Trasylol Pulled From Worldwide Market(indings the FDA requested last week that...),Health

In a company statement on its Web site Monday, Bayer stressed that the suspension was temporary. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the statement said.

The FDA also said Monday that it plans to do a detailed review of the preliminary results from the Canadian trial before deciding whether to allow Trasylol back on the U.S. market.

Trasylol was first approved by the FDA in 1993, and has had a checkered history since then.

In the Canadian trial, called BART, an elevated 30-day and overall death risk caused the study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

On Sept. 12, a U.S. Food and Drug Administration advisory panel recommended that Trasylol remain on the market, despite mounting evidence that it might have serious side effects.

In February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.

"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."

His team's study tracked the long-term survival of nearly 3,900 heart patients who underwent coro
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