Gestational exposure to valproate is associated with an unacceptably high risk of major congenital malformations, neurodevelopmental disorders, and other adverse outcomes. Prescription of valproate to reproductive-age women is therefore strongly discouraged in many parts of the world.
From January 2024, the United Kingdom began regulating that no one under the age of 55 will be newly prescribed sodium valproate unless two specialists agree that no other effective or tolerable treatment is available, or unless there are "compelling reasons that reproductive risks do not apply" (Medicines and Healthcare Products Regulatory Agency. Date of Issue: 28 November 2023; Reference No: NatPSA/2023/013/MHRA).
Divalproate (divalproex) is an equimolar combination of valproic acid and sodium valproate.
LIFE-THREATENING ADVERSE REACTIONS
See full prescribing information for complete boxed warning.