Supporting International Women’s Day 2023

In support of women and their children harmed by the prescription of epilepsy drug Epilim (Sodium Valproate) in pregnancy, OACS Ireland is reiterating its call for the commencement of a promised Government- inquiry into the prescription and licensing of this drug in Ireland.

By way of background, Sodium Valproate is a drug which is commonly prescribed in epilepsy and other conditions. It has been licensed in Ireland since 1975 and was in use off-label in Irish hospitals from 1973. It is a very effective drug in helping people with epilepsy to gain control over their seizures and is also licensed in Ireland for the treatment of bipolar disorder.

However, if prescribed to a woman or girl who becomes pregnant, the effects of this drug can be devastating. In 30-40% of cases, a child exposed to Sodium Valproate in-utero (in the womb) will have developmental disorders such as autism, autism spectrum disorders, ADHD, delayed walking and talking and learning difficulties. In approximately 11% of cases, the child will go on to have congenital malformations. Evidence of this impact began emerging from the 1970s.  The term “The Fetal Valproate Syndrome” was first used in 1984 in a case report series by Di Liberti et al (of the seven case reports, all the children had characteristic facial appearance, four had other congenital abnormalities, and two had psychomotor delay). In 2018 the term Foetal Valproate Syndrome was changed to Foetal Valproate Spectrum Disorder to encompass the neurodevelopmental disorders.

In Ireland the HSE estimates between 1975 and 2015 some 153 to 341 children may have experienced a major congenital malformation and up to 1,250 some form of neurodevelopmental delay. The women who were prescribed this medication in pregnancy, and the children who have been harmed, still wait on Minister Stephen Donnelly to confirm when he intends delivering on his 2020 commitment to holding an inquiry into the historical licensing and use of Sodium Valproate.

Three years ago, the Minister promised a ‘fair and fast’ inquiry. Yet Irish women are still none the wiser as to when the inquiry will commence, nor have we received clarity from the Minister on the version of the terms of reference meant to be governing the intended inquiry.

Letters in relation to the inquiry have gone into the Minister from OACS Ireland, all went unanswered. It is now well known that OACS Ireland members agreed to the Terms of Reference albeit reluctantly, in November 2022. This is because it was the only terms of reference that was allowed on the table. OACS Ireland were left with little to no choice to agree to said terms.

We at OACS Ireland will be releasing the final letter sent to the Minister on the 19th of October 2022 which will give a detailed account of what went on in discussions with the Department of Health and the Minister. It will show all how the Irish State has served the women and their children harmed by the medication.

Women who received this medication in pregnancy now want to know – what is the Irish State’s position on those women and children who have been adversely impacted by Epilim (Sodium Valproate) from 1975 to the present day.

Some of the injuries that the women’s children have suffered due to prescription of Epilim (Sodium Valproate) and the lack of warnings provided are outlined below.

This list is not extensive.

  • Asthma
  • Spina Bifida
  • Limb Defects
  • Incontinence
  • Congenital Heart Defects
  • Joint Laxity (Hypermobility)
  • A delay in reaching milestones.
  • Gross and fine motor difficulties
  • Attention and memory difficulties.
  • Speech and language difficulties
  • Noise Intolerant (doesn’t like loud noises, tends to cover their ears)
  • Autistic Spectrum Disorders (Dyspraxia, Asperger’s, ADHD)
  • Visual problems such as short sightedness or squints,
  • Characteristic Facial Features