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Friday, May 25, 2012

FDA says it will review azithromycin study.

euters (5/18) reports that, following the release of a study indicating that azithromycin may be linked to increase risk of death in certain adult patients, the US Food and Drug Administration said that individuals should not discontinue use of the drug without consulting a physician.
        On NBC Nightly News (5/17, story 8, 2:40, Williams) NBC's chief medical editor, Nancy Snyderman, MD, said, "There have been isolated reports from the FDA of problems with this drug with heart disease. Researchers at Vanderbilt have found the drug could increase the risk of sudden cardiac death in some patients."
        Meanwhile, on ABC World News (5/17, story 6, 1:50, Sawyer), ABC News medical editor Richard Besser, MD, said, "The researchers found that in a million patients taking" the drug, "there were 45 more deaths from heart disease. The risk is higher for those with heart problems."
        Medscape (5/18) reports that the FDA also indicated that it "will review" the "new study," which was published in the New England Journal of Medicine. The agency, "in its announcement...reminded clinicians that QT interval prolongation, which can trigger an abnormal and sometimes fatal heart arrhythmia called torsades de pointes (TdP), has been linked not only with azithromycin but also with other" macrolides. The agency "said that it would update the public on any new information on azithromycin or the potential risk for QT interval prolongation after it reviews the NEJM study."

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