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  • FDA Date: 08/28/2009

    Singulair (montelukast) FDA Drug Safety Communication

    Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA and the manufacturers of Singulair (montelukast), Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR (zileuton extended release) are announcing an update to the Precautions section of the prescribing information to include information about neuropsychiatric events reported in patients using these products. The events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Healthcare professionals should be aware of the potential for neuropsychiatric events and consider discontinuing these medications if patients develop neuropsychiatric symptoms.

    View the full FDA Drug Safety Communication on FDA.gov