Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020.

ABSTRACT:

Background

Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown.

Objectives

This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority.

Design

Retrospective cohort study.

Methods

This multicenter retrospective study included a cohort of 6233 women of childbearing ages (WCBAs) who had received isotretinoin therapy between 2015 and 2020. Exposure to isotretinoin use was ascertained from patients' electronic health records and was defined as any positive pregnancy t

SUBMITTER: Albogami Y 

PROVIDER: S-EPMC11406652 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature