The Food and Drug Administration (FDA) has announced that accumulating evidence suggests a Bayer AG drug used to prevent excessive bleeding during heart bypass surgery increases the risk of death when compared with other drugs.
The announcement came as a Canadian study comparing the safety and efficacy of the drug, Trasylol, with two others was halted. Preliminary results from that trial also suggested Trasylol increased the risk of death when compared with the other drugs. The trial was to include 3,000 patients.
Trasylol, (generic aprotinin) works by blocking enzymes that dissolve blood clots. Bayer said it believes Trasylol remains a safe and effective treatment option, but that the company would work with the FDA and regulators in other countries to re-evaluate the drug’s risks and benefits and determine where any label changes are needed.
The announcement came a month after FDA advisers recommended Trasylol remain on the market despite its links to an increased risk of death and other serious side effects. The FDA approved the drug in 1993 to slow the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.