Trasylol

Details

Product: Trasylol
Manufacturer: Bayer AG

Trasylol Removed From U.S. Market Due to Increased Risk of Kidney Failure and/or Death

A study reported January 25, 2006, in the New England Journal of Medicine shows that Trasylol is linked to serious, life-threatening side effects. The study of 4,374 patients demonstrated that Trasylol at least doubles the risk of kidney failure and stroke, or encephalopathy, and raises the risk of heart failure or heart attack by 55 percent. The study estimates that as many as 10,000 patients may now be on dialysis due to kidney failure after cardiac bypass surgery where they were administered trasylol. In the study, data was collected from more than 4,300 patients undergoing revascularization surgery at more than 69 centers around the world between 1996 and 2000. The patients received either Trasylol, aminocaproic acid, tranexamic acid or no treatment.

On November 5, 2007, Bayer AG, the manufacturer of Trasylol, suspended sale of the antibleeding drug from the U.S. market. The suspension came amid findings from a Canadian clinical trial that appear to link Trasylol to an increased risk of death as compared to the risk from other drugs. (Source: Anne Wilde Matthews, “Bayer Halts U.S. Sale of Trasylol,”WSJ.Com, November 5, 2007.)

While Trasylol is only approved for specific heart surgeries, it is commonly used for other surgeries including orthopedic procedures. Worldwide, approximately 1 million people per year have coronary artery bypass graft surgery, with nearly 2/3 of them given Trasylol during the procedure.


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