Frequently asked questions
I am currently prescribed a drug containing sodium valproate. Should I stop taking it?
Sodium valproate is an effective drug in the treatment of epilepsy and bi-polar disorder. It is very important you do not stop taking your prescribed medication without consulting your GP or other relevant healthcare provider.
What is sodium valproate?
Sodium valproate is an effective antiepileptic drug (AED) which is also used to treat bipolar disorder, migraine and other conditions. It is also known as valproic acid.
It is licensed in the State under the brand name Epilim.
What is Foetal Valproate Spectrum Disorder (FVSD)?
Sodium valproate is an effective and essential treatment for some patients. However it can cause birth defects, autism and problems with the development and learning of the child if their mother takes this medicine during pregnancy.
There is strong scientific evidence that some anti- seizure medications (ASMs), including sodium valproate, are teratogenic (can cause foetal abnormalities), and are associated with an increased risk of foetal anti-convulsant syndromes (FACS). FACS is an umbrella term for a group of conditions that can affect some babies exposed in utero to anti-convulsant drugs including valproate medicines.
In 2019, the new term Foetal Valproate Spectrum Disorder (FVSD) was adopted by the World Health Organisation to encompass neurodevelopmental outcomes. The term FVSD includes a diagnosis of Foetal Valproate Syndrome (FVS).
What is the ‘diagnostic pathway’?
The term Foetal Valproate Spectrum Disorder (FVSD) includes all the cases from major congenital malformation to neurodevelopmental delays. For the purpose of this Inquiry, a participant will be included in the process if they can confirm that the mother took sodium valproate during the pregnancy and that a healthcare provider has referred the child for diagnostic testing for FVSD.
Why was the Inquiry established?
Following a campaign by advocates, patients and their families, the Chair of this independent non-statutory Inquiry was appointed.
Phase One of the Inquiry will document the regulation of sodium valproate in the State from initial licensing to the present day. It will document the practices and controls in place relating to the prescribing and dispensing of this product to women and children of child bearing potential.
In the first phase, the Inquiry will also develop a timeline of significant developments in scientific knowledge relating to the teratogenicity (causation of birth defects) of sodium valproate.
In Phase Two of the Inquiry, it will assess the adequacy of services and supports currently in place for patients and their caregivers. The Inquiry will also consider the health service’s capacity to address safety issues relating to the use of sodium valproate in some groups of women and will make recommendations as deemed necessary.
I am, or a member of my family is affected by Foetal Valproate Spectrum Disorder (FVSD). Where can we access supports?
The Inquiry acknowledges that for some participants, engaging with the Inquiry may be a difficult experience. Some participants may, by reason of their health and wellbeing, or due to care commitments or other practical commitments, encounter barriers to participation in the Inquiry process.
For this reason, the Inquiry will provide access to counselling and legal supports to ensure full participation for those who wish to do so. Discover supports for Sodium Valproate Inquiry participants and contact details for the Sodium Valproate Inquiry.
How do I get in touch with the Inquiry?
Call the Inquiry office on (01) 2233 558. Calls can be received Monday to Friday from 10.00am to 4.00pm (closed for lunch from 1.00pm to 2.00pm). Outside of these hours, please leave a voicemail with your name and number to request a call back
Write to us at Sodium Valproate Inquiry, 7/8 Mount Street Upper, Dublin 2, D02FT59
Email info@svinquiry.ie
Or complete our contact form
How does the Inquiry process personal data?
The Chair of the Inquiry acts as data processor and, with the Minister for Health, is a joint data controller.
On the 21st of July 2025, the Minister for Health signed the necessary regulations made under Data Protection Act 2018 so as to enable the Inquiry process personal and special categories of data. The Inquiry processes personal data and special category data in accordance with regulations made under S.38(4), S.51(3) and S.60(6) of the Data Protection Act 2018.
A Joint Controller Agreement between the Minister for Health and the Chair was signed on the 21st of July 2025.
At the cessation of the Inquiry, decisions will be made regarding the disposal or retention of records, balancing data subjects rights with the Minister’s obligations under the National Archives Act 1986 and Regulations 1988.
Download the Inquiry’s protocol on the processing of personal data (PDF)