The FACS Forum spoke today at a health committee on Foetal Anticonvulsant Syndrome.
Karen Keely of OACS Ireland, whose three sons all had birth defects after she took sodium valproate, read out emotional statements on behalf of other Mothers who have been affected by the drug. Many of the families attended the hearing.
Explaining a Cork Mother's story, Karen said: "I took Epilim when I was pregnant. My 5-year-old son has a diagnosis of childhood Autism. My son was non- verbal and he needed speech therapy he also needed and an OT assessment for his sensory needs. None of these services were available to my son and my husband and I had to pay privately. The devastating impact this has had on our family is unthinkable to bear at times."
Joan O'Donnell, Chairperson of the FACS Forum also addressed the room and said: "There is an urgent need to fully implement the 2018 decision of the European Medicines Agency which outlines a new range of measures to reduce the future risk of valproate use in women and girls. We, in the FACS Forum have been greatly encouraged by the range of measures proposed in Ireland and the urgency and commitment shown by the Health products Regulatory Authority, the HSE, the Pharmaceutical Society of Ireland and other stakeholders. We want to see all the positive progress impact on the numbers of children being born with FACS.
"We also want a commitment from all stakeholders that all new risk reduction initiatives will be independently evaluated and additional action taken if necessary."
Epilepsy Ireland CEO Peter Murphy also attended and answered questions from Dail Deputies who included Stephen Donnelly (FF) and Kate O'Connell (FG). He said: "We're asking for three things: What happened in the past? Why did this happen? What can be learned?"
Murphy added: ""We don't want to sit here in three years time and be in the same position. Action is needed."
In response to questions, The HPRA (Health Products Regulatory Authority) said it would review why there had been differences in the drug warnings in Britain compared to Ireland.
HPRA Risk Management Lead Almath Spooner said new measures were in place which would prevent similar errors. "Lessons have been learnt. We have a much more robust approach to the vigilance of medicines in pregnancy," she said.
Head of the HSE's Women and Infants Programme Kilian McGrane told Stephen Donnelly TD that a register would be needed to quantify the scale of the problem. He said the health service aims to have a register that would record incidents of birth defects connected with drugs such sodium valproate as well as examining any contemporary cases.
Minister for Health Simon Harris last week stated that parents affected by the drug sodium valproate have been 'let down' after the issue was raised in the Dáil by Fianna Fail TD, Bobby Aylward.