Bayer AG halted the sales of Trasylol, a drug used to prevent excess bleeding in patients undergoing heart bypass surgery, pending investigation of a Canadian study's claims that the drug had a death rate 50% higher than that of other drugs in a clinical study. The Canadian study was recently halted.
The FDA asked Bayer to stop selling its drugs so that it could take a look at the new study and possibly conduct its own. The FDA currently "cannot identify a specific patient population where we believe the benefits of using Trayslol outweighs the risk" says Dr. John Jenkins, director of the agency's Office of New Drugs.
Bayer, based in Germany, decided to stop selling the drug after talking to officials in the FDA, the German Federal Institute for Drugs and Medicine Products, and the Canadian health department. This is the third drug to be suspended this year.
The FDA says that the suspension of sales may be temporary for Trayslol but its broad use days are over.
Trayslol was approved in 1993 but has been under re-evaluation by the FDA since January of 2006 after the publication of two studies that linked its use to serious side effects such as kidney problems, heart attacks, and strokes. It works by blocking enzymes that dissolve blood clots and is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions.