Thirty states on Monday reached an $8 million settlement agreement with Bayer regarding allegations that the drug company failed to adequately warn consumers about risks associated with its cholesterol-reducing drug Baycol, the AP/Winston-Salem Journal (AP/Winston-Salem Journal, 1/24). Connecticut Attorney General Richard Blumenthal (D) said the company learned after introducing Baycol in the U.S. in May 1998 that the drug posed considerably greater health risks than similar drugs, especially when taken in higher doses or in combination with another cholesterol-lowering drug. Bayer informed FDA about the drug's elevated risks but did not sufficiently warn consumers or physicians about potential problems, including a severe and potentially fatal muscle reaction that could cause kidney failure, Blumenthal said. Bayer voluntarily withdrew Baycol from the market in August 2001 (Hartford Courant, 1/24). Bayer has not admitted any wrongdoing but has agreed to register relevant clinical drug trials and study results online (AP/Winston-Salem Journal, 1/24). The company also is prohibited from making false or misleading claims in future marketing and sales of its products. The company must pay $8 million to the 30 states for future consumer protection and enforcement programs. The settlement includes Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin (AP/Chicago Sun-Times, 1/24).
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Publication Date: 2007-01-26 16:00