Study questions surgery drug
Replacing the drug, which limits bleeding during heart surgery, may save 10,000 lives, study says.
By ASSOCIATED PRESS
Published February 7, 2007
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 percent, an international study found.
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.
But the company said it will "work with regulatory agencies and external experts in the field to further evaluate the findings."
The study, published in the 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 FDA 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 Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, lead author of both studies.
The FDA is reviewing aprotinin's safety. The new study is a contribution to that review, which could result in additional warnings, said Dr. 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 Mangano said clotting problems likely caused the deaths.
"I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano said.
Dr. Brett Sheridan, a heart surgeon with the University of North Carolina Health Care System, said he has almost quit giving aprotinin because he had seen more kidney damage in patients who got the drug.
"It's not a perfect study, but the data are compelling enough that we have to use aprotinin judiciously," Sheridan said.
The study followed 3,876 patients who had heart bypass surgery at 62 medical centers in 16 nations.