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Safety review

12 July 2018

The TGA is undertaking additional risk mitigation activities following a new safety review of montelukast. The review evaluated literature published since 2013 (when the issue was last reviewed) and included consultation with international regulators and obtaining expert advice from the Advisory Committee on Medicines (ACM). This approach has the support of the Royal Australian College of General Practitioners (RACGP) and the Australian Medical Association.

Montelukast, which is 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 hayfever. It has been registered for use in Australia since 1997 and is listed on the Pharmaceutical Benefits Scheme as a single preventative medicine for the treatment of mild persistent or frequent intermittent asthma in children/adolescents aged 2 to 14 years. It is also listed on the PBS for the prevention of exercise-induced asthma in children/adolescents aged 6 to 14 years.

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. The Product Information (PI) for montelukast contains a precaution about this risk.

The Government requested the latest safety review following reports in the media of serious neuropsychiatric events occurring in association with montelukast in children and adolescents.

Expert advice and TGA actions

The ACM reviewed the issue on 5 April 2018 and offered the following advice (see meeting statement):

  • In current clinical practice, montelukast is a useful first-line treatment for mild to moderate asthma in a small but well-defined population.
  • It would be helpful if the TGA liaised with various authoring bodies of guidance documents used by prescribers and asthma nurse educators to insert advice similar to that in the Asthma Australia fact sheet, which provides one page of consumer-friendly advice on this issue. They also recommended
    • liaison with relevant parties who provide templates for asthma management plans to include a prompt in these plans regarding counselling on potential neuropsychiatric events
    • inclusion of the Consumer Medicine lnformation (CMI) in the packaging and encouraged active provision of the CMl to the parent/carer, with counselling, at the point of dispensing.
  • Liaison with the Australian Paediatric Surveillance Unit may be useful to provide additional Australian data on the association between montelukast and neuropsychiatric events.
  • Consideration could be given to developing a more general consumer educational activity using montelukast as an example.

In response to the ACM's advice and the findings of its safety review, the TGA has:

  • written to State and Territory health departments, NPS MedicineWise, Health Direct and Therapeutic Guidelines to formally request inclusion of advice regarding montelukast and neuropsychiatric events in relevant clinical guidelines and educational activities.
  • written to all sponsors of montelukast to request inclusion of the CMI in the packaging with information regarding potential neuropsychiatric events
  • contacted the Australian Paediatric Surveillance Unit about potentially including montelukast and neuropsychiatric events in their monthly survey of clinicians.

Information for consumers

If you or someone you provide care for takes montelukast, please be aware of the potential for neuropsychiatric events (such as agitation, sleep disturbance and depression) associated with this medicine.

If you notice a change in behaviour, seek medical attention. If the patient is a child or adolescent, or the symptoms are severe (such as suicidal thinking or behaviour), seek urgent medical attention.

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals

You are reminded of the known association between montelukast and neuropsychiatric events, particularly when initiating therapy or increasing the dose. This is especially important if your patient is a child.

Prescribers should consult the PI for further information on 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 you also educate caregivers about these potential adverse effects and consider providing them the CMI. Advise them to seek medical advice if they have any concerns.

The TGA has previously published information about this issue in it medicines safety bulletin, Medicines Safety Update.

The RACGP has also published related information:

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.