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U.S. Department of Health and Human Services

For Consumers

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Marketing Suspension of Trasylol for Heart Surgery

Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA, Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies will undertake a thorough analysis to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose. Also, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

FDA was recently notified that researchers with the Ottawa Health Research Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, 2007, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination.

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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: November 5, 2007