Analysis

Weighing the risks of valproate in women who could become pregnant

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1596 (Published 18 April 2018) Cite this as: BMJ 2018;361:k1596
  1. Heather Angus-Leppan, consultant neurologist1 2 3,
  2. Rebecca S N Liu, consultant neurologist1
  1. 1Epilepsy Initiative Group, Royal Free London, London, UK
  2. 2University College London
  3. 3Centre for Research in Public Health and Community Care, University of Hertfordshire
  1. Correspondence to: H Angus-Leppan heather.angus-leppan{at}nhs.net

Despite international consensus on the harmful effects of valproate during pregnancy, women should not be denied the human right to make their own decisions after fully informed discussion, say Heather Angus-Leppan and Rebecca Liu

An estimated one million people take valproate worldwide each day.1 Valproate is a γ-aminobutyric acid (GABA) agonist licensed for use in epilepsy, bipolar disorder, and, in some countries, migraine. In the United States in 2012, about 1.5 million outpatients received valproate, and roughly 22% (341 000) of these were women of reproductive potential (13-45 years); 67% of the total took the drug for mood and psychiatric disorders, 9% for migraine, and 9% for epilepsy.2

The international consensus is that valproate is a serious teratogen, but there is no agreement on the appropriate regulation of valproate in people who may become pregnant. Some advocate a ban on valproate in pregnancy and in women and girls, while others support restricted availability of valproate in certain circumstances, including during pregnancy. We summarise these positions, the implicit assumptions for each, and the implications for patients and healthcare professionals in the light of European and United Kingdom regulatory announcements made in March 2018 (box 1).34

Box 1

Regulatory authority statements about valproate use in women of childbearing age

European Medicines Agency's Pharmacovigilance Risk Assessment Committee 20183

  • Migraine or bipolar disorder

    • Valproate must not be used in pregnancy

    • In female patients from the time they become able to have children—valproate must not be used unless pregnancy prevention programme conditions are met

  • For epilepsy

    • Valproate must not be used in pregnancy. However, it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy

    • In female patients from the time they become able to have children—valproate must not be used unless the conditions of the new pregnancy prevention programme are met. This …

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