Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many prescriptions for mirtazapine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for mirtazapine in each year since 2014; and what consideration NHS England has given to adding sexual dysfunction as a side effect on the patient information leaflets for mirtazapine.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the total number of items issued for mirtazapine, each year since 2014 to 2023:
Time Period | Total items issued |
2014 | 6,056,918 |
2015 | 6,783,906 |
2016 | 7,526,200 |
2017 | 8,198,345 |
2018 | 8,938,362 |
2019 | 9,702,599 |
2020 | 10,532,577 |
2021 | 11,249,963 |
2022 | 11,776,025 |
2023 | 12,401,593 |
Source: Data was provided by the NHS Business Services Authority, using the British National Formulary chemical substance mirtazapine
Note: Items have been dispensed, but not necessarily prescribed, in England.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.
The MHRA has received a total of 46 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine, four of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn. The following table shows the number of Yellow Card reports of suspected mirtazapine related sexual dysfunction, and reports of sexual dysfunction that persisted after the drug was withdrawn, each year from 2014 to 2024:
Year | Reports of sexual dysfunction | Reports of sexual dysfunction that continued after mirtazapine was withdrawn |
2014 | 3 | 0 |
2015 | 1 | 0 |
2016 | 2 | 0 |
2017 | 3 | 0 |
2018 | 1 | 0 |
2019 | 5 | 1 |
2020 | 3 | 0 |
2021 | 5 | 1 |
2022 | 10 | 1 |
2023 | 9 | 0 |
2024 | 4 | 1 |
Source: data provided by the MHRA.
It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.
The MHRA continuously monitors the safety of medicines on the United Kingdom’s market, including mirtazapine. Reports of suspected adverse reactions are reviewed weekly by a multidisciplinary team as part of the MHRA’s signal detection process. The term signal is used to define any suspected adverse reaction or potential safety concern that requires further evaluation.
Responsibility for adding a side effect to the product information leaflet sits with the MHRA. The product information for mirtazapine reflects the data currently available, and does not include sexual dysfunction as a possible side effect. However, data from Yellow Card reports and other sources such as published studies and periodic safety assessments are kept under continuous review by the MHRA. The marketing authorisation holder has recently submitted the latest periodic safety update report to the MHRA, and this will be carefully assessed. If there is sufficient evidence and associated data about the potential to experience sexual dysfunction as a side effect, the patient information for mirtazapine can be updated.
Asked by: John Hayes (Conservative - South Holland and The Deepings)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many children in England have been issued puberty blockers since 2019.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We have always been clear that children’s safety and well-being is paramount, so we welcomed NHS England’s landmark decision to ban routine use puberty blockers to children experiencing gender dysphoria. This decision was based on the available evidence and expert clinical opinion.
Gonadotropin-releasing hormone agonists or puberty blockers are used to treat several medical conditions in children and young people. These can include precocious puberty, some forms of cancer, endometriosis, and gender dysphoria.
Information on the clinical indication for which these medications have been prescribed is not held centrally. The following table shows the number of identifiable patients prescribed and dispensed gonadotropin-releasing hormone agonists for all purposes, in primary and secondary care in England from 2019 to September 2022:
Financial year | Patients identified |
2018/19 | 1,072 |
2019/20 | 1,048 |
2020/21 | 936 |
2021/22 | 864 |
April to September 2022 | 693 |
Source: NHS Business Services Authority
Note: Prescriptions have only been included where a National Health Service number has been identified during processing, and an age has been recorded. The same patients may appear in multiple years.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
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.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
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.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the adequacy of funding provided to the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking to (a) monitor and (b) report on the performance of the Medicines and Healthcare Products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has received representations from the scientific community on the efficiency of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to take steps to help increase productivity in the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking to help increase the capacity of the Medicines and Healthcare products Regulatory Agency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom. It achieves this through the expertise of its staff, and its assets of ground-breaking science, innovative regulation, and real-world data.
Ministers receive regular updates on the performance of the MHRA. The agency is taking significant steps to assess licensing applications within the shortest time possible. It is working to reduce timelines by bringing in additional resources and developing processes that will result in significantly improved response times, while protecting patient safety. As an effective regulator, it is committed to the highest of standards of performance, and delivering the right outcomes for patients and public health. These changes are already resulting in improvements.
The Department holds the MHRA to account for their work, including their performance and the impact of any organisational changes, through regular established mechanisms including quarterly and annual accountability reviews. The minutes of the latest Annual Accountability Review with the MHRA are available at the following link:
The MHRA also publishes performance figures each month, and annually through their annual report and accounts. As set out in its 2023-26 Corporate Plan, the MHRA is committed to delivering predictable, optimised, and sustainable services, across all functions.
As part of the 2023 Spring Budget, the MHRA also received £10 million of additional funding. This is to support the acceleration of routes for bringing innovative medical products developed in the UK onto the market, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. The Government is committed to supporting the MHRA to meet its statutory obligations.
The Department receives regular feedback from a wide range of stakeholders. In 2023 the Department did receive representations from the scientific community, and industry, expressing concern about delays in the MHRA’s approvals of clinical trials. The MHRA has since improved its performance in this area, and there are currently no delays in approving clinical trials.
Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether her Department has made an assessment of the potential merits of increasing the use of the capsule sponge test to detect oesophageal cancer.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
NHS England commissioned an evaluation to assess the impact of the capsule sponge test in secondary care, for patients on a routine reflux pathway. The evaluation report was completed in September 2023 and the national pilot will conclude in March 2024.
On 26 February 2024, NHS England published the results of the capsule sponge test pilot for secondary care routine reflux and Barrett’s surveillance cohort, which began in January 2021, and launched at 30 hospitals across England. The pilot tested over 8,500 patients with the capsule sponge test. Evaluation of a cohort of patients showed almost eight out of 10 patients, who completed a test, were discharged without the need for further testing, freeing up endoscopy capacity for higher risk patients and those referred for urgent tests for oesophageal cancer. Patients with positive results from the capsule sponge test who were referred on for an endoscopy had the highest prevalence of Barrett’s oesophagus, at 27.2%, compared to zero patients with negative results who completed an endoscopy.
NHS England has not committed to national uptake of capsule sponge, but will continue to support integrated care boards (ICBs) and local systems to deliver in their area. The evaluation report was published and shared with local National Health Service systems including Cancer Alliances, NHS providers, and ICBs to support with local service provision. The evaluation findings should be interpreted and used locally, based on need.
NHS England is continuing to explore other capsule sponge use cases, including in primary and community care settings jointly funded by the National Institute for Health and Care Research and Cancer Research UK. Separately to this, the CYTOPRIME2 project is funded through the NHS Cancer Programme’s Innovation Open Call and is assessing the feasibility and safety of using capsule sponge in a primary care setting, and evaluating key outcome metrics.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the level of awareness by doctors of any dangers of the commonly prescribed drug montelukast, as highlighted by the US Food and Drug Administration in March 2020, that the use of the drug resulted in “a wide variety of mental health side effects have been reported, including completed suicides".
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
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.