November 5, 2007

Bayer stops sales of Trasylol globally

Matt Moore, AP Business Writer

FRANKFURT, Germany - Bayer AG said Monday it halted worldwide sales of its antibleeding drug Trasylol after a Canadian clinical study last month found that it could be linked to a higher risk of death than other drugs.

The drug is designed to stem blood less and enable patients receiving heart bypass surgery to avoid the use of transfusions.

Leverkusen-based Bayer said it made the decision after talks with the U.S. Food and Drug Administration, the German Federal Institute for Drugs and Medicine Products along with Health Canada.

Last week the FDA said that accumulating evidence suggests Trasylol increased the risk of death compared with other drugs.

The announcement came as a Canadian study comparing the safety and efficacy of Trasylol with two others was halted. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs. The trial was to include 3,000 patients. Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots.

That announcement came a month after FDA advisers recommended Trasylol remain on the market despite its links to an increased risk of death and other serious side effects. The FDA approved the drug in 1993 to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries. The agency began re-evaluating the drug's safety after the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.

More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a "regrettable human error."

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery, the FDA noted in its announcement. The agency said it was working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Bayer said it wanted to review the results from the Canadian trials before moving forward.

"Once the complete ... dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol," the company said. "At that time the temporary marketing suspension will be reevaluated."