Leukotriene inhibitors associated with neuropsychiatric events

September 14, 2009

In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.

In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.

Neuropsychiatric events such as agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, and tremor have been reported in patients treated with these agents.

The agency recommends that patients and healthcare professionals should be aware of the potential for these adverse events to occur, and healthcare professionals should consider discontinuing treatment with these agents if patients develop neuropsychiatric symptoms.