Drugs
Aprotinin Injection (marketed as Trasylol) Information
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This product is not currently available for purchase in the U.S.
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[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.
Historical Information
- Manufacturer Removes Remaining Stocks of Trasylol
5/14/2008 - FDA Requests Marketing Suspension of Trasylol
Issued 11/5/2007 - November 5, 2007 Transcript of FDA Press Conference on Trasylol (PDF - 23KB)
7:30 a.m. conference - November 5, 2007 Second Transcript of FDA Press Conference on Trasylol (PDF - 35KB)
11:45 a.m. conference - FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations
12/15/2006 - FDA Statement Regarding New Trasylol Data
9/29/2006 - FDA Issues Public Health Advisory for Trasylol
2/8/2006
Related Information
- Early Communication about an Ongoing Safety Review on Aprotinin Injection (marketed as Trasylol)
10/25/2007 - Information for Healthcare Professionals Aprotinin Injection (marketed as Trasylol) text version
FDA ALERT [2/2006, Updated 9/2006 and 12/2006] - Information for Healthcare - Professionals Aprotinin (marketed as Trasylol) 9/2006
FDA ALERT [9/2006] - Public Health Advisory: Aprotinin Injection (marketed as Trasylol)
9/29/2006, Updated 11/5/2007 - Public Health Advisory: Aprotinin Injection (marketed as Trasylol) 5/2008
5/2008 - Questions and Answers on Aprotinin (marketed as Trasylol)
- Regulatory History of Aprotinin from Drugs@FDA
Regulatory History of Aprotinin
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