WASHINGTON (AP) The government has asked Bayer Pharmaceuticals to suspend sales of a drug used to prevent excessive bleeding during heart bypass surgery that may increase the risk of the patient's death.
The Food and Drug Administration said Monday that Bayer AG has agreed to stop selling the drug, Trasylol, pending detailed review of preliminary results from a Canadian study that suggested an increased risk of death. The study comparing the safety and efficacy of the drug, Trasylol, with two others was recently halted.
Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots.
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery, the FDA noted in its announcement. The agency said it was working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Bayer has 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 more than 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 it in 1993 to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.
The agency 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.