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After Vioxx, Trasylol : FDA under the scanner again.

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F.D.A. Says Bayer Failed to Reveal Drug Risk Study

 

 

By GARDINER HARRIS

http://www.nytimes.com/2006/09/30/health/30fda.html?_r=1 & th & emc=th & oref=login

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.

 

 

"Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo.

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