Sodium Valproate Inquiry Officially Begins

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Sodium Valproate Medication

The inquiry into the historical licensing and prescribing of Sodium Valproate (Epilim) in Ireland has officially begun its work.

While the official commencement has been a long time coming for families and individuals impacted by Sodium Valproate, this is an incredibly important milestone for these families. The establishment of the inquiry is something that was jointly campaigned for by Epilepsy Ireland and our colleagues in OACS Ireland (the representatives of families affected) for many years.

We are very proud of our contributions in advocating for this important inquiry and are very pleased to see the inquiry officially begin. We’d like to thank all TDs and Senators who worked with us over the years in making this possible – with a particular mention to Deputy Rose Conway-Walsh who has been a tireless advocate for this entire cause, and former Minister for Health, Stephen Donnelly, who secured Government approval for the inquiry.

When the inquiry completes its work, we hope it will provide the answers and recommendations that families deserve.

Why has the inquiry been established?

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. The HSE estimate that up to 1,250 families may have impacted from the 1970s onwards.

For this reason, then 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. 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. The Government gave approval to the inquiry and its terms of reference in Jul 2023. When the Terms of Reference was agreed for the inquiry, there were several outstanding issues including the appointment of a Chair, the resourcing of the inquiry, the supports available for families, and most recently with data protection regulations. It was vitally important that these decisions on these specific matters met the needs of those directly affected. Therefore, OACS Ireland have since led on these final steps in establishing the inquiry, leading to it officially commencing its work.

The aims of the Inquiry

The inquiry will be chaired by Bríd O’Flaherty BL and as dictated by the Terms of Reference, key aims of the inquiry will be as follows:

  • To provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FSVD), or progressing through the diagnostic pathway, their mothers and other family members.
  • To document the regulation of sodium valproate in the State from initial licensing until the present day and the corresponding practices and controls in place relating to the prescribing and dispensing of this product to women of child-bearing potential throughout this time.
  • To develop a timeline of significant developments in the scientific knowledge relating to the teratogenicity of sodium valproate.
  • To assess the Irish health system’s current capacity to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential, and to provide recommendations regarding same, with consideration of relevance of other anti-seizure medications (ASMs).
  • To assess the adequacy of services and supports currently provided to those diagnosed with FVSD and their caregivers, and to provide recommendations in this regard to the Minister for Health.
  • To make recommendations as appropriate to the Minister for Health.

The inquiry will work in two phases; the first investigating the timeline for use of Sodium Valproate in Ireland; the second giving voice to families affected to share their experiences. 

For the second phase, the Inquiry would like to hear from those with a diagnosis of Foetal Valproate Spectrum Disorder (FVSD), those progressing through the diagnostic pathway, and/or their family members. If you fall into these categories and are interested in engaging with the inquiry, you can get in touch with the inquiry team by:

  • Calling the inquiry office on 01 2233 5558
  • Writing to the inquiry team at Sodium Valproate Inquiry, 7/8 Mount Street Upper, Dublin, D02FT59
  • Emailing info@svinquiry.ie
  • Completing the enquiry form by visiting the ‘Sodium Valproate Inquiry’ website

As noted above, the Sodium Valproate Inquiry has a dedicated website – and provides further details on the inquiry, its team and FAQs. You can visit the website via the button below:

Visit the Inquiry Website.

If you are hearing about Sodium Valproate for the first time and suspect your child may be affected, we would encourage you to talk to our colleagues in OACS Ireland, as representatives of families who have been affected. You can find out more and get in touch by visiting the ‘OACS Ireland website.

Further information on how to enter the diagnostic pathway for FVSD has also been provided below:

  • Under 16 years of age
    If a child needs to be referred for a potential diagnosis and they are under 16 years of age, a referral can be made to CHI at Crumlin from their GP or a Consultant Paediatrician (as appropriate). This referral is sent to the Department of Paediatrics in CHI at Crumlin. Once the referral is received it will be clinically triaged by the Consultant Paediatrician, and where appropriate an appointment will be arranged to attend outpatients. At this appointment there may be a decision to carry out blood tests. Where necessary a referral may then be sent to a Consultant Geneticist in the Department of Clinical Genetics.
  • 16 year of age and over
    For patients and clients who are 16 years and older, a referral should be sent from their GP or a Consultant (as appropriate) to the Department of Clinical Genetics, in CHI Crumlin. This referral will be triaged by the Consultant Geneticist, and where appropriate an appointment will be arranged. An assessment will be carried out and relevant blood tests taken for DNA analysis (genetic tests). Genetic tests are sent abroad and depending on the type of test they can take from 6 weeks to a number of months to be tested. Once the results are received, they will be reviewed by the Consultant Geneticist, and the patient's case will be reviewed at a multidisciplinary team meeting to determine the diagnosis.

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

We look forward to engaging with the inquiry when formally invited to do so.

Further Information 

If you need any information or support on your or your loved one’s journey with epilepsy, please do not hesitate to contact your local Community Resource Officer. Visit the ‘Our Local Service’ page on our website for details of your local Community Resource Officer.