Bayer Voluntarily Withdraws Statin After 31 Deaths
Prompted by 31 deaths linked to use of the cholesterol-lowering drug Baycol, Bayer AG announced yesterday that it is voluntarily withdrawing the drug from the world market, the New York Times reports. The drug, a statin, apparently caused an "unusual condition" -- rhabdomyolysis -- in which muscle tissue breaks down (Kolata/Andrews, New York Times, 8/9). In the United States, more than 700,000 people take Baycol, which was approved by the FDA in 1997 (Willman, Los Angeles Times, 8/9). Patients with an increased risk for rhabdomyolysis were those taking Baycol in combination with another drug called Lopid, as well as those taking a 0.8 milligram dose of Baycol. The FDA has advised those patients to stop taking Baycol. Before and after the first known death linked to Baycol, Bayer had warned doctors against prescribing Baycol with Lopid and advised that patients begin taking a low dose -- 0.4 milligrams -- of the drug. However, the Washington Post reports that some deaths did occur among those patients taking the lower dose (Brown, Washington Post, 8/9). Bayer voluntarily approached the FDA in 1999 with a proposal to warn against prescribing Baycol in combination with Lopid, which lowers a fatty substance in the blood. This April, Bayer again approached the FDA after additional fatalities from the drug occurred, and in June, the drug's labeling was changed to warn doctors of the risk of prescribing high doses of the medicine. Despite being taken off the worldwide market, Baycol will still be available in Japan, where neither the higher dose of the drug nor Lopid is used.
Rhabdomyolysis is a risk for patients taking any kind of statin, including Mevacor, Prayachol, Zocor, Lescol and Lipitor. But in a statement released yesterday, the FDA said that deaths from rhabdomyolysis were reported "significantly more frequently" for Baycol than for other available statins (Willman, Los Angeles Times, 8/9). John Jenkins, director of the FDA's office of drug evaluation, said, "We are not considering any regulatory action with regard to the other approved statins" (Washington Post, 8/9).Cardiologist Sidney Smith, chief science officer at the American Heart Association, added that statins "have an impressive record of safety" and are "known to save lives" (Fuhrmans/Harris, Wall Street Journal, 8/9). But Dr. Sidney Wolfe of Public Citizen said his organization would prepare a petition to urge the FDA to impose new safety warnings for statins. Daniel Sigelman, former counsel to the House Subcommittee on Human Resources and Intergovernmental Relations during the 1980s, added, "This underscores the urgent need for Congress to resume investigations of FDA's efforts to protect the public from unsafe drugs. Regrettably, for many years now, Congress has abdicated its responsibility here." Baycol is the 12th prescription drug in the last four years to be withdrawn for safety reasons (Los Angeles Times, 8/9).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.