Bayer Discloses Trasylol (aprotinin) Trials Not Disclose Facts

On September 29, 2006, as reported in Yahoo, German-based Bayer acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid, and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the FDA because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. Bayer has submitted a copy of the preliminary Trasylol report to the FDA and has notified other regulatory authorities.

FDA Statement Regarding New Trasylol Data

Since January 2006, the FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: One study reported an increase in the chance of kidney failure, heart attack, and stroke in patients treated with Trasylol compared to those treated with other similar drugs. The second study reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.

While the FDA is conducting its study based on new Trasylol data, they recommend physicians who use Trasylol should carefully monitor patients for the occurrence of kidney, heart, or brain toxicity and promptly report observed adverse event information to the FDA MedWatch program. Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.