Anti-Bleeding Drug Trasylol Linked to Increased Risk of Death, Kidney Failure, Congestive Heart Failure, and Stroke.

February 21, 2008—The results of two new studies published this week in the New England Journal of Medicine show an increased risk of death for heart patients given the anti-bleeding drug Trasylol (aprotinin injection). Trasylol, which has been on the market for 14 years, was used during cardiac bypass surgery to reduce blood loss and decrease the need for blood transfusions. Trasylol manufacturer, Bayer Pharmaceuticals, has come under scrutiny by the U.S. Food and Drug Administration (FDA) for not sharing data on the risks associated with Trasylol use.

One Thousand Lives a Month

The release of these two new Trasylol studies comes on the heels of a 60 Minutes interview with medical researcher Dr. Dennis Mangano, which aired Sunday, February 17, 2008. Dr. Mangano conducted the largest ever Trasylol study, which included 5,065 patients in 17 countries. The study, published in the New England Journal of Medicine in January 2006, revealed that patients treated with Trasylol have twice the rate of kidney failure and an increased risk of heart attacks, heart failure, strokes and encephalopathy.

At a public meeting held on September 21, 2006 regarding the safety and effectiveness of Trasylol, the drug's manufacturer failed to disclose to the FDA the data from its own Trasylol study that confirmed Mangano’s study results. The Bayer study examined 67,000 hospital records of patients undergoing coronary artery bypass graft surgery. About half those patients were treated with Trasylol, while the other half was treated with alternate drugs. The study suggested that the patients who received Trasylol were at increased risk for death, kidney failure, congestive heart failure, and stroke.

In Sunday’s 60 minutes report Mangano stated that the FDA should have pulled Trasylol from the market in January 2006, after the release of his study; instead the drug remained on the market until November 2007. Between that time approximately 431,000 patients received the drug. According to Mangano, 22,000 lives (1,000 per month) could have been saved if the drug was taken off the market in January 2006.