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Keyword: montelukast

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  • Asthma Drug Label to Include Psychiatric Risk

    07/21/2009 9:08:43 AM PDT · by neverdem · 12 replies · 489+ views
    Family Practice News ^ | 1 July 2009 | LORINDA BULLOCK
    The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs. The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR). Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April. In its review, the FDA...