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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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects.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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Bayer Withdraws the Anticholesterol Drug Baycol from the Market - because it caused 52 cases of fatal rhabdomyolysis worldwide
From American Family Physician, 9/1/01 by Rosemarie Sweeney

Bayer Pharmaceutical Division voluntarily withdrew cerivastatin (Baycol), their cholesterol-lowering medication, from the United States market in August because of a side effect called rhabdomyolysis that was linked to 52 deaths worldwide. Symptoms of rhabdomyolysis, an acute condition where muscle cells are destroyed and released into the bloodstream, include severe muscle pain usually in the calves or lower back, weakness, tenderness, fever, dark urine, nausea and vomiting, and can lead to the development of fatal kidney or other organ failure. While all of the popular anticholesterol drugs known as statins have been linked to rare reports of rhabdomyolysis, the U.S. Food and Drug Administration (FDA) linked Baycol to significantly more fatal cases. The FDA stated that this side effect of Baycol was reported most frequently when used at higher doses, when used in the elderly, and especially when used in combination with gemfibrozil, another lipid level lowering drug. The FDA recommends that the 700,000 Americans currently taking Baycol consult their physician about switching to alternate medications to control their cholesterol levels. For more information regarding the withdrawal of Baycol, contact Bayer Customer Service at 800-758-9794 or the FDA's Drug Information Office at 888-INFO-FDA, or visit http://www.fda.gov/bbs/topics/ANSWERS/ 2001/ANS01095.html.

COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group

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