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 Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for bupropion 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 bupropion.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
In the United Kingdom there are two authorised products containing bupropion. The first contains bupropion hydrochloride and is prescribed to help individuals stop smoking, when they also have motivational support, for instance through a stop smoking programme. The second is a combination product containing bupropion hydrochloride and naltrexone hydrochloride, and is prescribed in obese or overweight adults to manage weight, together with a reduced calorie diet and physical exercise.
The Medicines and Healthcare products Regulatory Agency (MHRA) has received three Yellow Card reports of sexual dysfunction related reactions suspected to be associated with bupropion hydrochloride, the single constituent, and one Yellow Card report of sexual dysfunction for the combination product, bupropion hydrochloride and naltrexone hydrochloride, between 1 January 2014 and 29 October 2024.
The following table shows the number of suspected Yellow Card reports of sexual dysfunction related reactions and bupropion containing products received by the MHRA between 2014 and 2024:
Year | Reports of sexual dysfunction single constituent bupropion | Reports of sexual dysfunction combination product bupropion and naltrexone |
2014 | 0 | 0 |
2015 | 0 | 0 |
2016 | 0 | 0 |
2017 | 0 | 0 |
2018 | 0 | 0 |
2019 | 0 | 0 |
2020 | 1 | 1 |
2021 | 0 | 0 |
2022 | 1 | 0 |
2023 | 0 | 0 |
2024 | 1 | 0 |
Source: data provided by the MHRA.
Note: the data includes reactions grouped under the Medical Dictionary for Regulatory Activities’ (MedDRA) Higher Level Terms: erection and ejaculation conditions and disorders; orgasmic disorders and disturbances; sexual and gender identity disorders NEC; sexual arousal disorders; sexual desire disorders; sexual dysfunction NEC; sexual function and fertility disorders NEC; and spermatogenesis and semen disorders.
Persistent sexual dysfunction does not represent a specific medical condition, so this precise term is not a category available to undertake a structured search of the MHRA’s Adverse Drug Reaction database, and would rely on manual assessment of individual cases. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as the Diagnostic and Statistical Manual of Mental Disorders or the International Classification of Diseases.
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 product information, which includes the patient information leaflet, for single constituent bupropion reflects the data currently available, and does not include sexual dysfunction as a possible side effect. The product information for the combination bupropion and naltrexone product contains the terms loss of libido, libido disorder, and erectile dysfunction. As with other medicines, the safety of bupropion is kept under review by the MHRA, and consideration will be given to any emerging evidence on this issue.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what discussions they have had with the Medicines and Healthcare products Regulatory Agency about expediting the use of phage treatments in last-resort medical cases.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting innovation and the development of new, safe, and effective medicines. Officials in the Department are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to explore the use of bacteriophages, also known as phages.
Although there are currently no licensed bacteriophage medicines in the United Kingdom, patients may still access them as part of a clinical trial, as unlicensed medicines, or as medicines prepared under the supervision of a pharmacist.
The MHRA is actively developing non-binding, regulator-agnostic information to help innovators understand what type of quality, safety, and efficacy data is needed by regulators to evaluate phage products for market authorisation.
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 bupropion were issued in each year since 2014; and what was the annual cost to the National Health Service of those prescriptions for each of those years.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The attached table shows the number of prescriptions issued for buproprion and the net ingredient cost (NIC) from 2014 to 2023, and from January to August for 2024, as this is the latest data available.
Based on the information within the Prescription Cost Analysis published statistics from the NHS Business Services Authority, there are two chemical formulations that include buproprion, those being: bupropion hydrochloride; and the combination of naltrexone and buproprion. It should also be noted that the total NIC shown in the attached table is the basic price of the prescribed medicine before discounts, dispensing costs, or fees. This includes items that have been dispensed in the community in England regardless of where prescribed.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of (1) the quality of maternity services across England and, in particular, of reports about unnecessary deaths or injuries to mothers and babies in units in Shrewsbury, Telford and Nottingham; (2) of the role played by claimant lawyers in securing justice for victims or their families; and (3) of the impact of the culture of the NHS in responding to claims in respect of such injuries and deaths.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
We are taking the findings and recommendations made in independent reviews and reports into maternity services, including the Shrewsbury and Telford Hospital NHS Trust, very seriously. This includes the need to develop and sustain a culture of safety, learning, and support within the National Health Service, which has formed part of NHS England’s Three year delivery plan for maternity and neonatal services. We will carefully consider the findings of the Nottingham University Hospitals NHS Trust when it reports next year.
It is right that where people have been negligently harmed by the NHS, they are able to receive appropriate compensation. It is the role of NHS Resolution (NHSR) to manage clinical negligence claims against the NHS in England. NHSR is accountable to the Department, and its performance is subject to regular review. However, NHSR is responsible for its own management of individual claims. The Government has not made a general assessment of the role claimants lawyers play in NHS litigation claims.
NHSR has a responsibility to resolve claims promptly and fairly, and to defend unmeritorious claims to secure NHS resources. The large majority of claims, 81%, are settled without court proceedings.
