Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the dangers to some users of the asthma drug montelukast; and what discussions they have had with the montelukast UK action group, which has highlighted the risks of the drug.

Montelukast remains a safe and effective medicine in the treatment of asthma. Montelukast is indicated for use in the United Kingdom as an add on treatment for asthma patients who are inadequately controlled on inhaled corticosteroid treatment, and can be prescribed for the symptomatic relief of seasonal allergic rhinitis in patients with asthma.

Neuropsychiatric effects such as depression have been included in the UK product information for montelukast since 2007. This has been subsequently updated with additional terms, based on emerging evidence. This includes the most recent update in 2019, to more fully describe the neuropsychiatric effects. In order to remind prescribers of the risk of the neuropsychiatric effects with montelukast, a Drug Safety Update article was published by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2019 to accompany the updated warnings.

Following a growing number of Yellow Card reports and queries from patients and caregivers raising concerns about a potential ongoing lack of awareness of the risk of the neuropsychiatric effects with montelukast, the MHRA is conducting a further review of the latest data. As part of our review, we are evaluating all available evidence including Yellow Card reports and queries received by the MHRA, literature publications, international regulatory changes, including those made by the United States’ Food and Drug Administration, and listening to and learning from patients’ experiences.

The MHRA has sought advice from our independent expert groups including paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety. Patient representatives from the UK action group, including parents of children and young people who had taken montelukast, were invited to the MHRA’s independent pharmacovigilance expert advisory group (PEAG), to share their lived experiences of dealing with the impact of the neuropsychiatric effects, including the impact of lack of awareness of the side effect. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.