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Although previous studies and media reports have highlighted an association between suicidality and depression in patients taking isotretinoin, “our results suggest that other, underappreciated psychiatric adverse events may be linked to its use,” wrote senior author Arash Mostaghimi, M.D., M.P.A., M.P.H., of Brigham and Women’s Hospital, and colleagues. The findings suggest the importance of incorporating regular psychiatric screenings as part of follow-up care of patients taking isotretinoin, they noted.
The researchers analyzed reports of 17,829 psychiatric adverse events with isotretinoin as the primary suspect drug in the FDA’s Adverse Event Reporting System from 1997 through 2017. There were 7,547 reports of depressive disorders (42.3% of all adverse event reports); 2,962 reports of emotional lability, such as mood swings and irritability (16.6%); and 2,412 reports of anxiety disorders (13.5%). Additionally, there were 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide. Among the 13,553 adverse events that reported patient age, more than half occurred in patients aged 10 to 19.
Additional analysis of suicide data from patients enrolled in an isotretinoin risk-management program known as iPLEDGE in 2009 and 2010 revealed rates of completed suicide per 100,000 persons were 8.4 in 2009 and 5.6 in 2010. (iPLEDGE requires patients meet with physicians monthly to confirm medication is being taken correctly.) The authors noted that these rates were lower than the national suicide rates in the general population and in those aged 15 to 24 during those years.
“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions,” the authors wrote. “Mandated monthly visits under the current iPLEDGE infrastructure may provide an opportunity to screen patients for psychiatric conditions and improve patient outcomes.”
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(Image: iStock/Yuri_Arcurs)
