Tuesday, February 26, 2008

Bayer's Trasylol Boosts Death, Kidney Risks After Heart Surgery

From Bloomberg:
Bayer AG's Trasylol, a drug whose sales were halted last year, raises the risk of death and kidney damage when used to control bleeding in heart surgery, two studies in the New England Journal of Medicine found.

Trasylol patients were 27 percent more likely to die than those getting a rival drug a decade after open-heart surgery, according to a review of 10,275 consecutive patients at Duke University Medical Center. Another study of 78,199 patients, presented to regulators last year after Bayer initially withheld it, found a 78 percent higher death risk a week after surgery.

Trasylol was approved in the U.S. in 1993 to reduce transfusions and bleeding during open-heart surgery. It became a mainstay of care, generating about $333 million in 2005, until an international study the next year tied it to higher rates of heart attack, stroke, kidney failure and death. Leverkusen, Germany-based Bayer suspended sales in November after a pivotal Canadian trial linked it to higher death rates. ...more

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