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Marketing of Trasylol Suspended

Posted on April 29, 2008

Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given Trasylol experience fewer serious bleeding events, they may also have a greater risk of death than patients taking either of two other antifibrinolytic drugs.

Sales of Trasylol will be suspended until FDA can conduct a thorough analysis of the study and gain a better understanding of the risks and benefits of the drug. Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA is working with Bayer to gradually phase Trasylol out of the marketplace so that it doesn't cause shortages of other drugs used for this purpose.

FDA is also exploring ways that physicians may continue to have access to Trasylol in specific cases where the benefits of the drug outweigh the risks.

Additional Information:

FDA MedWatch Safety Alert. Trasylol (aprotinin injection). November 5, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol

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