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Updated: Jun 15, 2025

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Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures

Joan D Garey1, Per Damkier2,3, Anthony R Scialli1

  • 1Reproductive Toxicology Center, A Non-Profit Foundation, Washington, DC, USA.

Birth Defects Research
|August 27, 2024
PubMed

Insights

European and UK drug agencies issued premature warnings about valproate risks. Experts believe current data do not support a paternally-mediated risk of neurodevelopmental disorders in children exposed to valproate.

Area of Science:

  • Pharmacovigilance
  • Reproductive Toxicology
  • Neurodevelopmental Disorders

Background:

  • Recent recommendations from the European Medicines Agency (EMA) and UK's Medicines and Healthcare products Regulatory Agency (MHRA) advised precautionary measures for valproate use.
  • These measures were based on a potential risk of neurodevelopmental disorders in children born to men treated with valproate.

Purpose of the Study:

  • To evaluate the scientific basis for the EMA and MHRA's precautionary recommendations regarding paternal valproate exposure.
  • To assess the evidence for a paternally mediated risk of neurodevelopmental disorders linked to valproate.

Main Methods:

  • Review and critical analysis of existing scientific literature and data on valproate.
  • Expert opinion from members of the European Network of Teratology Information Services (ENTIS) and the Organization of Teratology Information Specialists (OTIS).

Main Results:

  • The available scientific data do not convincingly support the inference of a paternally mediated risk.
  • The evidence is insufficient to justify the stringent precautionary measures recommended by regulatory agencies.

Conclusions:

  • The EMA and MHRA warnings regarding paternal valproate use are considered premature.
  • Further robust scientific evidence is required before implementing widespread, restrictive prescribing guidelines.

Keywords:
lamotriginelevetiracetamneurodevelopmental disorderspaternal valproatevalproate

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