Sodium valproate use in males of reproductive potential
Sodium valproate use in males1 has previously been considered unlikely to impact risk of neurodevelopmental disorders in children; however, a registry-based study2 of males with epilepsy who took sodium valproate in the 3 months before conception found an increased risk of neurodevelopmental disorders (autism spectrum disorder, intellectual disability, communication disorder, attention deficit hyperactivity disorder and movement disorders) in their children. The findings of this study have not been reproduced in other studies, so the clinical implications are currently uncertain. A discussion about potential risks and harms is appropriate with males of reproductive potential; seek neurologist advice.
Advice from the Therapeutic Goods Administration (TGA) safety alert about the potential risk of neurodevelopmental disorders in children born to males taking sodium valproate is to:
- inform the patient about the potential increased risk of neurodevelopmental disorders
- discuss the need for effective contraception (for both the male patient and the female partner) during and for 3 months after stopping treatment
- discuss alternative treatment options if planning for pregnancy, and before stopping contraception
- avoid sperm donation during and for 3 months after stopping treatment
- ensure the patient is reviewed regularly (at least annually) by a specialist, particularly when the patient is planning to conceive.