TGA updates montelukast safety information

The Therapeutic Goods Administration (TGA) has updated its safety information for montelukast – the leukotriene antagonist most commonly used for the management of asthma in children.
 
The update, announced on Thursday, includes a new warning at the start of the product information and consumer medicine information sheets.
 
It also includes additional information for doctors and patients on what to do if these rare but serious changes in behaviour and mood are observed.
 
‘Please note that this is not new information,’ the TGA said.
 
‘It is a reminder to watch out for these possible side effects if taking montelukast.’
 
The changes follow long-running concerns about the medication, which is known to cause behavioural and neuropsychiatric disturbance, that in rare cases have been linked to suicidal ideation.
 
Dr Kerry Hancock, Chair of RACGP Specific Interests Respiratory Medicine, told newsGP this is a catalyst for GPs to review their processes around prescribing and monitoring this medication.
 
‘This is a good opportunity for us as clinicians to remind our patients of the potential for these adverse effects,’ she said
 
‘It’s good this information is now more available for patients, including for carers of children and young people.’
 
Dr Hancock encourages her GP colleagues to ‘highlight the warnings’ and ‘provide consumer medicine information to every patient or their carer’ with every prescription or re-prescription of montelukast. 
 
The prescription medication is used widely in the treatment and prevention of chronic asthma in children from the age of two years and adults, it may also be used in the management of hay fever.
 
Dr Hancock said though this safety information is not new, it provides a ‘timely reminder’.
 
‘I encourage all clinicians to have a conversation with their patients and/or their carers about these possible adverse effects, to be on the alert for them, and to advise ceasing montelukast if new or worsening symptoms occur,’ she said.
 
‘It is important for GPs to familiarise themselves with the updated information in the product information, the information on the TGA website, and the medicine safety update article.’
 
Highlighting the benefits of multidisciplinary teamwork, Dr Hancock also suggested working with the broader healthcare team to help increase awareness and monitoring.
 
‘GPs could also consider referral for a Home Medicines Review for their patients taking montelukast to ensure they or their carers are aware of these potential adverse effects,’ she said.
 
The TGA’s advice for healthcare professionals is to:

• look out 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 if they occur
• provide the consumer medicine information to patients to remind them of these effects, if needed.

asthma medication safety montelukast TGA