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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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects. more...

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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

On August 8, 2001 the U.S. 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.

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Baycol voluntarily withdrawn by manufacturer - Updates - Bayer Pharmaceutical Division - Brief Article
From FDA Consumer, 11/1/01

The maker of a popular cholesterol-lowering drug has voluntarily withdrawn the product from the market after reports that people taking the drug died of a condition that causes muscle-cell breakdown known as rhabdomyolysis.

Baycol (cerivastatin), made by Bayer Pharmaceutical Division, is a member of a class of drugs known as "statins," used to lower cholesterol. Statins block a specific enzyme in the body that is involved in the formation of cholesterol. While all statins have been associated with rare reports of rhabdomyolysis, deaths as the result of using Baycol have been reported much more frequently than for other approved statins, especially when used at higher doses, by the elderly, and particularly in combination with the cholesterol-lowering drug gemfibrozil (Lopid and generics).

According to the FDA, people who are currently taking Baycol should ask their doctors about switching to one of the following alternative medications to control their cholesterol levels: Mevacor (lovastatin), Pravachol (pravastatin), Zocor (simvastatin), Lescol (fluvastatin), and Lipitor (atorvastatin).

COPYRIGHT 2001 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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