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More data needed on link between isotretinoin, psychiatric events

Depressive disorders and suicidal ideation accounted for 55.1% of all reported psychiatric adverse events among patients taking isotretinoin from 1997 to 2017, according to researchers in JAMA Dermatology. However, the rate of completed suicide among these patients may be not be higher than those reported in the general U.S. population.

“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,” Priyank Sharma, MD, of the department of dermatology at Brigham and Women’s Hospital, Harvard Medical School, and colleagues wrote.

In a retrospective review of data from the FDA Adverse Event Reporting System database, researchers found high rates of emotional lability, anxiety disorders, insomnia, self-injurious behavior and psychotic disorders reported with isotretinoin as the primary suspect drug, they wrote.

Of 17,829 total psychiatric adverse events with isotretinoin, the most commonly reported were depressive disorders (42.3%), emotional lability (16.6%) and anxiety disorders (13.5%).

Depression and anxiety were reported equally in men and women. However, eating disorders were more prevalent in women (68.2%), whereas ADHD was more often reported in men (66.3%).

Patients aged 10 to 19 years accounted for 52.5% of the total psychiatric adverse events and those aged 20 to 29 years accounted for 30.6% of adverse events.

The researchers also utilized data from the iPLEDGE program, which was launched by the FDA in 2006 as a risk management system geared towards eliminating the risk of fetal exposure to isotretinoin.

The researchers identified 602 reports of attempted suicide and 368 reports of completed suicide. The reported rates of completed suicide per 100,000 persons enrolled in iPLEDGE in 2009 and 2010 were 8.4 and 5.6, respectively, which are lower than the national suicide rates in the U.S. for those years in both the general population and in those aged 15 to 24 years.

The iPLEDGE program requires male and female patients who begin isotretinoin therapy to first register with iPLEDGE. Females must have two negative pregnancy tests and agree to use two forms of birth control before they receive the prescription and must visit their physician monthly to confirm negative pregnancy testing. Males and females who are not of childbearing age must visit their physician monthly to confirm they are properly using the medication, according to the researchers.

In addition to its current use, Sharma and colleagues propose using the iPLEDGE system as an opportunity for mental health screening in this patient population.

The adverse events may represent symptoms of other psychiatric disorders and the direct link to isotretinoin therapy is unclear and needs further inquiry, according to the researchers.

“Although the iPLEDGE system was designed to reduce exposure to isotretinoin, the required monthly visits for all patients under this system create an ideal opportunity for mental health screening in this population,” Sharma and colleagues wrote. – by Abigail Sutton

Disclosures: Singer reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.