EMA Hearing on Epilim Addressed by Irish Woman

A Co Meath mother of three sons, who have suffered major illness as a result of complication caused  by the Epilepsy treatment drug Epilim, has addressed at the European Medicines Agency review (EMA) into its use by pregnant women.

In September 2017), Karen Keely, a representative of the Foetal Anti-Convulsant Syndrome Forum impressed on the review hearing the ramifications that her sons have experienced due to her being prescribed the drug at the time she was pregnant with them. They will now face issue over the remainder of their lives, two of them can neverhope to live a ‘normal’ life.

Ms Keely said: ““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.”

Karen implored that a national register in Ireland of those who were on the medicine and people who are being prescribed it in the future must be set up. In addition to this Ms Keely asked for more research into the scale of the problem and accountability to be funded and supported. According to her the HSE had information available on the Internet but wider publicity about it’s available is necessary.

The EMA public hearing, which begun on 9 March 2017 at the request of the French medicines regulator, ANSM hosted citizens of six European Union member states describing their experience to the PRAC (Pharmacovigilance Risk Assessment Committee) members attending. it has been acknowledged that Epilim can cause physical deformities, brain damages and autism in children whose mothers are treated with it when they are pregnant.  At present being considered a major factor in 40 cases of birth defects and disabilities, made known to the Health Products Regulatory Authority (HPRA) in recent times.

The outcomes of the EMA review are predicted to lead to new recommendations regarding the use of Epilim in Ireland will be drawn up by the HPRA.