BREAKING NEWS: Stent Panel Recommends Warnings on Devices

December 8, 2006

GAITHERSBURG, Md. -- The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.

GAITHERSBURG, Md., Dec. 8 -- The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.