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Cooper announces settlement over Bayer cholesterol drug

Release date: 1/24/2007

Raleigh: Attorney General Roy Cooper today announced an $8 million settlement with Bayer Corporation over its marketing of Baycol, a drug used to lower cholesterol that was withdrawn from the market on August 7, 2001.

The settlement is part of a 30-state consumer protection enforcement action brought by Cooper and the other attorneys general because of concerns that Bayer did not adequately disclose safety problems associated with the drug.

“Drug makers need to be straight with people about risks and side-effects,” Cooper said. “Consumers and their doctors should have all of the information they need to choose a medication that will make them better, not sicker.”

Under the judgment filed today in Wake County Superior Court, Bayer must now make public the results of most of its clinical studies instead of picking and choosing which results to share. This will help healthcare providers and patients get more complete information about the risks and benefits of prescription drugs. Bayer is also barred by the settlement from making false and misleading claims about its products and must comply with the law in the marketing, sale and promotion of its drugs. In addition, Bayer will pay a total of $8 million to the states, including $200,000 to North Carolina.

In May of 1998, Bayer introduced Baycol, a “statin” cholesterol-lowering drug, in the United States. All statin drugs carry the known risks of causing a weakening of the muscles and the more serious muscular disease rhabdomyolysis which can cause kidney failure. Bayer learned that these risks turned out to be significantly higher with Baycol compared to other statins, particularly at higher doses and when combined with another cholesterol-lowering drug called genfibrozil.

Cooper and the other attorneys general allege that while Bayer informed the US Food and Drug Administration about these adverse effects, it failed to adequately warn consumers and their doctors.

On August 7, 2001, Bayer voluntarily withdrew Baycol from the market.

Along with North Carolina, states participating in the settlement are Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin.