The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis

Objective Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systema...

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Main Authors: Eun Jeong Choi, NaeRy Kim, Ho-Seok Kwak, Hae Ji Han, Kyoung-Chul Chun, Young-Ah Kim, Jae-Whoan Koh, Jung Yeol Han, Sung Hong Joo, Ji Sung Lee, Gideon Koren
Format: Article
Language:English
Published: Korean Society of Obstetrics and Gynecology 2021-07-01
Series:Obstetrics & Gynecology Science
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Online Access:http://ogscience.org/upload/pdf/ogs-20373.pdf
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Summary:Objective Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. Methods Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3. Results Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04. Conclusion The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.
ISSN:2287-8572
2287-8580