More Evidence of Danger From Heart Surgery Drug

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This study looked at the risk of death over the short term, with average follow-up of about a week after surgery. More than 33,500 patients in the study received Trasylol, while almost 45,000 got the other drug.

After adjusting for a number of factors, the risk of death was 64 percent higher in the Trasylol group compared to those who got aminocaproic acid, the study found. It also found an increased need for dialysis, a blood-cleaning procedure used in kidney failure, among those who got the drug.

This data was already available to the FDA when it asked Bayer to remove Trasylol from the market, noted the study's lead author, Dr. Sebastian Schneeweiss, vice chief of pharmacoepidemiology at Brigham and Women's.

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Both he and Shaw said a final verdict on use of the drug hinges on the release of all of the data from the Canadian study, expected in the near future.

"What is still needed is information on whether there might be subgroups in the patient population where there might be more benefit than harm in using aprotinin," Schneeweiss said. Analysis thus far has failed to find such a benefit among subgroups, including people with diabetes or other ailments that complicate their coronary problems, he said.

The basic message is that when you have a new drug that acts similarly to an older medication, comparative studies need to be done before the new drug gets widely used, concluded an accompanying editorial by Dr. Wayne A. Ray, a professor of preventive medicine at Vanderbilt University in Nashville, Tenn.

"Had this been done 10 years ago with Trasylol, many lives would have been saved," he said.

A push for such testing needs to come from the FDA, however, because "there is no commercial incentive to do them," Ray said. "The public is not being adequately protected if we let millions of people use a drug before we truly understand it."

More information

There's more on coronary artery bypass surgery at the American Heart Association.

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