADRs is unknown. Areas covered This article covers the roles OATPs play in ADRs when considered in the context of genetic or environmental factors. The reader will gain a greater appreciation for the current evidence regarding the salience and importance of each factor in OATP-mediated ADRs. Expert opinion A SNP in a single OATP transporter can cause changes in drug pharmacokinetics and contribute to ADRs but, because of overlap in substrate specificities, there is potential for compensatory transport by other OATP isoforms. By contrast, the expression of multiple OATP isoforms is decreased in liver diseases, reducing compensatory transport and thereby increasing the probability of ADRs. To date, most research has focused on the genetic factors in OATP-mediated ADRs while the impact of environmental factors has largely been ignored.

Clarke, John D; Cherrington, Nathan J

2013-01-01

335

On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios.  

PubMed

A well-known problem in spontaneous reporting systems (SRSs) for adverse drug reactions (ADRs) is under-reporting, that is, the problem that not all occurrences of ADRs are reported to the SRS. We look at the question of how to draw statistical conclusions from analyses of SRS data using reporting odds ratios. We will show that certain under-reporting problems play no role in assessing ADRs from SRSs: the results from the analyses turn out to be biased by some specific under-reporting problems, but not by others. SRS data can be particularly useful for the assessment of drug-drug interactions. If the assumption holds that there is an under-reporting problem for a first drug, and an under-reporting problem for a second drug, but that these two under-reporting problems do not influence each other, then reporting odds ratios estimated from SRSs are useful for signalling drug-drug interactions in the ADR-experiencing population. Similar results hold for covariate-drug interactions. We illustrate our results using two examples. PMID:12111885

van der Heijden, Peter G M; van Puijenbroek, Eugène P; van Buuren, Stef; van der Hofstede, Jacques W

2002-07-30

336

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

PubMed Central

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

Wallach, Izhar; Jaitly, Navdeep; Lilien, Ryan

2010-01-01

337

Severe Infusion Reactions to Cetuximab Occur within 1 h in Patients with Metastatic Colorectal Cancer: Results of a Nationwide, Multicenter, Prospective Registry Study of 2126 Patients in Japan  

PubMed Central

Objective Infusion reactions are common adverse reactions associated with antibody preparations. However, no studies have examined the time to onset of serious infusion reactions after administering cetuximab. We aimed to investigate the timing and severity of IRs affecting Japanese patients after administration of cetuximab. Methods Study subjects were identified from a nationwide prospective registry of 2126 metastatic colorectal cancer patients scheduled to receive cetuximab. Infusion reactions were examined in 2006 patients with adequate safety data. Results Infusion reactions of any grade occurred in 114 patients (5.7%), including Grade 3–4 infusion reactions in 22 patients (1.1%). Premedications were antihistamine plus corticosteroid (88.9% of patients with infusion reactions), antihistamine alone (9.2%) or corticosteroid alone (1.1%). In 95 patients (83.3%), infusion reactions occurred after the first dose. Twenty of the 22 Grade 3–4 infusion reactions occurred within 1 h of the first dose (the timing of the infusion reaction was unknown in one patient while another infusion reaction occurred after the fourth dose). Infusion reactions resolved in 111/114 patients (97.4%) while one patient recovered with sequelae, one patient died and one patient failed to recover within the follow-up period. Thirteen patients (15.7% of patients with infusion reactions) with Grade 1–2 infusion reactions showed recurrence after readministration of cetuximab; the recurrent infusion reactions were less severe than the initial reactions. Conclusions Grade 3–4 infusion reactions occurred in 1.1% of colorectal cancer patients, and most occurred within 1 h of receiving the first dose of cetuximab. Therefore, patients should be carefully observed following cetuximab infusion, especially during the first hour after the first infusion.

Yamaguchi, Kensei; Watanabe, Toshiaki; Satoh, Taroh; Ishiguro, Megumi; Izawa, Makiko; Inoshiri, Shogo; Sugihara, Kenichi; Sakata, Yuh

2014-01-01

338

The Effect of Race/Ethnicity on Adverse Perinatal Outcomes among Patients with Gestational Diabetes  

PubMed Central

OBJECTIVE To determine racial/ethnic differences in perinatal outcomes among women with gestational diabetes mellitus (GDM). STUDY DESIGN Retrospective cohort study of 32,193 singleton births among GDMs in California from 2006, using Vital Statistics Birth and Death Certificate and Patient Discharge Data. Women were divided by race/ethnicity: White, Black, Hispanic, or Asian. Multivariable logistic regression analyzed associations between race/ethnicity and adverse outcomes, controlling for potential confounders. Outcomes included: primary cesarean, preeclampisa, neonatal hypoglycemia, preterm delivery, macrosomia, fetal anomaly, respiratory distress syndrome (RDS). RESULTS Compared to other races, Black women had higher odds of preeclampsia [aOR=1.57, 95%CI(1.47-1.95)], neonatal hypoglycemia [aOR=1.79, 95%CI(1.07-3.00)], and preterm delivery <37 weeks [aOR=1.56, 95%CI(1.33-1.83)]. Asians had the lowest odds of primary cesarean [aOR=0.75, 95%CI(0.69-0.82)], large for gestational age infants [aOR=0.40, 95%CI(0.33-0.48)], and neonatal RDS [aOR=0.54, 95%CI(0.40-0.73)]. CONCLUSION Perinatal outcomes among women with GDM differ by race/ethnicity and may be attributed to inherent sociocultural differences that may impact glycemic control, the development of chronic co-morbidities, genetic variability, and variation in access to as well as quantity and quality of prenatal care.

