The Risk of Hospital Admission for an Acute-Onset Psychiatric Disorder in Adolescents and Adults Treated with Isotretinoin: A French, Nationwide, Population-Based, Case-Time-Control Study.

Abstract

Introduction: Oral isotretinoin is the only effective treatment for severe acne without an alternative. Isotretinoin has been linked to the occurrence of acute psychiatric disorders outside suicidal behaviors. There are few large-scale epidemiological studies in this area, and the putative associations are unclear. Our objective was to determine whether adolescents and young adults have an elevated risk of acute-onset psychiatric disorder requiring hospital treatment within 2 months of starting isotretinoin treatment.

Methods: Our data source was the French national health insurance database (Système National des Données de Santé, SNDS), 2010-2015. We performed a case-time-control study nested in an exhaustive, nationwide cohort of all French adolescents and young adults aged 10-25 years treated with isotretinoin. The outcome was an acute-onset psychiatric disorder requiring hospitalization (including anxiety, depressive, mood, adjustment, and psychotic disorders). A conditional logistic model was used to estimate odds ratios (ORs) with their 95% confidence interval (CI) for acute psychiatric events.

Results: 2,284 acute-onset psychiatric disorder requiring hospitalization were recorded for the study population of 262,786 patients. Among the patients with at least one psychiatric event, 88 had started taking isotretinoin in the risk period (0-2 months before the date of the event), versus 81 in the reference period (2-4 months before the event). A comparison with the 383 and 355 time-trend matched controls who started taking isotretinoin in the risk and reference periods, respectively, yielded a case-time-control OR (95% CI) of 1.01 (0.72-1.41).

Conclusion: Psychiatric events managed outside the hospital system were not recorded. Our findings are reassuring for clinicians concerning the risk of severe acute-onset psychiatric events after isotretinoin initiation.