Valproate in treatment of epilepsy in girls and women of childbearing potential

Randomized studies have consistently shown that valproate is the most effective antiseizure medication (ASM) for the treatment of generalized tonic-clonic seizures. Unfortunately, its use in the treatment of epilepsy in girls and women of childbearing potential has been limited by its teratogenic potential. Use of valproate during pregnancy has been associated with a high prevalence of major congenital malformations in the offspring as well as with increased risk of adverse neurodevelopmental outcomes including decreased IQ, autism spectrum disorders and ADHD. Due to these risks regulatory agencies such as FDA and EMA have issued firm restrictions for the use of valproate in girls and women of childbearing age, thereby denying many female, unlike male, patients the most effective treatment for their seizure disorder. We will review the details of these regulatory restrictions and their implications for the management of female patients.