NGUYEN, Brian T.; CHENG, Yvonne W.; SNOWDEN, Jonathan M.; ESAKOFF, Tania F.; FRIAS, Antonio E.; CAUGHEY, Aaron B.

2012-01-01

339

Blood Transfusion Reactions in Elderly Patients Hospitalized in a Multilevel Geriatric Hospital  

PubMed Central

Background/Objectives. Blood transfusion is a critical issue for patients with chronic diseases such as heart failure, chronic kidney disease, and malignancy. However, side effects are not rare. The purpose of the study is to evaluate the frequency of adverse blood transfusion reactions in hospitalized elderly patients during a one-year period. Design/Setting/Participants. Blood transfusion reactions such as fever, chills, dyspnea, and others following blood transfusions in hospitalized geriatric patients during one-year period were examined. Results. 382 blood units (242 patients) were administered during the study period. In 40 (11%) cases, blood transfusion reactions occurred. Fever was the most common reaction in 29 cases (72%), four (10%) had shortness of breath, and 3 (8%) had vomiting and chills each. There were no lethal cases in the 24-hour period following blood transfusions. Conclusion. A relatively low rate of adverse blood transfusion reactions occurred in our geriatric patients. We may speculate that this is related to underreporting of minor symptoms due to the high percentage of demented patients in this population.

Lubart, E.; Segal, R.; Tryhub, N.; Sigler, E.; Leibovitz, A.

2014-01-01

340

Adverse Events Associated With Procedural Sedation in Pediatric Patients in the Emergency Department  

PubMed Central

Purpose: To determine the agents used by emergency medicine (EM) physicians in pediatric procedural sedation and the associated adverse events (AEs) and to provide recommendations for optimizing drug therapy in pediatric patients. Methods: We conducted a prospective study at Stanford Hospital’s pediatric emergency department (ED) from April 2007 to April 2008 to determine the medications most frequently used in pediatric procedural sedation as well as their effectiveness and AEs. Patients, 18 years old or younger, who required procedural sedation in the pediatric ED were eligible for the study. The data collected included medical record number, sex, age, height, weight, procedure type and length, physician, and agents used. For each agent, the dose, route, time from administration to onset of sedation, duration of sedation, AEs, and sedation score were recorded. Use of supplemental oxygen and interventions during procedural sedation were also recorded. Results: We found that in a convenience sample of 196 children (202 procedures) receiving procedural sedation in a university-based ED, 8 different medications were used (ketamine, etomidate, fentanyl, hydromorphone, methohexital, midazolam, pentobarbital, and thiopental). Ketamine was the most frequently used medication (88%), regardless of the procedure. Only twice in the study was the medication that was initially used for procedural sedation changed completely. Fracture reduction was the most frequently performed procedure (41%), followed by laceration/suture repair (32%). There were no serious AEs reported. Conclusion: EM-trained physicians can safely perform pediatric procedural sedation in the ED. In the pediatric ED, the most common procedure requiring conscious sedation is fracture reduction, with ketamine as the preferred agent.

Wang, N. Ewen; Bardas, Sandra L.; Nguyen, Carolyn N.

2013-01-01

341

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

ERIC Educational Resources Information Center

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)

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

1985-01-01

342

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

ERIC Educational Resources Information Center

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

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

2008-01-01

343

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

PubMed Central

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

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

2007-01-01

344

Risk of mortality and adverse cardiovascular outcomes in type 2 diabetes: a comparison of patients treated with sulfonylureas and metformin  

Microsoft Academic Search

Aims\\/hypothesis  The aim of this study was to evaluate the risk of adverse cardiovascular outcomes in patients with type 2 diabetes newly treated with sulfonylureas and metformin.Subjects and methods  The Diabetes Audit and Research in Tayside Scotland (DARTS) diabetes information system and the Medicines Monitoring Unit (MEMO) dispensed prescribing database for the population of Tayside, Scotland (400,000 people) were employed. Patients newly

J. M. M. Evans; S. A. Ogston; A. Emslie-Smith; A. D. Morris

2006-01-01

345

The role of data mining technology in the identification of signals of possible adverse drug reactions: value and limitations  

Microsoft Academic Search

Background: The emergence of large databases of adverse event (AE) data and the need to identify signals of new, unknown adverse effects of newly marketed drugs by regulators and pharmaceutical sponsors have coincided with the development of several methods of “data mining” for identifying new associations within all types of databases.Objective: This paper provides a broad overview of the data

Judith K. Jones

2001-01-01

346

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

PubMed Central

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.

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

2013-01-01

347

The Reaction of Delayed Hypersensitivity in Patients with Malignant Melanoma.  

National Technical Information Service (NTIS)

A study was made to evaluate allergic skin reactions of a delayed type in patients with malignant melanoma, mammary cancer and nonmelanoma skin tumors. Melanoma antigen was injected into these patients with the following results: allergic reactions to mel...

V. V. Gorodilova Z. M. Saraeva R. I. Slesareva G. D. Monzul

1973-01-01

348

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

PubMed Central

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

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

2010-01-01

349

Drug Reactions  

MedlinePLUS

... adverse drug reaction. One medicine might cause an adverse reaction if it’s taken with another medicine. One way ... reaction. Are prescription medicines the only cause of adverse reactions? No. Even medicines that you don't need ...

