title: Valproate in the treatment of epilepsy in girls and women of childbearing potential.
abstract: 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.
authors: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
authors: Torbjörn
authors: T
authors: Tomson
authors: Department Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.|The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom.
authors: Anthony
authors: A
authors: Marson
authors: Reference Center for Refractory Epilepsy, Ghent University Hospital, Ghent, Belgium.
authors: Paul
authors: P
authors: Boon
authors: Epilepsy Center, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.
authors: Maria Paola
authors: MP
authors: Canevini
authors: Department of Neurology, The Children Hospital "Agia Sophia", Athens, Greece.
authors: Athanasios
authors: A
authors: Covanis
authors: Department of Pediatric Neurology, Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
authors: Eija
authors: E
authors: Gaily
authors: Department of Neurology, School of Medicine, University of Eastern Finland, Kuopio, Finland.|Kuopio Epilepsy Center, Kuopio University Hospital, Kuopio, Finland.
authors: Reetta
authors: R
authors: Kälviäinen
authors: Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg, Salzburg, Austria.|Centre for Cognitive Neuroscience, Salzburg, Austria.|Department of Public Health and Health Technology Assessment, UMIT - Health & Life Sciences University, Hall in Tirol, Austria.
authors: Eugen
authors: E
authors: Trinka
mesh_terms: D000367:Age Factors; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004827:Epilepsy / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced / Q000517:prevention & control; D016896:Treatment Outcome; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D014635:Valproic Acid
keywords: Anticonvulsants; Epilepsy; Pregnancy; Teratogenicity; Valproate; Valproic acid