Trasylol Heart Drug Dangers Hidden By Manufacturer

Two studies have concluded that heart surgery patients are more likely to die if given the anti-bleeding drug Trasylol. The drug has been widely used for the last 14 years to treat hundreds of thousands of heart bypass patients each year. Drug manufacturer Bayer AG ceased sales of the last fall, after a Canadian study was halted because of deaths among patients taking Trasylol.
The new studies are being published this week in the New England Journal of Medicine. Bayer funded one of the two new studies, and had the preliminary results before a September 2006 federal hearing on the drug’s safety. It did not present the results at the hearing.
The company issued a statement this week saying both the new studies are flawed.
“I just don’t know how much further evidence you need,” said Dr. Sidney Wolfe of Public Citizen’s Health Research Group. Federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006, Wolfe said.
Trasylol was used in heart bypass surgeries to control bleeding. The FDA approved it in 1993 after studies showed its clotting powers clearly reduced the need for blood transfusions, and it became a top choice for surgeons.
Bayer officials still say they believe Trasylol’s benefits outweigh its risks when used properly. The company said it’s waiting for the final results of the Canadian study before deciding whether to permanently suspend the drug’s sales.