350

[Adverse drug reactions following immunization in Germany pursuant to the German Infection Protection Act and the German Medicinal Products Act from January 1, 2004 to December 31, 2005].  

PubMed

Sufficient post-marketing surveillance is necessary for safety monitoring of vaccines. In this respect the spontaneous reporting system of reporting suspected adverse drug reactions (ADR) following vaccination is an essential tool for safety monitoring. The marketing authorization holder and/or pharmaceutical manufacturer has the legal obligation to report suspected adverse drug reactions (German Drug Law and European Regulation). In addition physicians and traditional healers have to report suspected cases of complications after immunizations pursuant to the German Infection Protection Act (Infektionsschutzgesetz, IfSG). The reports are medically assessed and stored in a database at the Paul Ehrlich Institute. For the publication referenced here, all reported suspected cases of adverse drug reactions after immunizations were evaluated for the period from January 1, 2004-December 31, 2005 according to different criteria. In 2004 (2005) a total of 1237 (1393) suspected cases of adverse drug reactions or suspected complications after immunizations were notified. 858 (919) of these adverse drug reactions (ADR) were serious (69 % and 66 %, respectively). 414 (517) of the ADRs (i.e. 33 % and 37 %, respectively) were reported by physicians according to the IfSG; the other reports were from industry and other reporting sources. 251 (229) i.e. 61 % (44 %) of these reactions were serious. The total number of reports divided by the total number of vaccine doses launched on the German market during the observation period (according to the data provided by the pharmaceutical industry) revealed an overall "reporting rate" of approx. 3 reports per 100,000 vaccine doses. The age groups with the highest absolute number of reported cases were infants and young children (0-2 years), and adults (18-59 years) accounting for approx. one third each of the reports. The age distribution of the suspected cases was comparable with that of previous years. In both years, approx. half of all suspected adverse drug reactions following immunization were of transient nature, i.e. there was a complete recovery (restitution ad integrum). In both years, a very small proportion of cases were reported as permanent damage (30 and 34 cases respectively; 2.4 % of all cases) or resulted in death (35 or 23 cases, respectively; 2.8 % or 1.7 %, respectively). With a few exceptions these adverse events were considered to be related to other diseases and unlikely related to vaccination. Overall, the association between vaccination and adverse events was assessed by the PEI as "possible" in 58 % (62 %) of all cases, respectively, as "likely" in 6 % (8 %) of all cases, and as "certain" in 0.4 % (0.6 %) of all cases. In 14 % (13 %) of the cases, the causal relation was stated as "unlikely". In 17 % (15 %) of all cases, a scientific evaluation was not possible on the basis of the data provided. A separate analysis of reports was conducted for all suspected adverse drug reactions following varicella immunization. According to these data varicella vaccination is considered to be well tolerated. With the exception of an increase in local reactions following pneumococcal polysaccharide vaccination no new safety signal has been recognised during the observation period. PMID:17999134

Weisser, K; Meyer, C; Petzold, D; Mentzer, D; Keller-Stanislawski, B

2007-11-01

351

Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions Recommendations to the Advisory Committee on Immunization Practices (ACIP).  

National Technical Information Service (NTIS)

This report provides updated information concerning the potential adverse events associated with vaccination for hepatitis B, poliomyelitis, measles, mumps, diphtheria, tetanus, and pertussis. This information incorporates findings from a series of recent...

1996-01-01

352

HLA-A*31:01 and different types of carbamazepine-induced severe cutaneous adverse reactions: an international study and meta-analysis.  

PubMed

HLA-A*31:01 was reported to be associated with carbamazepine (CBZ)-induced severe cutaneous adverse reactions (SCAR), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). We conducted an international study using consensus diagnosis criteria to enroll a total of 93 patients with CBZ-SCAR from Europe or Asia. We found that HLA-A*31:01 showed a significant association with CBZ-DRESS in Europeans (P<0.001; odds ratio (OR) (95% confidence interval (CI))=57.6 (11.0-340)), and the strong association was also found in Chinese (P<0.001; OR (95% CI)=23.0 (4.2-125)). However, HLA-A*31:01 had no association with CBZ-SJS/TEN in neither Chinese nor Europeans. By comparison, HLA-B*15:02 showed a strong association with CBZ-SJS/TEN in Chinese (P<0.001, OR (95% CI)=58.1 (17.6-192)). A meta-analysis of this and other published studies confirmed that in all populations, HLA-A*31:01 had an extremely strong association with CBZ-DRESS (P<0.001, a pooled OR (95% CI)=13.2 (8.4-20.8)), but a much weaker association with CBZ-SJS/TEN (P=0.01, OR (95% CI)=3.94 (1.4-11.5)). Our data revealed that HLA-A*31:01 is a specific predictor for CBZ-DRESS but not for CBZ-SJS/TEN. More studies are needed to investigate the genetic determinant of CBZ-SJS/TEN in Europeans. Considering the potential clinical utility, the cost-effectiveness of the combined HLA-A*31:01 and HLA-B*15:02 genetic test to prevent CBZ-SCAR in Chinese needs further investigation. PMID:24322785

Genin, E; Chen, D-P; Hung, S-I; Sekula, P; Schumacher, M; Chang, P-Y; Tsai, S-H; Wu, T-L; Bellón, T; Tamouza, R; Fortier, C; Toubert, A; Charron, D; Hovnanian, A; Wolkenstein, P; Chung, W-H; Mockenhaupt, M; Roujeau, J-C

