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FDA Panel: New Warnings for Stents

Drug-Coated Stents That Prop Open Arteries May Up Risk for Heart Attack

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.

Reality Check

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.

"I haven't seen anything today that's going to change my practice on Monday morning when I go back," said Christopher J. White, chairman of cardiology at the Ochsner Clinic Foundation in New Orleans and a member of the FDA panel.

Mark Turco, MD, a researcher at Washington Adventist Hospital in Washington, D.C., said that drug-coated stents were greeted by "unbridled enthusiasm" that outpaced scientific proof for many patients. He said recent news of increased risks then swung public perception to one of near-panic over the dangers.

"Hopefully we will soon move to a realistic application where the data will far outweigh the perceptions," he said.


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