TGA ‘closely monitoring’ suicide and depression risk with asthma drug

Both the European and US medicines regulators have recommended changes to the product information for montelukast in recent years.

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.