Health risks are linked to drug for heart surgery

drug used worldwide to reduce bleeding during heart surgery can increase the risk of kidney failure, heart attacks and strokes, and should be abandoned, according to a report published Thursday in the New England Journal of Medicine.

The report says other medicines are safer and cheaper, and should be used instead. The drug is aprotinin, made by Bayer and sold under the brand name Trasylol. It has been on the market for 13 years. Halting its use globally would prevent 10,000 to 11,000 cases of kidney failure a year, and save more than $1 billion a year in dialysis costs as well as nearly $250 million spent on the drug itself, according to the report. The report is based on a study of 4,374 patients having bypass surgery or other heart operations in the United States, Europe, Canada, Colombia, Mexico, Israel and Thailand. To limit blood loss, 1,295 received aprotinin, and 1,705 were given one of two other drugs, both generics: aminocaproic acid or tranexamic acid. A control group, 1,374 patients, were given no drugs to prevent bleeding.

The patients given aprotinin suffered kidney failure at a rate of 5 percent twice the rate of the other patients. They also had increases in other serious problems, including heart attacks, heart failure, strokes and a diffuse type of brain damage called encephalopathy.

"It would be nearly impossible for me to recommend using the drug in this patient population," said Dr. Dennis Mangano, director of the study and the founder of a nonprofit group that paid for it, the Ischemia Research and Education Foundation. But Bayer issued a statement that questioned the study, noting that the findings differed from the company's own research. "Bayer believes that Trasylol is a safe and effective treatment," the company said.

The Food and Drug Administration is examining Mangano's data, said a spokeswoman, Susan Cruzan. So far, she said, "there isn't anything that prompted us to raise questions." Worldwide, about a million people a year have bypass surgery, and as many as three- quarters of them are given Trasylol or one of the other two drugs to limit blood loss, Mangano said. Use of Trasylol has varied, with some doctors favoring it and others avoiding it because of concerns that it might cause blood clots. Some doctors have also resisted using Trasylol because of its cost: more than $1,000 per patient, as opposed to $10 to $50 for the other drugs. Last year, sales totaled about $200 million, but this year Bayer's projections are three times as high because the company received government permission to market Trasylol to prevent inflammation as well as bleeding in bypass patients. Bayer is also studying the drug to prevent blood loss in hip-replacement and spinal surgery.

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