After decades of warnings against valproate in the event of pregnancy, the National Agency for the Safety of Medicines and Health Products (ANSM) published a study in November 2025 which highlights a “increased risk of neurodevelopmental disorders in children whose father was treated during spermatogenesis”. This revelation opens a new chapter in the valproate file, and imposes new precautions for men.
Dépakine, an antiepileptic drug dangerous for mothers
For several years, the use of valproate (Dépakine) in women of childbearing age has been under close surveillance. The drug, used in epilepsy or bipolar disorders, has been shown to be teratogenic: it exposes people to
risk of congenital malformations estimated at 11%
and to neurodevelopmental disorders which can reach 30 to 40% when the mother is treated during pregnancy.
This observation led French authorities to block new prescriptions for women of childbearing age and to impose effective contraception, as well as reinforced information on medicine boxes. The fight of hundreds of families, led in particular by the APESAC association, has thus made it possible to give a face to the victims and to impose social recognition of these silent tragedies.
In this context, any progress relating to this drug requires empathetic listening: behind the figures, there are children whose lives are marked, exhausted parents, disrupted care pathways.
Risks which had already led to more regulated prescriptions for men
Until now, vigilance has focused on the mother. But today, the study of the ANSM and the French national register marks a turning point. According to the press release: “The results show an overall increase of 24% in the risk of TND in children of fathers treated with valproate at the time of conception, compared to those whose fathers were treated with lamotrigine or levetiracetam (two other antiepileptic drugs).
This study, which covers approximately 2.8 million children born in France between 2010 and 2015, among whom 4,773 were born to a father treated with valproate during spermatogenesis, identifies 583 children with at least one neurodevelopmental disorder: 149 attention deficit disorders (ADHD), 42 intellectual development disorders, 77 autism spectrum disorders, 294 cognitive disorders. communication, 160 learning disorders.
If the risk doubles for intellectual development disorder (i.e. +3.5 cases per 1,000 children), it remains “much lower” than that observed when the mother is exposed to this drug. But the message is clear: men taking valproate must now be informed, and doctors too.
In France, since January 6, 2025, the initial prescription of valproate for an adolescent or a man likely to have children is reserved for a neurologist, a psychiatrist or a pediatrician, and dispensation is conditional on a certificate of shared information co-signed each year.
Towards compensation for the “Dépakine dads”?
In May 2023, an initial study carried out by the pharmaceutical laboratories concerned, at the request of the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA), suggested a potential risk of neurodevelopmental disorders. This discovery led the ANSM to introduce information measures for patients and healthcare professionals. This Nordic study showed a risk varying between 5.6% and 6.3% in children born to fathers exposed to valproate, compared to 2.5% to 3.6% for other antiepileptic drugs (lamotrigine or levetiracetam). The results of the French study will be transmitted to the European level where the evaluation continues.
Marine Martin, representative of APESAC, who warned of the dangers of Dépakine in 2016, revealed that she was quickly contacted by around 80 “dépakine fathers”. The latter shared their concerns about their children suffering from autistic disorders or dys. During an intervention on France Info, she expressed the hope that this new study will make it possible to include the children of these fathers in the already existing compensation fund for women, managed by the National Office for Compensation for Medical Accidents. In the midst of budgetary discussions, she is asking parliamentarians to modify this system in order to include the children of these fathers.