The Food and Drug Administration advised physicians that it has received more than 290 reports of blood clotting, resulting in 60 deaths, in patients implanted with Johnson & Johnson's drug-eluting stent to prop open previously blocked coronary arteries. More than 50 additional reports, including some deaths, suggest there may be possible hypersensitivity reactions as well, the FDA said. Symptoms include blood pressure changes, fever, hives, itching, pain, rash and respiratory problems. Hundreds of thousands of patients have been treated with the Cypher stent, which is manufactured by Cordis Corp., a J&J company. Regulators said they did not have enough information to determine if the complications differed from complications associated with traditional bare metal stents, and the FDA is working with Cordis to quickly gather information. The FDA approved the Cypher stent in April. Because its drug-eluting properties significantly reduce the risk of reblockage following coronary angioplasty, the technology is expected to change the economic and clinical landscape of open-heart surgery. -- by Cinda Becker
FDA advises of 60 deaths associated with J&J stent
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