WASHINGTON (AP) - More than 60 patients who received a popular new drug-coated heart stent have died, the government disclosed Wednesday - a surprising increase since the last health warning about the device just months ago.
The Cypher stent is a tiny metal scaffold used in patients with heart disease. It props open a cleaned-out artery and, unlike other stents, emits a drug to reduce the chances the artery will clog again.
But that drug doesn't prevent a different risk posed by all stents: blood clots that form around the device and can cause a heart attack.
Cypher stents began selling in April, and in July the Food and Drug Administration warned that it already had received reports of those blood clots in 34 Cypher recipients, including five who died.
Wednesday, the FDA issued a second warning: It now has counted more than 290 reports of blood clots in Cypher recipients, and in more than 60 the device was associated with the patient's death. Those clots occurred up to 30 days after the stent was implanted.
In addition, the FDA has received more than 50 reports of allergic-type reactions: pain, hives, fever and problems with breathing and blood pressure. The FDA said some of those people died, although it did not reveal how many.
The cause of the problems hasn't been determined, the FDA said, stressing that it doesn't yet know whether the Cypher is riskier than a bare-metal stent. In studies that led to the Cypher's approval, it proved no more likely to cause blood clots than competing stents.
Some 260,000 Cypher stents have been distributed to U.S. hospitals and 180,000 abroad, making the number of problems reported very small in comparison. And some of the increased reporting since July is likely due to increased publicity, cautioned FDA cardiology devices chief Dan Schultz.
However, the FDA often learns of only a fraction of the side effects that occur with medical products. So, in a public health warning to doctors posted on its Web site, the FDA urged physicians to promptly report any problems with Cypher recipients.
"We have a signal," Schultz explained. "It's a strong enough signal that as a responsible public health organization we need to at least inform people" while scientists determine if there's really a serious risk.
As part of the probe, FDA is requiring that Cypher maker Cordis Corp. conduct a 2,000-patient study that will track rare side effects.
"There's no perfect treatment," noted Dr. Richard Nesto, cardiovascular medicine chief at the Lahey Clinic in Burlington, Mass., and a spokesman for the American Heart Association.
Still, "this does merit scrutiny," he added, saying cardiologists are watching the Cypher saga closely and probably will remind patients of the importance of taking their anti-clotting medication.
Cypher recipients must take anti-clotting drugs for three months after getting the stent, not the mere two weeks prescribed for bare-metal stents.
In addition, the FDA wants doctors to be sure they choose the right size stents and implant them properly.
Cordis, a Johnson & Johnson subsidiary, did not immediately comment.
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On the Net:
Food and Drug Administration: http://www.fda.gov/cdrh/safety/cypher.html
