May 1st 2024

By Ailsa Colquhoun

New safety warnings for Singulair

More prominent warnings relating to neuropsychiatric reactions are to be added to the patient information leaflet for montelukast (Singulair).

New guidance concludes that patients are potentially unaware about frequently reported neuropsychiatric reactions to the drug such as sleep disorders, hallucinations, anxiety and depression, and changes in behaviour and mood.

Prescribers should note that the risk of neuropsychiatric reactions with montelukast remains unchanged. To raise awareness, new boxed warnings will be added to the PIL. 


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