U.S. 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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Most patients with drug-coated stents face an increased risk of heart attacks and death, but it's unclear whether their already poor health or the devices are to blame, federal health advisers said Friday.
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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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GAITHERSBURG, Md. -- Federal advisers yesterday said that drug-coated stents, which have been implanted in millions, offer clear benefits to many patients but present higher clotting risks to others, suggesting they may be overused.
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The FDA is about to make it harder for drug-eluting stents to win its approval.
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Drug-coated stents -- tiny wire-mesh tubes used to prop open clogged heart arteries -- may not be as dangerous as previously thought, Swedish researchers who had earlier raised concerns over the devices said on Sunday.
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Doctors can safely use drug-coated stents to open up complicated blockages in coronary arteries for which the devices were not originally designed, according to new research. In fact, they appear to work better than older, bare-metal stents in those situations.
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U.S. advisers will start considering on Thursday the risks of drug-coated stents implanted in millions of heart patients, examining evidence showing the devices may lead to dangerous blood clots.
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NEW YORK  - For patients with several blockages in their coronary arteries, mortality rates are lower when they undergo bypass grafting rather than having the new generation of drug-eluting stents inserted, a study shows.
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The two manufacturers of drug-coated stents used to prop open the arteries of about 3 million people in the U.S. say the devices' benefits outweigh their risks, even though patients could face a small but significant risk of blood clots.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts  the medicine could be used safely without a doctor's guidance.
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A panel recommended that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents.
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FDA advisory panel gives the nod to its heart drug.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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Drug-coated heart stents on the U.S. market are associated with a small but significant risk of blood clots months after they are implanted, U.S. Food and Drug Administration staff said in documents released on Tuesday.
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GAITHERSBURG, Maryland  - A U.S. advisory panel heard evidence on Thursday about risks of drug-coated stents, the tiny mesh tubes used to prop open arteries in millions of heart patients.
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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.