Montelukast safety review

The TGA is undertaking additional risk-mitigation activities following a new safety review of  asthma medication montelukast.

The government had requested the TGA conduct a safety review of the drug following reports in the media of serious neuropsychiatric events occurring in association with montelukast in children and adolescents.

The review evaluated literature published since 2013 (when the issue was last reviewed) and included consultation with international regulators and input from the Advisory Committee on Medicines. This approach has the support of the Royal Australian College of General Practitioners and the Australian Medical Association.

Montelukast, marketed in Australia under the brand name Singulair and multiple generic brands, is used to prevent and treat chronic asthma in adults and children aged two years and older. It can also be used for the symptomatic treatment of seasonal hay fever. It has been registered for use in Australia since 1997 and is listed on the PBS as a single preventative medicine for the treatment of mild persistent or frequent intermittent asthma in children/adolescents aged two to 14 years. It is also listed on the PBS for the prevention of exercise-induced asthma in children/adolescents aged six to 14 years.

The TGA says there is a known association between montelukast and neuropsychiatric events (such as agitation, sleep disturbance and depression) including, in rare cases, suicidal thinking and behaviour. A precaution about this risk is contained in the product information for montelukast, and the TGA advises prescribers they should consult this for further details of potential neuropsychiatric adverse events and carefully evaluate the risks and benefits of continuing treatment with montelukast if such events occur.

When treating children with montelukast, the TGA recommends that healthcare professionals also educate caregivers about these potential adverse effects, consider providing them the consumer medical information, and advise them to seek medical advice if they have any concerns.