Bayer admits failure to discolose Trasylol risks

Paul Kiesel

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German drug manufacturer Bayer failed to notify the FDA of increase risks of death, serious kidney damage, congestive heart failure and strokes associated with taking the drug Trasylol.

In yet another example of the Pharmaceutical industry's failure to provide complete information, Bayer acknowledged, this week, it "mistakenly" failed to notify the Federal Drug Administration (FDA) about increased risk of death, serious kidney damage congestive heart failure and strokes associated with their drug Trasylol. It is hard to imagine the series of "mistakes" made by the pharmaceutical industry in trying to peddle their drugs without adequately informing patients of their risks. Recently the FDA has come under scrutiny for their failure to have the resources necessary to adequately police the drug industry. Bayer attempted to downplay their failure by suggesting the study's methodology and findings, which demonstrated the increase risks, we're merely preliminary.

The Food and Drug Administration said the early findings from a new review of hospital records from 67,000 patients suggested that Trasylol use might increase the chances of death, serious kidney damage, congestive heart failure and strokes.

The FDA said it was reviewing the data to decide how they would affect current advice to limit Trasylol use to cases in which doctors believe that reducing blood loss during bypass surgery is essential and outweighs possible risks.