A European directive published by the European Medicines Agency in November 2014 highlighted new evidence on the risks of sodium valproate (Epilim) in pregnancy. Recent studies have shown a risk of developmental problems of up to 30-40% in pre-school children exposed to valproate in the womb. In addition, data shows that children exposed to valproate in the womb are at an approximately 11% risk of major malformations at birth compared to 2-3% risk for children of the general population.
The European directive states that valproate should not be used to treat epilepsy or bipolar disorders in women who are pregnant or can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option, should use effective contraception. Doctors who prescribe valproate, including doctors who issue repeat scripts for women who are already on valproate, should provide full information to women about these new study findings to ensure they have full understanding of the risks.
In practice, this means that GPs should seek to review all women in their practice being prescribed valproate, to inform them of the risks associated with pregnancy, to offer adequate contraception, and to refer them to a specialist clinic to discuss their options if they are considering a pregnancy. Epilepsy Ireland has produced this useful patient information leaflet. A good patient leaflet on valproate is also available at www.hse.ie/valproate.
For further information please read the following:
PRAC recommends strengthening the restrictions on the use of valproate in women and girls
HPRA Drug Safety Newsletter – December 2014
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