New Studies Link Heart Surgery Drug to Patient Deaths

By Daniel Hawn

Published on March 06, 2008

The new studies, published in the Feb. 21 issue of the New England Journal of Medicine, have fueled the controversy over Trasylol, a drug used to restrict bleeding in patients undergoing heart bypass surgery. The drug was pulled from the market in November by its maker, Bayer AG, in response to a Canadian study that was suspended due to deaths among patients using the drug.

The first of the new studies examined more than 10,000 patients who underwent bypass surgery between 1996 and 2005. The researchers found that patients who were given Trasylol were 2 ½ times more likely to die within the first year of surgery than were patients who received comparable medications or none at all. The study's lead author, Dr. Andrew Shaw of Duke University, said it remains unclear why Trasylol patients had a higher rate of death.

The other study, funded by Bayer and conducted by Harvard medical researchers, involved 78,000 patients who were examined between Jan. 1, 2003, and March 31, 2006. Individuals who received Trasylol were 64 percent more likely to die than patients given another drug, the researchers found.

Bayer officials have since questioned the reliability of the Harvard study. The company said it is awaiting the final results of the halted Canadian study to decide whether to permanently end sales of Trasylol.

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