FDA Cautions Regarding Psychiatric Events With Leukotriene Inhibitors

FDA has requested that the manufacturers of montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR) include a labeling precaution related to potential psychiatric events.

Post marketing surveillance of this class of drugs, leukotriene inhibitors, has revealed potential neuropsychiatric events such as agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. The FDA has recommened the following:

• Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
• Patients should talk with their healthcare providers if these events occur.
• Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.
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