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 trazodone have been issued in each year since 2014; how many 'Yellow Card' reports of sexual dysfunction and persistent sexual dysfunction in respect of trazodone the MHRA has received 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 trazodone.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the total number of items issued for trazodone from 2014 to 2023, and from January to May 2024:
Year | Total number of items |
2014 | 1,050,069 |
2015 | 1,083,974 |
2016 | 1,112,437 |
2017 | 1,133,363 |
2018 | 1,157,717 |
2019 | 1,168,715 |
2020 | 1,191,060 |
2021 | 1,226,973 |
2022 | 1,238,983 |
2023 | 1,281,049 |
2024 | 553,866 |
Source: data was provided by the NHS Business Service Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance trazodone hydrochloride.
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 the available data, including from the Yellow Card scheme, and where appropriate it seeks advice from its independent advisory committee, the Commission on Human Medicines, to inform on regulatory decisions, including the amending of product information.
The MHRA has received a total of 20 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with trazodone, between 1 January 2014 and 29 July 2024. This includes reactions grouped under the medical dictionary’s (MedDRA) Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction, and include erection and ejaculation conditions and disorders, orgasmic disorders and disturbances, sexual arousal disorders, and others. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with trazodone in the United Kingdom, received by the MHRA each year from 2014 to 2024:
Year | Reports of sexual dysfunction |
2014 | 1 |
2015 | 2 |
2016 | 2 |
2017 | 1 |
2018 | 1 |
2019 | 2 |
2020 | 2 |
2021 | 1 |
2022 | 5 |
2023 | 2 |
2024 | 1 |
Source: data provided by the MHRA.
“Persistent sexual dysfunction” does not represent a specific medical condition, so this precise term is not a category available for a structured search of the MHRA’s Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.
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 product information for trazodone, which includes the patient information leaflet, reflects the data currently available, and does not include sexual dysfunction as a possible side effect but does include priapism, the prolonged erection of the penis. The Summary of Product Characteristics for healthcare professionals states that there have been reports of priapism which have required surgical intervention, or led to permanent sexual dysfunction. Patients developing priapism should stop using trazodone immediately.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 26 March (HL3163), in each year since 2014, how many prescriptions for vortioxetine were issued; what was the annual cost to the National Health Service of those prescriptions; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for vortioxetine; and what consideration has NHS England given to adding sexual dysfunction as a side effect on the patient information leaflets for vortioxetine.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The following table shows the number of items issued for vortioxetine and the net ingredient cost (NIC) from 2014 to 2023, and from January to May of 2024:
Year | Items issued | Total NIC |
2014 | 0 | £0 |
2015 | 74 | £2,068.11 |
2016 | 12,736 | £298,577.07 |
2017 | 43,023 | £987,197.31 |
2018 | 80,922 | £1,877,715.10 |
2019 | 134,351 | £3,127,305.68 |
2020 | 193,682 | £4,553,134.74 |
2021 | 248,533 | £5,720,498.19 |
2022 | 290,907 | £6,859,280.34 |
2023 | 339,017 | £8,188,709.76 |
2024 | 156,164 | £3,787,227.18 |
Total | 1,499,409 | £35,401,713.48 |
Source: data provided by the NHS Business Services Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance vortioxetine.
Note: items have been dispensed, but not necessarily prescribed, in England.
"Persistent sexual dysfunction" does not represent a specific medical condition, so this term is not a category available for a structured search of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, the medical dictionary (MedDRA), or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.
The MHRA has received a total of 29 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with vortioxetine, between 1 January 2014 and 21 July 2024. This includes reactions grouped under MedDRA Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with vortioxetine in the United Kingdom, received by the MHRA each year from 2014 to 2024:
Year | Reports of sexual dysfunction |
2014 | 0 |
2015 | 0 |
2016 | 2 |
2017 | 1 |
2018 | 1 |
2019 | 0 |
2020 | 7 |
2021 | 6 |
2022 | 3 |
2023 | 6 |
2024 | 3 |
Source: data provided by the MHRA.
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.
Sexual dysfunction was assessed as part of the clinical studies to support the authorisation of vortioxetine. The clinical studies indicated that doses between 5 milligrams and 15 milligrams did not show a difference from placebo in relation to the risk of sexual dysfunction. However, the 20 milligram dose was associated with an increase in sexual dysfunction. This information was included in the Summary of Product Characteristics (SmPC) for healthcare professionals for all strengths of vortioxetine since authorisation in 2021. The SmPC and patient information leaflet were subsequently updated in April 2024 to list sexual dysfunction as a possible side effect for all strengths, following reports of sexual dysfunction associated with doses below 20 milligrams.
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 amitriptyline, imipramine and atomoxetine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA has received for each of these drugs in each year since 2014; and whether they will ensure that persistent sexual dysfunction is listed as a side effect in the patient information leaflets for each these drugs.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
Over the next year, the Medicines and Healthcare products Regulatory Agency (MHRA) plans to review the risk of sexual dysfunction and whether these side effects persist for all antidepressants marketed in the United Kingdom. As a result of the review product information will be updated, as necessary, and consideration will be given to whether additional risk minimisation measures are needed.
