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Withdrawal of cerivastatin from the world market.

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  • 1Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA. cfurberg@wfubmc.edu

Abstract

Cerivastatin was recently withdrawn from the market because of 52 deaths attributed to drug-related rhabdomyolysis that lead to kidney failure. The risk was found to be higher among patients who received the full dose (0.8 mg/day) and those who received gemfibrozil concomitantly. Rhabdomyolysis was 10 times more common with cerivastatin than the other five approved statins. We address three important questions raised by this withdrawal. Should we continue to approve drugs on surrogate efficacy? Are all statins interchangeable? Do the benefits outweigh the risks of statins? We conclude that decisions regarding the use of drugs should be based on direct evidence from long-term clinical outcome trials.

PMID:
11806796
[PubMed - as supplied by publisher]
PMCID:
PMC59524
Free PMC Article
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