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Large French Study Links Fathers’ Valproate Use Before Conception to Higher Risk of Child Intellectual Disability

Health officials urge patients to consult clinicians before conception-related changes, with France already limiting valproate for men likely to have children.

Les dangers du valproate sont bien connus lorsqu’il est pris par une femme enceinte. Prescrite depuis les années 1960, la Dépakine a ainsi causé des malformations congénitales et troubles neurodéveloppementaux graves chez environ 2 000 à 4 000 enfants.
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Overview

  • EPI-PHARE analyzed 2.8 million births (2010–2015) and found that paternal valproate use during spermatogenesis was associated with a doubled risk of intellectual development disorders, or about 3.5 additional cases per 1,000 births.
  • Among 4,773 children conceived while their fathers were treated with valproate, 583 had at least one neurodevelopmental diagnosis.
  • The exposure window assessed was the three months of spermatogenesis preceding conception.
  • Links to ADHD, autism spectrum and communication disorders were less certain, with a modest increase in risk not excluded and further confirmation needed.
  • The observational study compared fathers on valproate with those on lamotrigine or levetiracetam; EMA flagged concerns in 2023, France tightened prescribing in January 2025, and authorities warn against abrupt treatment cessation.