FDA Issues Second Warning On Side Effects From Popular New Heart StentOct 29, 2003 | 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 device evaluation 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.
Cypher maker Cordis Corp., a Johnson & Johnson subsidiary, is conducting a 2,000-patient study that, among other things, will track rare side effects. Enrollment is nearing completion, and data on blood clots should be available by the end of January, Cordis said.
"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' own analysis of the side-effect reports suggests blood clots are no more common with the Cypher than with bare-metal stents, said spokesman Martin Schildhouse.
Questions about blood clots haven't hurt Cypher usage: Today, about 60 percent of all stents implanted are Cyphers, up from about 45 percent in July, Schildhouse said.