2014-06-01

353

Comorbidities, Sphincterotomy, and Balloon Dilation Predict Post-ERCP Adverse Events in PSC Patients: Operator Experience Is Protective  

Microsoft Academic Search

Background  Primary sclerosing cholangitis (PSC) is a chronic cholestatic disease. Interventional ERCP improves survival in PSC patients.\\u000a \\u000a \\u000a \\u000a Aims  To describe the frequency and risk factors for post-ERCP adverse events in patients with PSC via multivariate analysis.\\u000a \\u000a \\u000a \\u000a Methods  Retrospective cohort study included patients with a diagnosis of PSC who underwent ERCP at academic institutions between February\\u000a 2000 and October 2009. Demographis, co-morbid conditions, antibiotic

Amer A. Alkhatib; Kristen Hilden; Douglas G. Adler

354

Adverse events after endovascular treatment of chronic cerebro-spinal venous insufficiency (CCSVI) in patients with multiple sclerosis.  

PubMed

Although it is debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients undergo endovascular treatment (ET) of CCSVI. A study is ongoing in Italy to evaluate the clinical outcome of ET. Severe adverse events (AEs) occurred in 15/462 subjects at a variable interval after ET: jugular thrombosis in seven patients, tetraventricular hydrocephalus, stroke, paroxysmal atrial fibrillation, status epilepticus, aspiration pneumonia, hypertension with tachicardia, or bleeding of bedsore in the remaining seven cases. One patient died because of myocardial infarction 10 weeks after ET. The risk of severe AEs related to ET for CCSVI must be carefully considered. PMID:23380649

Ghezzi, A; Annovazzi, P; Amato, M P; Capello, E; Cavalla, P; Cocco, E; Falcini, M; Gallo, A; Patti, F; Perini, P; Rodegher, M E; Rovaris, M; Rottoli, M R; Comi, G

2013-06-01

355

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

PubMed Central

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

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

356

Performance Characteristics of a Methodology to Quantify Adverse Events over Time in Hospitalized Patients  

PubMed Central

Objective To assess the performance characteristics of the Institute for Healthcare Improvement Global Trigger Tool (GTT) to determine its reliability for tracking local and national adverse event rates. Data Sources Primary data from 2008 chart reviews. Study Design A retrospective study in a stratified random sample of 10 North Carolina hospitals. Hospital-based (internal) and contract research organization–hired (external) reviewers used the GTT to identify adverse events in the same 10 randomly selected medical records per hospital in each quarter from January 2002 through December 2007. Data Collection/Extraction Interrater and intrarater reliability was assessed using ? statistics on 10 percent and 5 percent, respectively, of selected medical records. Additionally, experienced GTT users reviewed 10 percent of records to calculate internal and external teams' sensitivity and specificity. Principal Findings Eighty-eight to 98 percent of the targeted 2,400 medical records were reviewed. The reliability of the GTT to detect the presence, number, and severity of adverse events varied from ?=0.40 to 0.60. When compared with a team of experienced reviewers, the internal teams' sensitivity (49 percent) and specificity (94 percent) exceeded the external teams' (34 and 93 percent), as did their performance on all other metrics. Conclusions The high specificity, moderate sensitivity, and favorable interrater and intrarater reliability of the GTT make it appropriate for tracking local and national adverse event rates. The strong performance of hospital-based reviewers supports their use in future studies.

Sharek, Paul J; Parry, Gareth; Goldmann, Donald; Bones, Kate; Hackbarth, Andrew; Resar, Roger; Griffin, Frances A; Rhoda, Dale; Murphy, Cathy; Landrigan, Christopher P

2011-01-01

357

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

Microsoft Academic Search

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

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

2008-01-01

358

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

PubMed Central

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

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

2013-01-01

359

Coping with adverse drug events in patients with heart failure: Exploring the role of medication beliefs and perceptions  

Microsoft Academic Search

This study describes coping strategies that patients with heart failure (HF) use to manage adverse drug events (ADEs). The included coping strategies were social support seeking, information seeking, non-adherence and taking alleviating medication. The role of beliefs about medication and ADE perceptions in explaining these coping strategies was assessed using the Self-Regulation Model. We performed a cross-sectional study including 250

R. H. De Smedt; T. Jaarsma; A. V. Ranchor; K. van der Meer; K. H. Groenier; F. M. Haaijer-Ruskamp; P. Denig

2012-01-01

360

Coping with adverse drug events in patients with heart failure: Exploring the role of medication beliefs and perceptions  

Microsoft Academic Search

This study describes coping strategies that patients with heart failure (HF) use to manage adverse drug events (ADEs). The included coping strategies were social support seeking, information seeking, non-adherence and taking alleviating medication. The role of beliefs about medication and ADE perceptions in explaining these coping strategies was assessed using the Self-Regulation Model. We performed a cross-sectional study including 250

R. H. De Smedt; T. Jaarsma; A. V. Ranchor; K. van der Meer; K. H. Groenier; F. M. Haaijer-Ruskamp; P. Denig

2011-01-01

361

Development of a computerised alert system, ADEAS, to identify patients at risk for an adverse drug event  

Microsoft Academic Search

IntroductionAdverse drug events (ADEs) are frequent and pose an important risk for patients treated with drugs. Fortunately, a substantial part of ADEs is preventable, and computerised physician order entry with a sophisticated clinical decision support system may be used to reach this goal.ObjectiveTo develop a new automated system that could improve the quality of medication surveillance. The system should focus

M K Rommers; M H Zegers; P A De Clercq; M L Bouvy; P H E M de Meijer; I M Teepe-Twiss; H-J Guchelaar

2010-01-01

362

Frequency of changing enteral alimentation bags and tubing, and adverse clinical outcomes in patients in a long term care facility.  

PubMed

Enteral alimentation, given via nasogastric or gastrostomy tubes, is a well established practice to provide nutrition for patients with significant neurological injury. The frequency with which enteral feeding bags and tubes require change and potential adverse effects associated with bacterial contamination of tube feeds remain controversial. The authors studied different times between enteral feeding bag and tube changes, and the effect on adverse clinical outcomes in residents of a long term care facility. In the first study, residents were randomized to 24 h (n = 2), 48 h (n = 3) or 72 h (n = 6) tube feeding and bag changes with clinical status monitored in a standardized fashion for six months. In the second study, patients were randomized to 24 h (n = 6) or 72 h (n = 6) changes. Patient-days of follow-up were 382, 574 and 1000 for the three arms of the first study period and 556 and 496 for the two arms of the second study. No differences in potential clinical adverse events--including fever, gastrointestinal symptoms or pneumonia--were observed with different durations of tubing change. This study suggests it is appropriate to change alimentation tube and feeding bags every 72 h (rather than every 24 h). The less frequent changes will decrease supply costs and free nursing time for other activities. PMID:8400342

Graham, S; McIntyre, M; Chicoine, J; Gerard, B; Laughren, R; Cowley, G; Morrison, J; Aoki, F Y; Nicolle, L E

1993-01-01

363

Elevated serum osteoprotegerin levels predict in-hospital major adverse cardiac events in patients with ST elevation myocardial infarction.  

PubMed

The aim of our study was to investigate whether osteoprotegerin (OPG) is related to in-hospital major adverse cardiac events (MACE) and reperfusion parameters in patients with ST elevation myocardial infarction (STEMI). The OPG/receptor activator of nuclear factor-?B (RANK)/RANK ligand pathway has recently been associated with atherosclerosis. OPG is a predictor of cardiovascular events in patients with acute coronary syndrome. This study included 96 consecutive patients with STEMI undergoing primary percutaneous coronary intervention (PCI). Two groups with equal number of patients were formed according to median OPG level. The association of OPG levels on admission with post-procedural reperfusion parameters, and in-hospital MACE were investigated. Patients with higher OPG levels displayed higher neutrophil/lymphocyte ratio, admission troponin, admission glucose, and high-sensitive C-reactive protein. Higher OPG levels were associated with increased thrombolysis in myocardial infarction (TIMI) risk score, TIMI risk index, pain to balloon time, need for inotropic support, shock, and MACE, mainly driven by death. Reperfusion parameters were not different between the two groups. TIMI risk score, TIMI risk index, myocardial blush grade, estimated glomerular filtration rate (eGFR), number of obstructed vessels, and OPG significantly predicted adverse cardiac events. Multiple logistic regression analysis revealed OPG as an independent predictor of MACE as well as eGFR, number of obstructed vessels, and corrected TIMI frame count. OPG, a bidirectional molecule displaying both atheroprotective and pro-atherosclerotic properties, is currently known as a marker of inflammation and a predictor of cardiovascular mortality. The present study, for the first time, demonstrated that an increased OPG level is related to in-hospital adverse cardiovascular events after primary PCI in patients with STEMI. PMID:22727437

Çanga, Aytun; Durako?lugil, Murtaza Emre; Erdo?an, Turan; Kirba?, Aynur; Yilmaz, Adnan; Çiçek, Yüksel; Ergül, Elif; Çetin, Mustafa; Kocaman, Sinan Altan

2012-11-01

364

Patient risk factors and adverse drug interactions in the treatment of acute gouty arthritis in the elderly: a case report  

PubMed Central

Introduction Non-steroidal anti-inflammatory drugs and corticosteroids are both used in the treatment acute gouty arthritis and may adversely interact with colchicine. Gastrointestinal toxicity of colchicine is dose-dependent and can be aggravated by drug-drug and drug-patient interactions. Case presentation Colonic perforation associated with second-line administration of colchicine for acute gouty arthrtitis was identified in an elderly man with several comorbidities who was also treated with non-steroidal anti-inflammatory drugs and corticostroids. Underlying diverticular disease was discovered at the time of surgical therapy. Conclusions Initial treatment of acute gouty arthritis with non-steroidal anti-inflammatory drugs or corticosteroids may increase colchicine toxicity by subsequent pharmacokinetic and pharmacodynamic interaction in the gut wall. The literature is reviewed suggesting that diverticular disease should be included in the list of adverse event risk factors when colchicine is being considered.

Zagler, Bernhard; Kaneppele, Angelika; Pattis, Peter; Stockner, Ingrid; Sitzmann, Gunther; Widmann, Josef; Pernthaler, Heinrich

2009-01-01

365

Hypersensitivity reaction to all drugs of category-1 anti-tuberculosis regime in an adult tuberculosis patient.  

