By Will Boggs MD
NEW YORK—People taking isotretinoin for severe acne commonly experience psychiatric adverse events, according to data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) and the iPLEDGE program.
"We were most surprised by the range of psychiatric concerns reported by patients taking isotretinoin," Dr. Arash Mostaghimi from Brigham and Women's Hospital, Harvard Medical School, in Boston, told Reuters Health by email. "Although depression and suicidal ideation have been reported previously, emotional lability and anxiety have not received as much attention."
Several reports have linked isotretinoin use to depression and suicidality, and its association with fetal abnormalities led to the establishment of the iPLEDGE risk management system that aims to eliminate the risk of fetal exposure to isotretinoin.
Dr. Mostaghimi's team used FAERS and iPLEDGE data to evaluate psychiatric adverse events reported in patients taking isotretinoin from 1997 through 2017.
During this interval, there were 17,829 psychiatric adverse events with isotretinoin as the primary suspect drug.
Depressive disorders accounted for 42.3% of all adverse event reports, emotional lability accounted for 16.6%, and anxiety disorders accounted for 13.5%.
There were also 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide, the researchers report in JAMA Dermatology, online July 3.
Depression and anxiety were reported equally between the sexes, eating disorders were more common in females, and attention-deficit/hyperactivity disorder was more common in males. Males and females were equally represented in reports of suicidal ideation and suicide attempts, but most completed suicides (78.8%) occurred in men.
Just over half of the psychiatric adverse events (52.5%) occurred in 10- to 19-year-olds, 30.6% occurred in people in their 20s, 11.5% occurred in people in their 30s, and 5.4% occurred among those 40 years or older.
The 10- to 19-year-old age group also accounted for 57.7% of completed suicides where age was reported.
Among individuals enrolled in iPLEDGE, the completed suicide rates per 100,000 patients were 8.4 in 2009 and 5.6 in 2010, which were lower than reported national suicide rates in the United States for these years (11.8 and 12.1, respectively, for the general population, and 10.2 and 10.5, respectively, for people aged 15 to 24 years).
"The risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy," the researchers note.
"Physicians prescribing isotretinoin should be aware that patients who take isotretinoin may have significant mental health challenges," Dr. Mostaghimi said. "Whether or not the isotretinoin is, in and of itself, causative is unclear and not addressed in this study. Nonetheless, mandated monthly appointments as currently required by iPLEDGE should be seen as opportunities to evaluate our patients and connect them to resources they need."
"Future efforts should aim to study, in a prospective and randomized fashion, the potential impact of changes in iPLEDGE on identification and reduction of psychiatric morbidities among these patients," he said.
JAMA Dermatol 2019.
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