FDA Panel: New Warnings for Stents
Drug-Coated Stents That Prop Open Arteries May Up Risk for Heart Attack
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Today more than 60% of all drug-coated stent implants are "off-label," according to the FDA.
Experts also said doctors should be urged to extend the use of the blood-thinning drug Plavix in patients who receive drug-coated stents off-label. Current recommendations advise patients to take Plavix along with aspirin for three to six months after stent placement, though experts said that should be extended to one year.
The recommendations were not made by a formal vote but were the consensus of panel members. The FDA does not have to follow the advice of advisory panels, but it usually does.
Options for the FDA
FDA officials said they would move to communicate the recommendations to the public, though the method of that communication is yet to be decided. The agency could choose to add warnings to drug-coated stent labeling, communicate directly with doctors about the risks, or both.
"At the end of the day what I heard loud and clear is that we need to do a better job ... communicating to patients and communicating to doctors the best and the latest information," said Dan Schultz, MD, director of FDA's Center for Devices and Radiologic Health. "This meeting needed to happen."
News of the potential for increased risk sparked anxious news reports and worry among many U.S. patients. Experts stressed Friday that there was little need for patients with drug-coated stents to have them removed. Suspected clots and heart attacks blamed on the stents are still thought to be relatively rare. Patients who take blood-thinning drugs according to doctors' recommendations reduce their risk.
Some experts described the two days of FDA meetings as a kind of reality check on the use of drug-coated stents by U.S. doctors
"I think we've got to come back to earth here," said Steven Nissen, chairman of cardiovascular medicine at The Cleveland Clinic and one of the FDA advisors.
Still, there was some dissent among panel members. Some worried that issuing new warnings would further frighten patients and doctors away from using the stents.