Isotretinoin exposure in pregnant women in Korea
2
조회
0
다운로드
4
인용
0
참고문헌
키워드
초록
Objective Isotretinoin is a notorious teratogen otherwise used for the treatment of acne vulgaris. Some countries, includingthose in North America and the European Union, implemented the pregnancy prevention program (PPP); however,no PPP has yet been established in South Korea. So the aim of this study was to evaluate the rate of pregnant womenexposed to isotretinoin among the callers of the Korean Mother Safe Counseling Center. Methods This is a prospective cohort study. We evaluated the demographic characteristics, obstetric history, and isotretinoinexposure of pregnant women based on the mother safe registry from April 2010 to July 2016. Results Among 22,374 callers, 650 (2.9%) pregnant women were exposed to isotretinoin. The mean age was 29.0±4.4 yearsin the isotretinoin-exposed group and 32.0±4.2 years in the unexposed group (P<0.001). Moreover, the incidence ofpregnancies within 30 days after isotretinoin discontinuation or during isotretinoin intake was 78.9% (513/650). Themedian duration of isotretinoin exposure was 18 (1–4,231) days. Furthermore, from 2011 to 2015, the incidence ofisotretinoin exposure was 2.9±1.2 pregnancies per 10,000 births in South Korea. Conclusion Approximately 80% of pregnant women are exposed to isotretinoin within the recommended 30 days ofcontraception or during pregnancy. Therefore, the PPP has to be established in South Korea.
Abstract
Objective Isotretinoin is a notorious teratogen otherwise used for the treatment of acne vulgaris. Some countries, includingthose in North America and the European Union, implemented the pregnancy prevention program (PPP); however,no PPP has yet been established in South Korea. So the aim of this study was to evaluate the rate of pregnant womenexposed to isotretinoin among the callers of the Korean Mother Safe Counseling Center. Methods This is a prospective cohort study. We evaluated the demographic characteristics, obstetric history, and isotretinoinexposure of pregnant women based on the mother safe registry from April 2010 to July 2016. Results Among 22,374 callers, 650 (2.9%) pregnant women were exposed to isotretinoin. The mean age was 29.0±4.4 yearsin the isotretinoin-exposed group and 32.0±4.2 years in the unexposed group (P<0.001). Moreover, the incidence ofpregnancies within 30 days after isotretinoin discontinuation or during isotretinoin intake was 78.9% (513/650). Themedian duration of isotretinoin exposure was 18 (1–4,231) days. Furthermore, from 2011 to 2015, the incidence ofisotretinoin exposure was 2.9±1.2 pregnancies per 10,000 births in South Korea. Conclusion Approximately 80% of pregnant women are exposed to isotretinoin within the recommended 30 days ofcontraception or during pregnancy. Therefore, the PPP has to be established in South Korea.
참고문헌 (19)
- Layton A, "The use of isotretinoin in acne", Dermatoendocrinol, 1, pp.162~169 (2009)
- "Isotretinoin information" (2018)[URL]
- Azoulay L, "Patterns and utilization of isotretinoin for acne from 1984 to 2003: is there need for concern?", Eur J Clin Pharmacol, 62, pp.667~674 (2006)
- Honein MA, "Continued occurrence of Accutane-exposed pregnancies", Teratology, 64, pp.142~147 (2001)
- Lammer EJ, "Retinoic acid embryopathy", N Engl J Med, 313, pp.837~841 (1985)
- Stern RS, "When a uniquely effective drug is teratogenic. The case of isotretinoin", N Engl J Med, 320, pp.1007~1009 (1989)
- "Health insurance statistical information" (2017)[URL]
- Han JY, "Unintended pregnancies and exposure to potential human teratogens", Birth Defects Res A Clin Mol Teratol, 73, pp.245~248 (2005)
- Dathe K, "Drug safety in pregnancy: the German Embryotox institute", Eur J Clin Pharmacol, 74, pp.171~179 (2018)
- Abroms L, "What is the best approach to reducing birth defects associated with isotretinoin?", PLoS Med, 3, pp.e483~ (2006)
- "iPLEDGE information" (2016)[URL]
- Zomerdijk IM, "Isotretinoin exposure during pregnancy: a population-based study in the Netherlands", BMJ Open, 4, pp.e005602~ (2014)
- "Newborn statistical information" (2014)[URL]
- Mitchell AA, "A pregnancyprevention program in women of childbearing age receiving isotretinoin", N Engl J Med, 333, pp.101~106 (1995)
- 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)
- Bérard A, "Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective", Br J Clin Pharmacol, 63, pp.196~205 (2007)
- Stathakis V, "Descriptive epidemiology of acne vulgaris in the community", Australas J Dermatol, 38, pp.115~123 (1997)
- Bhate K, "Epidemiology of acne vulgaris", Br J Dermatol, 168, pp.474~485 (2013)
- "Health insurance statistical information" (2017)[URL]
