The TGA is “closely monitoring” reports of suicide, sleep disturbances and other potential adverse neuropsychiatric events in children prescribed the asthma medication montelukast. 

Although prescribers and patients were explicitly warned of these risks with montelukast (Singulair) in a 2018 safety alert, the watchdog said it would consider taking further regulatory action if required.

Last November, the European Medicines Agency issued a directive for manufacturers of montelukast-containing products to update their product inserts with new text, printed in bold and boxed, to increase awareness of the neuropsychiatric events.

“Neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast,” it now reads.