Sodium Valproate (Epilim) Campaign

pack of Sodium Valproate medication

Background to this issue

Sodium Valproate (Epilim) is a commonly used epilepsy drug which was first 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. 

Approximately 30–40% of children exposed to valproate in utero will have some form of neurodevelopmental disorder (this includes developmental delay, autism spectrum disorder and ADHD). 

Exposure to valproate in utero is also strongly associated with major congenital malformations. This includes neural tube defects such as spina bifida, cleft lip and palate, cardiovascular defects, and limb anomalies. Studies indicate that the risk is around 10%, significantly higher than the baseline population risk.

When a child has been confirmed as having been exposed to valproate - and where no other genetic cause can be found for the disabilities/conditions they are experiencing - they are diagnosed with a condition known as Foetal Valproate Spectrum Disorder (FVSD). 

Despite the effects of valproate and developing evidence over several decades, 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 the drug. In the years since it was first licensed in Ireland, many women continued to be prescribed valproate with no warnings. 

The HSE estimate that up to 1,250 families may have been impacted by exposure to valproate over the past 50 years - with many requiring significant care and tailored supports. 

What did we want?

Working with our colleagues in OACS Ireland - the organisation that represents families caring for children/adults who were exposed to Sodium Valproate in-utero and who are now living with a range of disabilities as a result, we approached the campaign through the lens of the Past, Present and Future. 

  • The Past
    Although evidence was emerging from the 1960s onwards that valproate could have a teratogenic impact if prescribed in pregnancy, it was only in the mid-late 2010s where targeted efforts were made to warn patients directly of the risks via the development of the Pregnancy Prevention Programme (PPP) for women of childbearing age on the medication. In the intervening period, thousands of women were prescribed the medication with no warnings or insufficient warnings and as a result, are now caring for children with a range of severe disabilities. The question these families have is why this was allowed to happen. Working alongside OACS Ireland, we believed that these questions could only be answered by a state inquiry, and this became a key element of our advocacy efforts.
  • The Present 
    As the representatives of the families impacted, OACS Ireland led on advocating for the necessary services to be put in place for children who had been impacted by exposure and are living with a range of disabilities. 
  • The Future
    It is important to highlight that Sodium Valproate continues to be a very effective anti-seizure medication. For some people living with epilepsy, it may be the only medication that has given them seizure control. However, despite efforts to address the risks in pregnancy, including the introduction of a strengthened PPP in 2018, evidence suggests that significant gaps in awareness persist. Surveys conducted by Epilepsy Ireland, together with research studies involving healthcare professionals, have consistently found ongoing insufficient awareness of the potential risks - both among women who may be taking the medication and among the healthcare professionals who prescribe it. There is still a risk that a child could be exposed to valproate today. For this reason, we campaigned for the establishment of a Sodium Valproate Stakeholder Group to assess the current risk reduction measures, and to recommend and implement measures that could be taken to reduce these risks. We also campaigned for adequate staffing and resourcing to enable clinical teams to properly counsel women on the risks of the medication and to meet the obligations of the PPP. This would help to prevent anyone being impacted by exposure to Sodium Valproate in the Future.

    Our work in campaigning for a state inquiry and addressing what happened in the past is also critical for shaping the future care of women with epilepsy. Dozens of anti-seizure medications are currently available, with more likely to emerge in the coming years. It is therefore essential that we learn from past experiences to ensure that data is proactively generated, that patients receive accurate and timely information, that the state responds promptly to emerging evidence, and that clinicians are adequately resourced to counsel their patients effectively. 

What did Epilepsy Ireland do? 

Working alongside our colleagues in OACS Ireland since 2013, we advocated amongst policy makers, Oireachtas members and in the media for commitments to the measures outlined above. 

This led to: 

  • A Government commitment to a non-statutory inquiry in November 2020. Terms of Reference for the Inquiry were agreed in July 2023.  An independent chairperson for the inquiry was appointed in July 2024; and the inquiry officially got underway in July 2025.
  • A Stakeholder Group was established by the Minister/ Department of Health to assess and strengthen current risk reduction measures associated with the medication in December 2022.
  • Funding was secured by the HSE to recruit three outstanding epilepsy nurse specialists in December 2022 - these nurses’ primary role would be to add additional capacity to help with the implementation of the Pregnancy Prevention Programme. These additional roles had been recommended since 2018. 

Conclusion 

While work is continuing in this area e.g. the ongoing Sodium Valproate inquiry and the Sodium Valproate Stakeholder group, there have been significant state commitments and progress made, thanks to our collaborative campaigning alongside OACS Ireland. We are confident that our efforts will lead to significant positive developments in the future care of women with epilepsy in Ireland. 

Achieving these results would not have been possible without the support of our members and volunteers, who helped amplify the issue with their local TDs and Senators at every opportunity. A huge thank you to everyone involved in helping us secure these significant commitments. 

Thank you also to all TDs and Senators who raised the valproate issue over the years. A special mention to Deputy Rose Conway-Walsh who has been a tireless advocate for those affected, and to former Minister Stephen Donnelly for his leadership in securing Government support for the establishment of the inquiry and other measures. 

Finally, at the heart of our work over the past decade on this matter are the families whose lives have been profoundly impacted by exposure to sodium valproate. It has been a privilege to work alongside them. Despite the most challenging circumstances, these families have been tireless advocates throughout this continuing campaign and we would like to thank them for all their assistance and support. 

News Updates

Below are some of the updates on this matter as it progressed and associated articles in the news section of our website and some associated press coverage where you can read more. 

Further information

**PLEASE CONTACT YOUR HEALTHCARE TEAM IF YOU HAVE ANY CONCERNS. DO NOT STOP TAKING VALPROATE WITHOUT FIRST SPEAKING WITH YOUR PRESCRIBER.**

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