Off-Label Use of Clotting Drug Soars, Report Finds

Stanford researchers question use of expensive drug for other medical treatments despite risk

MONDAY, April 18 (HealthDay News) -- Hospitals are using a pricey blood-clotting drug in treating people who do not have hemophilia, a rare disorder in which blood does not clot normally -- even though its use in such patients is potentially risky, according to new research.

Stanford University researchers found that use of the drug, known as recombinant factor 7a, grew by 140 times from use in 125 cases in 2000 to 17,813 in 2008, with off-label uses accounting for most of the increase.

The $10,000-a-dose drug was used in people with hemophilia just 4 percent of the time, according to U.S. hospital statistics from 2000 to 2008. The rest of the time, it was used during heart surgery and to treat medical problems such as trauma and bleeding in the brain. The researchers contend that such use puts patients at risk for heart attack and stroke because the drug can boost the risk of blood clots.

"The stakes are high with this one," Dr. Veronica Yank, an instructor in medicine at Stanford and the first author of one of two new studies on the drug, said in a university news release. "Because it's such a powerful clotting agent, it has the potential when used off-label to damage the lives of patients without providing any real benefit."

Yank and her colleagues said that physicians should be more cautious with the drug until there's more research into whether it's appropriate to use in certain cases.

The studies, published April 19 in Annals of Internal Medicine, are accompanied by a commentary from Harvard Medical School researchers, which says the research provides "compelling data about the runaway use, uselessness and risk for this expensive treatment."

The studies were funded by the U.S. Agency for Healthcare Quality and Research after previous research raised concerns that RF7a increased the risk for blood clots. The agency asked for an assessment of five off-label uses of RF7a: heart surgery, intracranial hemorrhage, body and brain trauma, liver transplantation and prostate surgery.

More information

The U.S. National Heart, Lung and Blood Institute has more on hemophilia.

Randy Dotinga SOURCE: Stanford University School of Medicine, news release, April 18, 2011

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