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Mirtazapine Approved in Japan for Major Depressive Disorder NEW YORK -- July 9, 2009 -- Mirtazapine 15 mg (Remeron) tablets has been approved for the treatment of major depressive disorder in Japan. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behaviour, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. In 6-week controlled clinical trials in the United States, the most commonly reported adverse events associated with mirtazapine were somnolence (54%), increased appetite (17%), weight gain (12%), and dizziness (7%). In short-term clinical trials, 10.4% of patients discontinued therapy due to somnolence. In a pool of premarketing US studies, including patients in long-term, open-label treatment, 8% of patients discontinued therapy due to weight gain. SOURCE: Schering-Plough Corporation E-mail this page to a friend or colleague! To print, use this version