CDRH's Hands May be Tied on Stent Issue

The members of CDRH's Circulatory System Devices Panel suggested that doctors and patients be given stronger warnings about the risks of drug-eluting stents in high-risk patients, but were unable to forge much more of a consensus than that, reports the New York Times. The problem is that more than 60% of patients receiving the devices have more complex cardiovascular problems than those who received them in clinical trials.

December 11, 2006

1 Min Read
CDRH's Hands May be Tied on Stent Issue

What research exists indicates that risks of clotting, heart attack, and death are higher for these patients. But there's not enough data out there to draw firm conclusions. So all the panel could recommend was to strengthen the warnings and to put high-risk patients on anti-clotting medication for at least a year. But it's unclear what actions FDA might be able to take, as some logical steps might get into the territory of encouraging off-label promotion.

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