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| Myasthenia Gravis For support and discussions on Myasthenia Gravis, Congenital Myasthenic Syndromes and LEMS. |
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02-12-2007, 10:48 PM
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Just received this info in my Yahoo email alert: WASHINGTON (CNN) -- The Food and Drug Administration on Monday announced labeling changes for the antibiotic Ketek, stripping it of two previously approved indications and adding a black-box warning, the agency's strongest.
The agency removed from the label the drug's approval for use in the treatment of acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. "The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications," the agency said in a news release. With Monday's announcement, Ketek remains approved for just one indication: the treatment of mild to moderate cases of pneumonia acquired outside hospitals or long-term care facilities. The boxed warning says the drug should not be used in patients with myasthenia gravis, which causes muscle weakness.
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Lois . |
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Ketek antibiotic a no-no!
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