Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate
2024.02.19
Active substance: valproate
The marketing authorisation holders of valproate-containing medicinal products in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that a retrospective observational study in 3 Nordic countries suggests an increased risk of neurodevelopmental disorders (NDDs) in children (from 0 to 11 years old) born to men treated with valproate as monotherapy in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam as monotherapy. Prescribers should inform male patients about the potential risk and discuss with them the need to consider effective contraception, including for a female partner, while using valproate and for 3 months after stopping the treatment.
Please note that the EU PAS number was not correctly stated in the paper version of this DHPC. In the electronic version (pdf) the correct EU PAS number EUPAS34201 is given.
Further informationen:
Risk information from January 26th, 2024
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN