EMBRYOPATHIES AND FETAL MALFORMATIONS DUE TO ISOTRETINOIN: AN INTEGRATIVE REVIEW

Abstract

Isotretinoin (13-cis-retinoic acid), the active ingredient in the drug Roacutan®, is widely used to treat various types of acne. However, its use during pregnancy poses a serious risk to fetal health due to its high teratogenic potential. Classified as category X for pregnant women, isotretinoin can cause various congenital malformations, such as craniofacial, cardiovascular, and central nervous system anomalies, even at minimal doses. Despite the contraindications, the drug is still prescribed to women of childbearing age without proper monitoring, which increases the risks of fetal exposure. This research aims to highlight the teratogenic effects of isotretinoin, analyze the mechanisms of action of the substance in embryonic development, investigate the most common types of associated malformations, and evaluate existing preventive protocols. This is a descriptive literature review, based on scientific articles from the PUBMED, SCIELO, and BVS databases, published between 2007 and 2025. The expected results aim to contribute to raising awareness about the risks of inappropriate isotretinoin use, promoting the prevention of exposed pregnancies, and reinforcing the need for effective public policies for the safe use of this drug.