PubMed

Adverse drug reaction to tuberculous chemotherapy is not an uncommon problem. Usually it occurs to single drug and can be treated easily with minimal intervention. We follow WHO recommended guideline for National Tuberculosis Control Programs to treat these adverse reactions. Here we found an adult who has been suffering left sided pleural tuberculosis developed anaphylactic reaction to first dose of category-1 anti-TB regime. Later on it was found that he could not even tolerate smaller challenging doses of isoniazide, Ethambutol, Rifampicin and Pyrazinamide separately. It became very difficult to choose an alternate regime for this patient. Lastly a regime with levofloxacin, streptomycin and clarithromycin was give to treat him and patient was recovered with this regime successfully. This experience will help in management of unusual drug reactions to anti-tuberculosis drugs. PMID:23982557

Rashid, M M; Hoque, M N; Hossain, D A; Hassan, M R

2013-07-01

366

Promoting engagement by patients and families to reduce adverse events in acute care settings: a systematic review  

PubMed Central

Introduction Patient-centeredness is central to healthcare. Hospitals should address patients’ unique needs to improve safety and quality. Patient engagement in healthcare, which may help prevent adverse events, can be approached as an independent patient safety practice (PSP) or as part of a multifactorial PSP. Objectives This review examines how interventions encouraging this engagement have been implemented in controlled trials. Methods We searched Medline, CINAHL, Embase and Cochrane from 2000 to 2012 for English language studies in hospital settings with prospective controlled designs, addressing the effectiveness or implementation of patient/family engagement in PSPs. We separately reviewed interventions implemented as part of selected broader PSPs by way of example: hand hygiene, ventilator-associated pneumonia, rapid response systems and care transitions. Results Six articles met the inclusion criteria for effectiveness with a primary focus on patient engagement. We identified 12 studies implementing patient engagement as an aspect of selected broader PSPs. A number of studies relied on patients’ possible function as a reporter of error to healthcare workers and patients as a source of reminders regarding safety behaviours, while others relied on direct activation of patients or families. Definitions of patient and family engagement were lacking, as well as evidence regarding the types of patients who might feel comfortable engaging with providers, and in what contexts. Conclusions While patient engagement in safety is appealing, there is insufficient high-quality evidence informing real-world implementation. Further work should evaluate the effectiveness of interventions on patient and family engagement and clarify the added benefit of incorporating engagement in multifaceted approaches to improve patient safety endpoints. In addition, strategies to assess and overcome barriers to patients’ willingness to actively engage in their care should be investigated.

Berger, Zackary; Flickinger, Tabor E; Pfoh, Elizabeth; Martinez, Kathryn A; Dy, Sydney M

2014-01-01

367

Models developed from the PLCO may help identify at-risk patients for adverse smoking outcomes  

Cancer.gov

Risk prediction models developed from an ancillary study of the Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO) may be useful in the public health sector for identifying individuals who are at risk for adverse smoking outcomes, such as relapse among former smokers and continued smoking among current smokers, and those who may benefit from relapse prevention and smoking cessation interventions, according to a study from the Lombardi Comprehensive Cancer Center at Georgetown University published October 26 in the Journal of the National Cancer Institute.

368

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

PubMed Central

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

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

2014-01-01

369

Extent of poly-pharmacy, occurrence and associated factors of drug-drug interaction and potential adverse drug reactions in Gondar Teaching Referral Hospital, North West Ethiopia  

PubMed Central

The aim of this study was to assess the extent of poly-pharmacy, occurrence, and associated factors for the occurrence of drug–drug interaction (DDI) and potential adverse drug reaction (ADR) in Gondar University Teaching Referral Hospital. Institutional-based retrospective cross-sectional study. This study was conducted on prescriptions of both in and out-patients for a period of 3 months at Gondar University Hospital. Both bivariate analysis and multivariate logistic regression were used to identify risk factors for the occurrence of DDI and possible ADRs. All the statistical calculations were performed using SPSS® software. A total of 12,334 prescriptions were dispensed during the study period of which, 2,180 prescriptions were containing two or more drugs per prescription. A total of 21,210 drugs were prescribed and the average number of drugs per prescription was 1.72. Occurrences of DDI of all categories (Major, Moderate, and Minor) were analyzed and DDI were detected in 711 (32.6%) prescriptions. Sex was not found to be a risk factor for the occurrence of DDI and ADR, while age and number of medications per prescription were found to be significant risk factors for the occurrence of DDI and ADR. The mean number of drugs per prescription was 1.72 and hence with regard to the WHO limit of drugs per prescription, Gondar hospital was able to maintain the limit and prescriptions containing multiple drugs supposed to be taken systemically. Numbers of drugs per prescription as well as older age were found to be predisposing factors for the occurrence of DDI and potential ADRs while sex was not a risk factor.

Admassie, Endalkachew; Melese, Tesfahun; Mequanent, Woldeselassie; Hailu, Wubshet; Srikanth, B Akshaya

2013-01-01

370

No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain.  

