Billy Kelleher (Cork North Central, Fianna Fail)
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87. To ask the Minister for Health if his Department or the HSE will undertake a comprehensive review of the use of the drug valproate by pregnant women here. [20745/17]

Simon Harris (Wicklow, Fine Gael)
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Sodium valproate is among a number of medicines licensed in Ireland for the treatment of epilepsy. Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland; valproate-containing medicines are also approved nationally in Ireland to treat bipolar disorder.

In March of this year, the Pharmacovigilance Risk Assesssment Committee of the European Medicine Agency (EMA) initiated a new review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. A previous EMA review of valproate, in 2014, resulted in measures to strengthen the warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA has highlighted the results of previous reviews of valproate to Irish healthcare professionals and provided revised educational materials for both healthcare professionals and patients. The HPRA has already informed healthcare professionals and relevant patient groups that the new EMA review is underway, and will disseminate the results of the review to Irish patients and healthcare professionals as soon as they become available.

In October 2016, the HSE's Medicines Management Programme (MMP) launched its Valproate Toolkit, an online resource consisting of a patient information booklet, summary guide for prescribers and a patient/prescriber checklist. This information highlights that sodium valproate should not be prescribed to girls or women of childbearing age or pregnant women unless other treatments are ineffective or not tolerated. The MMP is in contact with the HPRA regarding the EMA's current review of valproate, and any further recommendations will be considered.

Neither my Department nor the HSE has plans to conduct a separate review of the use of valproate by pregnant women in Ireland.