A European study has alerted to the increased risk of neurodevelopmental disorders in children whose fathers were treated with valproate, an antiepileptic, before their conception.
- Valproate is a treatment prescribed to treat epilepsy.
- Paternal exposure to valproate exposes to a 30 to 40% risk of developing a neurodevelopmental disorder.
- There is also a risk of neurodevelopmental disorders in children whose fathers received valproate treatment in the three months before conception.
In a statement published on May 16, the National Medicines Safety Agency (Ansm) revealed the results of a European study, which observed an increased risk of neurodevelopmental disorders in children whose father was exposed to valproate in three months before conception. Prescribed mainly to treat epilepsy, valproate belongs to the family of non-barbiturate anticonvulsants.
Paternal exposure to valproate: higher risk of autism spectrum disorders in children
In 2018, the European Medicines Agency (EMA) asked pharmaceutical companies producing medicines containing valproate or one of its derivatives to conduct various studies, in order to better assess the risks associated with taking these treatments.
One of the studies focused on the malformative and neurodevelopmental risks in children who had a father treated with valproate or one of its derivatives before conception. This work used a database of several Scandinavian medical registers (Norway, Sweden and Denmark) over a long period. The researchers notably compared children whose father was treated with valproate in the three months preceding conception, and children whose father was treated with lamotrigine or levetiracetam.
Valproate: do not stop treatment without the approval of your doctor
The scientists then observed an increased risk of neurodevelopmental disorders, such as autism spectrum disorders, in children whose fathers were treated with valproate. “This risk varies between 5.6% and 6.3% in children born to fathers exposed to valproate compared to 2.5% and 3.6% for children born to fathers treated with lamotrigine or levetiracetam. As a reminder, this risk of neurodevelopmental disorders is of the order of 30 to 40% after maternal exposure to valproate”can we read in the document of the Ansm.
However, the health authority clarified that this study has several limitations. In particular, the EMA asked the laboratories to carry out additional research in order to confirm these results. “If you are a man treated with a medicine containing valproate or one of its derivatives, do not stop your treatment without talking to your doctor. Stopping treatment exposes epileptic patients to the recurrence of seizures”warned the Ansm.
