Considerations in using sodium valproate for bipolar disorder in males of reproductive potential
Therapeutic Goods Administration (TGA) 2025
Previously the use of sodium valproate in males1 was considered unlikely to increase the risk of neurodevelopmental disorders in their children. However, a registry-based study of males with epilepsy who took sodium valproate in the 3 months before conception found an increased risk of neurodevelopmental disorders in their children, including autism spectrum disorder, intellectual disability, communication disorder, attention deficit hyperactivity disorder and movement disorders2.
The findings of this study have not been reproduced in other studies, so the clinical implications are currently uncertain. Any decision regarding sodium valproate therapy, including whether to start, modify or stop treatment, must be carefully weighed against the risk of relapse and its associated harms (eg impulsivity, problem drug use, reputational consequences, relationships difficulties, self-harm, suicidality, psychiatric admission). Psychiatrist consultation is recommended to discuss potential benefits and harms before making treatment changes.
The Australian Therapeutic Goods Administration (TGA) safety alert provides guidance on the potential risk of neurodevelopmental disorders in children born to males taking sodium valproate, advising 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.
If pregnancy occurs and the patient has taken sodium valproate in the 3 months before conception, seek specialist advice (eg from a psychiatrist or obstetrician) and ask the patient to consider sharing this information with the pregnant partner.