FDA Convenes Advisory Panel Meeting To Assess Safety of Drug-Eluting Stents
MedSun: Newsletter #10, December 2006
FDA convened a public meeting of the Circulatory System Devices Advisory Panel December 7–8 to discuss the safety of drug-eluting stents (DES). FDA has been closely monitoring DES since they came to the U.S. market in 2003 and 2004. Recent data have suggested a small but significant increase in late stent thrombosis in patients treated with DES. This panel of outside experts was brought together to assist the agency in the review and analysis of the available scientific data regarding the incidence and timing of stent thrombosis and the appropriate duration of treatment with clopidogrel bisulfate (Plavix®). Clopidogrel is the drug used in combination with aspirin to reduce and prevent clotting in both DES and bare metal stents (BMS) patients. FDA will post the advisory panel’s findings and recommendations on the Web site, but, in the meantime, patients should be aware of the importance of adhering to the recommended duration of antiplatelet therapy to reduce the risk of stent thrombosis. Also, patients should be advised to address concerns about their DES with their physicians.