Bayer Stops Worldwide Sales of Trasylol Pending Safety Data

- FDA News

11/08/2007 - Bayer is suspending global marketing of its clotting drug Trasylol as the FDA waits for additional data from a study that suggested the drug was associated with an increased risk of death.

The FDA requested the marketing suspension once it learned additional information from the study might not reach the agency for six weeks or longer, Office of New Drugs Director John Jenkins said. The FDA will gradually remove products from the marketplace to avoid shortages of the few alternative drugs used to limit blood loss during coronary artery bypass surgery. 

Enrollment in the Blood Conservation using Anti-fibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients study was halted after a safety monitoring board observed an increased risk of all-cause mortality in patients receiving Trasylol (aprotinin) compared to the control arms.

Once it receives more information, the FDA will act quickly with Bayer, the study researchers and other regulatory agencies to analyze the data and Trasylol’s overall risk-benefit profile.

The agency did not identify a specific patient population where Trasylol’s benefit would outweigh the risks in the study. However, doctors who wish to prescribe Trasylol to a specific patient could be allowed to obtain the drug under an investigational new drug program, Jenkins said, adding that the details of the program had not been determined yet.

Bayer has defended the drug, saying the total available data support a favorable risk-benefit profile for Trasylol.

More information on the marketing suspension can be seen at www.fda.gov/bbs/topics/NEWS/2007/NEW
01738.html.

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