by Torbjörn Tomson on behalf of the Joint Task Force*
The Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) of the European Medicines Agency (EMA) has recently strengthened warnings on the use of valproate medicines in women and girls due to the risk of malformations and intellectual and cognitive developmental problems in babies who are exposed to valproate in the womb. To assists physicians, the Commission of European Affairs of the International League Against Epilepsy (CEA-ILAE) and the European Academy of Neurology (EAN) appointed a joint Task Force. The mission of the Task Force has been to make recommendations on the use of valproate for the treatment of epilepsy in female children and adolescents, and in women of childbearing potential, in the context of EMA’s new warnings. The Task Force has considered teratogenic risks associated with use valproate and treatment alternatives, the importance of seizure control and of risks to patient and foetus due to seizures, and the effectiveness of valproate and treatment alternatives for the different epilepsies. The Task Force report is under review for consideration for Epilepsia but given the urgency of the matter the recommendations are summarized on the EAN website with the permission of ILAE, EAN and the Editors of Epilepsia.
Torbjörn Tomson is Professor of Neurology at Karolinska Intitutet in Stockholm, Sweden.
* Torbjörn Tomson, Sweden; Anthony Marson, UK; Maria Paola Canevini, Italy; Athanasios Covanis, Greece, Eija Gaily, Finland; Eugen Trinka, Austria
** Paul Boon, Belgium; Reetta Kälviäinen, Finland