On French Pharmacovigilance System

Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. French Pharmacovigilance Centres.

The incidence of adverse reactions to drugs has been assessed with prospective epidemiological studies conducted within single units, departments, or hospitals. Because of the variability of the results and a lack of representativeness, it is difficult to confidently extrapolate these results to a national level. To calculate the incidence of admissions caused by adverse drug reactions we condu...

Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

AIMS To evaluate putative associations between drugs and dilated cardiomyopathy. METHODS We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive cont...

[Liver damage and nonsteroidal anti-inflammatory drugs: case non-case study in the French Pharmacovigilance Database].

This study investigates the relationship between exposure to non-steroidal anti-inflammatory drugs (NSAIDs) and liver injuries using the French Pharmacovigilance Database. We use the case/non-case methodology, where 'cases' were reports of the reactions of interest (liver injuries as recorded in the database according to the WHO-ART classification including cytolytic and cholestatic hepatitis, ...

Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

BACKGROUND Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. METHODS Type 2 diabetic patients were identified from the French Database o...

Forensic pharmacovigilance.