Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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1319. To ask the Minister for Health the regulations for the prescription of Epilim to pregnant women; and if he will make a statement on the matter. [27941/17]

Simon Harris (Wicklow, Fine Gael)
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I understand that the Deputy's question refers to the prescribing of Epilim. Epilim is a product which contains the active substance sodium valproate, which 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.

It is well established that women who take anti-epileptics during pregnancy face a higher risk of having a child with birth defects than women in the general population. This risk is further increased if a woman takes more than one anti-epileptic medicine during pregnancy. However, epilepsy and seizures during pregnancy also carry a significant risk of complications for both the woman and the unborn child. Anti-epileptic medicines should not be stopped abruptly during pregnancy as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.

The product information Summary of Product Characteristic (SmPC) and package leaflet for sodium valproate includes detailed information on use, precautions and recommendations, as well as information on the known side effects of the medicine associated with use in pregnancy and more generally. The SmPC and package leaflet are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of the medicine. Each pack of the medicine dispensed carries a copy of the latest package leaflet.

In March of this year, the Pharmacovigilance Risk Assessment Committee of the European Medicines 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. This review is examining the available evidence and will consult with relevant stakeholder groups, including holding a public hearing to listen directly to the experience of EU patients with these medicines, so that this experience can be taken into account as part of the Committee's considerations. 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.