Contributed by William Angelos| 10 December, 2006  01:22 GMT
 Drug-coating stents used to keep arteries open following procedures to remove blockages have been linked to increased risk of heart attacks. An FDA panel is recommending that warning information be added to labeling for the devices.
Drug-coated stents frequently used in patients with heart disease to keep their arteries open following procedures to remove blockages may increase the risk of a sudden heart attack, warns a
US Food and Drug Administration (FDA) advisory panel.
The two brands of the devices currently available in the US -- Taxus, made by Boston Scientific and Cypher, made by Cordis, a division of Johnson & Johnson -- should include warning labels, the group recommends.
Stents are implanted in about a million patients each year in the US. The tubes, which are either constructed of bare metal mesh or coated metal that steadily releases drugs into artery walls, are usually inserted in angioplasty procedures.
Although the use of stents has become a popular alternative to heart bypass surgery, researchers reported earlier this year that the drug-coated versions may increase the risk of heart attacks and death, prompting the FDA to establish the review panel.
Still, the benefits of the devices outweigh the potential risks for most patients, according to an informal vote of the panel. The heightened risk should be taken into account in determining the best treatment plan for more complicated cases. |
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