FDA Meets Regarding Defective Drug-Eluting Stents

Christina Cole

Contributor

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The FDA met today regarding problems related to drug-eluting stents.

Many independent studies, The World of Congress and leading cardiologists have shown that drug-eluting stents might actually cause additional blood clots, rather than helping to keep heart arteries open. Since their inception in 2003, drug-eluting stents have been commonly used with over 4 million patients receiving such devices.

"There may be something there. From an evidence-based perspective, I can't say definitively one way or another," said panel member Dr. Norman Kato of the Cardiac Care Medical Group of Encino, Calif.

Another panel member, Dr. Steve Nissen of the Cleveland Clinic, said the clotting risk is real and that only its magnitude is in question.

Studies estimate that these stents may have caused up to 4,500 new heart attacks per year, also including 2,000 fatalities. Some physicians have proposed increasing patients use of the anti-blood clotting medication Plavix. However, in some patients, Plavix itself might lead to other health risks such as bleeding and strokes.