Minister for Health Stephen Donnelly has secured Government approval to progress an inquiry into the historical licensing and use of sodium valproate in women of child-bearing potential in the State.
While valproate is an effective and essential treatment for some patients, valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy.
The purpose of this inquiry is to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVS), their mothers and other family members. The inquiry will also seek to document the evolution of sodium valproate regulation and the practices around the control of this product.
The Chair of this inquiry will be tasked with assessing the health service’s current capacity to respond to safety issues relating to use of anti-seizure medications in women of child-bearing potential.
Minister Donnelly said the inquiry will “give a voice to patients and their families while looking at the use of sodium valproate in Ireland since it was first licensed”.
The Minister added that there is work to be done before the non-statutory inquiry can commence, “but this is an important milestone, and my officials will now work to bring this forward”.
