Press Release: Tuesday 22 July 2025
Minister for Health welcomes the commencement of Sodium Valproate Inquiry
Minister for Health, Jennifer Carroll MacNeill TD, has today welcomed the commencement of the Non-Statutory Inquiry into the Historical Licensing and Use of Sodium Valproate in Women of Childbearing Potential in the State. The Inquiry will be chaired by Ms. Bríd O’Flaherty BL.
Minister Carroll MacNeill said:
“I welcome the commencement of the Inquiry, which will give those directly affected by sodium valproate an opportunity to have their voices heard. I was grateful to meet with Organisation Anticonvulsant Syndromes Ireland (OACS Ireland) recently and I know this is an important day for them and the families they represent.
“I have every confidence that the Chair will conduct an independent and fair Inquiry and finally get answers for those affected and their families.”
The inquiry will examine the historical and current context of sodium valproate use through three distinct strands:
- Review Phase
The first strand will be the review phase, which will establish a timeline for the use of sodium valproate in the State in women of childbearing potential including information on regulation, prescribing, dispensing and safety information issued. The Inquiry will seek to document the evolution of sodium valproate regulation and the practices around the control of this product. The Inquiry will have responsibility to request documentation and submissions from a range of stakeholders. The Chair will highlight, and record difficulties encountered where such requests are refused as part of their reporting function.
- Personal Statements
The second strand of the Inquiry will enable oral statements from individuals diagnosed with Foetal Valproate Spectrum Disorder (FVSD), their mothers and other family members who may wish to participate in this Inquiry. Other stakeholders may also be invited to provide oral statements, in separate sessions. All sessions will be held in private.
- Health Service Capacity
The third strand will focus on assessing the health service’s current capacity to respond to safety issues related to use of anti-seizure medications (ASMs) in women of child-bearing potential. It will involve an assessment of the current systems in place to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential; development of other recommendations regarding current control systems for sodium valproate and other ASMs, and the services and supports for those impacted by sodium valproate. The results of this assessment will inform future service development.
A communications campaign will be launched in the coming weeks to raise public awareness and support engagement with the Inquiry.
While sodium valproate is an effective and essential treatment for some patients, sodium valproate-containing medicines can cause birth defects, neuro-developmental disorders and autism in children whose mothers take such medicines during pregnancy.
Women and girls who have been prescribed sodium valproate must not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy or bipolar disorder should be avoided as this could have serious consequences for a woman and, if pregnant, their unborn child.
For more information on the Inquiry, visit svinquiry.ie/.