AADA Updates Position on Isotretinoin


The American Academy of Dermatology Association (AADA) recently updated its position statement on the use of isotretinoin. The position continues to state that patient safety is dermatologists’ primary concern and that the AADA is committed to the safe and responsible use of isotretinoin, which is the most effective treatment for severe acne.

“Isotretinoin continues to be considered a critically important drug for treating patients with severe acne who fail other therapies,” said William D. James, MD, FAAD, president of the AADA and its sister organization, the American Academy of Dermatology (AAD). “Isotretinoin offers our patients with severe acne significant, life-changing benefits. Providing this medicine safely is our top priority.”

The updated position states:

A correlation between isotretinoin use and depression/anxiety symptoms has been suggested but an evidence-based causal relationship has not been established. Other studies give evidence that treatment of acne with isotretinoin was accompanied by improvement of both depressive and anxiety symptoms, as well as improved quality of life of patients with acne.

Current evidence is insufficient to prove either an association or a causal relationship between isotretinoin use and inflammatory bowel disease (IBD) in the general population. While some recent studies have suggested such a relationship, further studies are required to conclusively determine if an association or causal relationship exists and/or whether IBD risk may be linked to the presence of severe acne itself.

Compliance should still be maintained with the manufacturer-sponsored and FDA-approved risk management program for prescribing isotretinoin (iPLEDGE). The AADA opposes on-line Internet dispensing, sharing, or use without physician supervision, because these activities do not provide for sufficient patient education about isotretinoin risks and do not require participation in the iPLEDGE program.

The position statement concludes that the prescription of isotretinoin for severe nodular acne continues to be appropriate as long as prescribing physicians are aware of the issues related to isotretinoin use.

“Physicians should to be alert to potential concerns, including IBD or psychiatric disturbance, educate their patients about these and other potential risks, and monitor their patients for any indication of these symptoms,” said Dr. James.

The updated position statement is based on review of the latest evidence regarding isotretinoin and the treatment of severe acne. “The effectiveness of isotretinoin therapy in the treatment of acne has been demonstrated in numerous clinical studies which are referenced in the position statement,” said Stephen P. Stone, MD, FAAD, chair of the AADA’s retinoids task force. “When and if new data become available, additional updates to the position statement will be considered.”

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