Trasylol (Aprotinin)

New studies have shown an increased risk of death for heart patients given the anti-bleeding drug Trasylol (Aprotinin). 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.

Bayer Pharmaceuticals, the manufacturer of Trasylol, has come under scrutiny by the U.S. Food and Drug Administration (FDA) for not sharing data on the risks associated with Trasylol use.

Bayer removed Trasylol from the U.S. and worldwide markets in November 2007 after a Canadian clinical study found it could be linked to a higher risk of death than similar drugs. More recent studies have shown the use of Trasylol doubles the risk of kidney failure and increases the risk of heart attack and stroke. One of those studies previously was withheld by Bayer from the FDA.

In a report on CBS’s 60 Minutes, medical researcher Dr. Dennis Mangano stated that the FDA should have pulled Trasylol from the market in January 2006, after the release of his study. Between that time and when it was finally pulled, approximately 431,000 patients received the drug. According to Mangano, 22,000 lives (approximately 1,000 per month) could have been saved if the drug was taken off the market in January 2006.

If you or someone you know suffered from kidney damage, heart attack, stroke or death after cardiac bypass surgery, it may be due to Trasylol which was used during surgery. Many bypass patients do not know what medication was used during their surgery.

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