How often are psychiatric events related to Accutane?

Although the use of isotretinoin (Accutane) has often been associated with psychiatric adverse events, the suicide rate in people taking acne medications may be lower than in the general population, according to a retrospective analysis.

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

In 2009 and 2010, respectively, 8.4 and 5.6 suicides occurred per 100,000 people taking isotretinoin, which was lower than national rates during the same period (11.8 and 12.1 per 100,000 people taking isotretinoin). 100,000), they wrote in JAMA Dermatology.

“Depressive disorders and suicidal tendencies were the most frequently reported adverse events associated with isotretinoin use, but these reports must be viewed in the context of the high rates of depression and suicide in patients with acne.” , wrote Mostaghimi and colleagues. “Our study suggests that the suicide rate in patients taking isotretinoin may be lower than in the general United States population, but more study is needed to assess the suicide rate in this population.”

Although some clinicians recognize isotretinoin as “gold standard” for the treatment of severe acne, the drug was in the media spotlight after numerous cases of depression, suicide and other psychiatric effects were reported in the decade after its approval in 1982.

In response to concerns about the drug’s potential to cause miscarriage, inflammatory bowel disease and psychiatric events, 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 assess its safety.

Although some anecdotal reports of increased rates of depression have persisted, the American Academy of Dermatology backed the drug in 2010, stating that the use of isotretinoin for severe lumpy acne was “appropriate,” as long as doctors were aware of his potential for psychiatric disorders and followed their patients carefully.

Mostaghimi and colleagues pointed out that an increased risk of suicidal ideation in patients with acne has been reported in previous studies, regardless of the processing method.

“The increased risk is likely the result of the psychosocial effect of severe acne, and this psychiatric burden has been shown to be felt in both adolescent and adult patients with acne,” they wrote.

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

A total of 17,829 psychiatric events were reported during this 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 roughly evenly split between males (50.1%) and females (46.9%) – some reports did not specify gender. The average age of those in the reports was 22.1 years.

Although the rates of suicidal ideation and attempted suicide were roughly evenly distributed between genders, the majority of those who died by suicide were males (78.8%), which is consistent with national statistics, have reported. reported the authors. People aged 10 to 19 accounted for a higher proportion of suicides than those in their 20s or 30s (57.7% vs. 37.3% vs. 3.9%, respectively).

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

Finally, although men and women had similar rates of depression (48.1% vs. 49.8%) and anxiety (48.1% vs. 47.5%), more women suffered from diet (68.2%) and more men were diagnosed with attention deficit hyperactivity disorder (66.3%), Mostaghimi and her team reported.

They noted some limitations of the research, such as the fact that certain events like suicides are probably more likely to be reported than anxiety or emotional lability.

  • Elizabeth Hlavinka covers clinical news, articles and investigative articles for MedPage Today. She also produces episodes for the Anamnesis podcast. To pursue

Disclosures

The study was partially funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, and a Pfizer scholarship.

Mostaghimi reported charges from Pfizer outside of the submitted work.




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