Bayer Halts Sales of Anti-Bleeding Drug

A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global marketing of its anti bleeding drug Trasylol after a Canadian clinical study last month found that it could be linked to a higher risk of death than other drugs. (AP Photo/Roberto Pfeil) (Roberto Pfeil - AP)

WASHINGTON -- Bayer AG halted worldwide sales Monday of its anti-bleeding drug Trasylol at the request of U.S. and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50 percent higher risk of death than the other drugs in the clinical trial.

The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, until it could receive and review further results from the study. The study comparing the safety and efficacy of the drug with two others was recently halted.

"FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk," said Dr. John Jenkins, director of the agency's Office of New Drugs, during a briefing Monday.

Bayer, based in Leverkusen, Germany, said it made the decision to suspend sales after talks with FDA, the German Federal Institute for Drugs and Medicine Products along with the Canadian health department.

In the U.S., Trasylol is the third prescription drug to be suspended from sale this year.

The suspension may be only temporary, at least for some patients. The FDA said it was exploring with Bayer whether to make the drug available on a restricted basis for use by physicians in certain patients they believe could benefit from the drug.

"The broad use of the drug, unless there is a real surprise when the data are finally analyzed, is unlikely to ever return," predicted Dr. A. Michael Lincoff, vice chairman of research in the Cleveland Clinic's cardiovascular medicine department, who's advised the FDA on the drug.

Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots. It is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions.

Bayer estimates Trasylol has been used in roughly 4.8 million people over the last 14 years. Last year, about 110,000 U.S. patients, and another 87,000 overseas, received the drug, though its use has declined in the wake of earlier indications of safety issues, said Dr. Timothy Gardner, a Delaware heart surgeon Gardner is a spokesman for the American Heart Association, whose annual scientific conference in Orlando, Fla., buzzed Monday with news of the drug's suspension.

While current year usage figures were not available, Bayer estimates worldwide sales of the injection drug were roughly $135 million for the nine months through September. The U.S. accounted for about $91 million of that total.

The Canadian study comparing the safety and efficacy of Trasylol with two other drugs was halted when preliminary results suggested Trasylol exposed patients to a greater risk of death. The actual number of deaths was not available.

The FDA said it requested the drug be pulled rather than wait the six weeks for further, more definitive results from the study, which was to include 3,000 patients.