Deaths Spur New Caution From FDA On Stent UseOct 30, 2003 | AP
More than 60 patients who received a popular new drug-coated heart stent have died, the government disclosed yesterday a surprising increase since the last health warning about the device months ago.
The Cypher stent is a tiny metal scaffold used in patients with heart disease. It props open a cleaned-out artery but goes beyond other stents to emit a drug to reduce the chance the artery will clog again. But that drug does not prevent a different risk posed by all stents: blood clots that form around the devices and can cause a heart attack.
Sale of Cypher stents began in April; in July, the Food and Drug Administration warned that it had received reports of blood clots in 34 recipients, including five who died.
Yesterday, the FDA issued a second warning: It now has more than 290 reports of blood clots, and in more than 60 patients, the device was associated with death. Those clots occurred up to 30 days after the stent was implanted.
The FDA has also 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 patients died, but it did not say how many.
The cause of the problems has not been determined, the FDA said, stressing that it does not know whether the Cypher is riskier than a bare-metal stent. In studies that led to the Cypher's approval, it was found 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 small in comparison. Some of the increase in reports since July is likely due to increased publicity, FDA device evaluation chief Dan Schultz cautioned.
Cypher maker Cordis Corp. is conducting a 2,000-patient study that will track side effects. Enrollment is nearly complete, and data on blood clots should be available by the end of January, Cordis said.