There are/have been several aspects to our ongoing campaign surrounding Sodium Valproate, some of which have been progressed and are now in a different phase to when we first began campaigning on this matter. We continue to work with our colleagues in OACS Ireland to progress the outstanding issues and this page provides a summary of this entire campaign
- That the inquiry into the historical licensing and prescribing of Sodium Valproate announced by Minister Donnelly in November 2020 is established. Current status: Terms of reference agreed with Department of Health and awaiting cabinet approval.
- That the three outstanding epilepsy nurse specialists promised in 2018, and for which funding was secured in 2022, be recruited. Current status: Funding approved in 2022 and awaiting recruitment of nurses.
- That a Stakeholder Group be established to assess and strengthen the risk reduction measures associated with Sodium Valproate. Current status: The Stakeholder Group was established in November 2022 and the work of the group is continuing.
- That the necessary services are put in place to support families who have been affected by Sodium Valproate. Current status: Our colleagues in OACS Ireland are continuing to engage with the HSE on the services families need to support their loved ones.
About the campaign and key issues
Sodium Valproate (Epilim) is a common epilepsy drug which was licensed in Ireland in 1975. However, since the 1960s, evidence was emerging that the drug could have a severe impact on the unborn child if prescribed in pregnancy. Despite this, it was not until 2014 and again in 2018 that significant measures were taken to warn women of childbearing age about the potential impacts of this drug. In the years since it was first licensed in Ireland, many women continued to be prescribed Sodium Valproate with no warnings.
For this reason, Minister for Health, Deputy Stephen Donnelly announced in Nov 2020 that an inquiry would be established into the historical licensing and prescribing of Sodium Valproate. This was a very welcome development. Families affected by this drug have waited long enough for answers on why this was allowed to happen to them, and the promised inquiry needs to be urgently established. In the years that followed the Minister’s announcement, a lengthy process between the Department of Health and OACS Ireland & Epilepsy Ireland was undertaken to agree the strongest Terms of Reference possible for the prospective inquiry. Towards the end of 2022, the terms of reference were finally agreed, and we await Government sign-off for these terms.
A key aspect of this campaign has also related to increased Epilepsy Nurse Specialist capacity to assist with the implementation of the Pregnancy Prevention Programme associated with Sodium Valproate. In 2018 as part of the HSE Valproate Response Project, it was agreed that six Epilepsy Nurse Specialists would be appointed to epilepsy services in Ireland. The recruitment of the nurses would help to ensure that women currently on the drug were being informed yearly about the risks and to have discussions around family planning. This would help prevent families from being impacted by Sodium Valproate in the future. To date, only three of these nurses have been recruited. However, following continued campaigning by Epilepsy Ireland and OACS Ireland, in 2022, we received confirmation that funding had been secured for the outstanding positions. It is now vital that these posts are filled without delay. You can read more on this key development of our campaign by visiting the ‘News’ section of our website.
Another key aspect of our campaign surrounded the establishment of the Sodium Valproate Stakeholder Group. While good work has been conducted in strengthening risk reduction measures on the use of Sodium Valproate since 2018, there is still much work left to do. The pinnacle of the risk reduction measures introduced is what is called the Pregnancy Prevention Programme. This meant that any women on Sodium Valproate had to be reviewed annually by their clinician and that they had to sign an acknowledgement every year stating they were fully aware of the risks associated with the drug. In 2020, an Epilepsy Ireland survey found that many women who had taken or were taking the drug were dangerously unaware of the impacts Sodium Valproate could have and indeed, were equally unaware of the risk reduction measures that should be applied when on the medication. In addition, subsequent research from the RCSI reported concerning findings around the awareness of the risk reduction measures associated with Sodium Valproate amongst Healthcare Professionals.
For this reason, we alongside our colleagues in OACS Ireland called for the establishment of a stakeholder group. This would involve all involved in this issue (Department of Health, HSE, HPRA, GP & Pharmacy representatives, Patient Representatives etc) coming together to review the measures that are currently in place and to discuss where they can be strengthened – so we can ensure that no child is affected by exposure to Sodium Valproate (Epilim) in the future. Our campaigning led to this Stakeholder Group being established in late 2022 and the important work of this group is now underway. You can read more about this key development by visiting the ‘News’ section of our website.
As the representative organisation of families who have been impacted by Sodium Valproate, our colleagues in OACS Ireland are leading discussions regarding the services which need to be in place for the families whose children have been impacted by Sodium Valproate. Families are caring for children (many of whom are now adults) with severe disabilities and need a pathway of services in place to support their vast and varying needs.
The below are some of the latest updates on this matter in the news section of our website and from national media reports, where you can read more:
- March 2023 - Families urge Donnelly to hold inquiry into use of epilepsy drug during pregnancy
- March 2023 - Irish Times; Solicitor calls for redress scheme to avoid ‘perpetual litigation’ over anti-epilepsy drug
- March 2023 - RTÉ; Court approves two settlements over epilepsy drug use
- March 2023 - Irish Examiner; Boy with autism settles for €15m over use of epilepsy drug during mother's pregnancy
- March 2023 - Irish Independent; Boy (13) with autism who sued over failure to inform his mother of epilepsy treatment risks during pregnancy settles for €15m
- March 2023 - Irish Examine; Siblings' family take cases over prescribing of valproate during pregnancy
- February 2023 - OACS Ireland; Oacs Ireland write to Minister for Health regarding inquiry.
