Medicines Healthcare Products Regulatory Agency
As part of our ongoing monitoring of valproate safety, we continue to rigorously review all emerging data on valproate. This includes a new study on outcomes in children whose fathers took valproate at the time of conception commissioned by the European Medicines Agency.
Sanofi, the brand leader company, has recently informed us of errors in the study that may impact the results. As a result, the researchers from the original study are conducting a full re-analysis before any final conclusions can be drawn.
The governments expert scientific body, the Commission on Human Medicines (CHM), has advised that further guidance in respect of risks in children of men taking valproate should be based upon data that are accurate and complete. As soon as the revised study analysis is available, it will be carefully re-assessed by the MHRA. Any further guidance will be communicated to patients and healthcare professionals as soon as possible.
In December 2022, in light of data showing ongoing exposure to valproate in pregnancy, as well as growing information about potential risks in male patients from preclinical studies and data on infertility, the CHM recommended strengthened safety measures for valproate. The implementation of these new measures has been carefully considered by the CHMs Valproate Implementation Group.
Further communications on the new safety measures will be issued in due course.