A drug used to limit blood loss during heart surgery is linked to an increased five-year risk of death compared to cheaper alternatives, a new study suggests.

The drug, called aprotinin or Trasylol, has already been linked to a higher risk of kidney failure, heart attacks and strokes.

In Wednesday's Journal of the American Medical Association, Dr. Dennis Mangano of the non-profit Ischemia Research and Education Foundation and his team reviewed five years of data on 3,876 heart bypass patients.

The death rate among the 1,072 patients who received aprotinin was nearly 21 per cent, compared with 12.7 per cent among patients who received no anti-bleeding drug.

"Use of aprotinin among patients undergoing [coronary artery bypass graft] surgery does not appear prudent because safer and less expensive alternatives are available," the authors concluded.

In the U.S., the Food and Drug Administration is reviewing the safety of aprotinin. Trasylol is approved for use in Canada, according to Health Canada's online database.

"I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano said.

The drug should remain on the market because it may help some high-risk patients, he added.

The study was not a randomized trial in which patients are randomly assigned to receive the drug or not. The researchers took into account how sick patients were before surgery but other factors may have contributed to the extra deaths, they said.

Drug safety lesson

"It's not a perfect study, but the data are compelling enough that we have to use aprotinin judiciously," said Dr. Brett Sheridan, a heart surgeon with the University of North Carolina Health Care System who was not involved in the study.

There are no standards for using aprotinin in cardiac surgery worldwide, Dr. Bruce Ferguson of the Brody School of Medicine at East Carolina University, Greenville, said in an editorial accompanying the study.

"Ultimately, going forward, the most important lesson learned from the aprotinin story is determining better ways to ensure drug safety and to eliminate and prevent these harms."

In a statement, Bayer AG, makers of Trasylol, called the findings unreliable because the drug tends to be used in more complex cases, and the researchers did not sufficiently take that into account.

Bayer said it will "work with regulatory agencies and external experts in the field to further evaluate the findings."

A two-hour bypass surgery might need $792 US of Trasylol, compared with $7 to $35 for generics, depending on the dose.

With files from the Associated Press