Tuesday, 25 June 2019

Ceisteanna (321, 335)

Pat Casey

Ceist:

321. Deputy Pat Casey asked the Minister for Health the way in which he has managed the risks associated with the use of valproate in pregnancy; the actions taken to minimise risk from 1990 when studies concluded clear evidence of risk of congenital abnormalities; and if he will make a statement on the matter. [26107/19]

Amharc ar fhreagra

Pat Casey

Ceist:

335. Deputy Pat Casey asked the Minister for Health the status of a proposed inquiry into foetal valproate syndrome; and the status of the work of the HSE valproate response team on the matter. [26160/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 321 and 335 together.

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 HSE's Valproate Response Project is expected to be completed within the coming weeks, and a final report will be submitted to my Department upon completion of the project. Once that report is received and reviewed in the Department, I will give further consideration as to whether an inquiry is appropriate.