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Another Study Warns of Risk From Cardiac Surgery Drug
Date:12/2/2008

l, the BART study was stopped in October 2007, before the schedule completion date.

In November 2007, Trasylol manufacturer Bayer AG suspended the drug's marketing in the United States after the preliminary results from the BART trial were released. Bayer removed all remaining stocks of the drug from the U.S. market earlier this year. However, the German drug maker continues to sell Trasylol in some areas of the world.

Trasylol has been on the market since 1987 and widely used. At the time of the BART study's release, one expert questioned why the truth about the dangers of the drug took so long to come out and how many patients may have died "because of this misadventure in therapeutics?"

"Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" asked Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.

The U.S. Food and Drug Administration is high on the blame list, Topol told HealthDay.

"The FDA has to be considered part of the problem," he said. "Why weren't trials like this part of the early approval process, rather than getting the data many years later?"

More information

The U.S. National Heart, Lung, and Blood Institute has more about coronary artery bypass surgery.



-- Robert Preidt



Canadian Medical Association Journal, news release, Dec. 2, 2008


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