A divided Food and Drug Administration advisory panel Friday said cardiac patients should be warned they face a higher rate of life-threatening complications from unapproved use of drug-coated stents.
The panel said product labels for the stents should be revised to caution doctors and patients that off-label use carries an increased risk of blood clots, heart attack or death.
The devices, which are used to keep arteries open after blockages have been cleared, were approved in 2003 for use in patients with just one clogged vessel. But the stents are widely used off-label in sicker patients with multiple blockages or complicating illnesses, such as diabetes.
In the U.S., unapproved uses of the stents, made by Johnson & Johnson and Boston Scientific Corp., account for about 60% of sales.
These "patients should be warned they should not expect the same outcome" as healthier patients, said panel chairman Dr. William H. Maisel of Beth Israel Deaconess Medical Center in Boston.
The FDA called the panel meeting after a series of studies found the tiny mesh stents increased the risk of complications months and years after they were implanted. Several studies found the devices carried small but significant risk of heart attack or death.
The devices, known as drug-eluting stents, release drugs that prevent blockages caused by a buildup of scar tissue -- a complication of bare-metal stents. But the drugs slow healing inside the artery, and that can lead to the formation of clots.
About 3 million people in the U.S. have the drug-coated stents, which generated worldwide sales of more than $5 billion last year.
The panel decided that the devices were safe and effective for the narrow group of patients for whom the devices were approved.
But panel member Dr. Norman S. Kato of Cardiac Care Medical Group in Encino said there is a shortage of conclusive medical research on the safety of the stents in other patients. He said off-label use of the stents could not be justified. He said the increased risk of death "makes me very, very nervous."
Panelist Dr. Eric Topol of Scripps Clinic in San Diego called for "more judicious" use of stents.
Despite the concerns, the panel of 21 experts said there is not enough evidence to restrict use of the stents.
Dr. Christopher J. White of Ochsner Clinic in New Orleans and a member of the advisory panel said it was not surprising to see an increase in complications in sicker patients. He noted that sicker patients who have bare-metal stents also have a higher rate of complications.
"Nothing I heard today is going to change what I do," White said.
The panel recommended those patients who use the stents for unapproved conditions should receive anti-clotting medicine for one year after their procedure. Currently, patients take the anti-clotting drug Plavix for three to six months.
Because the drug is expensive and can cause severe bleeding, the panel said, patients who cannot take the drug for 12 months should not receive coated stents.
The FDA isn't required to follow the panel's advice, but it typically does.