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Medications and More during pregnancy and breastfeeding

Isotretinoin (Accutane®)

Selected References:

  • Abdelmaksoud A, et al. 2023. Isotretinoin and pregnancy termination: an overview. Int J Dermatol. 62(4):e255-e256. 
  • Adams J, et al. 1991. Relationship between dysmorphology and neuropsychological function in children exposed to isotretinoin “in utero”. In: T. Fujii and G. J. Boer (eds), Functional Neuroteratology of Short Term Exposure to Drugs. Tokyo: Teikyo University Press, pp.159-170.  
  • Adams J, et al. 1993. Neurobehavioral teratology of isotretinoin. Reprod Toxicol. 7(2):175-177.  
  • Adams J. 1996. Similarities in genetic mental retardation and neuroteratogenic syndromes. Pharmacol Biochem Behav. 55(4):683-690.  
  • Alay MT, et al. 2023. A new perspective on isotretinoin in pregnancy: Pregnancy outcomes, evaluation of complex phenotypes, and importance of teratological counselling, Eur J Obstet Gynecol Reprod Biol. 291:148-155.  
  • Alshaalan ZD. 2022. Knowledge on the Use of Isotretinoin and Its Side Effects and Awareness towards Saudi FDA-Pregnancy Prevention Program among the Female Acne Patients: A Northern Saudi Study. Medicina (Kaunas). 58(11):1609. 
  • Autret-Leca E, et al. 2010 Isotretinoin exposure during pregnancy: assessment of spontaneous reports in France. Drug Saf. 33(8):659-665.  
  • Cha EH, et al. 2022. Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans. Obstet Gynecol Sci. 65(2):166-175.  
  • Chelliah P, et al. 2020. Comprehensive review of reports of menstrual irregularities associated with isotretinoin. Int J Womens Dermatol. 6(5):365-367. 
  • Choi EJ, et al. 2021. The rates of major malformations after gestational exposure to isotretinoin; a systemic review and meta-analysis. Obstet Gynecol Sci. 64(4):364-373. 
  • Coleman R, et al. 1994. Effects of isotretinoin on male reproductive system. Lancet 344:198.  
  • Committee on Drugs, American Academy of Pediatrics. 1992. Retinoid therapy for severe dermatological disorders. Pediatrics. 90:119-120.   
  • FDA. 2008 ACCUTANE® (isotretinoin capsules) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf. 
  • Dai WS, et al. 1989. Safety of pregnancy after discontinuation of isotretinoin. Arch Dermatol. 125(3):362-365.   
  • Dai WS, et al. 1992. Epidemiology of isotretinoin exposure during pregnancy. J Am Acad Dermatol. 26(4):599-606. 
  • DiGiovanna JJ, et al. 1984. Etretinate: persistent serum levels of a potent teratogen. Clin Res 32:579A.   
  • Eun-Hwan C, et al. 2022. Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans. Obstet Gynecol Sci. 65(2):166-175. 
  • Fallah H, et al. 2022. Isotretinoin for acne vulgaris – an update on adverse effects and laboratory monitoring. J Dermatol Treat. 33(5)2414-2424. 
  • Goldsmith LA, et al. 2004. American Academy of Dermatology Consensus Conference on the safe and optimal use of isotretinoin: summary and recommendations. Journal of the American Academy of Dermatology, 50(6), 900–906. 
  • Gurel A, et. Al 2023. Effect of systemic isotretinoin therapy on semen parameters. Annals of medicine, 55(1), 2207038.  
  • Jajoria H, et al. 2020. Washout Period for Pregnancy Post Isotretinoin Therapy. Indian Dermatol Online J. 11(2):239-242.
  • Ivask M, et al. 2023. Compliance with Pregnancy Prevention Recommendations for Isotretinoin Following the Amendment of the European Union Pregnancy Prevention Program: A Repeat Study in Estonia. Drugs Real World Outcomes. 11(1):91-98. 
  • Lammer EJ, et al. 1985. Retinoic acid embryopathy. New Engl J Med. 313:837-841. 
  • Lammer EJ, et al. 1988. Isotretinoin dose and teratogenicity. Lancet. 2(8609):503-504.   
  • Lee SM, et al. 2009.  A case of suspected isotretinoin-induced malformation in a baby of a mother who became pregnant one month after discontinuation of the drug. Yonsei Med J. 50(3):445-447. 
  • Loureiro KD, et al. 2005. Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy. Am J Med Genet A. 136(2):117-121. 
  • Mitchell AA. 1992. Oral retinoids. What should the prescriber know about their teratogenic hazards among women of child-bearing potential? Drug Saf. 7(2):79-85. 
  • Nulman I. 1998. Steady-state pharmacokinetics of isotretinoin and its 4-oxo metabolite: implications for fetal safety. J Clin Pharmacol. 38(10):926-930.  
  • No Author listed. 1991. Recommendations for isotretinoin use in women of childbearing potential. Teratology. 44(1):1-6.  
  • O’Malley S, et al. 2024. Isotretinoin prescribing and pregnancy prevention; insights from dispensing pharmacists in Ireland. Int J Pharm Pract. 32(5):426-427.  
  • You W, et al. 2024. Adverse Pregnancy and Child Outcomes in Oral Retinoid-Exposed Pregnancies: A Nationwide Population-Based Study. J Korean Med Sci. 39(26):e201.  
  • Zeynep Tırmıkçıoğlu Z, et al. 2024. Face-to-face: isotretinoin use and pregnancy outcome. Int J Dermatol. 63(2):232-238. 
  • Zhu Y, et al. 2025. Isotretinoin Risk Evaluation and Mitigation Strategy and Pregnancy Incidence. JAMA Intern Med. 185(10):1289-1291. 

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