February 6, 2007 4:08 p.m. EST
CHICAGO -- A drug widely used to prevent excessive bleeding during heart surgery appears to raise the risk of dying in the five years afterward by nearly 50%, an international study found.When researchers adjusted for other factors, they found that patients who got Trasylol ran a 48% higher risk of dying in the five years afterward.
The researchers said replacing the drug -- aprotinin, sold by Bayer AG under the brand name Trasylol -- with other, cheaper medications for a year would prevent 10,000 deaths worldwide over the next five years. The findings were more bad news for Trasylol: The same scientists found the drug raised the risk of kidney failure, heart attacks and strokes in a study published last year. Most of the deaths in the new study were related to those problems. Bayer said in a statement that the findings are unreliable because Trasylol tends to be used in more complex operations and the researchers' statistical analysis did not fully account for the complexity of the surgery cases.
Nevertheless, the drug company said it will "work with regulatory agencies and external experts in the field to further evaluate the findings." The study, published in Wednesday's Journal of the American Medical Association, intensifies questions about how best to track the safety of drugs after they have gone on the market. The Food and Drug Administration approved aprotinin in 1993. Last year's study and other research led the FDA to review Trasylol's safety and order stronger warning labels in December. But that action wasn't strong enough, said Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, lead author of both studies.
The FDA is already reviewing aprotinin's safety. The new study is an important contribution to that review, which could result in additional warnings, said Dwaine Rieves, deputy director in the FDA's Division of Medical Imaging and Hematology Products. The drug works by blocking enzymes that dissolve blood clots, and Dr. Mangano speculated that clotting problems caused the deaths.
Dr. Mangano advised patients to ask their doctors what drug, if any, they will be given to slow bleeding during heart surgery and about the risks. Past patients should find out if they have been given aprotinin so their doctors can watch for problems, he said. "I believe that for the vast majority of coronary bypass patients the drug should not be used," Dr. Mangano said. But he said the drug should remain on the market because some very high-risk patients may benefit from it.
Aprotinin joins the painkiller Vioxx, drug-coated stents and other drugs and devices where safety concerns arose after the products were on the market.
