Majority of Drug-Coated Stent Use Not Approved by FDA

More research on the controversial practice is needed, researchers say

By Ed Edelson
HealthDay Reporter

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MONDAY, Feb. 12 (HealthDay News) -- About 60 percent of the drug-coated stents that have become the center of intense controversy are being used in cases not approved by the U.S. Food and Drug Administration, studies show.

This high incidence of so-called "off-label" use is reported in a series of studies published in a major roundup scheduled to appear in the March 8 issue of the New England Journal of Medicine, but released early by the journal on Monday.

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The coated stents have FDA approval for use in patients with a single blocked artery who do not have any accompanying medical problems, such as diabetes. But the studies indicate that many patients are getting several stents, some under emergency conditions such as following a heart attack, even when there are other medical complications.

Researchers are calling for more studies of the practice of off-label use of stents -- wire, mesh tubes inserted to keep arteries open -- to measure any risks to patients.

"We attended the meeting of the FDA advisory committee in December," said Dr. Gregory D. Curfman, executive editor of the journal. "What we wanted to do is capture the essence of the presentations in manuscript form to give our readers a chance to judge the evidence."

The FDA meeting was held because of reports that patients receiving coated stents had a higher rate of blood clots. But that problem was "a small concern" compared to widespread off-label use, said Dr. Andrew Farb, an FDA medical officer who wrote an accompanying perspective piece in the journal.

The FDA panel said all patients receiving the drug-coated devices are at heightened risk for blood clots, and that many patients receiving the devices are at risk for heart attacks and death.

But there isn't enough evidence to say if the danger of heart attacks and strokes is due to the devices or the patients' poor health, the panelists added. On-label use is limited to no more than two stents; off-label covers three or more.

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