Suicidal ideation, depression linked to montelukast
The adverse events included five reports of suicidal ideation, five reports of depression, eight reports of agitation and other reports involving nightmares, altered mood and insomnia.
All these events are included in the PI precautions.
“Health professionals are reminded of the potential for neuropsychiatric adverse events during treatment with montelukast, particularly when initiating therapy and increasing the dose,” the TGA said.
Medicines Safety Update 2013; Vol 4, Number 2