Pregnancy and neonatal outcomes after periconceptional exposure to isotretinoin in Koreans
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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.
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.
참고문헌 (15)
- Layton A, "The use of isotretinoin in acne", Dermatoendocrinol, 1, pp.162~169 (2009)
- "Isotretinoin" (2000)[URL]
- Lammer EJ, "Retinoic acid embryopathy", N Engl J Med, 313, pp.837~841 (1985)
- Zomerdijk IM, "Isotretinoin exposure during pregnancy : a population-based study in the Netherlands", BMJ Open, 4, pp.e005602~ (2014)
- 김내리, "Isotretinoin exposure in pregnant women in Korea", Obstetrics & Gynecology Science, 61(6), pp.649~654 (2018), 대한산부인과학회[DOI]
- Yook JH, "Pregnancy outcomes and factors associated with voluntary pregnancy termination in women who had been treated for acne with isotretinoin", Clin Toxicol(Phila), 50, pp.896~901 (2012)
- Polyzos KA, "Maternal influenza vaccination and risk for congenital malformations : a systematic review and meta-analysis", Obstet Gynecol, 126, pp.1075~1084 (2015)
- Dai WS, "Epidemiology of isotretinoin exposure during pregnancy", J Am Acad Dermatol, 26, pp.599~606 (1992)
- Henry D, "Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy", CMAJ, 188, pp.723~730 (2016)
- Schaefer C, "Isotretinoin exposure and pregnancy outcome : an observational study of the berlin institute for clinical teratology and drug risk assessment in pregnancy", Arch Gynecol Obstet, 281, pp.221~227 (2010)
- Davis WL, "Changes in cytosolic calcium, bleb formation, and cell death in neural crest cells treated with isotretinoin and 4-oxo-isotretinoin", J Craniofac Genet Dev Biol, 11, pp.105~118 (1991)
- 최은정, "The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis", Obstetrics & Gynecology Science, 64(4), pp.364~373 (2021), 대한산부인과학회[DOI]
- Loureiro KD, "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, pp.117~121 (2005)
- Eun Jeong Choi, "Non-compliance with pregnancy prevention recommendations for isotretinoin in Korea between 2019-2020", Obstetrics & Gynecology Science, 64(2), pp.201~208 (2021), 대한산부인과학회[DOI]
- "Committed to pregnancy prevention" (2021)[URL]