The European Medicines Agency is examining whether there should be further restrictions on the use of valproate medicines to protect unborn babies.
Karen Keely, from Ratoath, Co Meath, voiced her concerns at a public hearing of the EMA’s Pharmacovigilance Risk Assessment Committee in London yesterday.
Following an EMA review in 2014, measures were introduced to strengthen the warnings and restrictions on the use of valproate medicines in women and girls. There is a risk of malformations and developmental problems in based who are exposed to valproate in the womb.
Ms Keely told the committee she was also speaking on behalf of FACS (Foetal Anti-Convulsant Syndrome) Forum Ireland, an umbrella group of Irish organisations, including Epilepsy Ireland.
FACS Forum Ireland is seeking to raise awareness of foetal valproate syndrome and to get better supports for the families affected. It believes more than 400 children in Ireland have been affected by in-utero exposure to the epilepsy drug, sodium valproate. The brand name is Epilim.
“It is beyond doubt that the drug significantly increases the risk of malformations, autism, and developmental delay,” said Ms Keely.
Her three adult children, Harry, Lee, and Lorcan, had all been affected by exposure to valproate, she said.
“We are living evidence of the risks and the devastating impact of this drug. Two of my three boys require lifelong care and will never be able to have a normal life. They have been robbed of all the joys of life. The effects of sodium valproate have been unbearable.”
Ms Keely said the measures introduced by the EMA in 2014 were a step in the right direction but patient information leaflets were not a solution.
“How many patients really read this information, especially when they are on the drug long term?” she asked.
“On-box warnings are crucial, but these are not yet in circulation in Ireland. Many patients also receive medications in plastic bags with no original packaging or patient information leaflet.”
Epilepsy Ireland chief executive Peter Murphy, who attended yesterday’s public hearing, said doctor-patient communication had improved since 2014 but is still not good enough.
Only 56% of women surveyed by Epilepsy Ireland last December had discussions with their doctor about the drug, and just one in five knew about the new restrictions in place since 2014.
“Warnings must be displayed on the external packaging of the drug and, importantly, medication should not be dispensed without original internal and external packaging,” said Mr Murphy.