Risk of psychiatric disorders in patients taking isotretinoin: A nationwide, population-based, cohort study in Taiwan

Abstract

BackgroundAfter isotretinoin's approval to treat patients with recalcitrant acne, there have been continued debates around its psychiatric safety profile. This study aimed to assess the risk of psychiatric disorders in patients with acne who are taking isotretinoin. MethodsWe used de-identified information from Taiwan's National Health Insurance Research Database from 2000 to 2015 to examine the risk for psychiatric disorders among patients with acne who were taking isotretinoin. We performed subgroup analyses based on the dosage and duration of isotretinoin administration. ResultsThis study included 29,943 participants during a 16-year follow-up period. We found no significantly increased risk for psychiatric disorders among patients taking isotretinoin compared with patients who did not receive isotretinoin treatment (adjusted hazard ratio [aHR]: 1.009, 95% confidence interval [CI]: 0.422–1.696). Subgroup analyses showed no significantly increased risk for psychiatric disorders in patients taking different doses of isotretinoin (≤ 20 mg per day, aHR: 0.892, 95% CI: 0.371–1.501; > 20 mg per day, aHR: 1.068, 95% CI: 0.446–1.798). There was also no significant increase in risk for patients undergoing isotretinoin treatment over different periods (≤ 6 months, aHR: 0.924, 95% CI: 0.392–1.612; > 6 months, aHR: 1.196, 95% CI: 0.488–2.004). LimitationsWe did not analyze the risk of suicidal ideation, and it could be underestimated in medical claims databases. ConclusionsWe found no increased risk of psychiatric disorders among Taiwanese patients with acne who were taking isotretinoin. Higher dosage or longer duration of isotretinoin treatment did not increase the risk for developing a psychiatric disorder.