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Expert opinion: use of valproate in girls and women of childbearing potential with epilepsy: recommendations and alternatives based on a review of the literature and clinical experience—a European perspective

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Abstract

Valproate is a broad-spectrum antiepileptic drug (AED) of particular interest in pediatric epilepsy syndromes and idiopathic generalized epilepsy, as it is relatively more effective in these syndromes than other AEDs. In 2018, the European Medicines Agency introduced new restrictions on the use of valproate in girls and women of childbearing potential to avoid exposure during pregnancy. The strengthening of existing restrictions sparked controversy and debate among patients and the medical community. The high prevalence of epilepsy syndromes amenable to valproate treatment in women of childbearing age and the little information available on the teratogenic potential of alternative treatments have created uncertainty on how to manage these patients. In this consensus statement, based on a review of the literature and the clinical experience of a panel of European epilepsy experts, we present general recommendations for the optimal clinical management of AED treatment in girls, women of childbearing potential, and pregnant women across the different epilepsy syndromes.

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Acknowledgements

The expert meetings on valproate in epilepsy held in Paris, France in October, 2018 and January 2019 were funded by Sanofi. Sanofi had not intervention in the elaboration of the recommendations. Sanofi’s review of this article was strictly limited to all references to valproate to ensure consistency with current labeling information and appropriate use.

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Authors and Affiliations

  1. Epilepsy Unit. Vall, D´Hebron University Hospital, Barcelona, Spain

    Manuel Toledo & Javier Salas-Puig

  2. IRCCS Institute of Neurological Sciences of Bologna, Bologna, Italy

    Barbara Mostacci

  3. Department of Neurology, Jagiellonian University Medical College, Kraków, Poland

    Magdalena Bosak

  4. Department of Neurology and Epileptology Centre of Postgraduate Medical Education, Warsaw, Poland

    Joanna Jedrzejzak

  5. Department of Neurology, Royal Victoria Infirmary, Institute of Neuroscience, Newcastle upon Tyne, UK

    Rhys H. Thomas

  6. Departement de Neurologie, CHU de Rennes (France), Unité d’épileptologie, Rennes, France

    Arnaud Biraben

  7. Department of Neurology, Vivantes Humboldt-Klinikum Berlin, Berlin, Germany

    Bettina Schmitz

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  1. Manuel Toledo
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  2. Barbara Mostacci
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  3. Magdalena Bosak
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  4. Joanna Jedrzejzak
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  6. Javier Salas-Puig
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Corresponding author

Correspondence to Manuel Toledo.

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Conflicts of interest

All the authors declare that they received advisory honoraria from Sanofi to work in this consensus. No other potential conflict of interest is declared.

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Toledo, M., Mostacci, B., Bosak, M. et al. Expert opinion: use of valproate in girls and women of childbearing potential with epilepsy: recommendations and alternatives based on a review of the literature and clinical experience—a European perspective. J Neurol 268, 2735–2748 (2021). https://doi.org/10.1007/s00415-020-09809-0

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  • DOI: https://doi.org/10.1007/s00415-020-09809-0

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