FDA to Evaluate Risk of Drug-Eluting StentsFDA to Evaluate Risk of Drug-Eluting Stents
In efforts to address recent controversy surroundingÂ drug-eluting stents, FDA will beÂ reexamining the safety of these devices.
September 15, 2006
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.Â FDA also released a statement on its website, which says that theÂ panel, consisting of outside experts,Â 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 notÂ 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.
You May Also Like