High risk of serious developmental disorders if exposed in womb (up to 30-40% risk, including 5x higher risk of autism) and congenital malformations (10%), including:
- Spina bifida
- face/skull malformations, including cleft lip/palate
- Limb, heart, kidney, genital abnormalities
- Deafness
In boys, pre-clinical data on transgenerational risks, and animal studies suggesting infertility.
Oral Valproate must not be started 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.”
Patient guide and checklist available.