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

Patients given Trasylol have a higher death risk, data review finds

TUESDAY, Dec. 2 (HealthDay News) -- A new study casts more doubt on the safety of the drug Trasylol (aprotinin), used to limit bleeding in patients undergoing surgery.

Trasylol is already the subject of controversy in the United States, where it was removed from the market in 2007.

In the new study, Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. They concluded that Trasylol posed a higher risk of death for patients than other anti-bleeding drugs, called lysine analogues.

While Trasylol was somewhat more effective at controlling blood loss and transfusions than lysine analogues, its higher risk of death and significantly higher price are deterrents to its use, said the authors. They recommended tranexamic acid or aminocaproic acid as alternatives to prevent blood loss during surgery.

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality," concluded Dr. David Henry and his co-authors of the study, which will be published in the Jan. 20 issue of the Canadian Medical Association Journal.

The findings were released early in advance of a Health Canada expert advisory panel meeting scheduled for Wednesday. The panel is expected to make a decision about the use of aprotinin.

The review included new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study published by the New England Journal of Medicine earlier this year. That study found that patients treated with aprotinin were 53 percent more likely to die than those treated with two similar drugs, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). The death rates were 6 percent, 3.9 percent and 4 percent, respectively.

Due to the significant risk of death associated with Trasylol, 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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