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U.S. Department of Health and Human Services

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Aprotinin Injection (marketed as Trasylol) Information

This product is not currently available for purchase in the U.S.

[UPDATE 5/14/2008]: Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals, the manufacturer of Trasylol (aprotinin), notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.  [See FDA Statement].  Because Trasylol has been shown to decrease the need for red blood cell transfusions in patients undergoing coronary artery bypass surgery, future supplies of Trasylol will continue to be available through the company as an investigational drug under a special treatment protocol.   In November 2007, Bayer suspended the marketing of this drug until final results of the BART study became available.  The BART study showed an increase in the risk of death with Trasylol compared with aminocaproic acid and tranexamic acid, consistent with findings from other recent studies.   FDA will be reviewing these data and will reassess the status and access to the product once the review is completed.

 

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