Topiramate ban in women of childbearing potential with idiopathic generalized epilepsy: Does effectiveness offset the teratogenic risks?

Author:

Cerulli Irelli Emanuele1ORCID,Cocchi Enrico2,Mostacci Barbara3,Orlando Biagio1,Gesche Joanna45,Caraballo Roberto H.6ORCID,Lattanzi Simona7ORCID,Strigaro Gionata8,Catania Cecilia1,Pulitano Patrizia1,Panzini Chiara1,Ferlazzo Edoardo910,Pascarella Angelo910ORCID,Casciato Sara11,Pizzanelli Chiara12ORCID,Giuliano Loretta13ORCID,Viola Veronica14,Fortunato Francesco15ORCID,Di Gennaro Giancarlo11,Gambardella Antonio15ORCID,Labate Angelo16ORCID,Operto Francesca F.17ORCID,Giallonardo Anna T.1,Baykan Betul18,Beier Christoph P.45ORCID,Di Bonaventura Carlo1ORCID,

Affiliation:

1. Department of Human Neurosciences Sapienza University Rome Italy

2. Department of Precision Medicine and Genomics, Department of Medicine Columbia University New York New York USA

3. IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy

4. Department of Neurology Odense University Hospital Odense Denmark

5. Department of Clinical Research University of Southern Denmark Odense Denmark

6. Department of Neurology Hospital de Pediatría “Prof. Dr. Juan P. Garrahan” Buenos Aires Argentina

7. Neurological Clinic, Department of Experimental and Clinical Medicine Marche Polytechnic University Ancona Italy

8. Neurology Unit, Department of Translational Medicine University of Piemonte Orientale, and Azienda Ospedaliero‐Universitaria “Maggiore della Carità” Novara Italy

9. Regional Epilepsy Center “Bianchi‐Melacrino‐Morelli” Great Metropolitan Hospital Reggio Calabria Italy

10. Department of Medical and Surgical Sciences Magna Graecia University of Catanzaro Catanzaro Italy

11. IRCCS Neuromed Pozzilli Italy

12. Neurology Unit, Department of Clinical and Experimental Medicine University of Pisa Pisa Italy

13. Section of Neurosciences, Department of Medical and Surgical Sciences and Advanced Technologies “G.F. Ingrassia” University of Catania Catania Italy

14. Department of Biomedical and Neuromotor Sciences (DIBINEM) University of Bologna Bologna Italy

15. Institute of Neurology University Magna Graecia Catanzaro Italy

16. Neurophysiopathology and Movement Disorders Clinic University of Messina Messina Italy

17. Department of Science of Health, School of Medicine University of Catanzaro Catanzaro Italy

18. Department of Neurology and EMAR Medical Center Faculty of Medicine, Istanbul University Istanbul Turkey

Abstract

AbstractRegulatory agencies have recently discouraged the prescription of topiramate (TPM) to women of childbearing potential with epilepsy due to growing evidence of the teratogenic and neurodevelopmental risks associated with its use during pregnancy. It remains, however, unclear whether the use of TPM in this population can be supported to some extent by its high effectiveness. In this multicenter, retrospective, cohort study performed at 22 epilepsy centers, we investigated the comparative effectiveness of TPM and levetiracetam (LEV) given as first‐line antiseizure medication in a cohort of women of childbearing potential with idiopathic generalized epilepsy (IGE). A total of 336 participants were included, of whom 24 (7.1%) received TPM and 312 (92.9%) LEV. Women treated with TPM had significantly higher risks of treatment failure and treatment withdrawal and were less likely to achieve seizure freedom at 12 months compared to women treated with LEV. In conclusion, this study highlighted a low tendency among clinicians to use TPM in women of childbearing potential with IGE, anticipating the recently released restrictions on its use. Furthermore, the available data on effectiveness do not appear to support the use of TPM in this population.

Publisher

Wiley

Subject

Neurology (clinical),Neurology

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