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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.
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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