FDA Investigating Safety of Antifibrinolytic Drug, Trasylol

The U.S. Food and Drug Administration (FDA) is conducting a safety review of Bayer Pharmaceuticals’ Aprotinin Injection (Trasylol), a drug used to control bleeding during heart surgery, after being notified that a Canadian research group halted 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.

This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees, which represent one part of FDA’s oversight and review of drugs throughout their life cycles.

FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully.

In the meantime, FDA 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.

UPDATE: On Monday, November 5, 2007, Bayer AG says it will halt worldwide sales of Traysol until further review of data from the Canadian study.

Source: FDA (October 26, 2007)

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