Psychiatric Disorders, Acne and Systemic Retinoids: Comparison of Risks.

M. Le Moigne , Samuel Bulteau (1) , Marie Grall-Bronnec (1) , M. Gerardin , Jean-Pascal Fournier , Annie-Pierre Jonville-Bera (1) , Pascale Jolliet (1) , Brigitte Dreno , Caroline Victorri-Vigneau (1)

1 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch

BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Mots clés: Acne Vulgaris/*drug therapy; Adverse Drug Reaction Reporting Systems; Alitretinoin; ArtThese; Databases; Factual; Dermatologic Agents; Dermatologic Agents/adverse effects/*therapeutic use; Female; France; Humans; Isotretinoin; Isotretinoin/adverse effects/therapeutic use; Male; Mental Disorders; Mental Disorders/*chemically induced/epidemiology; Pharmacovigilance; psychiatric disorder; retinoid; Retinoids; Retinoids/adverse effects/*therapeutic use; Risk; Severity of Illness Index; Tretinoin; Tretinoin/adverse effects/therapeutic use; Young Adult

Domaines: Sciences du Vivant [q-bio]

M. Le Moigne, Samuel Bulteau, Marie Grall-Bronnec, M. Gerardin, Jean-Pascal Fournier, et al.. Psychiatric Disorders, Acne and Systemic Retinoids: Comparison of Risks.. Expert opinion on drug safety, 2017, 16 (9), pp.989-995. ⟨10.1080/14740338.2017.1344641⟩. ⟨hal-03158144⟩