Cerivastatin

From DrugPedia: A Wikipedia for Drug discovery

In pharmacology, cerivastatin (Baycol, Lipobay) was a synthetic member of the class of statins, used to lower cholesterol and prevent cardiovascular disease. It was withdrawn from the market in 2001 because of the high rate of serious side-effects.

Cerivastatin was marketed by the pharmaceutical company Bayer A.G. in the late 1990s as a new synthetic statin, to compete with Pfizer's highly successful atorvastatin (Lipitor).

During post-marketing surveillance, 52 deaths were reported in patients using cerivastatin, mainly from rhabdomyolysis and its resultant renal failure.Risks were higher in patients using fibrates, mainly gemfibrozil (Lopid), and in patients using the high (0.8 mg/day) dose of cerivastatin. Bayer A.G. added contraindication about the concomitant use of cerivastatin and gemfibrozil to the package 18 months after the drug interaction was found. Frequency of deadly incidents of rhabdomyolysis with cerivastatin was 16 to 80 times higher than with other statins. Another 385 nonfatal cases of rhabdomyolysis were reported. This put the risk of this (rare) complication at 5-10 times that of the other statins. Cerivastatin also induced myopathy in a dose-dependent manner when administrated as monotherapy, but that was revealed only after producer of cerivastatin was sued and unpublished company documents were opened.

On August 8, 2001 the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceutical Division voluntarily withdrew Baycol from the U.S. market, due to the reports of fatal Rhabdomyolysis