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FDA Continues to Assess Data Regarding Neuropsychiatric Events Associated with Leukotriene Pathway Treatments
January 13, 2009 -- FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.
Source: Food and Drug Administration
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