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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 addition, due to the higher risk for anaphylactic reactions, re-administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated. [UPDATED 09/29/2006] FDA held a public advisory committee meeting September 21, 2006 to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing ... Read more

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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 based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery ... Read more

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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 and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death. FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions. Healthcare professionals who are considering use of ... Read more

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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 Trasylol posed a higher risk of death for patients than other anti-bleeding drugs, called lysine analogues. While Trasylol was somewhat more effective at controlling blood loss and transfusions than lysine analogues, its higher risk of death and significantly higher price are deterrents to its use, said the authors. They recommended tranexamic acid or aminocaproic acid as alternatives to prevent blood loss during surgery. "Lysine analogues are almost as effective as aprotinin in controlling blood ... Read more

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