Adverse Events in Isotretinoin Therapy: A Single-Arm Meta-Analysis

Jan Kapała, Julia Lewandowska, Waldemar Placek and Agnieszka Owczarczyk-Saczonek
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Jan Kapała: Medical Faculty, University of Warmia and Mazury in Olsztyn, 10-719 Olsztyn, Poland
Julia Lewandowska: Medical Faculty, University of Warmia and Mazury in Olsztyn, 10-719 Olsztyn, Poland
Waldemar Placek: Department of Dermatology Sexually Transmitted Diseases and Clinical Immunology, University of Warmia and Mazury in Olsztyn, 10-719 Olsztyn, Poland
Agnieszka Owczarczyk-Saczonek: Department of Dermatology Sexually Transmitted Diseases and Clinical Immunology, University of Warmia and Mazury in Olsztyn, 10-719 Olsztyn, Poland

IJERPH, 2022, vol. 19, issue 11, 1-21

Abstract: Isotretinoin (ISO) is an oral prescription-only retinoid, well known for its acne-treating effect. However, it affects a substantial number of human cell types, causing a broad spectrum of adverse effects. The purpose of this study is to establish the isotretinoin therapy adverse events among human clinical trials and their prevalence. Two authors (J.K., J.L.) systematically performed the literature review and assessment from December 2021–February 2022. Three databases (PubMed, ClinicalTrials, and Cochrane Library) were searched using the following terms: “isotretinoin acne vulgaris” for published studies in English from 1980–2021. Finally, 25 randomized controlled clinical trials (RCTs) and five open-label clinical trials provided 3274 acne vulgaris suffering patients. Isotretinoin therapy affects almost all of the systems in the human body, causing numerous adverse events. However, they mainly concern mild mucocutaneous conditions (severe cases are rare) and represent individual responses to a drug. In addition, all adverse events are reversible and can be avoided by specific preparations.

Keywords: isotretinoin; acne vulgaris; adverse events; single-arm meta-analysis (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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