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Sodium valproate in pregnancy

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

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Sodium valproate in pregnancy

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy

  • since 2018 any use of valproate in patients of childbearing potential has to be within the terms of the Pregnancy Prevention Programme (1,2) - is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant

Sodium valproate:

  • is highly teratogenic and evidence supports a rate of congenital malformations of 10% in infants whose mothers took valproate during pregnancy and neurodevelopmental disorders in approximately 30% to 40% of children (1)
    • for this reason, valproate should not be used in girls and women of childbearing potential unless other treatments are ineffective or not tolerated, as judged by an experienced specialist
    • birth defects seen when mothers take valproate during pregnancy include (2):
      • spina bifida
      • facial and skull malformations (including cleft lip and palate)
      • malformations of the limbs, heart, kidney, urinary tract and sexual organs
      • in women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems, and these disorders can be seriously debilitating and permanent effects on development can include:
        • being late in learning to walk and talk
        • lower intelligence than other children of the same age
        • poor speech and language skills
        • memory problems
        • children exposed to valproate in the womb are more likely to have autism or autistm spectrum disorders is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD)

Valproate should not be used in pregnancy (2)

  • valproate must not be used in any woman or girl able to have children unless there is a Pregnancy Prevention Programme (PPP) in place - is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant

Reference:

  • MHRA(January 2021).Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review Drug Safety Update volume 14, issue 6: January 2021: 1.
  • MHRA (November 2023). Valproate use by women and girls - Information about the risks of taking valproate medicines during pregnancy

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