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Home » OFF-LABEL STENT USE MAY BE RESTRICTED IN WAKE OF FDA MEETING
OFF-LABEL STENT USE MAY BE RESTRICTED IN WAKE OF FDA MEETING
After examining risks related to the off-label use of drug-eluting stents, an FDA panel has recommended the agency consider mandating labeling changes.
Drug-eluting stents implanted in lesions beyond current FDA-sanctioned indications are associated with an increased risk of adverse events, presenters said at a Dec. 8 meeting of the Circulatory System Devices Panel.
"Off-label use of drug-eluting stents, particularly in multivessel disease, is causing a huge problem in healthcare," Gregory Dehmer of the Society for Coronary Angioplasty and Interventions told the panel. But "we have seen success in serious lesions that would be considered off-label, [and] the panel should not restrict drug-eluting stents to noncomplex lesions," he said.
When it comes to overall stent thrombosis (blood clotting caused by stents), on-label use of drug-eluting stents and off-label use of bare-metal stents are both safer than off-label use of drug-eluting stents, Ron Waksman, a presenter from the Washington Hospital Center, said.
In the 7,752-patient DEScover registry, which was published in the Nov. 14 issue of the journal Circulation, "the off-label outcomes were worse and the off-label patients fared worse than the on-label patients," David Williams of Rhode Island Hospital told the panel.
KEYWORDS FDAnews Device Daily Bulletin
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