Antiseizure medications as migraine preventatives: a call for action for a teratogenic and neurodevelopmental risk removal

References

• Stovner LJ, Hagen K, Linde M, et al. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34.
   PubMed Web of Science ®Google Scholar
• Steiner TJ, Stovner LJ, Jensen R, et al. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1): doi: 10.1186/s10194-020-01208-0
   Web of Science ®Google Scholar
• Diener H-C, Holle-Lee D, Nägel S, et al. Treatment of migraine attacks and prevention of migraine: Guidelines by the German migraine and Headache Society and the German Society of Neurology. Clin Transl Neurol. 2019;3(1):2514183X1882337. doi: 10.1177/2514183X18823377
   Google Scholar
• Eigenbrodt AK, Ashina H, Khan S, et al. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021;17(8):501–514. doi: 10.1038/s41582-021-00509-5
   PubMed Web of Science ®Google Scholar
• PRAC. Recommends strengthening the restrictions on the use of valproate in women and girls [Internet]. 2014; [cited 2014 Oct 10]. Available from: https://www.ema.europa.eu/en/news/prac-recommends-strengthening-restrictions-use-valproate-women-girls
   Google Scholar
• Vatzaki E, Straus S, Dogne J-M, et al. Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation. J Headache Pain. 2018;19(1): doi: 10.1186/s10194-018-0898-3
   PubMedGoogle Scholar
• Bjørk M-H, Zoega H, Leinonen MK, et al. Association of Prenatal exposure to antiseizure medication with risk of autism and Intellectual disability. JAMA Neurol. 2022;79(7):672. doi: 10.1001/jamaneurol.2022.1269
   PubMed Web of Science ®Google Scholar
• PRAC. Starts review of topiramate use in pregnancy and women of childbearing potential. [Internet]. 2022 Feb 9; [cited 2023 May 22]. Available from: https://www.ema.europa.eu/en/news/prac-starts-review-topiramate-use-pregnancy-women-childbearing-potential
   Google Scholar
• Lampl C, Maassenvandenbrink A, Deligianni CI, et al. The comparative effectiveness of migraine preventive drugs: a systematic review and network meta-analysis. J Headache Pain. 2023;24(1). doi: 10.1186/s10194-023-01594-1
   Web of Science ®Google Scholar
• Crowe HM, Wesselink AK, Wise LA, et al. Pre-pregnancy migraine diagnosis, medication use, and spontaneous abortion: a prospective cohort study. J Headache Pain. 2022;23(1): doi: 10.1186/s10194-022-01533-6
   PubMed Web of Science ®Google Scholar
• Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343–349.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Nicholson RA, Reed ML, et al. Diagnosis, consultation, treatment, and impact of migraine in the US: Results of the OVERCOME (US) study. Headache. 2022;62(2):122–140. doi: 10.1111/head.14259
   PubMed Web of Science ®Google Scholar
• Ailani J, Burch RC, Robbins MS. The American Headache Society consensus statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021–1039. doi: 10.1111/head.14153
   PubMed Web of Science ®Google Scholar
• Sarchielli P, Granella F, Prudenzano MP, et al. Italian guidelines for primary headaches: 2012 revised version. J Headache Pain. 2012;13(S2):31–70. doi: 10.1007/s10194-012-0437-6
   Google Scholar
• Ducros A, de Gaalon S, Roos C, et al. Revised guidelines of the French headache society for the diagnosis and management of migraine in adults. Part 2: Pharmacological treatment. Rev Neurol (Paris). 2021 [2021 Sep 1];177(7):734–752. doi: 10.1016/j.neurol.2021.07.006
   PubMed Web of Science ®Google Scholar
• Reuter U, Ehrlich M, Gendolla A, et al. Erenumab versus topiramate for the prevention of migraine – a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. 2022;42(2):108–118. doi: 10.1177/03331024211053571
   PubMed Web of Science ®Google Scholar
• Ehrlich M, Hentschke C, Sieder C, et al. Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study. J Headache Pain. 2022;23(1): doi: 10.1186/s10194-022-01511-y
