HEALTH MINISTER STEPHEN Donnelly has committed to holding an inquiry into the historical licencing and use of the anti-epileptic drug sodium valproate (Epilim) in Ireland.
This decision follows a meeting with representatives from Epilepsy Ireland the the Organisation for Anti-Convulsant Syndrome Ireland.
Valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy.
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Sodium valproate has been subject to two recent reviews by the European Medicines Agency in 2014 and 2017. The HSE has estimated that up to 1,250 children may have been impacted in Ireland between 1975 and 2015. Strict measures were put in place 2018 to warn women of the dangers of the drug. It must now be initiated by a specialist and can no longer be used in women and girls unless the conditions of a pregnancy prevention programme (called Prevent) are met. A risk acknowledgement form must also be completed and signed by the patient and prescriber every year.
Epilepsy Ireland identified in a survey in July of this year, however, that less than 30% of women have heard of the mandatory Prevent programme and just 22% have been asked by their healthcare professional to sign the annual risk acknowledgement form.
Minister Donnelly has asked officials to examine a number of difficult options for the structure of the inquiry, but emphasised that he favours a streamlined process that builds on existing knowledge and findings from other jurisdictions. He also stressed that testimonies from families affected by disabilities associated with the drug will need to be central to the process.
“Parents and children impacted by sodium valproate have been fighting for many years for an inquiry into the licencing and use of this drug,” Donnelly said.
“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,” he said.
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. The Oireachtas Committee on Health first recommended the establishment of an independent inquiry to examine the licencing and use of valproate in Ireland in 2018.