PubMed

A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADRs collected by Midi-Pyrénées (France), Veneto (Italy) and Castilla y León (Spain) Regional Pharmacovigilance Centres (January 2007-December 2009). All the reports including a psychotropic medication were selected in a first step; age distribution, seriousness and type of ADRs were compared between men and women. Reports of nonpsychotropic drugs were similarly identified and treated. The absolute number of reports and the proportion, considering population, were higher in women than in men. This was observed for all reports, but was particularly higher for psychotropic drugs (592 vs. 375; P < 0.001) than for nonpsychotropics drugs (5193 vs. 4035; P < 0.001). Antidepressants were the most reported (women, 303; men, 141; P < 0.001); the reporting rates (number of reports divided by exposed patients in the same period, estimated through sales data) for these drugs, however, were not significantly different between women (0.87 cases per 10 000 treated persons per year) and men (0.81 cases per 10 000 treated persons per year). Although there was a higher number of reports of ADRs in women, ADR reporting rates might be similar as highlighted by the case of antidepressants. Antidepressant ADRs in fact were similarly reported in men and in women. Gender differences are sometimes subtle and difficult to explore. International networks, as the one established for this study, do contribute to better analyse problems associated with medications. PMID:23617454

D'Incau, Paola; Lapeyre-Mestre, Maryse; Carvajal, Alfonso; Donati, Monia; Salado, Inés; Rodriguez, Lauriane; Sáinz, María; Escudero, Antonio; Conforti, Anita

2014-06-01

371

Stakeholder perspectives on implementing the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)  

Microsoft Academic Search

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse\\u000a Events, called the “PRO-CTCAE.” The PRO-CTCAE consists of a library of patient-reported items which can be administered in\\u000a clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software\\u000a platform for administering these items via

Deborah Watkins Bruner; Laura J Hanisch; Bryce B Reeve; Andy M Trotti; Deborah Schrag; Laura Sit; Tito R Mendoza; Lori Minasian; Ann O’Mara; Andrea M Denicoff; Julia H Rowland; Michael Montello; Cindy Geoghegan; Amy P Abernethy; Steven B Clauser; Kathleen Castro; Sandra A Mitchell; Laurie Burke; Ann Marie Trentacosti; Ethan M Basch

2011-01-01

372

Randomized, double-blind, crossover challenge study in 53 subjects reporting adverse reactions to melon (Cucumis melo)  

Microsoft Academic Search

Background: Few studies have evaluated IgE-mediated hypersensitivity to melon with details of clinical reactions confirmed by double-blind, placebo-controlled, food challenges (DBPCFCs). Objective: We sought to investigate clinical features (type and severity of reactions, age at onset, results of skin prick and in vitro tests, and incidence of other allergic diseases and associated food allergies) of acute allergic reactions to melon

Julia Rodriguez; Jesus F. Crespo; Wesley Burks; Cesar Rivas-Plata; Silvia Fernandez-Anaya; Ramon Vives; Pilar Daroca

2000-01-01

373

Enterocolitis: an adverse event in refractory epilepsy patients treated with levetiracetam?  

Microsoft Academic Search

Introduction: Levetiracetam (LEV) is a recently marketed novel anti-epileptic drug with a promising efficacy and safety profile. In this report we describe two patients who presented with enterocolitis and discuss the possible relationship with concurrent LEV intake.Patients: In two patients, LEV was initiated to control refractory complex partial seizures (CPS). The first patient was treated with 1500mg\\/day and complained of

TOMMY BOSMAN; KRISTL VONCK; PIETER CLAEYS; HANS VAN VLIERBERGHE; MATTI DE CLERCQ; JACQUES DE REUCK; PAUL BOON

2004-01-01

374

Application of gene expression programming and neural networks to predict adverse events of radical hysterectomy in cervical cancer patients.  

PubMed

The aim of this article was to compare gene expression programming (GEP) method with three types of neural networks in the prediction of adverse events of radical hysterectomy in cervical cancer patients. One-hundred and seven patients treated by radical hysterectomy were analyzed. Each record representing a single patient consisted of 10 parameters. The occurrence and lack of perioperative complications imposed a two-class classification problem. In the simulations, GEP algorithm was compared to a multilayer perceptron (MLP), a radial basis function network neural, and a probabilistic neural network. The generalization ability of the models was assessed on the basis of their accuracy, the sensitivity, the specificity, and the area under the receiver operating characteristic curve (AUROC). The GEP classifier provided best results in the prediction of the adverse events with the accuracy of 71.96 %. Comparable but slightly worse outcomes were obtained using MLP, i.e., 71.87 %. For each of measured indices: accuracy, sensitivity, specificity, and the AUROC, the standard deviation was the smallest for the models generated by GEP classifier. PMID:24136688

Kusy, Maciej; Obrzut, Bogdan; Kluska, Jacek

2013-12-01

375

Frequency of Adverse Events of Antithyroid Drugs Administered during Pregnancy.  

PubMed

The frequency and types of adverse events after initial antithyroid drug (ATD) therapy during pregnancy have never been reported, nor has whether the frequency of adverse events is the same as among nonpregnant subjects ever been investigated. We investigated retrospectively the frequency of adverse events after initial ATD administration to previously untreated Graves' disease (GD) patients during pregnancy. We reviewed the charts of cases of 91 untreated pregnant women who came to our hospital for the first time and were newly diagnosed with GD during the period between January 1, 1999, and December 31, 2011. Thiamazole (MMI) was used to treat 40 patients and 51 patients were treated with propylthiouracil (PTU). Adverse events occurred in 5 patients (5/40; 12.5%) treated with MMI, and they consisted of cutaneous reactions in 5 patients. Adverse events occurred in five patients (5/51; 9.8%) treated with PTU, and they consisted of hepatotoxicity in two patients and cutaneous reactions in three patients. No patients experienced agranulocytosis or ANCA-related vasculitis. Comparison with the expected rate of adverse events in nonpregnant individuals showed that the frequency of adverse events in pregnant individuals was low. PMID:24523983

Yoshihara, Ai; Noh, Jaeduk Yoshimura; Watanabe, Natsuko; Iwaku, Kenji; Kobayashi, Sakiko; Suzuki, Miho; Ohye, Hidemi; Matsumoto, Masako; Kunii, Yo; Mukasa, Koji; Sugino, Kiminori; Ito, Koichi

