Other safety alerts
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| Australia: Safety review: Montelukast |
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The Therapeutic Goods Administration (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).
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.
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.
The ACM reviewed the issue on 5 Apr 2018 and offered the following advice:
- 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 (a) liaison with relevant parties who provide templates for asthma management plans to include a prompt in these plans regarding counselling on potential neuropsychiatric events; (b) 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/montelukast
In Hong Kong, there are 54 registered pharmaceutical products containing montelukast, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to montelukast, of which one case was related to neuropsychiatric events. Neuropsychiatric adverse effects of montelukast are documented in reputable drug references such as Martindale: The Complete Drug Reference. DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Jul 13, 2018
Issued at HKT 15:00
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