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

• Main Authors: Eun Jeong Choi (Author), NaeRy Kim (Author), Ho-Seok Kwak (Author), Hae Ji Han (Author), Kyoung-Chul Chun (Author), Young-Ah Kim (Author), Jae-Whoan Koh (Author), Jung Yeol Han (Author), Sung Hong Joo (Author), Ji Sung Lee (Author), Gideon Koren (Author)
• Format: Book
• Published: Korean Society of Obstetrics and Gynecology, 2021-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2287-8572; 2287-8580; 10.5468/ogs.20373
• Keywords: isotretinoin; congenital malformations; pregnancy; meta-analysis; systematic review; Gynecology and obstetrics; RG1-991
• Source: Obstetrics & Gynecology Science, Vol 64, Iss 4, Pp 364-373 (2021)

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.