2014-01-01

376

Frequency of Adverse Events of Antithyroid Drugs Administered during Pregnancy  

PubMed Central

The frequency and types of adverse events after initial antithyroid drug (ATD) therapy during pregnancy have never been reported, nor has whether the frequency of adverse events is the same as among nonpregnant subjects ever been investigated. We investigated retrospectively the frequency of adverse events after initial ATD administration to previously untreated Graves' disease (GD) patients during pregnancy. We reviewed the charts of cases of 91 untreated pregnant women who came to our hospital for the first time and were newly diagnosed with GD during the period between January 1, 1999, and December 31, 2011. Thiamazole (MMI) was used to treat 40 patients and 51 patients were treated with propylthiouracil (PTU). Adverse events occurred in 5 patients (5/40; 12.5%) treated with MMI, and they consisted of cutaneous reactions in 5 patients. Adverse events occurred in five patients (5/51; 9.8%) treated with PTU, and they consisted of hepatotoxicity in two patients and cutaneous reactions in three patients. No patients experienced agranulocytosis or ANCA-related vasculitis. Comparison with the expected rate of adverse events in nonpregnant individuals showed that the frequency of adverse events in pregnant individuals was low.

Yoshihara, Ai; Noh, Jaeduk Yoshimura; Watanabe, Natsuko; Iwaku, Kenji; Kobayashi, Sakiko; Suzuki, Miho; Ohye, Hidemi; Matsumoto, Masako; Kunii, Yo; Mukasa, Koji; Sugino, Kiminori; Ito, Koichi

2014-01-01

377

Usefulness of hyponatremia as a predictor for adverse events in patients with heart failure receiving cardiac resynchronization therapy.  

PubMed

Hyponatremia portends a poor prognosis in patients with heart failure (HF). The aim of this study was to evaluate prognostic implication of hyponatremia on adverse events in patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of improvement of hyponatremia after CRT device implantation was also evaluated. In this retrospective analysis, we included patients in whom a CRT device was implanted between April 2004 and April 2010 at our institution and had a baseline sodium level obtained within 72 hours of implantation. The patients were followed up for 3 years after implantation for subsequent primary composite end points, that is, hospitalization for HF, left ventricular assist device or heart transplant, and all-cause death. Sodium levels were followed up at 3 to 6 months after device implantation. Hyponatremia was defined as a serum sodium level of <135 mmol/L. A total of 402 patients were included (age 68.7 ± 12.3 years, women 20.9%). One hundred seventy-nine adverse events were noted in this period. In a Cox proportional hazards univariate model, hyponatremia (hazard ratio [HR] 1.54, 95% confidence interval [CI] 1.113 to 2.131, p = 0.009), creatinine (HR 1.267, 95% CI 1.156 to 1.389, p <0.001), and diuretics (HR 2.652, 95% CI 1.401 to 5.019, p = 0.003) were associated with occurrence of the composite end point. A total of 57.9% of patients with hyponatremia at baseline had the composite end point compared with 40.7% of those with normal sodium concentration (p = 0.004). Kaplan-Meier curve showed that hyponatremic patients fared worse. Also, patients in whom hyponatremia resolved after CRT device implantation had lower incidence of the composite end point compared with patients who had normal pre-CRT sodium levels but developed hyponatremia later. In conclusion, baseline hyponatremia is associated with poor prognosis in patients with HF. CRT can resolve hyponatremia in some patients after device implantation. Patients with postimplantation hyponatremia (either newly developed or persistent from baseline) have a poor clinical outcome. Post-CRT improvement of hyponatremia is associated with improved clinical outcomes. PMID:24852916

Sharma, Ajay K; Vegh, Eszter M; Kandala, Jagdesh; Orencole, Mary; Januszkiewicz, Lukasz; Bose, Abhishek; Miller, Alexandra; Parks, Kimberly A; Heist, E Kevin; Singh, Jagmeet P

2014-07-01

378

Accountability sought by patients following adverse events from medical care: the New Zealand experience  

Microsoft Academic Search

Background: Unlike Canada's medical malpractice system, patients in New Zealand who are dissatisfied with the quality of their care may choose between 2 well-established medi- colegal paths: one leads to monetary compensation and the other to nonmonetary forms of accountability. We compared the forms of accountability sought by patients and families in New Zealand who took different types of legal

Marie Bismark; Edward Dauer; Ron Paterson; David Studdert

379

Trends of reporting of 'serious'vs. 'non-serious' adverse drug reactions over time: a study in the French PharmacoVigilance Database  

PubMed Central

AIM To investigate trends in spontaneous reporting to the French Pharmacovigilance system of ‘serious’ (SADRs) and ‘non-serious’ (NSADRs) adverse drug reactions over time. METHODS Annual SADR : NSADR ratios were calculated for each drug and their evolution tested with linear trend tests. RESULTS Among the 39 new active substances commercialized in France in 2000, 16 had sufficient data to perform linear trend tests. An increasing linear relation was found for five widely prescribed drugs, a non-significant increasing trend for eight others, i.e. drugs mostly used in hospitals. CONCLUSION ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later.

Moulis, Guillaume; Sommet, Agnes; Durrieu, Genevieve; Bagheri, Haleh; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

2012-01-01

380

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

PubMed Central

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

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

2013-01-01