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FDA to Evaluate Risk of Drug-Eluting Stents

In efforts to address recent controversy surrounding drug-eluting stents, FDA will be reexamining the safety of these devices.

September 15, 2006

1 Min Read
FDA to Evaluate Risk of Drug-Eluting Stents

According to today's Boston Globe, the agency announced the formation of a public panel to evaluate the risk of blood clots in patients who have the stents implanted. FDA also released a statement on its website, which says that the panel, consisting of outside experts, will be looking at studies presented in Atlanta and Barcelona. Recent studies have revealed a small but significant risk of blood clots in patients with drug-eluting stents. The panel's evaluation will also determine if more clinical studies must be performed and whether or not anticoagulants should be used for a longer period of time. Currently, FDA states it believes drug-eluting stents are safe and effective when used for approved indications.

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