Sodium valproate inquiry begins after two-year wait
By Michael McHale 22nd July 2025
The Government’s intention to run a non-statutory review of the epilepsy drug was first announced in July 2023
More than one year after its chair was appointed, the Minister for Health has today announced the commencement of a non-statutory inquiry into the historical licensing and use of sodium valproate in women of childbearing potential in the state.
Trading under the name Epilim in Ireland, sodium valproate is regularly prescribed here for the treatment of epilepsy and bipolar disorder.
However, children exposed to sodium valproate in the womb are at a high risk of serious developmental disorders (in up to 40 per cent of cases) and congenital malformations.
The non-statutory inquiry will review how the drug has been prescribed in Ireland as well as the timeline of scientific knowledge about the product’s effects on foetal development.
It will also look into the capacity of Ireland’s health service to address safety concerns around the treatment and make recommendations where necessary.
Jennifer 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.
The inquiry will be chaired by Ms Bríd O’Flaherty BL, who was appointed in June 2024. That appointment came eleven months after it announced that a review into the drug would take place, meaning that advocates have had to wait two years since then for the inquiry to begin.
“I have every confidence that the chair will conduct an independent and fair Inquiry and finally get answers for those affected and their families,” added the Minister.
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 www.svinquiry.ie.