Trasylol Pulled after Study Links Higher Risk of Death
At the request of the U.S. and foreign health officials Bayer AG has stopped worldwide sales of its anti-bleeding drug Trasylol. A Canadian study suggests that the drug is linked to a 50 percent higher risk of death than other drugs in the same clinical trial. The Food and Drug Administration asked the company to stop selling the drug until it could review further results from the study. Trasylol is used to prevent excessive bleeding during heart bypass surgery. It is also known as Aprotinin and 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. The suspension of the drug may be temporary 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. Bayer estimates Trasylol has been used in roughly 4.8 million patients over the last 14 years. The Canadian study comparing 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 definitive results.
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