Brayer to Suspend Trasyol Marketing

Pete Strom

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The United States Food and Drug Administration announced that Bayer Pharmaceuticals Corporation has agreed to suspend marketing of the drug Trasyol until preliminary results from a Canadian study suggesting an increased risk for death can be reviewed.

Trasyol is used to control bleeding during heart surgery in patients with an increased risk for blood loss. In 2006, the FDA strengthened the safety warnings required for labeling of Trasyol to reflect the risk for increased blood loss.

The FDA requested the marketing suspension based on the expected data of a Canadian study at Ottawa Health Research Institute. The FDA is still awaiting the full study results. Because of a lack of treatment options for patients at risk for excessive bleeding during heart surgery, the FDA is working with Bayer to phase out Trasyol's use so as to avoid alternative drug shortages.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.