Neuropsychiatric adverse events are reported in some patients taking leukotriene inhibitors (e.g. montelukast and zileuton)
In 2009, the USA Food and Drug Administration (FDA) reported on an investigation of neuropsychiatric adverse events associated with the leukotriene pathway inhibitors, both the leukotriene receptor antagonists (e.g. montelukast) and the 5-lipoxygenase inhibitor (zileuton) (1). It was concluded that “reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor”. The FDA, therefore, issued the following advice to patients and healthcare professionals:
“Advice to patients and healthcare professionals
- 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.”