Important Safety Guidelines for the Use of Valproate Medicines
The safety committee of the European Medicines Agency has highlighted a possible link between the use of valproate in men and the occurrence of neurodevelopment disorders in their children.
On Jan. 12, 2024, the European Medicines Agency (EMA) made an announcement regarding the use of valproate medicines in male patients. The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended taking precautionary measures in their use. PRAC has reported a potential higher chance of neurodevelopmental disorders in children born to men who used valproate medicines in the three months leading up to conception. According to PRAC, it is recommended that male patients undergoing valproate treatments should be closely monitored by a specialist who specializes in the management of epilepsy, bipolar disorder, or migraine.
The recommendation is based on a thorough review of data from a retrospective observational study conducted by companies that market the drugs. This study builds upon a previous review of valproate use during pregnancy, which utilized registry databases in Denmark, Norway, and Sweden. The study examined the impact of certain medications on birth outcomes in children whose fathers took valproate, lamotrigine, or levetiracetam around the time of conception. Information was also gathered from non-clinical studies, scientific literature, and discussions with patients and clinical experts.
Based on the data, it appears that there is a slightly higher incidence of neurodevelopmental disorders in children whose fathers were treated with valproate compared to those whose fathers were treated with lamotrigine or levetiracetam. Specifically, around five out of 100 children born to valproate-treated fathers had a neurodevelopmental disorder, while approximately three out of 100 children born to fathers treated with lamotrigine or levetiracetam experienced the same. No studies have been conducted on the potential risks to children born when their fathers ceased using valproate more than three months prior to conception.
The potential danger to offspring of men who received valproate treatment in the three months prior to conception is now believed to be less than the previously established risk for children born to women who took valproate during pregnancy. According to the European Medicines Agency (EMA), there is a concern that children whose mothers took valproate during pregnancy may experience developmental issues. These issues can include delayed walking and talking, lower intellectual abilities compared to their peers, and difficulties with language and memory.
Source: EMA