The following table shows the total number of items in each calendar year between 2014 and 2023, as well as January 2024:
Calendar Year | Amitriptyline Hydrochloride | Atomoxetine Hydrochloride | Imipramine Hydrochloride |
2014 | 11,851,704 | 118,843 | 174,731 |
2015 | 12,404,537 | 125,680 | 167,072 |
2016 | 12,943,138 | 130,731 | 164,645 |
2017 | 13,256,893 | 134,785 | 156,555 |
2018 | 13,532,567 | 138,160 | 150,526 |
2019 | 13,975,389 | 141,907 | 151,889 |
2020 | 14,468,134 | 146,346 | 137,284 |
2021 | 14,930,177 | 158,339 | 123,450 |
2022 | 15,226,816 | 174,894 | 115,360 |
2023 | 15,662,619 | 178,150 | 108,197 |
January 2024 | 1,370,670 | 15,334 | 9,072 |
Data Source: NHS Business Services Authority Open Data Portal, PCA data
The MHRA has received a total of 38 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with amitriptyline, atomoxetine, and imipramine. Of these, 8 were for amitriptyline, 21 for atomoxetine, and 2 for imipramine.
‘Persistent sexual dysfunction’ does not represent a specific medical condition.
The following table shows a summary of these side effects listed in the product information:
| Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) | Rare (may affect up to 1 in 1,000 people) |
amitriptyline | erectile dysfunction, libido decreased |
|
|
imipramine | disturbances of libido, impotency or abnormal ejaculation |
|
|
atomoxetine | libido decreased, ejaculation disorder, erectile dysfunction, male genital pain | Ejaculation failure | Priapism |
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the five recommendations made in the report by the First 1001 Days Movement, A Manifesto for Babies, published on 19 March; and whether they intend to respond to each recommendation.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
There is strong evidence that the 1,001 days from pregnancy to the age of two years old set the foundations for our cognitive, emotional, and physical development. Investing in this critical period presents a real opportunity to improve outcomes and tackle health disparities by ensuring that thousands of babies and families have improved access to quality support and services. The Government is therefore already taking forward a range of actions in line with recommendations in the report by the First 1001 Days Movement to ensure that every baby gets the best start in life.
For example, in March 2021, the Government published The best start for life: a vision for the 1,001 critical days, a copy of which is attached. This vision sets out six action areas for improving support for families during the 1,001 critical days to ensure every baby in England is given the best possible start in life, regardless of background.
The Government is also investing approximately £300 million to improve support for families though the Family Hubs and Start for Life programme. The programme is implementing many elements of the Best Start for Life Vision and is delivering a step change in outcomes for babies, children and their parents and carers in 75 local authorities in England, including those with high levels of deprivation. Many local authorities without funding have also chosen to implement elements of the vision.
The programme funding package includes £10 million to enable five local authorities and their partners to pilot innovative early years workforce models, with the aim of improving the access, experience and outcomes of babies, children, and families, and supporting the capacity and job satisfaction of the workforces involved.
To support new parents, Statutory Maternity Pay is paid by employers to qualifying employed women for a maximum of 39 weeks, the first six weeks of which are paid at 90% of the women’s salary followed by 33 weeks at the lower of either the standard rate or 90% of the woman’s average weekly earnings. For those who cannot get Statutory Maternity Pay, Maternity Allowance may be available. This is a benefit paid by the Department for Work and Pensions to eligible women and is intended for those who cannot get Statutory Maternity Pay. The standard rate of maternity pay is reviewed annually.
Paternity Leave arrangements enable employed fathers and partners, including same sex partners, who meet the qualifying conditions to take up to two weeks of paid leave within the first eight weeks following the birth of their child or placement for adoption. The Government has recently announced changes to make Paternity Leave and Pay more flexible for working families from April 2024. This includes allowing fathers and partners to take their leave and pay at any point in the first year after the birth or adoption of their child.
A Shared Parental Leave and Pay scheme is also available, giving working families much more choice and flexibility about who cares for their child in the first year, and when.
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 - Shadow Minister (Science, Innovation and Technology)
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: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many antidepressant prescriptions were issued to patients under the age of 25 in each year since 2014.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
Many medicines, including medicines used to treat depression, are licensed and prescribed for other conditions. The Department expects prescribers to always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed.
The following table shows the number of patients aged under 18 and 25 years old, who were prescribed antidepressants, each year from 2015 to 2023:
Year | Antidepressants prescribed to people under 18 years old | Antidepressants prescribed to people under 25 years old |
2015/16 | 312,113 | 2,477,798 |
2016/17 | 332,706 | 2,759,953 |
2017/18 | 346,126 | 2,910,607 |
2018/19 | 367,850 | 3,202,784 |
2019/20 | 393,762 | 3,525,602 |
2020/21 | 406,391 | 3,890,347 |
2021/22 | 437,365 | 4,170,154 |
2022/23 | 448,515 | 4,119,463 |
Source: NHS Business Services Authority
Notes: