2023-05-24 09:07:54
As part of the European monitoring of medicinal products containing valproate and its derivatives, a recent study suggests an increased risk of neurodevelopmental disorders (NDD) in children whose father was treated with valproate in the three months before conception. . This study has limitations that do not allow definitive conclusions to be drawn at this stage and the European Medicines Agency (EMA) has asked the laboratories for additional analyzes to assess the robustness of these data.
In this context, the National Agency for the Safety of Medicines and Health Products (ANSM) “wishes to share these results now. If confirmed, they might lead to new security measures. » It specifies the context and alerts the people concerned in a press release (below).
In 2018, the EMA requested that pharmaceutical companies marketing medicines containing valproate or one of its derivatives conduct studies aimed at better characterizing the risks associated with taking them. One of these studies aimed to assess the malformative and neurodevelopmental risks in children whose father had been treated with valproate or one of its derivatives before conception.
This study, conducted on the basis of several Scandinavian registers (Norway, Sweden and Denmark) over a long period, compared children whose father was treated with valproate in the three months preceding conception, compared to children whose father was treated with lamotrigine or levetiracetam.
These results suggest an increased risk of neurodevelopmental disorders, such as autism spectrum disorders, in children whose fathers were exposed to valproate. This risk varies between 5.6% and 6.3% in children born to fathers exposed to valproate versus 2.5% and 3.6% for children born to fathers treated with lamotrigine or levetiracetam. As a reminder, this risk of neurodevelopmental disorders is around 30 to 40% following maternal exposure to valproate.
The limitations of this study do not allow us to conclude on this risk at this stage. Additional data have been requested from the laboratories by the EMA and a European assessment is underway.
If you are a man taking a medicine containing valproate or one of its derivatives, do not stop your treatment without talking to your doctor. Discontinuation of treatment exposes epileptic patients to the recurrence of seizures.
• Press release of May 16, European assessment of the potential risk of neurodevelopmental disorders in children whose father was treated with valproate in the months preceding conception, see the Ansm website
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