merrion street

Minister for Health Commits to Inquiry into Anti-Epilepsy Drug Sodium Valproate

Minister for Health Stephen Donnelly has committed to holding an inquiry into the historical licensing and use of the anti-epileptic drug sodium valproate (Epilim) in Ireland, following a meeting with representatives from Epilepsy Ireland and the Organisation for Anti-Convulsant Syndrome (OACS) Ireland.

Minister Donnelly said: “Parents and children impacted by sodium valproate have been fighting for many years for an inquiry into the licensing and use of this drug. I have asked officials in my Department to begin work on this as a priority, and have emphasised the need for a fair and fast inquiry. Inquiries on this drug have already taken place in other countries, including in France and in the UK, and so we can draw on those learnings, but I also want to ensure that the voices of Irish families and their experiences are listened to and reflected on throughout this inquiry.”

Valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy, and sodium valproate has been the subject of two recent reviews by the European Medicines Agency, in 2014 and 2017.

The Minister has asked officials to examine a number of different options for the structure of this inquiry, but emphasised that he favours a streamlined process that builds on existing knowledge and findings from other jurisdictions, will produce a speedy report and be low cost. He also stressed that testimonies from families affected by disabilities associated with the drug will need to be central to the process.

In July 2020, the Independent Medicines and Medical Devices Review in the UK published “First Do No Harm”, a comprehensive report into how the UK healthcare system has responded to concerns raised by patients and families about three medical interventions, including sodium valproate.