The Medicines and Healthcare products Regulatory Agency (MHRA) has provided an update on a new study regarding the risks associated with children born to men taking valproate. The new safety measures introduced in the UK are applicable to both male and female patients.
The MHRA continues to rigorously review emerging data as part of its ongoing monitoring of the safety of valproate. A new study commissioned by the European Medicines Agency focuses on outcomes in children whose fathers took valproate at the time of conception. The study, which has been resubmitted, suggests a potential increased risk of neurodevelopmental disorders in children fathered by men on valproate in the three months prior to conception compared with men on other antiseizure medicines.
According to the study, approximately 5 out of 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder. In comparison, 3 out of 100 children whose fathers were taking lamotrigine or levetiracetam around conception, two other anti-seizure medicines, were diagnosed with similar disorders. It’s important to note that this risk is much smaller than the risk associated with valproate in pregnancy.
The MHRA is currently analyzing the revised study results and will seek independent expert advice from the Commission on Human Medicines. Any further guidance resulting from this analysis will be promptly communicated to patients and healthcare professionals. As a precaution, male patients on valproate who are planning a family in the next year are advised to discuss their treatment with their healthcare professional.
It’s important to clarify that the review of paternal risk has no implications for the new strengthened safety measures being introduced as a result of the rigorous safety review into valproate launched in 2022. In November 2023, health organizations were instructed to prepare for new measures that will be introduced later in January to reduce the serious harms of valproate.
Under the new measures, valproate must not be initiated in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. For the majority of patients, alternative effective treatment options are available.
