• Efstratia Vatzaki, Sabine Straus, Jean-Michel Dogne, Juan Garcia Burgos, Thomas Girard, and Paolo Martelletti.
• European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK. Efstratia.Vatzaki@ema.europa.eu.
• J Headache Pain. 2018 Aug 14; 19 (1): 6868.

AbstractMigraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines. Previous (2014) European recommendations on limiting the use of valproate in women of childbearing age did not achieve their objective in terms of limiting the use of valproate in women of childbearing age and raising awareness regarding the hazardous effect of valproate to children exposed in utero. The teratogenic and foetotoxic effects of valproate are well documented, and more recent studies show that there is an even greater neurodevelopmental risk to children exposed to valproate in the womb. The latest 2018 European review from the European Medicines Agency, with the active participation of the European Headache Federation, concluded that not enough has been done to mitigate the risks associated with in utero exposure to valproate. The review called for more extensive restrictions to the conditions for prescribing, better public awareness, and a more effective education campaign in migrainous women.

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