- Nearly 18,000 psychiatric adverse events (AEs) were reported to the FDA between 1997 and 2017 by users of isotretinoin (Accutane), with depressive disorders accounting for >40% of complaints.
- Psychiatric AEs were most common among users aged 10-19 years.
Why this matters
- Although no causal relationship was established, the data underscore the need for regular clinical follow-ups among patients who use isotretinoin.
- "Although depressive disorders and suicidality were frequently reported with isotretinoin use, these reports must be considered in the context of elevated rates of depression and suicide among patients with acne at large," the authors write.
- Study of AEs reported with isotretinoin from US FDA’s Adverse Event Reporting System of psychiatric AEs and iPLEDGE program during 1997-2017.
- Funding: None disclosed.
- 17,829 psychiatric AEs with isotretinoin were reported to the FDA; most commonly:
- Depressive disorders (42.3%).
- Emotional lability (16.6%).
- Anxiety disorders (13.5%).
- Suicidal ideation (12.8%).
- The proportion of psychiatric AEs was highest among patients aged 10-19 years (52.5%), followed by those aged 20-29 years (30.6%).
- Rates of anxiety and depression were similar between males and females.
- 68.2% of eating disorders occurred in females, whereas 66.3% of ADHD cases and 78.8% of completed suicides occurred in males.
- Retrospective design.
Coauthored with Antara Ghosh, PhD