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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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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Drug-releasing stents used widely to keep clogged heart arteries open may increase the risk of potentially dangerous blood clots, but there is no conclusive evidence that the devices boost the likelihood of having a heart attack or dying if used as recommended, an expert panel said yesterday.
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Stent makers and cardiologists said reports at this yearâs major meeting of European cardiologists bolstered their confidence in the safety of the newer drug-coated versions of the devices.
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Coronary stents don&#39;t improve the long-term survival rates of heart patients, a Duke University Medical Center study contends.
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NEW YORK - Johnson &amp; Johnson and Boston Scientific Corp. reported new safety data yesterday for drug-coated stents that may help revive sales depressed by prior reports linking the devices to a higher risk of heart attacks.
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A flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart-disease patients.
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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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GAITHERSBURG, Maryland  - Drug-coated heart stents deliver benefits that outweigh any risks of blood clots when used as directed, a U.S. advisory panel said on Thursday.
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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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A Food and Drug Administration panel tomorrow will consider one of the most urgent questions in medicine: what to do about the risk of blood clots caused by drug-coated stents, tiny medical devices implanted in the arteries of millions of people.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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BETHESDA, Md.  - U.S. advisers are set to decide  on Friday whether they will recommend approval for Merck & Co.  Inc.'s plan to sell a cholesterol-lowering medicine on  drugstore shelves without a prescription.
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The most exhaustive studies yet published on drug-coated stents show that the widely used heart devices are no better at preventing heart attacks and death than the older, cheaper devices they replaced, and in some cases may be slightly worse.
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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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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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Advisers to the U.S. Food and Drug Administration on Friday will consider the risks of drug-coated stents in patients with medical complications who are not approved for the artery-opening heart devices.