- December 2022 - Families affected by prescribing of sodium valproate in pregnancy call for inquiry
- December 2022 - Sodium Valproate Campaign Update
- November 2022 - Irish Examiner; €12m epilepsy drug settlement in High Court could open floodgates to dozens more cases
- November 2022 - RTÉ.ie; €12m settlement for boy who suffered severe neurological damage
- November 2022 - Irish Times; Settlement of €12m for teen allegedly damaged by seizure control drugs during pregnancy
- November 2022 - Boy with autism who sued over epilepsy drug taken during mother's pregnancy settles for €12m
- November 2022 - RTÉ.ie; Epilepsy drug caused baby's neurological damage, court told
- November 2022 - Irish Examiner; Families affected by anti-epilepsy drug should be given 'no fault redress scheme'
- November 2022 - Irish Examiner; 'I took them and he's the one suffering' says mother prescribed anti-epilepsy pill when pregnant
- October 2022 - Irish Examiner; First sodium valproate injury case opens next month
- September 2022 - Epilepsy Ireland & OACS Ireland meet with Minister for Health regarding Sodium Valproate Inquiry
- September 2022 - Irish Examiner; Families to consider terms of inquiry into controversial epilepsy drug
- August 2022 - Irish Examiner; Families want answers on epilepsy drug that can damage babies in the womb
- August 2022 - Irish Independent publish Documentary on Valproate families
- August 2022 - Irish Independent; The Valproate Families: The stories of the families affected by Sodium Valproate in Ireland
- August 2022 - Epilepsy Ireland & OACS Ireland to meet with Minister for Health regarding Sodium Valproate Inquiry
- August 2022 - Irish Independent; Concern over State’s inaction on drug known to have caused birth defects
- June 2022 - Sodium Valproate Inquiry Update.
- June 2022 - Sodium Valproate Inquiry Update.
- May 2022 - Irish Examiner; Minister 'committed' to inquiry into drug linked to neurological problems in 1,500 children
- May 2022 - Minister for Health Questioned on establishment of promised Sodium Valproate inquiry
- May 2022 - Outstanding Valproate Commitments raised in Dáil and media.
- April 2022 - The Journal.ie; Timeframe still not decided for inquiry into epilepsy drug that can cause birth defects
- April 2022 - UK coverage outlines why outstanding valproate related commitments must be prioritised in Ireland
- October 2021 - Sodium Valproate campaign raised during Leaders Questions in Dáil Éireann
- September 2021 - New Irish study finds that ‘continued effort is needed’ in reducing valproate risks
- August 2021 - Epilepsy Ireland & OACS Ireland urge Minister to act immediately on Sodium Valproate commitments.
- July 2021 - Sodium Valproate (Epilim) Inquiry delay raised in the Dáil
- November 2020 - Minister for Health to establish inquiry into historical licensing & use of Sodium Valproate in pregnancy
- November 2020 - Department of Health; Minister for Health commits to inquiry into anti-epilepsy drug sodium valproate
- November 2020 - Epilepsy Ireland & OACS Ireland to meet with Minister for Health regarding Sodium Valproate
- October 2020 - Epilepsy Ireland & OACS Ireland to meet with Minister for Health regarding Sodium Valproate
- September 2020 - Epilepsy Ireland & OACS Ireland seek response from Minister Donnelly regarding Independent Inquiry on Sodium Valproate
- July 2020 - Letter to Minister for Health, Stephen Donnelly regarding IMMDS UK inquiry
- July 2020 - New Government face demands for Independent Inquiry from families impacted by Sodium Valproate (Epilim) in Ireland
- July 2020 - Statement from Epilepsy Ireland on Sodium Valproate Survey Findings
- July 2020 - Survey results on the awareness of risk factors associated with Sodium Valproate (Epilim)
- July 2020 - Non-Statutory Inquiry publishes long awaited "Cumberlege Review" in the UK
- May 2019 - Sodium Valproate – New videos on the risks in pregnancy
- Sept 2017 - Karen Keely's presentation to the European Medicines Agency
- To learn more about the Sodium Valproate Pregnancy Prevention Programme, visit the 'Sodium Valproate' section of our website
- Further information on OACS Ireland can be found by visiting the OACS Ireland website . If you believe you have been impacted by Sodium Valproate, please reach out to them.
- If you are hearing about Sodium Valproate for the first time, see our section on why an inquiry was announced in November 2020.
**PLEASE CONTACT YOUR HEALTHCARE TEAM IF YOU HAVE ANY CONCERNS. DO NOT STOP TAKING VALPROATE WITHOUT FIRST SPEAKING WITH YOUR PRESCRIBER.**