Blood-loss drug a risk to kidneys, study says

A popular drug given to more than a million people since 1993 to limit blood loss during heart surgery doubles a patient's risk of kidney failure and substantially increases the risk of a heart attack, a major study has found.

The research, being published today in the New England Journal of Medicine, concluded that use of the drug — Bayer's aprotinin, marketed under the brand name Trasylol — causes more than 11,000 patients worldwide to need kidney dialysis each year.

The authors said that in light of their findings, and the fact that two other less harmful and far less expensive alternatives exist, it is no longer "prudent" for doctors to use the drug except in unusual circumstances. If they continue with the drug, the authors said, doctors have a moral obligation to inform patients about the risks.

The Food and Drug Administration said it is reviewing the study and "will make recommendations for best use as soon as possible."

Bayer said that it had only recently become aware of the research and that it is "not consistent with the more than 15 years of clinical data ... Bayer has amassed on this drug."

The drug has been widely studied since it was approved in 1993, but most of the research has focused on its effectiveness.

The research, however, found not only a greatly increased rate of kidney failure, but also a 50 percent increase in heart attacks and an almost 200 percent increase in strokes.