News

Bayer decides to withdraw cholesterol lowering drug

Fred Charatan, Florida

Cerivastatin (Baycol in the United States, Lipobay in the United Kingdom), a cholesterol lowering drug made by Bayer Corporation and initially approved in the US in 1997, has been withdrawn by the manufacturer. There have been 31 deaths in the US from severe rhabdomyolysis in patients taking the drug. Twelve patients were taking concomitant gemfibrozil, which lowers blood concentration of triglycerides.

Rhabdomyolysis, a serious and potentially fatal adverse effect of all statin (cholesterol lowering) drugs, is about 10 times more common with cerivastatin than with other statins, according to Dr John Jenkins, director of the office of drug evaluation at the US Food and Drug Administration (FDA).

Fatal rhabdomyolysis after cerivastatin treatment has been reported most frequently when the drug is given at high doses, when it is used in elderly patients, and particularly when it is prescribed with gemfibrozil.

In a letter to health professionals dated 8 August 2001, Bayer said that its data indicated "an increased reporting rate of rhabdomyolysis at the 0.8 mg dose of Baycol alone." The FDA agreed with and supported Bayer's decision to withdraw cerivastatin from the US market.

In a "Talk Paper" the FDA wrote: "Patients who are taking Baycol should consult with their physicians about switching to alternative medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.

"There are five other statins available in the US that may be considered as alternatives to Baycol. They are: lovastatin (Mevacor), prevastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor)."

The United Kingdom's Medicines Control Agency has issued similar advice that patients who are currently taking cerivastatin should change treatment when their next prescription is due. Doctors should recall for review any patients taking cerivastatin with gemfibrozil. Any patient being treated with cerivastatin who feels unwell, particularly with fever or muscle pain, should seek medical advice, the agency says.

Meanwhile the European Agency for the Evaluation of Medicinal Products has announced that it plans to review all other cholesterol lowering drugs, as a precautionary measure.