Baycol LogoChemical structure of cerivastatin
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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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects.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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Merck may gain from Baycol's pain - Brief Article
From Drug Store News, 9/24/01

Bayer Pharmaceuticals' voluntary market withdrawal of its top-selling drug Baycol (cerivastatin) has Merck & Co. positioning itself to scoop up patients looking for an alternative to the beleaguered drug. Bayer withdrew Baycol from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction to the drug.

Merck subsequently added a prominent "Attention Baycol Users" headline to its consumer ads for Zocor (simvastatin), one of several other lipid-lowering statins still on the market. The ads feature football coach Dan Reeves and run in large circulation publications, such as The Wall Street Journal.

Baycol, sold as Lipobay outside the United States, accounts for more than 25 percent of Bayer's healthcare sales and about 16 percent of operating income, according to a report in the Financial Times. In addition to Zocor, the Food and Drug Administration suggested former Baycol users consider Mevacor (lovastatin), Pravachol (pravastatin), Lescol (fluvastatin) and Lipitor (atorvastatin).

COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2001 Gale Group

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