Terms of reference for an inquiry into the licensing and use of sodium valproate (Epilim) in Ireland are now detailed in legislation enacted in July 2025. The inquiry will focus on three stands, the first of which will focus on the timeline for the use of valproate (Epilim) in Ireland including the information available in respect of its regulation, prescribing, dispensing and the safety information issued. The second strand will provide an opportunity for those impacted by valproate (Epilim) to give oral statements. The final strand of the inquiry will seek to address the current systems in place to “respond, disseminate and implement measures that address safety issues relating to use of sodium valproate”. The inquiry will also make any other recommendations considered appropriate by the Chair to support persons whose lives have been impacted. Although not specifically referred to in the Statutory Instrument it remains to be seen whether redress will be included in the recommendations for those impacted by Valproate (Epilim). If you wish to discuss further, please call (01) 833 8147 or alternatively you can email us at [email protected].
Valproate (Epilim): Background and History
Valproate was first licensed for use in Ireland in 1975 and it is prescribed to treat patients with epilepsy or bipolar disorder and it is noted as an effective method of treatment. However, warnings in respect of the higher risk of congenital malformations for children of women exposed to valproate (Epilim) during pregnancy were frequently not given and many women were either prescribed with or were not informed of the risks associated with valproate during pregnancy. Recent guidance approved by the HPRA (Ireland’s Regulator responsible for the safety, quality, and effectiveness of medicines for people) also includes precautionary statements in respect of the use of Valproate (Epilim) by male patients and notes the potential risk of “neurodevelopmental” disorders in children born to men treated with Valproate in the 3 months prior to conception. A statutory instrument enacted in Ireland in July 2025 provides the terms of reference which will apply to an inquiry in Ireland which will focus on the use of Valproate within the Irish State.
“If you do not give women a choice you deprive them of a voice to protect their child, the women who speak to you today, who have personal experience, have been deprived of a choice, of that voice, to protect their children”
Intervention Speaker at the European Medicines Agency Public Hearing, London, September 2017
The inquiry arises following many years of lobbying by those impacted by Valproate (Epilim) and following a review into the risks of Valproate (Epilim) carried out in 2014 by the European Medicines Agency together with a subsequent 2017 public hearing held in London by the European Medicines Agency. The public hearing held in London outlined amongst other matters the overwhelming evidence available detailing the teratogenic risks (any agent that causes an abnormality following fetal exposure during pregnancy) associated with valproate which were evident as far back as 1974, one year prior to the licensing of valproate in Ireland. Epilepsy Ireland has outlined on its website that “from the 1960’s onwards, evidence was emerging that the drug could have these devastating effects if prescribed in pregnancy.”
“from the 1960’s onwards, evidence was emerging that the drug could have these devastating effects if prescribed in pregnancy.”
Epilepsy Ireland
A review conducted by the European Medicines Agency (The European Agency Responsible for Oversight and evaluation, supervision and safety monitoring of medicines) in 2014 following a referral by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) under a European Directive in October 2013 concluded that children of women exposed to valproate (Epilim) during pregnancy resulted in a higher risk of congenital malformations. The review outlined that the most common types of malformations included: –
- Neural tube defects,
- Facial dysmorphism,
- Cleft lip and palate,
- Craniostenosis,
- Cardiac,
- Renal and urogenital defects,
- Limb defects
The review further outlined that “exposure to valproate in utero can have adverse effects on mental and physical development of exposed children” and data available to the review demonstrated that children who were exposed to valproate in utero were at an increased “risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) …………….and may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD)”.
September 2017 Public Hearing – European Medicines Agency.
In September 2017 a public hearing was held by the European Medicines Agency following its review of Valproate in 2014. The review opened by outlining the serious risks posed by valproate to the unborn. The public hearing invited speaker interventions to share their experiences with Valproate and the seriousness of the impact that Valproate can have on the children of mother’s prescribed with it. A speaker outlined that in 2013 their research into the Valproate administered in the United Kingdom indicated that no booklets were made available by the Department of Health or the NHS and that the majority of General Practitioner’s (GPs) were “unaware or opted not to give vital information” to those prescribed with Valproate. The speaker continued to outline that when Valproate was first licensed for use in the United Kingdom in 1973, the UK committee for safety and medicines sent instructions to doctors explaining the teratogenic risks (any agent that causes an abnormality following foetal exposure during pregnancy) but were “told that this was to be without the patients themselves seeing it”. The Speaker further stated that the warnings in respect of the risks associated with Valproate “should have and could have” been given as far back as 1974. The speaker further outlined that a Dear Doctor Letter (formal communication from a drug manufacturer or regulator to healthcare professionals about important safety information regarding a medicine) sent in 1973 following the licensing of valproate in the UK included the following paragraph:
“it would be best if the prescribers were all made aware of the nature and evidence and recommended that a statement…could be included in all relevant data sheets but not on the packaging inserts so that there could be no danger of the patients themselves seeing it.”
