Back to Trasylol®

The Food and Drug Administration (FDA) recently approved revised labeling for Trasylol® (aprotinin) to strengthen its safety warnings and to limit its usage. Trasylol® is given to patients before coronary artery bypass grafting (CABG) surgery to reduce bleeding and the need for blood transfusions.

"The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol® and to ensure they understand the new warnings and use the product as directed by the label," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

The new labeling states that Trasylol® should only be given to patients who are at an increased risk for blood loss and blood transfusion during CABG surgery. The label changes also include a warning that Trasylol® increases the risk for kidney damage and suggests ways to reduce the patient's risk for hypersensitivity reactions.

Trasylol® labeling changes follow a FDA review of safety information that became available after the product went to market. The review of aprotinin was triggered by the results of two published research studies.

One study reported an increase in the possibility of kidney failure, stroke, and heart attack in patients treated with Trasylol® compared to those treated with other medications. The other study reported an increase in the possibility of kidney damage compared to other drugs.

On September 21, 2006, the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety of Trasylol®. At that meeting, the committee discussed the findings from the two published studies and made recommendations for labeling changes. The labeling changes for Trasylol® are based upon the recommendations of that advisory committee.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006. The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol® may increase the chance for death, strokes, and congestive heart failure. The FDA review of this additional Trasylol® study is continuing and it may result in other actions.

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:

"FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations," FDA, December 2006.