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Sunday, October 1
Bayer says mistakenly failed to disclose drug data [MORE Reuters.com]
WASHINGTON (Reuters) - German drug maker Bayer AG "mistakenly" failed to inform U.S. regulators about a study on the risks of heart-surgery drug Trasylol before an advisory panel met and ruled the side effects were acceptable, the company said on Friday. The Food and Drug Administration said the early findings from a new review of hospital records from 67,000 patients suggested Trasylol use may increase the chances of death, serious kidney damage, congestive heart failure and strokes. The agency said it was reviewing the data to decide how they would impact current advice to limit Trasylol use to cases in which doctors believe reducing blood loss during bypass surgery is essential and outweighs possible risks..... |