Excerpt from Dear Doctor Letter, 1973
The intervention speaker concluded by adding “If you do not give women a choice you deprive them of a voice to protect their child, the women who speak to you today, who have personal experience, have been deprived of a choice, of that voice, to protect their children”. The matters discussed at the September public hearing included amongst other issues, further development of professional education ensuring that healthcare professionals were aware of risks of valproate and the need to ensure that when the Valproate is dispensed to a person, that the person also receives it in appropriate packaging accompanied by information and discussion on the risks.
Redress for Victims of Valproate: “First Do No Harm”:-
In the UK following a review entitled “First Do No Harm” which considered healthcare failures relating to women’s health and a subsequent report published in 2024 included recommendations in respect of redress for those impacted by the Valproate. Those recommendations at the time of writing remain to be implemented. In France, those impacted by valproate have access to a compensation scheme through the ONIAM (National Office for Medical Accidents’ Compensation).
The recent statutory instrument introduced into Irish law on 25th July 2025 entitled the “Data Protection Act 2018 (Section 60 (6)) (Inquiry Into Licensing and Use of Sodium Valproate In Women of Child-Bearing Potential In the State) Regulations 2025, seeks to restrict certain rights contained in the General Data Protection Regulation for reasons of substantial public interest. The terms of reference for the enquiry are outlined in the statutory instrument which are summarised as follows:
- To provide a voice to persons with a diagnosis of fetal valproate spectrum disorder which is the range of signs and symptoms which occur as a consequence of exposure to sodium valproate or valproic acid in the womb.
- 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. You will note that problems associates with the use of sodium valproate are documented as far back as the 1960s, however, it was not until 1975 that the drug was licensed in Ireland. This part of the enquiry would appear to focus on the a period encompassing approximately 50 years.
- To develop a timeline of significant developments in the scientific knowledge relating to the teratogenicity (*the ability of a substance to cause developmental malformations or birth defects) according to medical resources 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 to other anti-seizure medications (ASMs).
- To assess the adequacy of services and supports currently provided to those diagnosed with a diagnosis of foetal valproate spectrum disorder which is the range of signs and symptoms which occur as a consequence of exposure to sodium valproate or valproic acid in the womb to include an assessment of the adequacy of services and supports provided to caregivers, and to provide recommendations regarding same if identified.
An interim report is to be provided to the Minister for Health within 6 months of the commencement date of the inquiry and a final report is to be issued within 12 months but not later than 18 months after commencement of the inquiry. The report will make recommendations as to how to improve the communication of the risks associated with valproate and review the current systems in place to ensure “clear communication of risks to, and obtainment of informed consent from, women of child-bearing age who are prescribed sodium valproate.” It will review “the systems already in place for the dissemination of medicines safety information, make recommendations as to how these systems may be improved where risks are identified”. The inquiry will also make any other recommendations considered appropriate by the Chair to support those impacted. Although not specifically referred to in the Statutory Instrument it remains to be seen whether redress will be included in the recommendations for those impacted by Valproate.
Anyone wishing to read the terms of reference with respect of the inquiry into the use of sodium valproate (Epilim) in Ireland can do so by clicking on the following link https://bit.ly/4oMP8oTThe announcement in respect of the Inquiry from the Department of Health relating to the inquiry can be accessed by clicking on the following link also http://bit.ly/4626SFh . Should you wish to discuss any of the above matters, please get in touch by contacting us at (01) 833 8147 or alternatively you can email us at [email protected]. Telephone, Video Call and in person consultations are available by appointment.
Further Information.
The following Websites contain further information on valproate (Epilim):-
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