FDA: Heart Drug

May Boost

Risk Of Death

WASHINGTON, D.C. (AP) — The Food and Drug Administration said last week 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, also known as 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 reevaluate the drug’s risks and benefits and determine where any label changes are needed.

The FDA said such changes, as well as other, unspecified regulatory actions, may result.

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 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 reevaluating 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.

More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a “regrettable human error.”