Bayer kept Trasylol safety study hidden from FDA

Just days after an FDA advisory committee recommended against adding new warnings on the controversial heart surgery drug Trasylol, the German drug giant Bayer announced that it had not revealed new study data that indicated the drug--designed to prevent bleeding during surgery--was linked to elevated risks of kidney damage, increased risk of stroke, congestive heart failure and death. In a prepared statement, Bayer said that it had "mistakenly" not included data drawn from the evaluation of 67,000 hospital records. It made the announcement after the scientist in charge of the study asked the company to unveil the data. Bayer had contracted with the data mining company Ingenix to look at the records. The drug maker says the data was preliminary and that the study raised serious questions about its methodology, but should have been made available to the FDA. Bayer says it will investigate the incident and take action. The agency is particularly sensitive to safety data following two years of harsh accusations that it has been lax in safeguarding the public from dangerous drugs like Vioxx.

- read the report on the controversy from Forbes

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