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Hemophilia Drug Used Off-Label Raises Clot Risk
Date:11/4/2010

By Jenifer Goodwin
HealthDay Reporter

WEDNESDAY, Nov. 3 (HealthDay News) -- A drug approved to help staunch bleeding in people with hemophilia raises the risk of heart attacks and stroke when it's used to stop life-threatening bleeding due to other conditions, such as trauma or surgery, a new study finds.

Despite the nearly twofold rise in risk of dangerous clots that form inside blood vessels and cause heart attacks and stroke in those without hemophilia, researchers said doctors should use the information to carefully weigh the risks and benefits of using the drug, called recombinant activated factor VII (rFVIIa), for any "off-label" use.

"If you are a physician confronted with a patient with excessive blood loss, and you have done everything you can and this patient is almost dying because of the bleeding, it's quite acceptable to give the drug even if it's associated with a risk of thrombosis [clotting]," said study author Dr. Marcel Levi, a professor of Medicine at University of Amsterdam in the Netherlands. "On the other hand, if you are confronted with a patient who has less than excessive blood loss and you can try other things, then the twofold increased risk of thrombosis is considerable and I would not give the drug."

The study is published in the Nov. 4 issue of the New England Journal of Medicine.

What makes the study so unusual is that the drug maker, Novo Nordisk, gave researchers access to unpublished data on the drug and its potential side effects, said Dr. Louis Aledort, a professor of medicine at Mount Sinai School of Medicine in New York City, who wrote an accompanying editorial.

"The company is to be congratulated," Aledort said. "It would be really great if other companies would do the same so that clinicians thinking about using it a drug in an off-label setting would have all the information at hand so they could make the right decision, which is benefit vs. risk."

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