Back to Trasylol®

The Food and Drug Administration (FDA) is evaluating new data on Trasylol® (aprotinin) from a study that Bayer failed to provide earlier.

The FDA also reiterated a warning to physicians it issued in February of 2006.

Trasylol® data from two publications indicated the drug, which is used to control bleeding during coronary artery bypass grafting surgery, may increase the risk of kidney failure, stroke, and heart attack.

Bayer officials said it mistakenly did not inform the FDA about the new Trasylol® study, describing the study's data as preliminary. Despite the data being preliminary, Bayer added it should have shared the Trasylol® data before a September 21st FDA meeting.

The FDA also said doctors who use Trasylol® during heart surgery should watch for signs of toxicity, particularly to the kidneys, heart, or central nervous system.

The agency also requested doctors report adverse Trasylol® events to the FDA and Bayer.

Trasylol® was approved by the FDA in 1993 for use during heart surgery.

Reference:

"FDA Reiterates Trasylol Warning," eMaxHealth, October, 2006.