Isotretinoin use carries no risk of self-harm

Isotretinoin users do not appear to have an elevated risk of self-harm, with the risk of suicide attempts being lower at 2 to 4 years after treatment, according to the results of a meta-analysis.

Researchers used multiple online databases for randomized trials and observational studies wherein the absolute risk, relative risk, and risk factors for suicide and psychiatric disorders among isotretinoin users were reported.

A total of 25 studies involving 1,625,891 participants were identified and included in the review. All studies, except for one, were included in the meta-analysis. The average age of participants across the studies ranged from 16 to 38 years, and distribution by sex ranged from 0 percent to 100 percent men. Data were pooled using inverse variance-weighted meta-analyses.

The 1-year absolute risk estimates among isotretinoin users were as follows: 0.07 percent (95 percent confidence interval [CI], 0.02–0.31; I²=91 percent; 7 studies, n=786,498) for completed suicide, 0.14 percent (95 percent CI, 0.04–0.49; I²=99 percent; 7 studies, n=885,925) for suicide attempt, 0.47 percent (95 percent CI, 0.07–3.12; I²=100 percent; 5 studies, n=520,773) for suicide ideation, and 0.35 percent (95 percent CI, 0.29–0.42; I²=0 percent; 2 studies, n=32,805) for self-harm.

On the other hand, the 1-year absolute risk of depression was 3.83 percent (95 percent CI, 2.45–5.93; I²=77 percent) in 11 studies.

Compared with nonusers, isotretinoin users were less likely to attempt suicide at 2 years (relative risk [RR], 0.92, 95 percent CI, 0.84–1.00; I²=0 percent), 3 years (RR, 0.86, 95 percent CI, 0.77–0.95; I²=0 percent), and 4 years (RR, 0.85, 95 percent CI, 0.72–1.00; I²=23 percent) following treatment. In addition, there was no association between isotretinoin use and the risk of all psychiatric disorders (RR, 1.08, 95 percent CI, 0.99–1.19; I²=0 percent).

Additional data showed that studies with participants of older age had lower 1-year absolute risk of depression, while those with a higher percentage of male participants had a higher 1-year absolute risk of completed suicide.

Despite the reassuring findings, clinicians should still perform comprehensive mental health assessment and monitoring during isotretinoin therapy, the researchers said.