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Dangerous Practices

Critics see flaws in drug-safety monitoring

1:30pm, January 31, 2005

It was the best of statins, it was the worst of statins. The anticholesterol drug cerivastatin, sold under the brand name Baycol, was the most potent medicine in its class in the late 1990s. In 2001, however, it was ripped from the marketplace after being linked to an unusually high incidence of a rare, but sometimes deadly, side effect. In certain respects, the compound's meteoric career portended the recent deluge of bad news about one drug after another.

Baycol, made by Bayer of Leverkusen, Germany, appeared safe enough in the manufacturer-funded studies that the Food and Drug Administration considered before approving it for prescription use in the United States. In clinical trials, researchers had specifically looked for certain

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