Panel weighs unapproved drug-coated stent use
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GAITHERSBURG, Maryland  - The broad use of drug-coated heart stents in unapproved patients came under scrutiny on Friday as U.S. advisers weighed the risks of the tiny tubes implanted in millions to keep arteries open.
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The booming market for drug-coated   stents faces an uncertain future as some heart experts question   the long-term safety record of the devices.
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BARCELONA -- Specialists expressed concerns yesterday that drug-coated heart stents -- metal-mesh tubes used to prop open coronary arteries -- might increase the chances of potentially fatal blood clots.
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U.S. regulators said on Friday they  would review a study showing a Merck and Schering-Plough  cholesterol drug worked no better than a generic in preventing  the build-up of arterial plaque.
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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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Britain's medicines advisory agency is now planning to publish its latest recommendations on the cost-effectiveness of drug-coated stents late next week, in a decision that could draw fire from manufacturers.
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A panel of experts said federal regulators should relax restrictions on which patients are included in clinical trials of a widely used treatment for a common heart malfunction.
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It turns out the common practice of using stents to open the heart may not be right for some patients.
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The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
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The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.
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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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Federal advisers heard conflicting data today about the safety of new drug-oozing stents used to keep clogged arteries open as the experts struggled to advise government regulators about whether the risks of the devices outweigh their benefits for millions of patients.
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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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Growing evidence that deadly clots can form in drug-coated stents does not mean that the risks of using the devices the benefits, according to a panel of experts.
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The Food and Drug Administration said last night it would convene a public panel to examine the risk of blood clots in patients with drug-coated stents, among the world's most frequently implanted medical devices.
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A little-known Food and Drug program is testing the latest medical technology to determine how safe and useful it can be.    One cutting-edge experiment is designed to see if injecting certain drugs directly into diseased arteries works better than commonly used stents in keeping arteries clear...
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One of the nation's leading   cardiologists is calling for a sweeping study to evaluate the   risk of potentially fatal blood clots related to widely used   heart devices that treat blocked heart arteries.