Termination of Pregnancy Following Periconception Isotretinoin Exposure in South Korea

Abstract

Background: Despite South Korea’s Ministry of Food and Drug Safety (MFDS) risk management program (RMP) since June 2019, isotretinoin prescriptions have surged 2.5 times from 0.39 million in 2017 to 0.97 million in 2021. This study assesses pregnancy termination risk perception and termination following periconception isotretinoin exposure in South Korea. Methods: A dataset of 1785 pregnancies from January 2001 to September 2022 was collected by Korean Mother Safe Counselling Center, which is a call center for teratogenicity information. A semi-structured questionnaire was sent to 1107 women to evaluate the rate of pregnancy termination, trends of their risk of perceptive malformation and termination of pregnancy following isotretinoin exposure in periconception before and after getting the counselling on teratogenic risk from our center. Results: There were 317 respondents from the total 1107 women (28.6%). The termination rate was 29.0% (92 out of 317). The perception of major malformation risk decreased from 77.1% ± 24.5% before getting teratogenicity information to 60.4% ± 31.0% after getting teratogenicity information (p < 0.001). The inclination towards pregnancy termination decreased from 5.6 ± 3.1 before getting teratogenicity information to 4.6 ± 3.5 after getting teratogenicity information (p < 0.001). Among the 214 infants examined, 2 (0.9%) were identified to have major malformations, comprising cases of hydrocephalus (1) and biliary obstruction (1). Conclusions: Our study suggest that the perceptive risk of major malformations and termination of pregnancy is still high after getting the teratogenicity information following periconception exposure of isotretinoin. As a result, approximately 30% of pregnancies are terminated. We suggest that further study is needed.

Keywords

• isotretinoin
• teratogens
• pregnancy
• termination of pregnancy
• maternal exposure