Anti-bleeding drug Trasylol may increase mortality risk

30 October, 2007

There is accumulating evidence suggesting that the drug Trasylol, manufactured by Bayer AG and used to prevent excessive bleeding during heart bypass surgery, increases the risk of death when compared with other drugs, according to the United States Food and Drug Administration (FDA).

The FDA announcement came as a Canadian study comparing the safety and efficacy of Trasylol with two others was halted.

Preliminary results from the Canadian trial also suggested that Trasylol increased the risk of death when compared with the other drugs. The trial was to include 3,000 patients.

The FDA advised doctors in a notice posted on its website on October 25, 2007, to be aware of the “accumulating data suggesting” an increased mortality risk connected with Trasylol.

The FDA said it would revisit the drug’s safety, which may include label changes or other regulatory actions.

Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots.

A statement form Bayer AG said it believes that Trasylol remains a safe and effective treatment option, but that the company would work with the FDA and drug regulators in other countries to re-evaluate Trasylol’s risks and benefits and determine where any label changes are needed.

The FDA said would have to take unspecified regulatory actions regarding Trasylol.

The US Food and Drug Administration’s announcement came a month after the regulator’s advisers recommended that Trasylol remain on the market despite its links to an increased risk of death and other serious side effects.

The FDA approved Trasylol in 1993 to check the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.

It began re-evaluating the drug’s safety after the publication in January 2006 of two studies that linked the use of Trasylol to serious side effects, including kidney problems, heart attacks and strokes.

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