FDA Widens Heart Failure Therapy Pool
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Cardiovascular device maker Guidant  Corp. GDT.N said on Wednesday U.S. regulators cleared the use  of its implantable heart failure therapies for a wider group of  patients.
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The move follows recent studies suggesting that the medications might cause heart attacks.
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The Food and Drug Administration on Thursday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
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The results from the new clinical trial could increase the chances that the Food and Drug Administration will approve the drug for that use.
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Biotech companies, medical device  makers and food manufacturers joined patient groups and three  former U.S. health secretaries on Monday in calling for  increased funding for the Food and Drug Administration.
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Medicare has agreed to expand coverage by one-third for implantable cardiac defibrillators (ICDs) -- devices used to steady hearts that beat irregularly -- to 500,000 patients, the Minneapolis Star Tribune reports.
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A study finds a polyester mesh stocking pulled up over the wide bottom of a weak heart can help it pump better and even shrink back to a more normal size.
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A device that automatically detects early symptoms of congestive heart failure has been implanted in patients in the United States this month for the first time.
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WASHINGTON -- Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would allow drug companies to charge for the medicines.
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The U.S. Centers for Medicare and  Medicaid Services (CMS) on Tuesday proposed expanding coverage  for costly devices to restore normal heart rhythms to a much  broader population of heart patients.
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Biotech companies, medical device   makers and food manufacturers joined patient groups and three   former U.S. health secretaries on Monday in calling for   increased funding for the Food and Drug Administration.
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WEDNESDAY, Feb. 13 (HealthDay News) -- A greater percentage of patients than previously thought may develop heart failure when taking the breakthrough cancer drug Sutent, researchers report.
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In both studies, the drug Avandia, made by GlaxoSmithKline, raised risks of heart failure.
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A novel fabric mesh sleeve that works like a girdle to reshape enlarged hearts showed promise in treating patients with heart failure and will be submitted for U.S. regulatory approval this year, according to researchers and the company that makes the device.
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Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would allow drug companies to charge for the medicines.
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The federal Food and Drug Administration said Friday that it would strengthen its safety and review process for pharmaceuticals already on the market to learn more about their possible side effects.
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Sanofi-Aventis said on Friday that  U.S. regulators had approved wider use for its colon cancer  drug Eloxatin, lifting shares in the world's third-largest  pharmaceuticals group.