Trasylol

Trasylol is now indicated for use only in patients who are at increased risk for blood loss and blood transfusion in association with cardiopulmonary bypass in the course of coronary artery bypass grafting. It should be administered only in the operative setting where cardiopulmonary bypass can be rapidly initiated.

If you've taken Trasylol^®, you may be entitled to monetary compensation. Call Walker & Walker Attorney Network at 1-800-THE-LAW2 (1-800-843-5292) for your free consultation. Or fill out the FREE CONSULTATION box on the left of this page now.

Brand Names:

• Trasylol^®

Source: U.S. Food and Drug Administration,“Aprotinin Injection (marketed as Trasylol) Information", Drug Information, 2006, http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm (30 May 2007)

Warnings:

As of 2/8/2006 FDA issued a public health advisory and other advisory information to notify both healthcare professionals and consumers of recently published studies of serious renal and cardiovascular toxicity following Trasylol^® administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that Trasylol^® may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) has reported that Trasylol^® administration may increase the risk for renal toxicity.

As of 9/29/2006 the 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 database. On September 27, 2006, Bayer told FDA that it had conducted an additional safety study of Trasylol^®. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol^® may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

Source: U.S. Food and Drug Administration,"Trasylol (aprotinin)", The FDA Saftey Information and Adverse Event Reporting Program, 2006, http://www.fda.gov/medwatch/safety/2006/safety06.htm (30 May 2007)