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Several recent stories reported that Bayer Corp. has voluntarily removed its popular cholesterol drug, Baycol, from the market after it was linked to as many as 40 deaths. One such article, appearing on the August 8, 2001, MSNBC website, stated that the drug, taken by 700,000 Americans, was pulled off the market due to muscle destruction linked to at least 40 deaths around the world.

A similar story in the August 9, 2001, New York Times Health section noted that the U.S. Food and Drug Administration (FDA) “agrees with and supports this decision.” The agency said pharmacists would be instructed to return the drug to Bayer for refunds. The FDA approved Baycol for use in the United States in 1997. It is important to note that nowhere in the reports does it state that the FDA has removed its approval for Baycol.

Baycol was part of a class of drugs known as “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 FDA. The Times article also stated, “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 more frequent than with other statins, Dr. Jenkins said.

Lawsuits have already begun following the drug’s removal from the market. According to the website DrKoop.com, a Tallahassee, Florida, woman has sued Bayer Corp., claiming that 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 stated that 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 who have taken Baycol to monitor the existence of dangerous side effects.”