Isotretinoin not associated with increased risk for suicide, psychiatric conditions

Key takeaways:

• Among isotretinoin users, the 1-year pooled absolute risk for depression was 3.83%.
• The absolute risk for completed suicide, suicide attempt, suicide ideation and self-harm were each less than 0.5%.

Isotretinoin is not associated with an increased risk for suicide or psychiatric conditions on a population level, according to a study.

“Despite its efficacy in treating acne, isotretinoin has reportedly been associated with suicide and a range of psychiatric disorders, including depression and anxiety, which has resulted in a black box warning for suicide, depression, aggression, and psychosis issued by the U.S. Food and Drug Administration in 2005,” Nicole Kye Wen Tan, MBBS, of Yoo Long Lin School of Medicine, National University of Singapore, and colleagues wrote.

To clarify the absolute and relative risk as well as the risk factors associated with suicide and psychiatric disorders among isotretinoin users, Tan and colleagues conducted a review, which included 25 studies comprising 1,625,891 participants (average age range, 16 to 38 years).

The 1-year pooled absolute risk for completed suicide was 0.07% (95% CI, 0.02%-0.31%), suicide attempt was 0.14% (95% CI, 0.04%-0.49%), suicide ideation was 0.47% (95% CI, 0.07%-3.12%) and self-harm was 0.35% (95% CI, 0.29%-0.42%).

The 1-year pooled absolute risks for depression and psychiatric disorders were 3.83% (95% CI, 2.45%-5.93%) and 4.57% (95% CI, 1.58%-12.48%), respectively. Also, isotretinoin was not linked with risk for all psychiatric disorders (RR = 1.08; 95% CI, 0.99-1.19).

Patients treated with isotretinoin were less like likely to attempt suicide after 2 years (RR = 0.92 (95% CI, 0.84-1), 3 years (RR = 0.86; 95% CI, 0.77-0.95) and 4 years (RR, 0.85; 95% CI, 0.72-1) following treatment compared with non-isotretinoin users.

During a study-level meta-regression analysis, the authors found that older aged participants experienced lower 1-year absolute risk for depression, with this risk decreasing by a factor of 0.15 (95% CI, –0.03 to –0.28) with each year of age. On the other hand, male patients experienced higher 1-year absolute risk for completed suicide, which increased by a factor of 0.16 (95% CI, 0.01-0.32) for each male sex percentage increase.

“Pooled epidemiological evidence from this meta-analysis, though limited by heterogeneity and imprecision, suggests that there is no increased risk of suicide or psychiatric conditions among isotretinoin users at a population level,” the authors concluded. “In fact, isotretinoin use was associated with a lower risk of suicide attempt at 2 to 4 years following treatment.”