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Acta Clinica Belgica
International Journal of Clinical and Laboratory Medicine
Volume 77, 2022 - Issue 5
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Research Article

The implementation of risk minimization measures to prevent teratogenic pregnancy outcomes related to oral retinoid and valproate use in Belgium

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References

  • van de Kerkhof PC. Update on retinoid therapy of psoriasis in: an update on the use of retinoids in dermatology. Dermatol Ther. 2006 Sep-Oct;19(5):252–263.
  • Boon P, Dejonghe P, Legros B, et al. Impact of reimbursement restrictions on the choice of antiepileptic drugs: belgian study on epilepsy treatment (BESET). Seizure. 2008 Jun;17(4):350–357.
  • Legros B, Boon P, De Jonghe P, et al. Opinion of Belgian neurologists on antiepileptic drug treatment in 2006: belgian study on epilepsy treatment (BESET-2). Acta Neurol Scand. 2009 Dec;120(6):402–410.
  • Browne H, Mason G, Tang T. Retinoids and pregnancy: an update. Obstet Gynaecol. 2014;16(1):7–11.
  • Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313(14):837–841.
  • 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.
  • Tomson T, Battino D, Bonizzoni E, et al. Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol. 2018 Jun;17(6):530–538.
  • 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. The Lancet Neurology. 2013 Mar;12(3):244–252.
  • Ornoy A. Valproic acid in pregnancy: how much are we endangering the embryo and fetus? Reprod Toxicol. 2009 Jul;28(1):1–10.
  • Alsdorf R, Wyszynski DF. Teratogenicity of sodium valproate. Expert Opin Drug Saf. 2005 Mar;4(2):345–353.
  • 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 Apr 16;360(16):1597–1605.
  • Bromley RL, Mawer G, Love J, et al. Early cognitive development in children born to women with epilepsy: a prospective report. Epilepsia. 2010 Oct;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 Jul;96(7):643–647.
  • Bromley RL, Mawer GE, Briggs M, et al. The prevalence of neurodevelopmental disorders in children prenatally exposed to antiepileptic drugs. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):637–643.
  • European Medicine A. Isotretinoin - Art 31 referral - EMEA/CPMP/2811/03 - Annex I, II, III. 2003.
  • European Medicine A. Valproate and related substances - Art 31 referral - EMEA/H/A-31/1387 - Annex II. 2015. p. 34–39.
  • Crijns HJ, Van Rein N, Gispen-de Wied CC, et al. Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study. Pharmacoepidemiol Drug Saf. 2012 Oct;21(10):1060–1066.
  • Crijns I, Mantel-Teeuwisse A, Bloemberg R, et al. Healthcare professional surveys to investigate the implementation of the isotretinoin pregnancy prevention programme: a descriptive study. Expert Opin Drug Saf. 2013 Jan;12(1):29–38.
  • Veyries ML, Bertrand M, Miranda S, et al. Study of compliance with the isotretinoin pregnancy prevention programme regarding pregnancy testing in france using the EGB database. Drug Saf. 2015 Oct;38(10): 1039-1039.
  • Henry D, Dormuth C, Winquist B, et al. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ. 2016 Jul 12;188(10):723–730.
  • European Medicine A. EMA/254364/2018 - Pharmacovigilance Risk Assessment Committe (PRAC) assessment report: retinoids containing medicinal products. 2018.
  • European Medicine A. EMA/198940/2018 - Pharmacovigilance Risk Assessment Committee (PRAC) assessment report: medicinal products containing substances related to valproate. 2018.
  • European Medicine A. Valproate - Art 31 referral - EMEA/H-A31/1454 - Annex III. 2018.
  • European Medicine A. Retinoid - Art 31 referral - EMEA/H/A-31/1446 - Annex III. 2018.
  • FAMHP. Valproate: knowledge of the risks associated with taking during pregnancy - Results of the 2018 FAMHP survey. 2018 [cited 2021 Mar 04]. Available from: https://www.famhp.be/en/news/valproate_knowledge_of_the_risks_associated_with_taking_during_pregnancy_results_of_the_2018
  • FAMHP. Approved RMA materials 2021. [ cited 2021 Aug 30]. Available from: https://www.fagg-afmps.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/goed_gebruik_geneesmiddel/risicobeheerprogramma/rma
  • Picavet C. Zwangerschap en anticonceptie in Nederland. Tijdschrift voor Seksuologie. 2012;36(2):121–128.
  • Erens B, McManus S, Prescott A, et al. National survey of sexual attitudes and lifestyles II reference tables and summary report with National Survey of Sexual Attitudes and Lifestyles II. 2003. p. 33-33.

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