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Pharmacovigilance Database (pharmacovigilance + database)

Distribution by Scientific Domains
Medical Sciences85%

Kinds of Pharmacovigilance Database

  • french pharmacovigilance database
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    Selected Abstracts

    Overview of adverse reactions to nefopam: an analysis of the French Pharmacovigilance database

    FUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2007
    G. Durrieu
    Abstract Nefopam is widely used for the relief of moderate acute pain. Its safety profile remains to be specified. The objective of the study was to review adverse reactions to nefopam spontaneously reported to the French Pharmacovigilance system. All cases of adverse drug reactions (ADRs) associated with nefopam, registered in the French Pharmacovigilance database from January 1, 1995 to December 31, 2004, were reviewed. For each reported ADR, information about patient (age, gender, medical history), drug exposure (suspected and concomitantly used drugs), characteristics of ADRs (imputability score, time of onset, seriousness, outcome) were collected. A total of 114 ADRs with an imputability rated from ,plausible' (I2) to ,likely' (I3) and ,very likely' (I4) was analysed. The most frequent ADRs included ,expected' ADRs such as sweating, nausea, tachycardia, malaise or vomiting; 61 ADRs were ,unexpected. No overdose was reported; 26 ADRs (23%) were considered as ,serious'. Most of them were ,unexpected', including neuropsychiatric (hallucinations, convulsions) or cutaneous (pruritus, erythema, urticaria) ADRs. Six cases of anaphylactic ADRs (two angioedema and four anaphylactic shocks) were reported, all occurring shortly after use of nefopam during the post-operative period. Physicians should be aware of the possible occurrence of some serious ADRs when using nefopam such as convulsions and anaphylactic shocks, especially when the drug is used in special medical conditions, like post-operative periods. [source]

    Drug related falls: a study in the French Pharmacovigilance database,,

    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 1 2005
    Emmanuelle Souchet
    Abstract Objective To investigate the risk of falls associated with drugs among the French population using data reported to the French spontaneous reporting system and recorded in the French Pharmacovigilance database. Methods All cases including a fall were searched in the French Pharmacovigilance database between 1995 and 1999. Drugs involved and characteristics of patients were investigated. In a second step, we estimated the risk associated with psychotropic and cardiovascular drugs in a case/non case comparison, where cases were reports including a fall and non cases all other reports. This risk was estimated by calculation of crude and age and gender adjusted reporting odds ratios (ROR). Results During this period, 328 reports including a fall were reported (0.4% of the database). Patients were female in 70%. Mean age was 76,±,18 years. Comparisons between cases and non cases showed that cases were more likely to be women (OR: 1.9; 95% confidence interval (CI) [1.5,2.4]) and older. After adjustment on age and gender, falls remained significantly associated with exposure to benzodiazepines (4.7,[3.7,5.9]), imipraminic antidepressants (3.6 [2.5,5.1]), serotonin reuptake inhibitor (SRI) antidepressants (2.2 [1.5,3.1]) or nitrates (1.9 [1.2,2.8]). Conclusion This study confirms that taking psychotropic drugs strongly increases the risk of falls. The role of cardiovascular drugs (except nitrates) remains not significant when confounding factors are taken into account. According to the very high prevalence of psychotropic drug use in the French elderly, further study are needed to investigate the relative effect of some drugs on falls, like for example SRIs or short acting benzodiazepines. Copyright © 2004 John Wiley & Sons, Ltd. [source]

    Reports of withdrawal syndrome with the use of SSRIs: a case/non-case study in the French Pharmacovigilance database

    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2002
    T. Trenque
    Abstract The SSRIs can be associated with withdrawal reactions and the objective of this study is to test the existence of an association between reports of withdrawal syndromes with the selective serotonin re-uptake inhibitors in the French spontaneous reports database. All reactions are coded according to the WHO ART dictionary. Cases are reports of reactions of interest (withdrawal syndrome). Non-cases are all reports of reactions other than those being studied. We calculated the odds ratio (OR) as the ratio of the odds of the association of reports of withdrawal syndrome with SSRIs in cases and non-cases. SSRIs are clearly associated with a higher risk of withdrawal syndrome (OR: 5.05, 95% CI: 3.81,6.68) and in particular with venlafaxine and paroxetine (OR: 12.16, 95% CI: 6.17,23.35 and OR: 8.47, 95% CI: 5.63,12.65, respectively). The risk of withdrawal reactions appears to be greater with short half-life drugs such as paroxetine and venlafaxine. The precise mechanisms have not been identified. Copyright © 2002 John Wiley & Sons, Ltd. [source]

    FEIBAź safety profile in multiple modes of clinical and home-therapy application

    HAEMOPHILIA, Issue 2004
    H. Luu
    Summary., The development of neutralizing antibodies to factor VIII or IX therapeutic concentrates remains the most serious and challenging complication in the management of patients with haemophilia A and B. FEIBAź, Anti-Inhibitor Coagulant Complex, is an activated prothrombin complex concentrate that has been used to treat patients with such complications for almost 30 years. The mechanism of action of FEIBAź has been proposed to involve simultaneous FVIII/FIX inhibitor bypassing action in the common, intrinsic and extrinsic coagulation pathways. FEIBAź is derived from human plasma that undergoes stringent viral screening followed by significant viral inactivation and removal. To date, there have been no confirmed reports of transmission of hepatitis A, B or C, or of human immunodeficiency viruses associated with the use of the current, vapour-heat-treated FEIBAź concentrate. The incidence of thrombotic adverse events recorded in the Baxter pharmacovigilance database for the 10-year postmarket period (1990,99) was approximately 4 : 100 000 infusions of FEIBAź. Almost all documented thrombotic events with FEIBAź occurred with doses that exceeded dosing recommendations, and known risk factors for cardiovascular disease were evident in more than 80% of the patients involved. Overall, clinical data have shown FEIBAź to be safe and well-tolerated for use in a wide variety of clinical settings, including treatment of bleeding episodes, management of surgical procedures, home therapy, long-term prophylaxis, and prophylaxis during immune tolerance induction, when used according to dosing guidelines. [source]

    False Discovery Rate Estimation for Frequentist Pharmacovigilance Signal Detection Methods

    BIOMETRICS, Issue 1 2010
    I. Ahmed
    Summary Pharmacovigilance systems aim at early detection of adverse effects of marketed drugs. They maintain large spontaneous reporting databases for which several automatic signaling methods have been developed. One limit of those methods is that the decision rules for the signal generation are based on arbitrary thresholds. In this article, we propose a new signal-generation procedure. The decision criterion is formulated in terms of a critical region for the P-values resulting from the reporting odds ratio method as well as from the Fisher's exact test. For the latter, we also study the use of mid-P-values. The critical region is defined by the false discovery rate, which can be estimated by adapting the P-values mixture model based procedures to one-sided tests. The methodology is mainly illustrated with the location-based estimator procedure. It is studied through a large simulation study and applied to the French pharmacovigilance database. [source]