[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].

Abstract

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.

• Authors: Michel Andréjak, Valérie Gras, Jacques Caron
• Journal: Therapie (Therapie) 2005 May-Jun Vol. 60 Issue 3 Pg. 299-304 ISSN: 0040-5957 [Print] France
• Vernacular Title: Atteintes musculaires sévères sous statines: bilan des cas notifies en France jusqu'a fin février 2002 et données concernant les risques liés a la cérivastatine.
• PMID: 16128274 (Publication Type: English Abstract, Journal Article)

Chemical References

• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Hypolipidemic Agents
• Pyridines
• cerivastatin

Topics

• Aged
• Cross-Sectional Studies
• Female
• France (epidemiology)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (adverse effects)
• Hypolipidemic Agents (adverse effects)
• Male
• Muscular Diseases (chemically induced, epidemiology)
• Outpatients
• Product Surveillance, Postmarketing
• Pyridines (adverse effects)
• Risk Assessment