Deaths Lead to Withdrawal of Cholesterol Drug

The U.S. Food and Drug Administration (FDA) has announced that Bayer Pharmaceutical Division (a division of Bayer AG, Leverkusen, Germany) is voluntarily withdrawing the lipid-lowering drug cerivastatin (Baycol) from the market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from the drug. The FDA agrees with and supports this decision.

Fatal rhabdomyolysis has been reported most frequently when used at higher doses, when used in elderly patients, and particularly when used in combination with gemfibrozil, another lipid-lowering drug. The FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with the drug's use, 12 of which involved comcomitant gemfibrozil use.

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. In rare cases, the muscle injury may be so severe that patients develop renal failure and other organ failure, which can be fatal.

Bayer has announced plans to recall cerivastatin to pharmacies, which will be instructed to return the product to Bayer for a refund. Patients who are taking the drug should consult with their doctor about switching to other statin drugs or other medications to control their cholesterol levels. Patients who are experiencing muscle pain or are also taking gemfibrozil should discontinue the cerivastatin immediately and consult their doctor.




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