Risk of psychiatric events in women treated with isotretinoin: a self-controlled study with SIDIAP database. Issue 3 (4th March 2023)

• Record Type: Journal Article
• Authors: Vona-Giralt, Gemma; Vilaplana-Carnerero, Carles; Ouchi, Dan; Gomez-Lumbreras, Ainhoa; Morros, Rosa; Giner-Soriano, Maria
• Is Part Of: Expert opinion on drug safety. Volume 22:Issue 3(2023)
• Page Start: 213
• Page End: 219
• Publication Date: 2023-03-04
• Subjects: Isotretinoin -- mental disorders -- psychotropic drugs -- Self-Control study -- electronic health records -- primary health care; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2022.2120608
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Background: Since isotretinoin marketing, reports of psychiatric events have been noted. Howeverto date, a relation between these events and acne or isotretinoin treatment has not been clearly established. Our objective was to analyze the incidence of psychiatric events in women receiving isotretinoin. Methods: Self-controlled study including women treated with isotretinoin from July 2014 to December 2018. Data source was SIDIAP, a primary health care-based database from Catalonia, Spain. Risk of psychiatric events was analyzed during the isotretinoin exposure and during the previous and posterior periods of non-exposure. Results: We included 4, 738 women in the study, 25.3% of them had history psychiatric disorders prior to receiving isotretinoin. During the follow-up, 782 (16.5%) patients were diagnosed with new mental disorders and 925 (19.5%) received new psychotropic drug prescriptions. We found a trend to an increase of new events when the previous non-exposure and the isotretinoin exposure periods were compared, with no significant differences. Incident psychiatric events during isotretinoin exposure was significantly higher in those patients with previous psychiatric history. Conclusions: We cannot conclude any causality between acne and isotretinoin and the appearance of new psychiatric events. However, we contribute to the evidence with a more robust methodological approach, which minimizes the effect of confounding variables.