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Cholesterol-Lowering Drug Linked to 40 Deaths

© Maggie Herman

Bayer A.G. has announced plans to pull its cholesterol-lowering drug cerivastatin, sold under the trade name Baycol, after the drug was linked to 40 deaths worldwide, 31 of which occurred in the United States. Twenty-nine of the 31 U.S. fatalities were associated with kidney failure, a common side effect of a disease called rhabdomyolysis.

Baycol is part of a class of drugs known as statins that works to lower cholesterol levels by blocking enzymes that the body uses in cholesterol synthesis. According to the Food and Drug Administration (FDA), all statins carry a risk of myositis and rhabdomyolysis—both forms of muscle deterioration—the risk of these diseases is 10 times higher in persons taking Baycol than those taking other statins. Other statins include atorvastatin, sold as Lipitor; fluvastatin, sold as Lescol; lovastatin, sold as Mevacor; pravastatin, sold as Pravachol; and simvastatin, sold as Zocor. In addition, rhabdomyolysis can occur when statins are taken with several other medications, including warfin, used to prevent blood clotting; ketoconzole, an antifungal drug; and clarithromycin, an antibiotic.

The National Cholesterol Education Program reports that one in 1,000 statin users suffer from rhabdomyolysis. Rhabdomyolysis, and its more minor form—myositis, occurs when muscle tissue deteriorates and the cells are released into the bloodstream. It is a potentially fatal condition that can result in kidney and liver failure and is marked by the following symptoms: muscle pain, most commonly in the calves and lower back; weakness; fever; dark urine; nausea; and vomiting.

Of the deaths associated with Baycol use, the following appear to be risk factors: use in conjunction with gemfibrozil and higher-dosage prescriptions. Gemfibrozil is a drug, sold under the trade name Lopid, in the fibrate class that is typically prescribed to lower blood triglyceride levels. Twelve of the Baycol deaths, about one-third, were linked to this use. Bayer reports that its warning labels advised physicians against prescribing both Lopid and Baycol together because the drug manufacturer knew of this heightened risk In addition, Bayer has indicated that the drug, while virtually being withdrawn from the world market, will remain available in Japan, where Lopid is unavailable. Public Citizen (PC), a national non-profit consumer group, was critical of Bayer's decision with respect to Japan, noting that more than half of the deaths were neither associated with high-dose or Lopid use. With respect to the high-dosage risk, the higher dosage prescription of the drug was banned previously in the United Kingdom due to health concerns. According to a report published in The Washington Post, also indicated that older users and women may face increased risks.

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