Written answers

Tuesday, 12 October 2021

Department of Health

Medicinal Products

Photo of Catherine ConnollyCatherine Connolly (Galway West, Independent)
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647. To ask the Minister for Health if his attention has been brought to a recent academic study (details supplied) which has concluded that continued effort is needed around the awareness and implementation of the sodium valproate pregnancy prevention programme; his plans to address the findings of this study; and if he will make a statement on the matter. [49856/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Sodium valproate, sold under the brand name Epilim, is an approved medication for the treatment of epilepsy and bipolar disorder in Ireland; for some patients suffering from these conditions, in particular epilepsy, it may be the only effective or tolerated treatment option. Based on the totality of available scientific data on this drug, it is now known that children exposed in utero are at a high risk of serious developmental disorders (up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).

To help prevent exposure during pregnancy, there is a robust regulatory framework for the licensed use of Epilim in women of childbearing potential. This regulatory framework was strengthened in Ireland and the EU following two reviews conducted by the European Medicines Agency in 2014 and 2017.

Details of a proposed stakeholder group to address the ongoing concerns of women of childbearing potential in Ireland who are being prescribed valproate-containing medicines is currently under consideration by Department of Health officials.

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