This article is from the WebMD News Archive
Bypass Drug Linked to Increased Deaths
Feb. 6, 2007 -- A new study questions the continued use of the drug aprotinin, commonly used to limit blood loss during some types of cardiac surgery, due to safety concerns.
The study suggests use of the drug during coronary artery bypass graft surgery may be responsible for as many as 2,000 deaths a year.
“Our findings raise very serious concerns about this drug,” one of the study's authors, Dennis T. Mangano, MD, PhD, tells WebMD.
The researchers conclude that “continued use of aprotinin in this population does not appear prudent, given that safer alternatives ... are available.”
For the study, researchers examined outcomes among almost 4,000 bypass surgery patients followed for five years.
More deaths occurred in patients treated with aprotinin than in those treated with two other blood-loss-limiting drugs -- aminocaproic acid and tranexamic acid.
The scientists concluded that 10,000 deaths could have been avoided over the five-year period “had aprotinin been replaced with either of these generic agents.”
The report is published in the Feb. 7 issue of TheJournal of the American Medical Association.
Drug's Maker Responds
But Bayer Pharmaceuticals, maker of Trasylol, the trade name for aprotinin, questioned the “methodological and analytical approaches” used in both this and an earlier study from the same researchers that also raised questions about the drug.
A statement from the drugmaker says that “based on this initial review (of the new research), Bayer believes that the results of this study should not serve as a basis for affecting the use of aprotinin in clinical practice.”
Aprotinin is used during coronary artery bypass graft surgery -- a procedure to improve blood flow to the heart muscle.
In surgery patients who undergo a cardiopulmonary bypass, in which a machine is used to help pump blood and to add oxygen to the blood during the bypass graft surgery, aprotinin is sometimes used to reduce blood loss and the need for a transfusion.
But, says Mangano, “This drug has been approved for use in the United States for the past 13 years, but its long-term safety has not been studied until now.”
Kidney Damage a Concern
Early last year, Mangano and colleagues from the Ischemia Research and Education Foundation in San Bruno, Calif., reported that aprotinin use was associated with a doubling or tripling of the risk of kidney damage and kidney failure immediately following bypass surgery.
Findings from this and one other study led the FDA to strengthen its safety warning for the drug, calling for its use only in patients “at increased risk for blood loss and blood transfusion.”
But Mangano says the new labeling does little to increase patient safety.
“Just about any patient undergoing bypass surgery is at risk for bleeding,” he says.
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