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Trasylol News

FDA Medwatch Alert: Trasylol (aprotinin)

Posted 8 Feb 2006 by

[UPDATED 12/15/2006] FDA and Bayer Pharmaceuticals notified healthcare professionals of revisions to the prescribing information for Trasylol. The new labeling has a more focused indication, a new Warning that Trasylol administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period, and stronger warnings about anaphylactic reactions. In ...

FDA Medwatch Alert: Trasylol (aprotinin injection)

Posted 5 Nov 2007 by

[Posted 11/05/2007] FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety ...

FDA Medwatch Alert: Aprotinin Injection (marketed as Trasylol)

Posted 25 Oct 2007 by

[Posted 10/25/2007] FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid ...

Another Study Warns of Risk From Cardiac Surgery Drug

Posted 2 Dec 2008 by

TUESDAY, Dec. 2 – A new study casts more doubt on the safety of the drug Trasylol (aprotinin), used to limit bleeding in patients undergoing surgery. Trasylol is already the subject of controversy in the United States, where it was removed from the market in 2007. In the new study, Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. They concluded that ...

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