American Heart Association Advisory: Bayer Suspends Marketing of Aprotinin (Trasylol) at FDA Request

DALLAS, Nov. 5 /PRNewswire-USNewswire/ -- On Monday the FDA announced that Bayer Pharmaceuticals Corp. has voluntarily agreed to stop marketing aprotinin (Trasylol) due to concerns raised by a Canadian study and other investigations that suggest there may be an increased risk for death with its use. The drug is approved for use to control excessive bleeding during heart surgery in patients at particular risk for this complication.

"The American Heart Association supports the FDA in calling for the suspension of marketing of Trasylol, based on patient safety concerns raised by preliminary results of a Canadian study," said Timothy Gardner, M.D., American Heart Association president-elect.

Since 2006, clinical experience and observational studies have questioned the safety of the aprotinin. The most robust evidence to date has been collected through a randomized clinical trail called the Blood Conservation Using Antifibrinolytics: A Randomized Trial in a Cardiac Surgery Population (BART) study, funded by Bayer and conducted in Canada. This trial was suspended in October 2007 after preliminary review by its data safety committee appeared to identify an increased risk of death with the use of the drug. Although effective in controlling perioperative bleeding, subjects receiving the drug in this study had an increased risk of death, the immediate cause of which is under more detailed analysis.

Many types of cardiovascular surgery, including coronary artery bypass grafting (CABG) and heart valve replacement, have the potential for serious bleeding. Some patients having these operations may be at higher individual risk. Excessive bleeding remains a major risk factor in all surgeries.

Trasylol (aprotinin) is an anti-fibrinolytic agent that helps prevent breakdown of the clots that stop bleeding and is the newest type of drug for controlling such bleeding. Although many practitioners previously aware of safety concerns regarding Trasylol may have already stopped using the drug, Bayer plans to work through regulatory agencies to make it available for patients who meet strict usage criteria. This may also help mitigate potential shortages in the availability of alternative anti-fibrinolytic medications.

FDA News:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html

Early Safety Information:

http://www.fda.gov/cder/drug/early_comm/aprotinin.htm

Bayer Pharmaceuticals Information:

http://www.pharma.bayer.com/en/home/article/1060008165777/1193772934558/00.html