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Senior Citizen Health & Medicine

FDA Health Advisors Say Drug-Coated Stents are Safe When Used as Labeled

Disagree with increased risk if medication to prevent clots not used longer

December 7, 2006 – Despite the warning in a research report published this week in JAMA, which said patients receiving drug-coated stents to open heart arteries needed to take anti-platelet medication longer, health advisors to the Food & Drug Administration say the use of these stents do not increase the risk of heart attack or death when used as labeled but may put patients at risk for blood clots, according to an Associated Press report by Andrew Bridges.

 

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Death Risk Lowered for Patients Getting Drug-Eluting Stents by Longer Use of Anti-Clotting Drug

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December 6, 2006 - Patients who receive drug-coated stents to open heart arteries may lower their risks of heart attack or death by taking an anti-platelet medication longer than current recommendations, according to a study funded by the Agency for Healthcare Research and Quality and published December 5 in the online version of JAMA. (See FDA statement below news report.) Read more...


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While the panel of experts broadly dismissed the more serious risks, they split on characterizing the degree of the increased clotting risk in comparison with older, bare-metal stents. They agreed only that more study of the newer devices is needed, wrote Bridges today.

The panel also said, according to the AP, that any safety concerns fail to outweigh the benefits of the stents — tiny mesh tubes used like scaffolding to keep blood free-flowing through the arteries. Drugs that coat the stents elute, or dissolve, into the bloodstream to prevent reclogging of arteries.

"The message is drug-eluting stents are safe and that the safety concerns are far outweighed by evident clinical benefit," panel chairman Dr. William Maisel, of Beth Israel Deaconess Medical Center in Boston, told reporters.

Bridges reports the mixed verdict came at the outset of a two-day meeting of the Food and Drug Administration advisers, convened to discuss possible clotting and associated risks of the drug-coated stents. The panel's findings Thursday apply only to the minority of patients for whom the FDA-approved labeling says use of the devices is appropriate.

>> Read the full report by the Associated Press – click.

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