Sodium Valproate Inquiry in Ireland opens.

The Sodium Valproate Inquiry in Ireland officially commenced on 22 July 2025, having been initially announced in November 2020 and approved by the Cabinet in July 2023. Barrister Bríd O’Flaherty BL was appointed as the Chair of the non-statutory inquiry in June 2024. This Sodium Valproate Inquiry represents a significant investigation into the historical licensing and use of the epilepsy drug Sodium Valproate (also known as “Epilim”) in the country, particularly concerning its devastating effects on children exposed to it in the womb.

What is the Sodium Valproate Inquiry?

The Sodium Valproate Inquiry is Ireland’s official investigation into decades of prescribing practices surrounding this anti-epileptic medication. This comprehensive inquiry will examine how regulatory bodies, healthcare providers, and pharmaceutical companies handled information about the drug’s risks to unborn children from 1975 to the present day.

Background and purpose of the inquiry

Sodium Valproate is a commonly prescribed and effective drug for controlling epileptic seizures and is also used for bipolar disorder. However, studies have increasingly shown that if taken by pregnant women, it can cause severe harm to the unborn child. The Sodium Valproate Inquiry aims to investigate how these risks were communicated and managed over the past decades.

Risks to unborn children

The Sodium Valproate Inquiry will thoroughly examine the following documented risks:

• Neurodevelopmental disabilities: In 30-40% of cases, children are more likely to be born with issues such as autism, ADHD, memory problems, or learning difficulties.
• Congenital malformations: In approximately 10% of cases, babies are more likely to be born with physical congenital disabilities like spina bifida, cleft lip/palate, or other organ/limb abnormalities. These conditions are sometimes referred to as Foetal Valproate Spectrum Disorder (FVSD).

Historical context under investigation

The Sodium Valproate Inquiry will investigate the timeline from when the drug was first licensed in Ireland in 1975. Despite emerging evidence of risks from the 1960s and particularly in the 1980s, many women were reportedly not adequately informed of these dangers and were even encouraged to continue taking the drug during pregnancy.

A 2018 HSE report estimated that around 1,250 children in Ireland have been affected by Sodium Valproate exposure since the 1970s. Advocacy groups, such as OACS (Organisation Anticonvulsant Syndromes) Ireland, and affected families have been campaigning for years for answers, accountability, and support efforts that have culminated in the Sodium Valproate Inquiry.

Key findings expected from the Sodium Valproate Inquiry

The Sodium Valproate Inquiry will examine critical gaps in patient safety and informed consent. Evidence suggests that, despite international warnings emerging in the 1980s about teratogenic risks, many Irish women continued to be prescribed Sodium Valproate during pregnancy without adequate counselling about potential consequences. The inquiry will investigate whether regulatory authorities and healthcare professionals responded promptly to emerging safety data.

Inquiry’s Goals and Scope

The Sodium Valproate Inquiry, announced by Minister for Health Stephen Donnelly in November 2020 and approved by Cabinet in July 2023, aims to:

• Document the evolution of Sodium Valproate regulation in Ireland from its initial licensing to the present day.
• Examine the practices and controls related to the prescribing and dispensing of medications to women of childbearing potential.
• Map the timeline of scientific knowledge about the drug’s impact on foetal development.
• Give a voice to those affected by FVSD through the Sodium Valproate Inquiry process.
• Assess the adequacy of current services and supports for patients and caregivers.
• Evaluate the health service’s capacity to address safety issues concerning the drug and make recommendations, potentially for other anti-seizure medications (ASMs) as well.

Impact and expectations

The Sodium Valproate Inquiry represents a critical step for Ireland to address a significant historical medical scandal, seeking to provide answers, ensure accountability, and improve future patient safety and care. Families affected by FVSD hope this Sodium Valproate Inquiry will finally give the recognition, answers, and systemic changes they have long sought. The findings of the Sodium Valproate Inquiry are expected to influence future drug safety protocols, informed consent procedures, and support services for affected families throughout Ireland and potentially across the European Union.

Contact us

If your child has been affected by Sodium Valproate exposure and you are seeking legal advice regarding the Sodium Valproate Inquiry or potential compensation claims, specialist legal support is available. For confidential advice about your rights and options, contact Coleman Legal LLP on freephone 1800-844-104 or email [email protected].