Bayer Pharmaceuticals Corp. Suspends Marketing of Trasylol

Chrissie Cole

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The Food and Drug Administration (FDA) has requested Bayer Pharmaceuticals Corp., halt all marketing of Trasylol, a drug used to stop bleeding during heart surgery.

The decision was made to pull the drug off the market following a Canadian study that showed an increased risk of death during use.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

The study showed an increased risk of heart attack, kidney damage and stroke after using Trasylol. There are limited treatment options for patients at risk for excessive bleeding during heart surgery. Bayer is working with the FDA to phase, Trasylol, out in such a way that it will no cause shortages of other drugs used for this purpose.

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