Panel to weigh unapproved drug-coated stent use
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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.
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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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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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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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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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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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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc  and Schering-Plough's  cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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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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A Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug.
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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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A U.S. advisory panel on Friday will review data on an experimental drug that is injected into the eye to stop vision loss in elderly patients at risk of going blind.
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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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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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Even some heart attack patients would be better off if their doctors avoided using drug-coated stents to open their clogged arteries, an international study found, raising new concerns about the devices.
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The panel will weigh evidence that stents used to treat clogged arteries can cause fatal blood clots, and is expected to recommend stricter regulation of the devices.
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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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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.