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Isotretinoin is ‘Not Independently Linked’ to Psychiatric Disorders

— May 4, 2022

Researchers find that this cystic acne treatment does not, by itself, cause adverse psychiatric outcomes.

A new, broad retrospective study published in the British Journal of Dermatology showed isotretinoin (aka, Zenatane, Absorica or Myorisan), a drug used to treat acne outbreaks, was not associated with an increase in incidents of psychiatric disorders compared with oral antibiotics.  Isotretinoin, a retinoid, is commonly prescribed to treat cystic acne which has not responded to other treatment options.  It decreases the skin’s overall production of facial oils.

According to WebMD, “isotretinoin is usually taken twice daily for 15 to 20 weeks, or as directed by [a] doctor.  Directions for most generic forms of isotretinoin state that it should be taken with meals.  However, the FDA has indicated that Absorica may be taken with or without food.”

Neuropsychiatric effects associated with isotretinoin have been reported in the past.  However, “the evidence base…is mixed and inconclusive, and many studies are small,” said Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, Oxford.  Fazel added, “The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne.”

Isotretinoin is 'Not Independently Linked' to Psychiatric Disorders
Photo by Miguel á Padriñán from Pexels

WebMD reports that side effects may include chapped lips, dry mouth, swelling of the eyelids or lips, nosebleeds, upset stomach, or hair thinning, and suggests that patients consult with their treating physician should they experience unpleasant effects.

In the current study, researchers analyzed patients’ electronic health records in the six-year span from 2013 to 2019.  The data, pulled from patients (ages 12 to 27), was inputted into TriNetX and participants were followed up with up to one year after their prescriptions were first picked up.

Those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical treatments (108,367), and those who had not been prescribed any treatment (78,666) were analyzed.  “The primary outcomes were diagnoses of psychiatric disorders (i.e., psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and self-harm).”

Taking a closer look at these outcomes, the research team found that “the odds ratio (OR) for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% CI, 0.74 -0.87) compared with patients on oral antibiotics; 0.94 (95% CI, 0.87 – 1.02) compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97 – 1.16) compared with those without a prescription for anti-acne medicines.”

Thus, the co-authors concluded that isotretinoin “was not independently linked” to neuropsychiatric outcomes “at a population level.”  Furthermore, “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of psychiatric disorders, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics.  Isotretinoin treatment appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne.”

Fazel explained, “The dermatology community has been interested in the impact isotretinoin has on mental health.  I think clinically, they see that people get better on isotretinoin and their mental health improves.”  In other words, when the acne clears following isotretinoin treatment, this has a positive impact on the well-being of patients.


Study Provides New Analysis of Isotretinoin and Risk for Adverse Neuropsychiatric Outcomes

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Isotretinoin and adverse neuropsychiatric outcomes: retrospective cohort study using routine data

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