[Side effects of fibrates (except liver and muscle)].
If the iatrogenic acute muscular syndromes (rhabdomyolysis) and hepatic diseases following hypolipidemic drugs therapy are very well known, the other unwanted effects associated with fibrate therapy are not well established. It is the reason why we have selected, in the computerised data base of side effects from the French Network of "Centres de Pharmacovigilance" organisation, the pathological events associated with fibrate therapy during five years (1985 to 1989) (with exception for the acute muscular and hepatic diseases). The 277 side effects represent 67% of the side effects in which the product is regarded as "suspect" (S). These effects were observed in 132 men (mean age = 57 years) and 145 women (mean age = 61 years). The most frequently encountered products are: fénofibrate (Lipanthyl) for 30%; ciprofibrate (Lipanor); gemfibrozil (Lipur); bézafibrate (Befizal); each for about 10%. The mean doses used were the same that suggested in the french therapeutic dictionary ("Vidal"). The unwanted effects observed were: Skin reactions: 22.8% Blood disturbances (and hemorrhage): 9.8% Gl diseases (pancreatitis), Libido and psychic disturbances, nervous system disorders: about 6% each. All clotting disturbances (5.8%) are interactions with coumarin derivatives. The incidence of serious side effects was low and the recovery very good in 80.9% of cases: no death. In conclusion, the toxicity of fibrates (with exception for rhabdomyolysis and hepatic reaction) appears unimportant: the most frequently observed side effects are skin reactions and blood disturbances (interactions) and rarely nervous system, psychic or libido disturbances. The recovery is good, and the general toxicity of all products appear to be of the same order of magnitude.
Sgro
C
C
Centre Régional de Pharmacovigilance de Bourgogne, CHU de Dijon, UER de Médecine.
Escousse
A
A
D001778:Blood Coagulation Disorders / Q000139:chemically induced; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D007989:Libido / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced; D012871:Skin Diseases / Q000139:chemically induced
D000960:Hypolipidemic Agents
Effets indésirables des fibrates (hors foie et muscle).