   PubMed Web of Science ®Google Scholar
• Sacco S, Amin FM, Ashina M, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. J Headache Pain. 2022 [2022 Jun 11];23(1):67. doi: 10.1186/s10194-022-01431-x
   PubMed Web of Science ®Google Scholar
• Dodick D, Diener H, Turkel C, et al. OnabotulinumtoxinA for chronic migraine treatment: 75% responder analysis from double-blind, randomized, placebo-controlled phase of PREEMPT. J Headache Pain. 2013;14(S1):197. doi: 10.1186/1129-2377-14-S1-P197
   Google Scholar
• Silberstein S, Dodick DW, DeGryse RE, et al. The percent of chronic migraine patients who responded to onabotulinumtoxinA treatment per treatment cycle in the PREEMPT clinical program. J Headache Pain. 2013 [2013 Feb 21];14(1):200. doi: 10.1186/1129-2377-14-S1-P200
   Google Scholar
• Bendtsen L, Sacco S, Ashina M, et al. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018;19(1): doi: 10.1186/s10194-018-0921-8
   PubMedGoogle Scholar
• Negro A, Curto M, Lionetto L, et al. A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2016 [2016 Jan 21];17(1):1. doi: 10.1186/s10194-016-0591-3
   Google Scholar
• Rothrock JF, Adams AM, Lipton RB, et al. FORWARD study: Evaluating the comparative effectiveness of OnabotulinumtoxinA and topiramate for Headache prevention in Adults with chronic migraine. Headache. 2019;59(10):1700–1713. doi: 10.1111/head.13653
   PubMed Web of Science ®Google Scholar
• Wong H-T, Khalil M, Ahmed F. OnabotulinumtoxinA for chronic migraine during pregnancy: a real world experience on 45 patients. J Headache Pain. 2020;21(1). doi: 10.1186/s10194-020-01196-1
   Web of Science ®Google Scholar
• Brin MF, Kirby RS, Slavotinek A, et al. Pregnancy outcomes in patients exposed to OnabotulinumtoxinA treatment: a cumulative 29-year safety update. Neurology. 2023;101(2):e103–e113. Publish Ahead of:10.1212/WNL.000. doi: 10.1212/WNL.0000000000207375
   PubMed Web of Science ®Google Scholar
• Tanoshima M, Kobayashi T, Tanoshima R, et al. Risks of congenital malformations in offspring exposed to valproic acidin utero: a systematic review and cumulative meta-analysis. Clin Pharmacol Ther. 2015;98(4):417–441. doi: 10.1002/cpt.158
   PubMed Web of Science ®Google Scholar
• Ornoy A. Valproic acid in pregnancy: how much are we endangering the embryo and fetus?Reprod Toxicol. 2009 [2009 Jul 1];28(1):1–10. doi: 10.1016/j.reprotox.2009.02.014
   PubMed Web of Science ®Google Scholar
• Veroniki AA, Cogo E, Rios P, et al. Comparative safety of anti-epileptic drugs during pregnancy: a systematic review and network meta-analysis of congenital malformations and prenatal outcomes. BMC Med. 2017;15(1): doi: 10.1186/s12916-017-0845-1
   Google Scholar
• Jentink J, Loane MA, Dolk H, et al. Valproic acid monotherapy in pregnancy and major congenital malformations. N Engl J Med. 2010;362(23):2185–2193. doi: 10.1056/NEJMoa0907328
   PubMed Web of Science ®Google Scholar
• Clayton-Smith J, Bromley R, Dean J, et al. Diagnosis and management of individuals with fetal valproate spectrum disorder; a consensus statement from the European Reference network for congenital malformations and Intellectual disability. Orphanet J Rare Diseases. 2019;14(1): doi: 10.1186/s13023-019-1064-y
   PubMedGoogle Scholar
• Weston J, Bromley R, Jackson CF, et al. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev. 2016 Nov 7;11(11):Cd010224.
   PubMedGoogle Scholar
• Meador K, Reynolds MW, Crean S, et al. Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts. Epilepsy Res. 2008 Sep;81(1):1–13. doi: 10.1016/j.eplepsyres.2008.04.022
   PubMed Web of Science ®Google Scholar
• Faught E. Topiramate in the treatment of partial and generalized epilepsy. Neuropsychiatr Dis Treat. 2007 Dec;3(6):811–821. doi: 10.2147/NDT.S512
   PubMedGoogle Scholar