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The FDA plans to update the label of montelukast sodium (Singulair, Merck) zafirlukast (Accolate, AstraZeneca), and zileuton (Zyflo, Cornerstone) with a precaution concerning neuropsychiatric events such as agitation, depression, insomnia, and suicidal thinking.
Montelukast drug is indicated for use in children and adults as an asthma and allergy treatment; zafirlukast and zileuton are approved as asthma treatments. All three products are generic leukotriene modifiers.
Neuropsychiatric events also included agitation, aggression, anxiousness, restlessness, dream abnormalities, hallucinations, irritability, suicides, and tremor.
Sources: FDA and The Wall Street Journal, June 12, 2009
