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FDA Warns Of Trasylol Risks

Study terminated because of increased risk of death

By Mark Huffman
ConsumerAffairs.com

October 29, 2007

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The U.S. Food and Drug Administration has issued an Early Communication about an Ongoing Safety Review – government-speak for “look out, this drug may have a serious problem.”

The drug in question is aprotinin, marketed under the trade name Trasylol by Bayer AG.

Last week, FDA said it was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study.

Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.

The FDA says this most recent data support the results from other comparison studies of Trasylol.

FDA said it "anticipates further review" of the risk and benefits of Trasylol. It said it will work with the sponsor of the recently terminated study to evaluate the data fully.

In the meantime, the agency recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.

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.

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