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Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers

Safety Assessment Acute toxicity A single subcutaneous injection of AOD 9604 (50 mg/kg) did not cause death or obvious toxic reactions in mice