Baycol (cerivastatin) is made by Bayer Pharmaceutical Division.

On August 8, 2001 , the FDA (Baycol info. page) today 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.

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.

Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

Baycol, which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund.

Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil shoulddiscontinue Baycol immediately and consult their physician.

Baycol Links

MDL 1431 — Baycol Product Liability Litigation

Federal Court Orders Expedited Case Management Schedule in Baycol Products Litigation, MDL 1431

CNN.com — Bayer: Baycol anti-cholesterol drug linked to 52 deaths

Bayer Facing 7400 Baycol Suits

Cholesterol drug damaged woman, she says

Bayer Facing 7400 Baycol Suits

Bayer faces more suits

Germany's Bayer Faces Drug Lawsuits

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