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Bayer Agrees to Strengthen Baycol Warnings

January 24, 2007

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In a settlement with 30 states, Bayer has agreed to more prominently warn patients and doctors about the dangers of Baycol, its prescription painkiller.

The consent order requires Bayer to register most of its clinical studies and then post the results at the end of each study.

This clinical trial registry will give physicians, consumers and researchers access to more information on the efficacy of the drugs, type and severity of side effects, goals of treatment, and timing and reasons for termination of clinical trial studies.

"Prescribers and patients need to know about adverse side effects of prescription medications. This settlement will ensure that everyone has the necessary information to make the best decision when prescribing and taking medication," said Maryland Attorney General Douglas F. Gansler.

The judgment also orders Bayer's future compliance with the law in the marketing, sale, and promotion of its pharmaceutical and biological products, and prohibits Bayer from making false and misleading claims relating to any such product sold in the United States. In addition, Bayer will pay a total of $8 million to the 30 participating states.

The complaint contends that Bayer Corporation failed in its marketing to adequately disclose safety risks associated with Baycol, a statin drug used to lower cholesterol that was withdrawn from the market on August 7, 2001. All statins carry a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease).

Bayer learned that the risk for Baycol was significantly higher compared to other statins, particularly at higher doses and when combined with genfibrozil, another cholesterol-lowering drug. It was charged that while Bayer informed the U.S. Food and Drug Administration about these adverse effects, it failed to adequately warn prescribers and consumers about them. Bayer denied any wrongdoing.

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