A statistical analysis revealed in increased risk for suicide among patients taking Accutane/Isotretinoin for acne. It was discovered that 199 cases reported between 2004 and 2017 cited Isotretinoin as the primary suspect in self-inflicted death:
Background: Isotretinoin (ISO) is a synthetic oral retinoid used mainly for the treatment of nodulocystic acne and some other dermatologic disorders. There have been reports of increased suicidal behavior with ISO, however there is no conclusive evidence supporting this.
Objective: Examine the FAERS database (January 2004 to March 2017; total count of individual safety reports [ISRs] 9,215,422) for all adverse event reports of completed suicide (CS) when ISO was used to treat acne.Methods: Medical Dictionary for Regulatory Activities (MedDRA) preferred terms were searched to account for ISRs which specified acne as the indication (MedDRA codes: acne 10000496 and acne cystic 10000503) for which ISO was reported (under all trade and generic names) as the documented primary suspect responsible for the adverse event reaction of CS (10010144). Reporting odds ratios (RORs) with 95% CIs were calculated to assess baseline risk of CS with the use of ISO.
Results: There were 161,541 ISRs where ISO was used for the indication of acne and was listed as the primary suspect. The average age was 21.945 years ± 7.845 years (age data documented for 136,421/161,541 ISRs); there were 50.60% male and 45.00% female (4.40% coded as “unknown”; gender data documented for 154,436 ISRs). Total CS count where ISO was specified as primary suspect (versus CS count where all other acne medications were primary suspect) was 199 (versus 24) (mean age 20.768 ± 4.999 years; 75.38% male for ISO). Evaluation of the risk of CS with ISO used for acne (versus CS with all other acne medications) revealed the following: ROR 2.2872 (95% CI 1.4973-3.4938); z = 3.828; P = .0001. The risk of CS was significantly higher among men versus women (ROR 3.5149, 95% CI 2.4618-5.0183; z = 6.919; P < .001), and higher among the 0-25 years age group versus >25 years age groups (ROR 2.3654, 95% CI 1.4489-3.8618; z = 3.443; P = .0006).
Comment: Our results indicate an increased risk of CS with use of ISO for acne. Interestingly, our analysis further indicates that the risk of CS is greater in male patients and the younger 0-25 years age group, demographic factors that are both associated with an increased risk of CS in general, independent of ISO use. Acne is most common in the 12-24 years age group and nodulocystic acne is more severe in male patients. The overlap of these demographic factors involved in both CS and acne suggests that this could be a confounding factor in the association between ISO and CS.