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While use of isotretinoin (Accutane) has frequently been linked with psychiatric adverse events, the rate of completed suicides among those taking the acne medication may be lower than in the general population, a retrospective analysis found.

Over the past two decades, nearly 18,000 cases of depression, anxiety, and emotional lability linked to isotretinoin use were reported to the FDA, including 2,278 cases of suicidal ideation, 602 cases of attempted suicide, and 368 reports of completed suicide, reported Arash Mostaghimi, MD, MPA, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

In 2009 and 2010, respectively, 8.4 and 5.6 suicides occurred for every 100,000 individuals taking isotretinoin, which was lower than national rates across the same time period (11.8 and 12.1 per 100,000), they wrote in .

"Depressive disorders and suicidality were the most frequently reported adverse events associated with isotretinoin use, but these reports must be considered in the context of elevated rates of depression and suicide among patients with acne," Mostaghimi and colleagues wrote. "Our study suggests that the rate of completed suicide in patients taking isotretinoin may be lower than that of the general U.S. population, but further study is necessary to assess the rate of completed suicide in this population."

Although some clinicians recognize isotretinoin as the , the drug came under the media spotlight after numerous cases of depression, suicide, and other psychiatric affects were reported in the decade following its approval in 1982.

In response to concerns about the drug's potential to cause , the FDA added a warning to its labeling in 1998 detailing the increased risks associated with the drug and in 2000, a congressional hearing was held to evaluate its safety.

Although some anecdotal reports of increased rates of depression persisted, the American Academy of Dermatology backed the drug in 2010, stating that the use of isotretinoin for severe nodular acne was "appropriate," as long as physicians were aware of its potential for psychiatric disturbance and monitored their patients carefully.

Mostaghimi and colleagues emphasized that an increased risk of suicidal ideation in patients with acne has been reported in , irrespective of treatment method.

"The increased risk is likely a result of the psychosocial effect of severe acne, and it has been shown that this psychiatric burden is experienced in both adolescent and adult patients with acne," they wrote.

For their study, the researchers used the FDA's and , a risk management system launched by the agency in 2006 specifically for women of childbearing age due to the risk of birth defects if isotretinoin is taken during pregnancy. They searched for all reported psychiatric events from 1997 to 2017 that were suspected to be related to isotretinoin.

In total, 17,829 psychiatric events were reported across this time period, of which 42.3% were depressive disorders, 13.5% were anxiety disorders, and 16.6% were classified as emotional lability. The distribution of events was split roughly evenly between males (50.1%) and females (46.9%) -- some reports did not specify sex. Mean age of those in the reports was 22.1 years.

Although suicide ideation and attempt rates were split about evenly between sexes, the majority of individuals to die from suicide were men (78.8%), which is consistent with national statistics, the authors reported. Those ages 10 to 19 accounted for a larger proportion of suicides than individuals in their 20s or 30s (57.7% vs 37.3% vs 3.9%, respectively).

In fact, the majority of psychiatric events overall occurred in teenagers, which could indicate that this group is "particularly vulnerable to psychiatric adverse events while taking isotretinoin," or simply that they are more frequently prescribed it, the authors noted.

Lastly, although males and females had similar rates of depression (48.1% vs 49.8%) and anxiety (48.1% vs 47.5%), more females experienced eating disorders (68.2%) and more males were diagnosed with attention-deficit hyperactivity disorder (66.3%), Mostaghimi and his team reported.

They noted certain limitations of the research, such as the fact that certain events like suicides likely have a higher chance of being reported than anxiety or emotional lability.

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