Several recent stories reported that the Bayer Corp. has voluntarily removed a popular cholesterol drug, Baycol, off the market after it has been linked to as many as 40 deaths. One such article appearing on the August 8, 2001 MSNBC website said that the drug was taken by 700,000 Americans, and was pulled off the market because of muscle destruction linked to at least 40 deaths around the world.
According to a similar story in the August 9, 2001 New York Times Health section, the United States Food and Drug Administration "agrees with and supports this decision," the agency said. It said pharmacists would be instructed to return the drug to Bayer for refunds. The F.D.A. approved Baycol for use in the United States in 1997. It should be noted that no where in the reports does it say that the FDA has removed its approval for Baycol.
Baycol was in a class of drugs called "Statins". "All statins have been linked to muscle cell damage in rare cases, but the problem is much more common with Baycol than with other such drugs," said Dr. John Jenkins, the director of the office of drug evaluation at the F.D.A. The Times article states, "From the beginning, medical experts said, statins were known to cause the muscle problem, rhabdomyolysis, which can lead to kidney failure and other problems. But it occurred very rarely and was almost never fatal." With Baycol, however, reports of serious rhabdomyolysis were about 10 times as frequent as with the other statins, Dr. Jenkins said.
Lawsuits have begun to appear following the drug being removed from the market. According to the website DrKoop.com, a Tallahassee, Florida woman has sued Bayer Corp., claiming its recently recalled cholesterol drug, Baycol, caused her to suffer muscle degeneration and chronic fatigue. Separately the Chicago-based law firm of Kenneth B. Moll & Associates said it plans to file a class action lawsuit against Bayer in Cook County, Illinois, on behalf of all patients who were prescribed Baycol. The law firm, which estimates that about 6 million people worldwide have taken the drug, said the suit will seek among other things the establishment of a medical monitoring fund "to enable people that have taken Baycol to monitor the existence of dangerous side effects."