Posted: January 23rd, 2018
Karen Keely, a Co Meath mother of three sons who have experienced illness due to use of the Epilepsy treatment drug Epilim, has given evidence at the European Medicines Agency review into its use.
Last September (2017) Ms Keely, a member of the Foetal Anti-Convulsant Syndrome Forum advised the review hearing of the difficulties her sons have gone through over the course of their lives.
Ms Keely said: “Two of my three boys require life-long care and will never live a normal life, will never be able to have children or get married. The effects of sodium valproate have been unbearable.
“I have been mourning my children since the day they came into my life and I’m determined to not let this injustice happen to other families in the same way that it has happened to mine.”
Ms Keely also said one of the problems was that some patients on valproate long term may get the medicine in a plastic bag. She called for a national register to be established in Ireland of those who were treated with the medicine and people who are being prescribed it in the future.
She also said that more research into the scale of the problem and accountability needs to be completed. Ms Keely said the HSE had details online but wider publicity was needed to spread the word.
The public hearing saw speakers from six EU Member States recounting their experience to the members of the PRAC (Pharmacovigilance Risk Assessment Committee). Epilim has been acknowledged to cause physical deformities, brain damages and autism in children whose mothers are prescribed it during their pregnancy. It is currently being implicated in 40 cases of birth defects and disabilities, reported to the Health Products Regulatory Authority (HPRA) in recent times.
Following the completion of the review, initiated on 9 March 2017 at the request of the French medicines regulator ANSM, by the European Medicines Agency is it expected that the HRPA will meet to review the use of Epilim in Ireland by medical professionals.