In pharmacology, cerivastatin (Baycol®, Lipobay®) is 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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects.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 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. 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.

In 2001, Bayer announced the voluntary withdrawal of the drug from the market.

Important Note

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On August 8, 2001 the U.S. Food and Drug Administration (Food and Drug Administration (FDA)) announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product ^*. The FDA agrees with and supports this decision. All patients taking Baycol should contact their healthcare providers to discuss treatment alternatives.

References

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• Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med 2001;2:205-207. PMID 11806796.
• World Health Organization - Alert: Voluntary withdrawal of Cerivastatin – Reports of Rhabdomyolysis.
• FDA Statement About Baycol: http://www.fda.gov/cder/drug/infopage/baycol

Statins | Withdrawn drugs

Cerivastatin | Cérivastatine | Cerivastatine | เซอวิวาสแตติน