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FDA: Bayer Hid Negative Study On Surgery Drug

Law360 (October 2, 2006, 12:00 AM EDT) -- The U.S. Food and Drug Administration said Friday that pharmaceutical company Bayer Pharmaceuticals failed to inform the agency of a study it conducted that showed its heart surgery drug, Trasylol, may endanger people’s health.

Bayer acknowledged the omission, and said it was a mistake. The information, it said, was “not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology.”

Since January, the FDA has been conducting a safety review of Trasylol because of...
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