Seán Fleming (Laois, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

678. To ask the Minister for Health the reason he is of the view that an investigation into State accountability for the drug sodium valporate is not required; and if he will make a statement on the matter. [35781/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

There are a number of different research projects and initiatives already under way with regard to sodium valproate (Epilim) use in Ireland.

The Health Products Regulatory Authority (HPRA) has compiled an overview of the information provided to prescribers and patients in Ireland with regard to sodium valproate since the drug was first licensed in Ireland in 1975. These documents indicate how the warnings evolved over the years, as new information became available, including those related to the risk of congenital abnormalities and neurodevelopmental disorders in children exposed to valproate during pregnancy.

The HSE’s Valproate Response Plan includes proposals for an epidemiological study of the numbers affected by FACS and the development of the existing Irish Epilepsy and Pregnancy Register at Beaumont Hospital.

In addition, the Royal College of Surgeons, in collaboration with the HPRA, will be conducting an impact assessment project on the effectiveness of risk minimisation measures to prevent harms from teratogenic medicines, including sodium valproate. This research will be undertaken within the framework of a HRB Applied Partnership award.