• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Costly Heart Bypass Medication Could Raise Death Risk Years Later

Posted on: Wednesday, 7 February 2007, 06:00 CST

By Rita Rubin

An expensive drug given to prevent excessive bleeding in coronary artery bypass surgery patients is linked to an increased risk of dying as long as five years after the operation, researchers report today.

More than 4 million patients worldwide have received aprotinin, sold as Trasylol, since 1985, the scientists write in the Journal of the American Medical Association. The Food and Drug Administration approved Trasylol for use in coronary bypass surgery patients in 1993. Last year, it was used 246,000 times in the USA, the researchers say.

Trasylol has been under scrutiny for at least a year and has raised fresh concerns about monitoring the safety of medications once they're on the market. The new study is a follow-up to one the authors published in January 2006 that linked Trasylol to serious kidney problems, heart attacks and strokes. Another study, posted online in January 2006, also linked Trasylol to kidney trouble.

The studies spurred the FDA to convene an advisory panel, which voted unanimously in September that Trasylol should stay on the market. The next week, the FDA announced that it had just learned of another study, by Trasylol maker Bayer, suggesting that Trasylol might increase the risk of serious kidney damage, death, heart failure and strokes. The FDA announced updated labeling for the drug that now warns about kidney problems and says Trasylol should be used only in coronary bypass patients who are at an increased risk for excessive bleeding.

The new, multi-center international study compared the death rates of four groups of patients who had had bypass surgery: 1,072 who were given Trasylol, 834 given aminocaproic acid, 442 given tranexamic acid and 1,374 who didn't receive any medication to prevent excessive bleeding.

Patients who received aprotinin were about 50% more likely to die in the five years after surgery than patients who received no drug. Neither of the other drugs was linked to a significantly higher risk of death than no treatment.

Trasylol costs $1,300 per use, compared with only $44 for aminocaproic acid and $11 for tranexamic acid, says lead author Dennis Mangano, head of the Ischemia Research and Education Foundation in San Bruno, Calif.

In a statement responding to the new study, Bayer said doctors tend to give Trasylol to the sickest of patients, which could skew findings about the drug's safety. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

More News in this Category