The Health Sciences Authority (HSA), in consultation with its Product Vigilance Advisory Committee (PVAC), would like to inform healthcare professionals of the new restriction on the use of montelukast due to the risk of neuropsychiatric events. This follows HSA’s benefit-risk assessment of montelukast which concluded that the benefits of montelukast for use in allergic rhinitis patients remain favourable if additional precautionary measures are put in place to mitigate the known but rare risk of neuropsychiatric events.
These measures include restricting the use of montelukast in the treatment of allergic rhinitis to patients who have inadequate response or are intolerant to alternative therapies, and the strengthening of existing warnings on neuropsychiatric risks in the package inserts (PIs) of montelukast-containing products. Healthcare professionals are advised to consider the benefits of treatment and risks of neuropsychiatric effects before prescribing montelukast.
Please refer to the Dear Healthcare Professional Letter (DHCPL) for details:
