FDA Update on Drug-Coated Stents

Drug-Coated Stents

Corporation’s Cypher Coronary Stent. The agency emphasized that it considers the drug-eluting stents safe and effective when label directions are followed, particularly in terms of patient selection and the appropriate use of the medication.

Numerous patients have been successfully treated with the stent, which was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. In October, however, the FDA notified physicians about reports of thrombosis and clotting occurring within 30 days after the device was implanted and of possible hypersensitivity reactions. The agency asked physicians and patients to report any adverse effects associated with the stents.
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To date, the rate of thrombosis has remained within the expected range for any stent. As of November 21, 75 additional (more than 360 total) cases of thrombosis have been reported, including 10 additional deaths (more than 70 in all).

In most cases, hypersensitivity reactions were minor (e.g., skin rashes and itching that cleared up within a few days), but some reactions were severe (e.g., anaphylaxis). Although some of the reactions remain unexplained, many of them are believed to be related to standard drug therapy associated with the procedure.