Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of any dangers to some users of the commonly prescribed asthma drug montelukast.

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. There is no licensed indication in the UK for the treatment of allergic rhinitis alone.

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, which more fully described the neuropsychiatric effects. In order to remind prescribers of the risk of 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 current 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 are 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.

We are considering all relevant regulatory actions that would provide the most effective way of increasing awareness to healthcare professionals, patients, and their caregivers. The MHRA is finalising the review process and will communicate on any further measures to minimise the risk, upon completion of our review.