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

p>rFVIIa was approved about 10 years ago by the U.S. Food and Drug Administration for use in people with hemophilia. Hemophilia is a group of blood disorders in which the blood doesn't clot properly, raising the risk of prolonged bleeding, internal bleeding and bleeding into the joints.

Increasingly, the drug has also been used for so-called "off-label" use, or to treat conditions not expressly licensed by the FDA, Aledort said. While it is legal for physicians to use a drug in this way, a drug's maker cannot promote its use for anything but the condition for which it is approved.

Such "off-label" uses include stopping brain bleeds and staunching bleeding during surgery due to trauma or advanced liver disease, according to the study.

Despite it's effectiveness in stopping bleeding and promoting beneficial clotting, there have been reports of complications, including heart attacks and stroke.

In the study, researchers looked at 35 published and unpublished studies on off-label usage of rFVIIa to treat or prevent bleeding. The studies involved more than 4,100 people who experienced excessive bleeding, some of whom were given rFVIIa and some who weren't. Overall, about 11 percent experienced arterial thrombosis, most often a heart attack, unstable angina (a precursor to a heart attack) or stroke.

About 5.5 percent of those who received rFVIIa experienced arterial thrombosis, compared to 3.2 percent of those who were given a placebo.

About 2.9 percent of those who received rFVIIa had a heart attack compared to about 1.1 percent given a placebo.

The risk of dangerous clots rose with age. Among those 65 and older, 9 percent of those given rFVIIa experienced arterial thrombosis compared to 3.8 percent given a placebo. For those 75 and up, rates rose to 10.8 percent and 4.1 percent, respectively.

There was no increased risk of venous thrombosis, such as clots in the legs or lungs (pulmonary embolism).

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