Karen Keely, from Rathoat Co Meath, is a mother of three sons who have experienced illness due to use of the Epilepsy treatment drug Epilim. Two of her sons will never live a normal life due to issues caused by the drug.
Last September (2017) Ms Keely, a member of the Foetal Anti-Convulsant Syndrome Forum gave evidence at the European Medicines Agency about the difficulties her sons have gone through over the duration of their lives.
She said: “Two of my 3 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.
Ms Keely added: “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.”
She also remarked said one of the issues was that some people treated with valproate long term may receive the drug medication contained in a plastic bag.
A national register in Ireland of those who were on the medicine and people who are being prescribed it in the future should established according to Ms Keely who also called for more studie into the scale of the problem and accountability to be conducted. Though the HSE makes the information available online but wider publicity was needed according to the Co Meath mother.
The EU hearing brought together speakers from six EU Member Countries to tell the story their experiences to the members of the PRAC (Pharmacovigilance Risk Assessment Committee). Epilim has been seen to be a leading cause of physical deformities, brain damages and autism in children whose mothers are treated with it while pregnant. At present it is being implicated in 40 cases of birth defects and disabilities, reported to the Health Products Regulatory Authority (HPRA) in Ireland.
Findings of the EMA review are expected to lead to new guidelines regarding it being prescribed to pregnant females.