Originally used to reduce bleeding during complicated surgery, Trasylol was recalled by manufacturer Bayer in 2007 and permanently withdrawn in 2008
On January 26, 2006, The New England Journal of Medicine (NEJM) published an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious renal toxicity, myocardial infarction and stroke in patients undergoing coronary artery bypass grafting surgery.
On February 8, 2006, the Food & Drug Administration (FDA) issued a Public Health Advisory noting that it was evaluating the NEJM study, along with other studies and adverse affect reports submitted through its MedWatch voluntary reporting program. Physicians were advised to carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or to the FDA MedWatch program. Physicians also were advised to limit Trasylol use.
On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.
FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006. The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.
In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks” and carefully monitor patients.
On October 29, 2006 the Food and Drug Administration issued a warning that aprotinin may have serious kidney and cardiovascular toxicity. The producer, Bayer, reported to the FDA that additional observation studies showed that it may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
December 15, 2006, the FDA approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. The labeling changes for Trasylol are based on the recommendations of the September 2006 advisory committee.
On November 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.
On May 14, 2008, the FDA announced Bayer had removed all remaining stocks of Trasylol from distribution in the U.S., and would limit access to the product to investigational use. The limited use agreement protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
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If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.
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