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[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].

AbstractBACKGROUND 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.
AuthorsMichel Andréjak, Valérie Gras, Jacques Caron
JournalTheĢrapie (Therapie) 2005 May-Jun Vol. 60 Issue 3 Pg. 299-304 ISSN: 0040-5957 [Print] England
Vernacular TitleAtteintes musculaires sévères sous statines: bilan des cas notifies en France jusqu'a fin février 2002 et données concernant les risques liés a la cérivastatine.
PMID16128274 (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

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