Dáil Éireann Debate, Wednesday - 15 May 2019
158. Deputy Louise O'Reilly asked the Minister for Health if further consideration will be given to the need for an inquiry into foetal valproate syndrome as soon as the valproate response team of the HSE has completed its work; when this work is expected to be completed; and when he expects to further consider the matter. [20971/19]
View answer159. Deputy Louise O'Reilly asked the Minister for Health if he will meet a group (details supplied) and provide a clear answer to its request for an inquiry into accountability issues and compensation for those individuals and families already affected by foetal valproate syndrome. [20972/19]
View answer160. Deputy Louise O'Reilly asked the Minister for Health when his attention was drawn to the risks associated with the use of valproate in pregnancy; the action taken to minimise these risks in particular prior to 2014 when the European Medicines Agency implemented its first series of risk reduction measures; and his views on the recent study published in a journal (details supplied). [20973/19]
View answer162. Deputy Louise O'Reilly asked the Minister for Health the information available in respect of the prevalence of foetal valproate syndrome within the population. [20975/19]
View answerI propose to take Questions Nos. 158 to 160, inclusive, and 162 together.
The HSE's Valproate Response Project is expected to be completed before the end of June, and a final report will be submitted to my Department upon completion of the project. Once that report is received in the Department, I will give further consideration to the requests made by the forum that the Deputy refers to.
I have been aware of the issues surrounding sodium valproate use in pregnancy since early 2017, when the European Medicines Agency (EMA) initiated its most recent review of the use of valproate-containing medicines in the treatment of women who are pregnant or of childbearing age. The risk reduction measures recommended by the EMA on foot of its previous review in 2014 were fully implemented in Ireland; prior to this, there were no specific restrictions over and above those listed in the Summary of Product Characteristics (SmPC) leaflet for healthcare professionals and the patient information leaflet. As with any medicine, these documents were regularly updated as new data emerged about the medicine and its potential side effects. The study referred to by the Deputy suggests that the association between valproate use in pregnancy and congenital malformations in children was firmly established by 2005. The SmPC and patient leaflets used in 2005 reflect this association, and the patient leaflet includes specific information for women who become pregnant, or could become pregnant, while taking this medicine, based on the increased risk of having a child with an abnormality.
An assessment conducted by the HSE estimates that between 153 and 341 children will have experienced a major congenital malformation and up to 1,250 children will have experienced some form of neurodevelopmental delay following exposure to sodium valproate in utero between 1975 and 2015. It should be noted that this assessment was subject to a number of assumptions and limitations, and relied heavily on international data when developing estimates of the numbers of children who may be affected.
