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Trasylol® data withheld from the Food and Drug Administration (FDA) that showed deadly side effects has caused Bayer to suspended two employees.

Bayer is currently investigating why a study showing that Trasylol® can increase the risk of kidney damage, heart failure, stroke, and death was not disclosed at a recent meeting with the FDA. Bayer did not make the study public until more than a week after the meeting.

Trasylol® (aprotinin) is the only FDA approved drug used to reduce blood loss during coronary artery bypass grafting surgery (CABG).

Preliminary investigations show there was a serious error in judgment made by two senior members of the Bayer's global drug safety group. The two employees have since been suspended.

Bayer also said it retained a law firm to conduct an independent investigation of the decision to withhold the Trasylol® data. The company also said it will publish the findings when the investigation is closed.

The FDA has been reassessing the safety of Trasylol® since February, when two separate studies suggested the drug was linked to kidney problems, stroke, and heart attack.

More than 600,000 people worldwide were treated with Trasylol® in 2005, according to Bayer.

If you or someone you know has undergone a coronary artery bypass grafting surgery and subsequently developed the onset of kidney failure, please use the form on the left to contact our law firm.

Reference:

"Bayer Suspends 2 Over Trasylol Data," AP, Matthew Perrone, October 2006.