Sodium Valproate (Epilim) Inquiry Update

An inquiry into the historical licensing and use of Sodium Valproate currently being completed by officials in the Department of Health is still awaited.

The inquiry, announced by the Minister for Health Deputy Stephen Donnelly in November 2020, is to be established due to the effects of the epilepsy drug Sodium Valproate – also known as epilim in Ireland – can have on children who are exposed to the drug in the womb when it was established that if the drug is taken by a pregnant woman, there can be devastating effects on the child noting in 30% – 40% of cases, the child will be born with neurodevelopmental disabilities such as delayed learning, ADHD, Autism and memory issues.

In 10% of cases, the child will be born with congenital malformations including spina bifida, cleft lip/pallet or a range of limb/facial/organ malformations.

The drug was first licensed in Ireland in 1975 however, from the 1960’s onwards evidence was emerging that the drug could have these devastating effects if prescribed in pregnancy. While the evidence accumulated over the subsequent years, it was not until 2014 and again in 2018 that State Agencies, such as the HPRA and HSE, took real measures to minimise the potential impacts of the medication if taken in pregnancy. In the intervening decades, thousands of women were prescribed the drug during pregnancy, often without any knowledge of the risk being posed.

A HSE report published in 2018 estimated that 1,250 children had been affected by Sodium Valproate since 1975 and in 2021 an investigation by Noteworthy.ie found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.

Despite the Minister promising a fair and fast inquiry in November 2020, the inquiry has yet to commence and recently there have been urgent calls for a Redress Scheme to be implemented for children affected by Sodium Valproate.

If you believe you or your child has been affected by prescribed Sodium Valproate during pregnancy, please contact our dedicated medical negligence team for confidential and expert advice.