Psychiatric disorders, acne and systemic retinoids: comparison of risks

• Published in: Expert opinion on drug safety Vol. 16; no. 9; p. 989
• Main Authors: Le Moigne, M, Bulteau, S, Grall-Bronnec, Marie, Gerardin, M, Fournier, Jean-Pascal, Jonville-Bera, A P, Jolliet, Pascale, Dreno, Brigitte, Victorri-Vigneau, C
• Format: Journal Article
• Language: English
• Published: England 02.09.2017
• Subjects: Acne Vulgaris - drug therapy; Adverse Drug Reaction Reporting Systems; Databases, Factual; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Female; France; Humans; Isotretinoin - adverse effects; Isotretinoin - therapeutic use; Male; Mental Disorders - chemically induced; Mental Disorders - epidemiology; Pharmacovigilance; Retinoids - adverse effects; Retinoids - therapeutic use; Risk; Severity of Illness Index; Tretinoin - adverse effects; Tretinoin - therapeutic use; Young Adult; psychiatric disorder; isotretinoin; mental disorder; Alitretinoin; pharmacovigilance; retinoid
• ISSN: 1744-764X
• DOI: 10.1080/14740338.2017.1344641

The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids. Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators. Each report was subjected to double-blind analysis by two psychiatric experts. A disproportionality analysis was performed, calculating the number of psychiatric ADRs divided by the total number of notifications for each drug of interest. Concerning acne systemic treatments: all 71 reports of severe psychiatric disorders involved isotretinoin, the highest proportion of mild/moderate psychiatric adverse events was reported with isotretinoin (14.1%). Among systemic retinoids, the highest proportion of severe and mild/moderate psychiatric events occurred with isotretinoin and alitretinoin. Our study raises the hypothesis that psychiatric disorders associated with isotretinoin are related to a class effect of retinoids, as a signal emerges for alitretinoin. Complementary studies are necessary to estimate the risk and further determine at-risk populations.