U.S. to ask advisers about drug-coated stent risks
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U.S. health officials said on   Thursday they will ask outside advisers later this year to   review recent studies suggesting drug-coated stents may raise   the risk of blood clots months after they are implanted.
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WASHINGTON -- Federal health officials asked experts Thursday whether the drug-coated stents used to prop open the arteries of about 3 million people in the U.S. pose a heightened risk of death or raise other safety concerns that require action.
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Blood clotting is four to five times more likely in patients getting drug-coated heart devices known as stents, compared to the older bare-metal variety, according to a large data analysis released on Wednesday.
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The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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The concerns that have been raised about the safety of drug-eluting stents at a major cardiology conference shouldn't mean it's time to go back to older treatments, the chief medical and scientific officer of Natick medical technology company Boston Scientific Corp. said yesterday.
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GAITHERSBURG, Maryland  - A U.S. advisory panel on Friday was divided over whether current data warrant changes to drug-coated heart stent labels for their use in patients with more medical complications unapproved for the device.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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The FDA is about to make it harder for drug-eluting stents to win its approval.
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Boston Scientific Corp. found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal versions, a company spokesman said Thursday.
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Experts expressed concerns Sunday that drug-coated heart stents &#151; metal-mesh tubes used to prop open coronary arteries &#151; may in rare instances lead to potentially fatal blood clots.
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Patients given drug-coated stents after an acute heart attack are nearly 5 percent more likely to die a year or more later than those with bare metal forms of the arterial scaffolding, new research showed on Tuesday.
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Johnson &amp; Johnson's drug-coated Cypher heart stent may be better than Boston Scientific's Taxus for repeat procedures to unclog some arteries, according to a study in the Jan. 12 Journal of the American Medical Association.
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One of the nation's leading   cardiologists is calling for a sweeping study that evaluates   the risks of potentially fatal blood clots related to widely   used heart devices that treat blocked heart arteries.
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U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
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Abbott Laboratories Inc.  on Friday said it submitted its application to the U.S. Food and Drug Administration for its drug-coated stent called Xience and expects to start selling the heart device in the first half of 2008.
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New drug-releasing stents used widely to keep clogged heart arteries open appear to increase the risk for potentially life-threatening blood clots more than older bare-metal versions, government investigators told an expert panel assessing the safety of the devices today.
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Results of a study showing patients with acute heart attacks are more likely to die if given a drug-coated stent than a bare metal one are out of line with other findings, stent maker Johnson & Johnson said on Tuesday.