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

Background and 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. Conclusion: Postmarketing surveillance appears to be a major tool for early detection of safety problems with a new drug.