References
- Shorvon SD. Drug treatment of epilepsy in the century of the ILAE: the second 50 years, 1959–2009. Epilepsia. 2009;50:93–130.
- European Medicines Agency. Valproate and related substances Article-31 referral - PRAC assessment report 2014. [cited 2020 May 11]. Available from: https://www.ema.europa.eu/en/documents/referral/valproate-related-substances-article-31-referral-prac-assessment-report_en.pdf
- Marson AG, Al-Kharusi AM, Alwaidh M, et al. The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial. Lancet. 2007;369(9566):1016–1026.
- Mole TB, Appleton R, Marson A. Withholding the choice of sodium valproate to young women with generalised epilepsy: are we causing more harm than good? Seizure. 2015;24:127–130.
- Marson A, Burnside G, Appleton R, et al. The SANAD II study of the effectiveness and cost-effectiveness of valproate versus levetiracetam for newly diagnosed generalised and unclassifiable epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial. Lancet. 397(10282): 1375–1386. 2021.
- 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;81(1):1–13.
- Robert E, Guibaud P. Maternal valproic acid and congenital neural tube defects. Lancet. 1982;320(8304):937.
- Bromley RL, Mawer G, Love J, et al. Early cognitive development in children born to women with epilepsy: a prospective report. Epilepsia. 2010;51(10):2058–2065.
- Cummings C, Stewart M, Stevenson M, et al. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine. Arch Dis Child. 2011;96(7):643–647.
- Meador KJ, Baker GA, Browning N, et al. Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs. N Engl J Med. 2009;360(16):1597–1605.
- Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurol. 2013;12(3):244–252.
- Bromley R, Weston J, Adab N, et al. Treatment for epilepsy in pregnancy: neurodevelopmental outcomes in the child. Cochrane Database Syst Rev. 2014;(10).
- European Medicines Agency. Valproate and related substances Article-31 referral - Review started 2013. [cited 2020 May 11]. Available from: https://www.ema.europa.eu/en/documents/referral/valproate-related-substances-article-31-referral-review-started_en.pdf
- European Medicines Agency. Valproate and related substances Article-31 referral - PRAC recommends strengthening the restrictions on the use of valproate in women and girls 2014. [cited 2020 May 11]. Available from: https://www.ema.europa.eu/en/documents/referral/valproate-related-substances-article-31-referral-prac-recommends-strengthening-restrictions-use_en.pdf
- Agence nationale de sécurité du médicament et des produits de santé. Etude observationnelle ANSM-CNAMTS de l’exposition à l’acide valproïque et ses dérivés au cours de la grossesse 2016. [cited 2020 May 11]. Available from: https://ansm.sante.fr/Dossiers/Valproate-et-derives/Valproate-et-derives/(offset)/0
- European Medicines Agency. Valproate Article-31 referral - Review started. New review of valproate use in pregnancy and women of childbearing age 2017. [cited 2020 May 11]. Available from: https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-review-started_en.pdf
- European Medicines Agency. Valproate Article-31 referral - PRAC recommends new measures to avoid valproate exposure in pregnancy 2018. [cited 2020 May 11]. Available from: https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf
- The Health Products Regulatory Authority. Drug Safety Newsletter Edition 87 – April 2018. 2018.
- The Health Products Regulatory Authority Ireland. Valproate (Epilim) – communications. [cited 2020 May 11]. Available from: http://www.hpra.ie/homepage/medicines/special-topics/valproate-(epilim)/valproate-(epilim)-communications
- Von Elm E, Altman DG, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147(8):573–577.
- The Health Products Regulatory Authority. Guide for Healthcare Professionals, 2018. [cited 2020 May 11]. Available from: http://www.hpra.ie/docs/default-source/default-document-library/epilim-hcp-guide_june-2018.pdf?sfvrsn=0
- The Health Products Regulatory Authority. Drug Safety Newsletter Edition 97 – may 2020 2020. [cited 2020 May 11]. Available from: http://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-drug-safety-newsletter-97th-edition.pdf?Status=Master&sfvrsn=13
- Angus‐Leppan H, Moghim MM, Cock H, et al. Valproate risk form—Surveying 215 clinicians involving 4775 encounters. Acta Neurol Scand. 2020;141(6):483–490.
- Atturu H, Odelola A. Valproate prescribing in women of childbearing age: an audit of clinical practice. Adv Psychiatry. 2015; 2015.
- James L, Barnes TR, Lelliott P, et al. Informing patients of the teratogenic potential of mood stabilizing drugs: a case note review of the practice of psychiatrists. J Psychopharmacol. 2007;21(8):815–819.
- Wieck A, Rao S, Sein K, et al. A survey of antiepileptic prescribing to women of childbearing potential in psychiatry. Arch Women’s Mental Health. 2007;10(2):83–85.
- Mulryan D, McIntyre A, McDonald C, et al. Awareness and documentation of the teratogenic effects of valproate among women of childbearing potential. BJPsych Bull. 2018;42(6):233–237.
- Shroukh WA, Steinke DT, Willis SC. Risk management of teratogenic medicines: a systematic review. Birth Defects Res. 2020;112(20):1755–1786.
- Crijns H, Straus S, Gispen‐de Wied C, et al. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. 2011;164(2):238–244.
- Raguideau F, Mezzarobba M, Zureik M, et al. Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin. Pharmacoepidemiol Drug Saf. 2015;24(5):526–533.
- Angus-Leppan H, Liu RS. Weighing the risks of valproate in women who could become pregnant. Bmj. 2018;361.
- Davies P, Reuber M, Grunewald R, et al. The impact and challenges of the 2018 MHRA statement on the use of sodium valproate in women of childbearing age during the first year of implementation, in a UK epilepsy centre. Elsevier. Seizure. 2020;79:8–13.
- Watkins LV, Cock HR, Angus-Leppan H, et al. Valproate and the Pregnancy Prevention Programme: exceptional circumstances. British Journal of General Practice. 2019.
- Morrison I, Cork H, Smith P, et al. Is the Medicines and healthcare products regulatory Agency (MHRA) guidance on sodium valproate acceptable to women of childbearing age? J R Coll Physicians Edinb. 2020;50(2):114–117.
- O’Callaghan J, Griffin BT, Morris JM, et al. Knowledge of adverse drug reaction reporting and the pharmacovigilance of biological medicines: a survey of healthcare professionals in Ireland. BioDrugs. 2018;32(3):267–280.
- Power K, McCrea Z, White M, et al. The development of an epilepsy electronic patient Portal: facilitating both patient empowerment and remote clinician‐patient interaction in a post COVID‐19 world. Epilepsia. 2020;61(9):1894–1905.