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Risk of neuropsychiatric reactions with montelukast reinforced in drug safety update

Healthcare professionals prescribing montelukast as an oral add-on therapy for the treatment of asthma in patients aged six months or older should be alert to serious behaviour and neuropsychiatric reactions associated with the treatment, according to a new drug safety update.

This reminder about montelukast from the Medicines and Healthcare products Regulatory Agency (MHRA) comes after continued Yellow Card reports of a range of neuropsychiatric reactions such as sleep disorders, hallucinations, anxiety and depression, and changes in behaviour and mood.

A review of evidence by the MHRA concluded that while the risk of neuropsychiatric reactions with montelukast remains unchanged since its last Drug Safety Update on montelukast in 2019, the Yellow Card reports have indicated this risk is potentially not well known by healthcare professionals, patients and their caregivers.

Commenting on the review, Dr Alison Cave, MHRA chief safety officer, said: ‘Patient safety is our top priority. Throughout our review, we have listened to patient representatives and taken independent clinical advice from paediatricians, specialists in mental and respiratory health and experts from the Commission on Human Medicine’s Expert Advisory Groups.’

She added: ‘We have now taken regulatory action to update the leaflet included in all montelukast medicine packs in the UK with prominent warnings and advice about the risk of serious behaviour and mood-related changes.’

The MHRA is urging healthcare professionals to make patients and their caregivers aware of this information and encourage them to immediately speak to their prescriber or seek urgent medical attention if neuropsychiatric reactions occur while using montelukast.

The regulator also confirmed that the benefits of montelukast continue to outweigh the risks for most patients for the management of asthma and that this is under continuous review.

The risk of neuropsychiatric side effects has been included in the product information for montelukast since 2008, and following a European review in 2019, additional warnings about these risks were included in the EU and UK product information.

Last year, researchers found that prenatal leukotriene receptor antagonist use was not associated with a higher incidence of neuropsychiatric events in their offspring.