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. 2022 Mar;65(2):166-175.
doi: 10.5468/ogs.21354. Epub 2022 Feb 23.

Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans

Eun-Hwan Cha  1   2 , NaeRy Kim  1   3 , Ho-Seok Kwak  1 , Hae Ji Han  1 , Sung Hong Joo  1   4 , June-Seek Choi  1   5 , Kyoung-Chul Chun  2 , Young-Ah Kim  2 , Jae-Whoan Koh  2 , Jung Yeol Han  1   2
Affiliations

Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans

Eun-Hwan Cha et al. Obstet Gynecol Sci. 2022 Mar.

Abstract

Objective: Isotretinoin should not be used during pregnancy because of the risk of birth defects. Most pregnant women exposed to isotretinoin choose voluntary pregnancy termination due to concerns about birth defects. However, birth outcome data supporting the termination of pregnancy are lacking. This study aimed to evaluate pregnancy and neonatal outcomes after periconception exposure to isotretinoin.

Methods: This was a prospective cohort study. We evaluated pregnancy and neonatal outcomes after exposure to isotretinoin in 151 pregnant women. Among 1,026 callers at the Korean Teratology Information Service from 2001 to 2017 exposed to isotretinoin during the periconception period, 151 pregnant women who received counseling on teratogenic risk after visiting the clinic were included.

Results: Among the 151 participants who visited the clinic, only 42 were evaluated using ultrasonography until approximately 20 weeks of gestation. Ultimately, 23 patients were included in the study. The average gestation period during the last exposure to the drug was 2 weeks, and the average daily exposure dose was 12 mg. There were two cases of major birth defects in the exposure group. Spontaneous abortion rates were 17.7% and 8.7% in the exposure and nonexposure groups, respectively (P=0.035). There was no significant difference between the exposure and non-exposure groups in terms of pregnancy and neonatal outcomes.

Conclusion: There was no significant difference in pregnancy and neonatal outcomes, including birth defects, between the exposure and non-exposure groups. Further studies with larger sample sizes are required to validate our findings.

Keywords: Congenital abnormalities; Isotretinoin; Maternal exposure; Pregnancy; Teratogens.

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Conflict of interest statement

Conflict of interest

The authors declare no conflict of interest. The authors alone are responsible for the content and writing of this paper.

Figures

Fig. 1
Fig. 1
Study flowchart.
See this image and copyright information in PMC

References

    1. Layton A. The use of isotretinoin in acne. Dermatoendocrinol. 2009;1:162–9. - PMC - PubMed
    1. Korea Pharmaceutical Information Center . Isotretinoin [Internet] Seoul (KR): Korea Pharmaceutical Information Center; c2000. [cited 2021 Aug 17]. Available from: http://www.health.kr/searchDrug/result_drug.asp?drug_cd=A11AHHHHH0355 .
    1. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, Braun JT, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313:837–41. - PubMed
    1. Zomerdijk IM, Ruiter R, Houweling LM, Herings RM, Sturkenboom MC, Straus SM, et al. Isotretinoin exposure during pregnancy: a population-based study in the Netherlands. BMJ Open. 2014;4:e005602. - PMC - PubMed
    1. Kim NR, Yoon SR, Choi JS, Ahn HK, Lee SY, Hong DS, et al. Isotretinoin exposure in pregnant women in Korea. Obstet Gynecol Sci. 2018;61:649–54. - PMC - PubMed