FDA Panel Seeks Warning That Stents May Be Unsafe
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New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded yesterday.
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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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Patients implanted with drug-coated stents to hold open their choked arteries face a small but significant risk of blood clots, health officials said Tuesday, and a new study recommended they take clot-busting medications indefinitely.
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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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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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ROCKVILLE, Md.  - 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to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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MONDAY, Dec. 4 (HealthDay News) -- Heart patients with drug-eluting stents implanted to keep their arteries open were found to have a much higher risk of sudden death than those getting bare metal stents if they stopped taking the blood thinner Plavix, a new Swiss study reports.
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Drug-coated stents are safe to implant in cardiac blood vessels immediately after a heart attack, according to two studies in today's New England Journal of Medicine.
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GAITHERSBURG, Maryland  - A U.S. advisory panel unanimously said the benefits of drug-coated heart stents outweigh their risks when used as directed, a Food and Drug Administration spokeswoman said on 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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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  - Drug-coated heart stents deliver benefits that outweigh any risks of blood clots when placed in appropriate patients, a U.S. advisory panel said on Thursday.
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BETHESDA, Md.  - A U.S. advisory panel urged  regulators on Tuesday to require a "black box" warning on  antidepressant labels about the increased risk of suicidal  behavior in youth who take the drugs.
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NEW YORK  - When people with diabetes  undergo coronary artery stenting to open clogs, women are more  at risk for major adverse events than men, doctors in Germany  report.
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A panel of experts reaches mixed conclusions on the safety and effectiveness of drug-coated stents.
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A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.'s  cholesterol-lowering drug Mevacor.