[Muscular involvement and fibrates. Analysis of databanks of the French System of Pharmacovigilance].
A retrospective study of the muscular adverse reactions of fibrates has been conducted from the last 5-years reports of the 30 French Regional Centers of Pharmacovigilance, centralized in the common data bank located in Lyon. Fifty four reports in which at least one fibrate stated as suspect (according to the WHO's definitions) have been reviewed. Those 54 reports represent 13% of the side-effects reported with fibrates during this same period. Fibrates seem to be involved as frequently as prescribed, so fenofibrate was the most frequently suspected and the most prescribed. The most usual terms found were "myalgia" and "elevation of CPK". This study shows evidence of the interest of the data-bank of the French System of Pharmacovigilance (which has collected 36,890 reports with all the drugs during the same period); harmonization in the choice of the terms selected for computerizing the cases would improve the exploitation of this sum of data.
Lavarenne
J
J
Centre Régional de Pharmacovigilance, Faculté de Médecine, Clermont-Ferrand.
Poinas-Caillaud
H
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D005602:France; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D012189:Retrospective Studies
D000960:Hypolipidemic Agents
Atteintes musculaires et fibrates. Analyse des données de la banque informatique du Système Français de Pharmacovigilance.