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
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
Still, there was some dissent among panel members. Some worried that issuing
new warnings would further frighten patients and doctors away from using the
"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
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.