[Severe muscle disorders associated with statins: analysis of cases notified in France up to the end of February 2002 and data concerning the risk profile of cerivastatin].
METHODS
After the withdrawal of cerivastatin from the market, a survey was performed concerning severe muscular disorders associated with statin treatments that were notified to the French national and pharmaceutical industry pharmacovigilance systems up to February 2002.


RESULTS
Among the 238 cases analysed, 69 were related to cerivastatin, 86 to simvastatin, 49 to pravastatin, 23 to atorvastatin and 9 to fluvastatin. The reporting rate was six- to ten-times higher for cerivastatin than for other statins. A major risk factor for rhabdomyolysis with cerivastatin was its association with gemfibrozil.


CONCLUSIONS
Postmarketing surveillance appears to be a major tool for early detection of safety problems with a new drug.
Andréjak
Michel
M
Centre de Pharmacovigilance, Service de Pharmacologie, Amiens, France. andrejak.michel@chu-amiens.fr
Gras
Valérie
V
Caron
Jacques
J
D000368:Aged; D003430:Cross-Sectional Studies; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D008297:Male; D009135:Muscular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D010045:Outpatients; D011358:Product Surveillance, Postmarketing; D011725:Pyridines / Q000009:adverse effects*; D018570:Risk Assessment
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D011725:Pyridines; C086276:cerivastatin