The NHS Business Services Authority (NHSBSA) holds patient identifiable data relating to drugs prescribed in England and dispensed within a community setting, and which are submitted to the NHSBSA for processing.

The following table shows the total number of identified children in the requested age bands that were prescribed Montelukast for the financial years 2020/2021 to 2024/2025:

Data Source: NHSBSA Information Services Data Warehouse.

It should be noted that the age ranges requested overlap for children aged five years old, so the given age bands should not be added or combined.

Care should be taken when interpreting the patient counts, as some patients could appear in the results for multiple time periods. For example, a single patient could appear in the results for multiple financial years. Therefore, the patient numbers should not be combined and reported at any other levels other than as provided in the dataset.

The NHS Business Services Authority (NHSBSA) holds patient identifiable data relating to drugs prescribed in England and dispensed within a community setting, and which are submitted to the NHSBSA for processing.

The following table shows the total number of identified children in the requested age bands that were prescribed Montelukast for the financial years 2020/2021 to 2024/2025:

Data Source: NHSBSA Information Services Data Warehouse.

It should be noted that the age ranges requested overlap for children aged five years old, so the given age bands should not be added or combined.

Care should be taken when interpreting the patient counts, as some patients could appear in the results for multiple time periods. For example, a single patient could appear in the results for multiple financial years. Therefore, the patient numbers should not be combined and reported at any other levels other than as provided in the dataset.

The Medicines and Healthcare products Regulatory Agency (MHRA) actively reviews the safety and efficacy of medicines throughout their life cycle. As well as through the licensing process itself, this is done via the Yellow Card safety reporting system, the actions of other international regulators, and patient feedback.

The MHRA updated the United Kingdom’s product information on using montelukast in 2019, to provide clearer warnings about the risk of neuropsychiatric side effects. The MHRA is currently conducting a further review of the safety data, and will communicate any changes when that review is concluded.

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.

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.

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.

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.

Warnings on mental health risks associated with the use of montelukast in children are included in the product information and in prescribing and other resources available to health professionals and patients. The warnings were strengthened in 2019 and the Medicines and Healthcare products Regulatory Agency issued an alert in its Drug Safety Update bulletin for prescribers. However, in response to concerns raised and in line with independent expert advice, more prominent warnings will be included in product information and patient alert cards and safety leaflets will be provided to patients. These materials are currently being developed and are expected to be introduced later this year.

Montelukast is effective in the treatment of asthma in adults, adolescents and children aged six months and older who are not adequately controlled on their usual/routine asthma medication and who need additional therapy. Montelukast also helps to prevent the narrowing of airways triggered by exercise. The benefits of montelukast have been shown to outweigh the risks in adults and children.

The very rare risk (up to 1 in 10,000 people) of neuropsychiatric reactions in association with montelukast treatment has been known for some time and information about adverse reactions including hallucinations and suicidal thinking and behaviour (suicidality) are already included in the product information for montelukast.

In September the Medicines and Healthcare Products Regulatory Agency published an article in Drug Safety Update to remind prescribers of the very rare risk of neuropsychiatric reactions with use of montelukast. The article outlines the risks and advises healthcare professionals to evaluate carefully the risks and benefits of continuing treatment with montelukast if neuropsychiatric reactions occur. Healthcare professionals are reminded to report any suspected adverse drug reactions associated with montelukast to the Yellow Card Scheme.

The Department fully understands that maintaining access to Montelukast is vitally important to many people in this country.

The Department has well established processes to manage and mitigate the small number of supply problems that may arise at any one time.

We are aware that one of the main suppliers of Montelukast 10 milligram (mg) tablets had a recent short-term supply issue. However, supplies of Montelukast from alternative suppliers remained available in sufficient quantities to meet normal demand. In addition, supplies of Montelukast 5mg tablets and Montelukast chewable 4mg tablets remained available.

Supplies of Montelukast tablets currently remain available in volumes that are sufficient to meet historic demand. We are continuing to work very closely with all the suppliers of Montelukast 10mg tablets and the supply situation continues to improve with further deliveries expected over the coming months.

Montelukast is an effective treatment for asthma in patients whose asthma is not adequately controlled by their usual medication.

As with many medications, there are some recognised side effects of this treatment. Individual patients should discuss risks and benefits of treatments with their general practitioner.