Aims of the Inquiry
The Inquiry is a non-statutory inquiry chaired by Bríd O’Flaherty BL.
The terms of reference of the Inquiry include the following:
To provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FSVD), or progressing through the diagnostic pathway, their mothers and other family members.
To document the regulation of sodium valproate in the State from initial licensing until the present day and the corresponding practices and controls in place relating to the prescribing and dispensing of this product to women of child-bearing potential throughout this time.
To develop a timeline of significant developments in the scientific knowledge relating to the teratogenicity of sodium valproate.
To assess the Irish health system’s current capacity to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential, and to provide recommendations regarding same, with consideration of relevance of other anti-seizure medications (ASMs).
To assess the adequacy of services and supports currently provided to those diagnosed with FVSD and their caregivers, and to provide recommendations in this regard to the Minister for Health.
To make recommendations as appropriate to the Minister for Health.
Women and girls who have been prescribed sodium valproate must not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy or bipolar disorder should be avoided as this could have serious consequences for a woman and, if pregnant, their unborn child.
Women and girls who have been prescribed sodium valproate must not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy or bipolar disorder should be avoided as this could have serious consequences for a woman and, if pregnant, their unborn child.