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Written Question
Epilepsy: Pregnancy
Thursday 11th March 2021

Asked by: Rosie Duffield (Labour - Canterbury)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what additional steps have been taken to ensure that medical professionals are equipped to provide awareness of the risk of physical and neurodevelopmental harm to a baby associated with the use of many anti-epileptic drugs taken in pregnancy, specifically when providing such information via digital consultations and telemedicine.

Answered by Nadine Dorries

The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that information is available electronically to support discussions between medical professionals and women and girls on the risk of physical and neurodevelopmental harm to babies born to mothers who take epilepsy medicines during pregnancy. Healthcare professionals have been reminded of their responsibility to inform women and girls of the risks of valproate specifically through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update.

On 6 May 2020 the MHRA published guidance for specialists to support adherence to the pregnancy prevention requirements for women of childbearing potential taking valproate during the pandemic, particularly patients who are shielding due to other health conditions. This included guidance on annual review of patients using digital consultations.


Written Question
Epilepsy: Pregnancy
Thursday 11th March 2021

Asked by: Rosie Duffield (Labour - Canterbury)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what plans his Department has to (a) collect and (b) disseminate data on individual women who have been prescribed anti-epileptic drugs to enable investigation into the reasons for the teratogenicity of valproate and other epilepsy medication.

Answered by Nadine Dorries

The Medicines and Healthcare products Regulatory Agency and NHS Digital have been working to build a Registry to monitor the use of valproate and compliance with the current regulatory position and to monitor any children born to women on valproate. The Registry is being built around routinely collected data on all women in England who are taking National Health Service-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is now ongoing to extend the Registry to include women in the devolved administrations. The Registry will also be extended to include all girls and women prescribed an antiepileptic drug. This has been prioritised within the next phase of development. Once available, this data will be accessible to support additional research.


Written Question
Epilepsy: Pregnancy
Friday 29th January 2021

Asked by: Valerie Vaz (Labour - Walsall South)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that clinicians are discussing with women and girls the risks of taking sodium valproate and other anti-epileptic drugs (AEDs) during pregnancy.

Answered by Nadine Dorries

The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that documents forming the basis of the valproate Pregnancy Prevention Programme are available electronically and distributed regularly as hard copies to prescribers and pharmacists to support discussions of the risks of taking sodium valproate during pregnancy with women and girls who require this medicine. Healthcare professionals have been reminded of their responsibility to inform women and girls taking valproate of the risks, through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update. The conclusions of a safety review by the Commission of Human Medicines of the risks of other epilepsy medicines in pregnancy have recently been published to aid discussions about the most suitable treatment options.

The MHRA is working with the wider healthcare network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting. The MHRA is working to establish a registry to monitor the use of valproate in women and girls and clinician and patient compliance with the current regulatory position.


Written Question
Epilepsy: Pregnancy
Thursday 21st January 2021

Asked by: Valerie Vaz (Labour - Walsall South)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Commission on Human Medicines' review of the use of epilepsy medicines in pregnancy, published on 7 January 2021, whether the provisions of the Pregnancy Prevention Programme will be extended to include any other anti-epileptic drugs identified in posing a risk.

Answered by Nadine Dorries

The Commission on Human Medicines’ review concluded that lamotrigine and levetiracetam are safer to use during pregnancy than other epilepsy medicines and that some of the other reviewed antiepileptic drugs may also be associated with harms to the child. Where the data support evidence of harm, neither the magnitude nor the nature of the risks observed with the reviewed epilepsy medicines are as severe as that associated with the use of valproate during pregnancy. A Pregnancy Prevention Programme therefore has not been recommended for any of the other reviewed epilepsy medicines at this time.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what discussions (a) he, (b) Ministers and (c) officials of his Department have had with their counterparts in the EU regarding valproate.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will make it his Department's policy to introduce a care compensation plan similar to plans already introduced in other EU states for people harmed by valproate prescribed during pregnancy since 1973.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps the Government is taking to reduce the number of babies harmed by valproate prescribed during pregnancy.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will meet the Chair of the All-Party Parliamentary Group on anti-epileptic drugs in pregnancy to discuss the effect of people harmed by sodium valproate prescribed during pregnancy.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will meet people who have been harmed by sodium valproate during pregnancy; and what steps he has to provide compensation to such people.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.


Written Question
Pregnancy: Sodium Valproate
Monday 16th October 2017

Asked by: Andrew Gwynne (Labour - Denton and Reddish)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what support the Government plans to provide to children and young adults affected by valproate after their birth (a) now and (b) over the next 10 years.

Answered by Steve Brine

Valproate is an effective treatment for epilepsy and bipolar disorder but should only be used in girls and women of childbearing potential if other treatments are ineffective or not tolerated. For some women there may be no other treatment option. Because of ongoing concerns about women’s awareness of the risks, the Medicines and Healthcare products Regulatory Agency (MHRA) has worked with professional bodies, voluntary organisations and patient groups to develop a set of materials to aid communication between health professionals and women and girls.

The valproate toolkit comprises booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy. The MHRA continues to work with stakeholders to disseminate information and ensure compliance with the statutory advice. On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. The alert directs organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices. Consistent action was taken in Scotland, Wales, and Northern Ireland.

The impact of the measures taken is being monitored and studies show a steady decline in prescribing to women in childbearing potential. The adequacy of measures taken to date across Europe is being reviewed in a Europe-wide review that started in March 2017. There are ongoing discussions at official level as the review progresses. An expert working group of the Commission on Human Medicines has been convened to inform the United Kingdom position during the ongoing European Union review and consider other measures which may be required across the healthcare system to ensure compliance with the regulatory position in clinical practice.

France has its own legislation that allows for a state funded compensation scheme for medical accidents and they have amended this to include claims from those affected by valproate. We understand that this has been operational from June 2017. We are monitoring developments in France and do not feel that commissioning research is necessary at this time. We are not aware of similar action in other member states. There is currently no proposal to establish a care compensation plan specifically for those affected by valproate in the UK. However, the Government has great sympathy for those families who have been affected by the use of valproate in pregnancy. There is support available for families with children born with a disability. The Children and Families Act 2014 introduced a new statutory framework for local authorities and clinical commissioning groups (CCGs) to work together to secure educational, health and social care services for children and young people up to the age of 25 who have special educational needs or a disability (SEND).

Local authorities and CCGs must commission services jointly around a set of locally agreed outcomes to ensure that the needs of children and young people with SEND are met. Local authorities must also publish a clear, transparent ‘local offer’ of services available which has been developed for, and with, parents and young people. The reforms introduced by the Act are designed to reduce health inequalities, improve the experiences of children and young people with SEND, and their families, and deliver integrated services to achieve improved outcomes.

The Parliamentary Under Secretary of State for Health (Lord O’Shaughnessy) is meeting with the Chair of the All-Party Parliamentary Group on Anti-epileptic Drugs in Pregnancy to discuss these issues later this year; members of the Independent Fetal Anti Convulsant Trust may wish to attend also.