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.
|
