Inquiry to be held into use of anti-epilepsy drug by pregnant women - Minister

The Minister for Health has committed to holding an inquiry into the historical licensing and use of anti-epilepsy medication Epilim by pregnant woman.

Valproate (also known as Epilim) can cause birth defects and problems with the development and learning of the child if the mother takes the medicine during pregnancy.

Campaigners had pushed for an inquiry to be set up to examine why mothers were not appropriately warned of the risks of taking the drug while pregnant until recent years.

Minister for Health Stephen Donnelly on Tuesday confirmed he has asked department officials to begin work on setting up a "fair and fast" inquiry, "as a matter of priority".

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“Parents and children impacted by sodium valproate have been fighting for many years for an inquiry into the licensing and use of this drug,” he 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,” Mr Donnelly said.

The Organisation for Anti-Convulsant Syndrome (OACS) Ireland, a group set up by mothers whose babies were diagnosed with foetal valproate syndrome (FVS), has pushed for accountability over the use of the drug in Ireland.

The founder of the group, Karen Keely, a mother from Ratoath, Co Meath, whose three sons all had FVS, spoke to The Irish Times about her experience in April 2017.

FVS is characterised by distinct deep-set facial features, physical malformations, developmental delay and autism, and can mean life-long care.

Despite studies since the late 1980s showing significantly increased risks of foetal malformations where pregnant women took sodium valproate, women of child-bearing age were not warned until recent years. The drug, called Epilim, is manufactured by the pharmaceutical giant Sanofi.

Mr Donnelly has told officials he would favour a “streamlined” process that draws on the work of similar inquiries in other countries, to keep the cost low. Testimonies from families affected by disabilities related to the drug would be central to the process, he said.

The decision to commit to an independent inquiry followed a recent meeting between Mr Donnelly, the campaign group OACS, and Epilepsy Ireland.

Sinn Féin TD Rose Conway-Walsh said the decision to hold an inquiry followed "a long and tortuous journey for the mothers and families" over recent years.

“We know up to 1,250 children born between 1975 and 2015 have been impacted here in Ireland. Some families have had a number of their children impacted,” she said.