Dangerous Drug Recalled: Baycol

Generic name: Cerivastatin (category known as “statins”)

Manufactured and marketed by: Bayer AG

Purpose: It is prescribed to those who suffer from high cholesterol levels. Studies have indicated that high levels of cholesterol may be a major contributing factor to the cause of cardiovascular disease.

Recall: In 2001, Bayer voluntarily withdrew Baycol from the market after the FDA received reports of 31 deaths associated with the side effect of rhabdomyolysis in patients. Research shows that while all drugs in the statin class carry the risk of rhabdomyolysis, the number of Baycol users who were stricken with rhabdomyolysis appeared to be much higher when compared to the number of patients who were prescribed other statins on the market.

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Side Effects Reported

• Similarly to other drugs in the statin class, some takers of Baycol have developed severe muscle damage and a condition called rhabdomyolysis.
• Rhabdomyolysis entails the breaking down of muscle tissue, which can release high levels of chemicals into the bloodstream. This condition could lead to kidney failure and is potentially fatal.
• Patients who take statins should be mindful of the symptoms of rhabdomyolysis, which may include muscle pain, weakness, fever, dark urine, nausea, and vomiting.

Industry Report

The increased risk of rhabdomyolysis from Baycol was even higher amongst elderly patients and those patients who were taking larger doses of Baycol. An elevated risk also existed for those patients who were prescribed gemfibrozil, a lipid-regulating drug marketed by Pfizer as Lopid, while also taking Baycol. After Baycol was withdrawn from the market by Bayer, physicians were advised to move their patients onto one of the other statins still available on the market which posed a lower risk of developing rhabdomyolysis.

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