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Isotretinoin users do not experience an increased risk of suicide. Instead, they may actually have a lower risk of suicide attempts 2-4 years after treatment, a meta-analysis in has found.

Of the 25 studies included in the analysis, which encompassed 1,625,891 participants, the 1-year absolute risk of completed suicide, suicide attempt, suicide ideation, and self-harm among isotretinoin users was less than 0.5% each, while depression risk was 3.83%. Isotretinoin was not associated with a relative risk for all psychiatric disorders.

The study was led by researchers from Yong Loo Lin School of Medicine at the National University of Singapore and the National Skin Centre and Skin Research Institute, also in Singapore. The following study excerpts were edited for length and clarity.

What was the specific impetus for this meta-analysis?

A potential link between isotretinoin and psychiatric disorders -- including suicide -- has been the subject of considerable debate, with conflicting findings in the literature. While some studies have suggested isotretinoin use may be linked to suicide and psychiatric disorders, others have found no such association. Still, the perceived risk resulted in a for suicide, depression, aggression, and psychosis from the FDA in 2005.

Given the ongoing debate -- and the continued widespread use of isotretinoin -- the meta-analysis sought to provide a comprehensive and up-to-date assessment of the absolute risk, relative risk, and risk factors for suicide and psychiatric disorders among isotretinoin users. The goal was to provide fresh insight into potential risks associated with isotretinoin use and, in turn, to help guide clinical practice in the management of acne vulgaris.

What were the key findings?

The results suggested a low absolute risk and no increased relative risk of suicide and psychiatric disorders among patients taking isotretinoin.

A psychiatric history was associated with an increased risk of suicide attempt and psychiatric disorders among isotretinoin users, while a higher cumulative dose of isotretinoin was associated with a lower risk of suicide attempt.

Further, the meta-analysis showed that 4.57% of isotretinoin users developed a psychiatric disorder over a 1-year period. The 1-year absolute risk of self-harm, suicide ideation, suicide attempt, and completed suicide were each less than 0.5%. The pooled 1-year absolute risk of suicide attempt was 0.14%, which is lower than the 1-year absolute risk of suicide attempts in adolescents reported in separate studies.

Did the research team suggest any underlying potential explanations for the findings?

The relationship among acne, isotretinoin, and psychiatric disorders is complex. Prior studies have provided strong evidence for a direct causal relationship between isotretinoin use and mood changes in rare individuals due to certain biological effects on the central nervous system.

However, isotretinoin may also improve mood in many users as a result of improved acne and self-image. This is consistent with the findings of the current meta-analysis.

What is the bottom-line takeaway for dermatologists?

While the findings are reassuring, clinicians should remain vigilant and provide counseling for rare idiosyncratic mood changes that could increase the risk of suicide.

Although isotretinoin appears to be safe at the population level, a holistic psychodermatologic approach to care is recommended, as is monitoring patients for signs of mental distress during isotretinoin treatment.

Key points

• Isotretinoin does not appear to increase the risk of suicide among users.
• Clinicians should remain vigilant for rare mood changes at the biological level.
• Isotretinoin appears safe and might actually improve well-being as a result of improved acne and self-image.