ISSUE 1 FEBRUARY
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 16 January 2025.
Summary
Montelukast is a prescription medicine used to prevent and treat chronic asthma in adults and children aged 2 years and older, and for symptomatic seasonal allergic rhinitis (hay fever).
Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events. These include behavioural changes, depression and suicidal thoughts and behaviour. The safety information includes:
- a new boxed warning
- additional guidance for prescribers and patients on the management of serious neuropsychiatric events.
This safety update follows a TGA safety investigation conducted in 2024 after international regulators strengthened warnings about neuropsychiatric events for montelukast products.
The update brings the Australian Product Information (PI) and Consumer Medicine Information (CMI) in line with international regulatory advice.
What health professionals should do
Health professionals are reminded about the potential neuropsychiatric effects associated with montelukast. These effects have been reported in all age groups taking montelukast, are generally mild and may occur by chance. However, symptoms can be serious and continue if treatment is not stopped. In rare cases, patients taking montelukast have died after experiencing suicidal behaviour.
Health professionals should be vigilant for neuropsychiatric reactions in patients taking montelukast and discontinue treatment if new or worsening symptoms occur.
Advise patients and their carers to be alert for changes in behaviour or for new neuropsychiatric symptoms and to seek medical advice immediately should they occur. Consider providing the CMI to remind patients of these effects.
See the full article on the TGA website.
