WASHINGTON - Bayer AG halted worldwide sales yesterday of its antibleeding drug Trasylol at the request of United States 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 yesterday.
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 United States, 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, the 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 US 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.
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 United States accounted for about $91 million of that total.
Shares of Bayer rose nearly 1.2 percent to $83.02 in Frankfurt.