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May 22, 2019  
HEART NEWS: Feature Story

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  • FDA Moves to Allay Concerns Over Stent

    FDA Moves to Allay Concerns Over Stent


    November 25, 2003

    WASHINGTON (AP) - The government moved to ease concerns Tuesday about deaths associated with a popular new drug-coated heart stent, saying it now appears the Cypher stent is no riskier than its competitors.

    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.

    Months after the Cypher began selling last spring, the Food and Drug Administration began warning about reports of those blood clots in Cypher recipients - totaling 360 cases last week, including more than 70 deaths.

    Considering more than 260,000 Cypher stents had been distributed to U.S. hospitals, the risk of any problem was small.

    Still, FDA blamed some cases on inappropriate use of the Cypher, such as doctors who chose the wrong size, or improper anti-clotting medication. Cypher recipients must take anti-clotting drugs for three months, longer than the mere two weeks prescribed for bare-metal stents.

    Last month, the agency said it didn't know whether Cypher was riskier than ordinary stents or if publicity was spurring complaints.

    The FDA answered that question on Tuesday, saying blood clots among Cypher recipients to date appear "within the expected rate for any stent."

    Hundreds of thousands of patients have been successfully treated with the Cypher, FDA said, calling it safe and effective when usage instructions are followed.

    The FDA said it will continue monitoring stents, like it does all medical devices. Also, the agency expects next year to get results from a 2,000-patient study by Cypher maker Cordis Corp., a Johnson & Johnson subsidiary, that will provide additional data on the stent by tracking rare side effects.

    ---=

    On the Net:

    Food and Drug Administration: http://www.fda.gov/cdrh/safety/cypher2.html


    Last updated: 25-Nov-03

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