Apr. 22 2021
Source Page: Membership and minutes of Scottish Government Sodium Valproate Advisory Group: FOI releaseFound: Membership and minutes of Scottish Government Sodium Valproate Advisory Group: FOI release
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.
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.
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.
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.
Jan. 07 2021
Source Page: Public Assesment Report of antiepileptic drugs: review of safety of use during pregnancyFound: Public Assesment Report of antiepileptic drugs: review of safety of use during pregnancy
Mentions:
1: None to optimise antiretroviral therapy in HIV, tailor anti-epilepsy drugs for seizure control and determine - Speech Link
2: None baby being damaged by sodium valproate. - Speech Link
3: Baroness Thornton (LAB - Life peer) I am not sure that I understand how this will avoid the problems with valproate and all the other situations - Speech Link
4: Baroness Penn (CON - Life peer) However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs - Speech Link
Mentions:
1: Freeman, Jeane (None - None) or services would be helpful for those affected by sodium valproate and Primodus, in line with the other - Speech Link
2: Cameron, Donald (Con - Highlands and Islands) the use of Primodos and other hormone pregnancy tests, and the use of sodium valproate for treatment - Speech Link
3: Cole-Hamilton, Alex (LD - Edinburgh Western) colleague at Westminster Norman Lamb called the use of sodium valproate during pregnancy in the 1970s - Speech Link
4: McNeill, Pauline (Lab - Glasgow) with the birth defects and miscarriages that Joan McAlpine talked about, and the anti-epileptic drug - Speech Link
5: Mackay, Rona (SNP - Strathkelvin and Bearsden) , the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and surgical mesh implants - Speech Link
Sep. 03 2020
Source Page: Non-technical summaries granted in 2019Found: Non-technical summaries granted in 2019
Mentions:
1: Nadine Dorries (CON - Mid Bedfordshire) The second is sodium valproate, an anti-epilepsy drug that has been definitively linked to autism and - Speech Link
2: Cat Smith (LAB - Lancaster and Fleetwood) As chair of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy - Speech Link
3: Nadine Dorries (CON - Mid Bedfordshire) Work is being undertaken—the all-party group for valproate and other anti-epileptic drugs in pregnancy - Speech Link
4: Fiona Bruce (CON - Congleton) As vice-chair of the all-party group on valproate and other anti-epileptic drugs in pregnancy, I thank - Speech Link