Bayer AG has suspended sales of Trasylol, an anti-bleeding drug, at the request of  the FDA and foreign health officials pending further analysis of a Canadian study that suggests it’s linked to a 50% higher risk of death than the other drugs in the trial.
   
Trasylol, also known as aprotinin, is used to prevent excessive bleeding during heart bypass surgery. The Canadian study comparing the safety and efficacy of Trasylol with two other drugs was stopped when preliminary results suggested Trasylol exposed patients to a greater risk of death. 
   
“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.
   
Bayer, based in Leverkusen, Germany, made the decision to suspend sales after talks with FDA, the German Federal Institute for Drugs and Medicine Products, and the Canadian health department.
   
The suspension may be temporary for some patients. The FDA and Bayer are determining whether to make the drug available on a restricted basis for use by physicians in certain patients they believe could benefit from the drug.
   
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 FDA approved the drug in 1993 and 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 further suggested the drug also raises the risk of death. 
   
“Once the study is complete, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” according to a company statement. “At that time the temporary marketing suspension will be reevaluated.”