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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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects.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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Other "Statin" Drugs May Share Baycol's Rare Side Effect - Brief Article
From Healthfacts, 10/1/01 by Maryann Napoli

Soon after the cholesterol-lowering drug, Baycol (cerivastatin,) was withdrawn due to a rare and serious muscle-damaging side effect, competing drug companies moved in to snare some new customers. Full- page ads began appearing in newspapers urging people who have stopped taking Baycol to ask their doctors about going on another drug in the same class called "statins." These include Pravachol (pravastatin), Zocor (simvastatin), Lipitor (atorvastatin), and Lescol (fluvastatin).

Bayer A.G., the German pharmaceutical and chemical conglomerate, voluntarily withdrew its drug, Baycol, last August after 31 confirmed deaths had occurred in people who had been taking the drug. All died of a rare condition called rhabdomyolysis, which causes a break down of muscle tissue. At the time, news reports acknowledged that other statin drugs have also been linked to rare cases of muscle cell damage, but the FDA found the problem to be much more common with Baycol than with other drugs in the same class.

This FDA contention was explored in a recent issue of The Medical Letter, a physician publication with no drug advertising. It concluded that there is no good evidence that any one of the statin drugs is less likely than any other to cause rhabdomyolysis. The risk, though rare, appears to increase with higher doses of statins, and may be greater in patients with renal failure, according to The Medical Letter. Doctors are advised to tell their patients to promptly report unexplained muscle pain, tenderness or weakness, especially if they are taking a statin and gemfibrozil (another anti-cholesterol drug) together.

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Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.

COPYRIGHT 2001 Center for Medical Consumers, Inc.
COPYRIGHT 2001 Gale Group

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