Montelukast under review

THE Therapeutic Goods Administration is undertaking “additional risk mitigation activities” in relation to montelukast, after a new safety review of the widely used asthma medication.

Marketed in Australia under the brand name Singulair as well as multiple generic brands, montelukast is indicated for the prevention and treatment of asthma in adults and children aged two years and older, and can also be used for the symptomatic treatment of seasonal hayfever.

A TGA update yesterday said there was a known association between montelukast and neuropsychiatric events such as agitation, sleep disturbance and depression, which is detailed in the medication’s product information.

The latest safety review was requested following media reports of serious neuropsychriatric events occurring with montelukast in children and adolescents.

The TGA has written to state and territory health departments, NPS MedicineWise and other groups to formally request inclusion of advice regarding montelukast and neuropsychiatric events in relevant clinical guidelines and CPD activities.

Prescribers are advised to carefully evaluate the risks and benefits of continuing montelukast treatment if neuropsychiatric events occur, and to educate caregivers about the potential adverse effects.