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Statement from OACS Ireland and Epilepsy Ireland on cabinet approval for non-statutory inquiry into historical licensing and prescribing of Sodium Valproate

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Sodium Valproate medication

OACS Ireland and Epilepsy Ireland welcome today’s official approval from cabinet to establish an inquiry into the historical licensing and prescribing of Sodium Valproate in Ireland.

Both organisations have campaigned for the establishment of an inquiry since 2014, and cabinet approval for the inquiry follows the Minister for Health’s commitment to an inquiry in 2020.

Commenting on today’s cabinet approval, Karen Keely, Chairperson of OACS Ireland said:

“From the outset, OACS Ireland members favoured the establishment of a Statutory Inquiry as being the most appropriate vehicle to fully investigate the history of the licencing and prescribing of Sodium Valproate in Ireland. However, we were left in no doubt during our prolonged negotiations that the terms of reference agreed by Cabinet today were the only terms on offer. Our members reluctantly agreed to proceed with a non-statutory inquiry.

“The last three years have been marked by lengthy and frustrating delays in getting the inquiry established with extensive discussions on the form of the inquiry and its terms of reference.

“While the structure is not what we would have chosen at the beginning of this process, we sincerely hope that this inquiry will, through transparency and public interest, act as a vehicle to finally answer our long-standing questions and give a voice to those who have been harmed, some catastrophically over the years. Families are trusting that the process, under the guidance of an independent Chair, will strike at the heart of key issues such as how and why this was allowed to happen; why it took so long for effective preventative regulatory steps to be put in place; and whether the steps taken by the State over time were in line with the progression of scientific knowledge.

“However, we are under no illusions about the non-statutory nature of the inquiry and recognise that we are at the end of a phase of our campaigning, rather than the end of the campaign.

“There is still a lot of work to be done and we look forward to working with the Chair, when appointed, and the Department of Health to ensuring that appropriate supports are put in place to facilitate maximum participation of families affected by Sodium Valproate in the inquiry and that an effective communications campaign is put in place to seek out affected families – something the Minister agrees is of paramount importance.

“Overall, today is an important day for all the families in Ireland whose children have been left with devastating birth defects and neurodevelopmental delay as a direct result of their mothers taking sodium valproate during pregnancy.

“It has taken over a decade of our lives to get to this stage and we are pleased to be moving forward at long last.

“I would like to thank the Minister for Health for his commitment to establishing and delivering this inquiry”.

Epilepsy Ireland CEO Peter Murphy commented:

“Today’s decision by cabinet paves the way for the State to begin the process of understanding the history of sodium valproate, and the impact that exposure to the drug has had for an estimated 1,250 families in Ireland. Other European countries including the UK and France have already taken action on this issue, and we hope that Irish families will soon have their voices heard, and in time, the answers they rightly deserve.

“By documenting the regulation and practices around the prescribing and dispensing of sodium valproate, alongside a thorough review of the development of scientific data over time, a clearer historical picture will emerge not just for those impacted but to inform recommendations to ensure that this never happens again. It is vital that public trust in how our medicines is regulated and prescribed is maintained. It is equally vital that we do all possible to ensure the safety of women who continue to be prescribed the medication to this day, as well as their future children”.

Both Epilepsy Ireland and OACS Ireland look forward to the swift establishment of this essential inquiry.



Further information

  • Sodium Valproate (Epilim) is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. If a woman becomes pregnant while taking Epilim, their baby is at risk of serious birth defects and developmental disorders. In 30-40% of cases where the child has been exposed to valproate in utero, the child will have serious developmental disorders. In 10% of cases, the child will have congenital malformations. The HSE estimate that up to 1,250 families have been impacted in these ways by exposure to valproate in pregnancy since the 1970s. To learn more about the Sodium Valproate Pregnancy Prevention Programme, visit the 'Sodium Valproate' section of Epilepsy Ireland’s website
  • OACS Ireland is a voluntary group that was set up in 2017. OACS Ireland provide support, help, and advice to other families, whose children have been affected by Foetal Anti-Convulsant Syndrome (F.A.C.S) in Ireland. The Purpose of OACS Ireland is to ensure that people living with FACS and their families will experience better recognition, improved public health services, and support. You can learn more about OACS by visiting the OACS Ireland website.
  • Fetal valproate spectrum disorder (FVSD) and Fetal valproate syndrome (FVS) describe the range of signs and symptoms which occur as a consequence of exposure to sodium valproate or valproic acid in the womb. A wide range of physical anomalies occur at increased frequency, including spina bifida, major and minor limb abnormalities, oral clefting, cardiac defects, hypospadias, and joint laxity. A characteristic pattern of facial dysmorphism is frequently present, especially notable in early childhood. Neurodevelopmental problems including reduced IQ, poorer language and motor development, increased rates of autistic spectrum disorder and attention deficit hyperactivity disorder are observed in up to 40% of those exposed. Vision problems such as myopia and astigmatism are also common. Risks are dose dependent and the impact on the brain may be seen at lower doses than those required for physical development alterations. You can learn more about FVSD/FVS by visiting the OACS Ireland website.
  • If you are hearing about Sodium Valproate for the first time, visit this section on Epilepsy Ireland’s website why an inquiry was announced by the Minister in November 2020.
  • Epilepsy is a neurological disorder characterised by a tendency to have recurring seizures. Over 45,000 in Ireland have epilepsy including 10,000–15,000 people who are living with uncontrolled seizures. For this group in particular, the consequences of epilepsy can be long-lasting and significant. It can affect the person’s education, employment, social functioning, self-esteem and independent living. People with epilepsy must also cope with the physical impact of seizures, the side-effects of medications and for many, the social stigma and economic impact that can be associated with it. Its individualised impact on those who live with it means that it is often considered as a hidden disability. There is also an increased risk of mortality associated with epilepsy with an estimated 130 epilepsy-related deaths in Ireland each year. Epilepsy Ireland’s vision is to achieve a society where no person’s life is limited by epilepsy. Since 1966, we have remained committed to working for, and meeting the needs of everyone with epilepsy in Ireland, their families, and carers. You can learn more about the work of Epilepsy Ireland by visiting
  • To learn more about the history of this campaign, visit the ‘Advocacy’ section of Epilepsy Ireland’s website.
  • You can read Minister Donnelly's announcement on the establishment of the inquiry by visiting the website.