This document provides guidance on the use of
valproate in girls and women of childbearing age from a joint Task Force of the Commission on European Affairs of the International League Against
Epilepsy (CEA-ILAE) and the European Academy of Neurology (EAN), following strengthened warnings from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) of the European Medicines Agency (EMA), which highlight the risk of malformations and developmental problems in infants who are exposed to
valproate in the womb. To produce these recommendations, the Task Force has considered teratogenic risks associated with use of
valproate and treatment alternatives, the importance of seizure control and of patient and fetal risks with
seizures, and the effectiveness of
valproate and treatment alternatives in the treatment of different
epilepsies. The Task Force's recommendations include the following: (1) Where possible,
valproate should be avoided in women of childbearing potential. (2) The choice of treatment for girls and women of childbearing potential should be based on a shared decision between clinician and patient, and where appropriate, the patient's representatives. Discussions should include a careful risk-benefit assessment of reasonable treatment options for the patient's seizure or
epilepsy type. (3) For seizure (or
epilepsy) types where
valproate is the most effective treatment, the risks and benefits of
valproate and other treatment alternatives should be discussed. (4)
Valproate should not be prescribed as a first-line treatment for
focal epilepsy. (5)
Valproate may be offered as a first-line treatment for
epilepsy syndromes where it is the most effective treatment, including idiopathic (genetic) generalized syndromes associated with
tonic-clonic seizures. (6)
Valproate may be offered as a first-line treatment in situations where pregnancy is highly unlikely (e.g., significant intellectual or physical disability). (7) Women and girls taking
valproate require regular follow-up for ongoing consideration of the most appropriate treatment regimen.