- The Washington Times - Wednesday, October 29, 2003


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 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.

Yesterday, 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 cases, 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 tiny in comparison. And some of the increased reporting since July is likely a result of increased publicity, said 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.

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