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.
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.
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.