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 introduced to encompass neurodevelopmental outcomes.
Will the Inquiry hear from those affected by Foetal Valproate Spectrum Disorder (FVSD)?
The Inquiry has been set up to give a voice to those affected by a diagnosis of Foetal Valproate Spectrum Disorder (FVSD), those on the diagnostic pathway, and their families.
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 patients and/or their families, engaging with the Inquiry may be a difficult experience. The Inquiry acknowledges that for some patients and/or their families who by reason of their health and wellbeing, or due to care commitments or other practical commitments, may 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. Details of the supports can be found here on the website or you can contact the Inquiry for further information.
What are the criteria for participating in the Inquiry?
A diagnosis of Foetal Valproate Spectrum Disorder (FVSD) or proof that you or a family member is on the diagnostic pathway for FVSD.
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.
What information do I need provide the Inquiry with?
The Inquiry team are available to discuss your circumstances and take your details over the phone or by whichever way is most convenient for you. The Inquiry will initially require the following information in order to consider if you are eligible to participate in the Inquiry:
Mother
Name, date of birth, address, phone number, email address, year(s) prescribed sodium valproate and confirmation from a healthcare provider that she was prescribed sodium valproate. This may, for example, take the form of a letter from the treating doctor or some other health record.
Other family member
Name, date of birth, address, phone number, email address, relationship to the mother, the year(s) she was prescribed sodium valproate and confirmation from a healthcare provider that she was prescribed sodium valproate. This may, for example, take the form of a letter from the treating doctor or some other health record.
Child
Name, date of birth, address, phone number, email address, evidence that their mother took sodium valproate in pregnancy, a diagnosis of FVSD or evidence the child is on the diagnostic pathway. These may, for example, take the form of letters from the mothers treating doctor, the child’s treating doctor or some other health record.
The Inquiry does not require those wishing to participate to furnish it with full medical files.
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
What can I expect from a meeting with the Chair?
Phase two of the Inquiry will involve the Chair, Bríd O’Flaherty BL and members of the Inquiry team, hearing from those diagnosed with FVSD and their families members. Those who wish to participate with the Inquiry are asked to initially make contact with the Inquiry. Please see the Contact us page.
These meetings will be held in private. The Inquiry will adopt a flexible approach so as to best facilitate full participation from those who wish to do so.
The Inquiry may meet individuals in groups or on a one-to-one basis, depending on the preference of the individual.
A meeting may be at an appropriate venue of your choosing, at the Inquiry Office or at a person’s home.
The Inquiry may receive written personal statements from individuals affected. There will be no requirement for these to be drafted by a legal representative.
The Inquiry may accept video recordings where practicable.
How is any personal data shared with the Inquiry processed by it?
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.
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.