An inquiry has begun into the drug sodium valproate which can cause birth defects if taken during pregnancy. Sodium valproate, also known as Epilim, is a drug used to treat epilepsy and bipolar disorder.
The Health Products Regulatory Authority stated that sodium valproate can cause birth defects and developmental disorders in children if taken during pregnancy. Up to 40% of children exposed to the drug while in the womb are at risk of developmental disorders.
A report published in 2021 in the Irish Medical Journal suggested that between 1975 and 2015, 3,126 babies had potentially been exposed to the drug while in the womb. The report noted that between 143 and 341 babies may have experienced some form of congenital malformation and 1,250 may have experienced some form of neurodevelopmental delay.
The inquiry was approved by Cabinet in July 2023, and it will have three strands. The first strand will be a review phase to develop a timeline of the use of the drug in Ireland, the second strand will seek oral evidence from those effected and the third phase will assess the health services capacity to respond to safety issues related to the use of anti-seizure medications in childbearing women.
It is unclear as of yet whether there will be a redress scheme, however, in 2020 then Minister for Health Stephen Donnelly said the Government must be open to establishing a redress scheme if an enquiry finds systemic issues.
If you or your child are affected by issues raised in the use of the drug sodium valproate we would be more than happy to arrange a consultation to discuss your concerns and steps required to seek redress.