This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryCompany is voluntarily withdrawing cerivastatin from the U.S. due to reports of 31 deaths from severe rhabdomyolysis, FDA says Aug. 8. The fatalities have been reported most frequently, FDA said, when Baycol has been "used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (Pfizer's Lopid and generics)." Twelve of the fatalities involved concomitant gemfibrozil use. Bayer says it has no plans to reintroduce the statin in the U.S. and will probably stop ongoing diabetes and longer-term cardiovascular trials
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