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I have dedicated my law practice for the last 25 years to the wrongfully injured and their families. The purpose of this blog is not to provide legal advice. If you need legal help you can contact me at cplacitella@cprlaw.com or visit our website at www.cprlaw.com. Thank You

Friday, October 20, 2006

F.D.A. Says Bayer Failed to Reveal Drug Risk Study - New York Times: "F.D.A. Says Bayer Failed to Reveal Drug Risk Study
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By GARDINER HARRIS
Published: September 30, 2006
WASHINGTON, Sept. 29 — Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.
Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.
In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said."

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