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BACKGROUND Since its introduction in France, ketoprofen for topical use has been associated with a large number of cutaneous adverse effect reports. Therefore, the French Medicine Agency progressively introduced warnings and contraindications to its use. Despite this, serious adverse drug reactions (ADRs) still occur. OBJECTIVE To describe clinical(More)
To assess the incidence of hospital admissions related to adverse drug reactions (ADRs) in France and the frequency of preventable ADRs in France, a prospective study was conducted among a representative randomly selected sample of medical wards in public hospitals between December 2006 and June 2007; all patients admitted during a 2-week period were(More)
BACKGROUND Benzodiazepines (BZD) are commonly prescribed in the elderly. Persons with dementia may be at a greater risk of adverse reactions of BZD such as cognitive impairment. OBJECTIVE To assess the prevalence of BZD use in Alzheimer's disease patients and to examine patient and drug-characteristics associated with this use. DESIGN Cross-sectional(More)
PURPOSE Data mining on electronic health records (EHRs) has emerged as a promising complementary method for post-marketing drug safety surveillance. The EU-ADR project, funded by the European Commission, is developing techniques that allow mining of EHRs for adverse drug events across different countries in Europe. Since mining on all possible events was(More)
BACKGROUND Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE The aim of the study was to explore the effects of competition bias on safety(More)
BACKGROUND Global introspection is, with operational algorithms and Bayes' theorem, one of the three main approaches used to assess the causal relationship between a drug treatment and the occurrence of an adverse event. OBJECTIVE To analyze and compare the judgments of five senior experts using global introspection about drug causation on a random set of(More)
BACKGROUND The French pharmacovigilance system is based on a network of 31 regional centres located in teaching hospitals and coordinated by the French Medicines Agency ("Agence Française de Sécurité Sanitaire des Produits de Santé" [Afssaps]). Since 1984, they have shared a common database of adverse drug reactions (ADRs) that are spontaneously reported by(More)
PURPOSE To study whether reports related to known drug-event associations could hinder the detection of new signals by increasing the detection thresholds when using disporportionality analyses in spontaneous reporting (SR) databases. METHODS The French SR database (2005-2006 data) was used to test this hypothesis for the following events: bleeding,(More)
Pharmacovigilance spontaneous reporting systems are primarily devoted to early detection of the adverse reactions of marketed drugs. They maintain large spontaneous reporting databases (SRD) for which several automatic signalling methods have been developed. A common limitation of these methods lies in the fact that they do not provide an auto-evaluation of(More)
BACKGROUND Different methods have been proposed for assessing a possible causal link between a drug treatment and an adverse event in individual patients. They approximately belong to three main categories: expert judgement, operational algorithms and probabilistic approaches. OBJECTIVE To compare, in a set of actual drug adverse event reports, three(More)