Louise O'Reilly (Dublin Fingal, Sinn Fein) | Oireachtas source

At the end of September the European Medicines Agency in London held a public hearing on the epilepsy drug sodium valproate, better known in Ireland as Epilim. The purpose of the hearing was to consider whether the warning against taking the drug while pregnant was strong enough. It followed on from a review in 2014 based on which the European Medicines Agency took the decision to strengthen the restrictions on valproate containing medicines owing to the risk of malformations and developmental problems in children exposed to the drug in the womb. The agency's most recent summary guide for health care professionals on the risks associated with valproate for female patients issued in 2016 states: "Sodium valproate should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate". In its most recent valproate patient toolkit the HSE states: "If you take valproate when you are pregnant it can harm your unborn child". The leaflet goes on to state that for women who take valproate while pregnant around ten babies in every 100 will have a birth defect and that about 30 to 40 children in every 100 may suffer from developmental problems. Shockingly, it was only earlier this year that instructions were issued to include a warning label for the outer packaging of Epilim products that had been introduced in Ireland, but they still not being adhered to everywhere. Unfortunately, these measures have come too late for some. A number of women in Ireland, some of whom are in the Visitors Gallery, were not informed about the harmful repercussions for their unborn child when they were prescribed and took sodium valproate while pregnant. In 2013 Epilepsy Ireland estimated that the drug had affected at least 400 children. The syndrome which affects these children is known as foetal anticonvulsant syndrome or foetal valproate syndrome. It can give rise to spina bifida, heart defects, breathing difficulties, overlapping fingers and toes, club foot, hip dislocation and distinctive facial characteristics.

Last week I met Karen, Wendy and Susan, all of whom had been prescribed sodium valproate while pregnant and all of whom have children with foetal valproate syndrome. They are not looking for much. Will the Government undertake an investigation into the current and historical use of the drug? Will it acknowledge that these women should be compensated for the impact of the drug on their families? Will it also commit to establishing a State-wide register for those who are on the medicine and those who will be prescribed it in the future, as well as a register for the children who have been affected by foetal anticonvulsant syndrome caused by exposure to sodium valproate? As a matter of urgency, will it put in place appropriate pathways for the diagnosis and treatment of foetal anticonvulsant syndrome, as well as providing additional services for children with the syndrome? Previous Governments did not exactly cover themselves in glory when it came to women's health issues. We have seen Taoisigh and Ministers for Health stand where the Tánaiste is and apologise to women. She has a chance to do this right. I ask her to take that chance.

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