American Academy of Dermatology Position Statement on Isotretinoin

The American Academy of Dermatology has released the following updated position statement addressing issues related to a possible link between inflammatory bowel disease and depression and the use of isotretinoin.

The Association is committed to the safe and responsible use of isotretinoin. Isotretinoin is FDA approved for and generally considered by dermatologists to be the most effective treatment for severe recalcitrant nodular acne. The effectiveness of systemic isotretinoin therapy in the treatment of acne has been demonstrated in randomized, double blinded clinical studies. It is known to effectively reduce acne and lead to a reduction in scarring.

The Association recognizes there is sufficient evidence for the use of isotretinoin in severe forms of acne, particularly (but not limited to) severe recalcitrant nodular acne or acne which has proven refractory to other forms of therapy. Assessment of severity includes the impact of the disease on the patient, both physical and psychological.

The Association recognizes that isotretinoin has been used off-label in the treatment of conditions such as disorders of cornification and in chemoprevention of skin cancer in high risk individuals. The Association believes such off-label uses are permitted under the FDA’s “practice of medicine” exception to its drug approval process. Physicians considering the use of isotretinoin in such off-label indications should make the patient aware that off-label usage has not been specifically approved by FDA.

The Association promotes compliance with the manufacturer-sponsored and FDA-approved risk management program for prescribing isotretinoin (iPLEDGE). It 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 Association supports continuing education for physicians, their office staff, allied medical personnel, and patients on the potential risks connected with the use of isotretinoin. In particular, prescribers, patients, pharmacies, and manufacturers must comply with the iPLEDGE risk management program as outlined on the iPLEDGE website to prevent fetal exposure during treatment with isotretinoin.

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 the association or causal relationship exists and/or whether IBD risk may be linked to the presence of severe acne itself.

The Association 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, including IBD or psychiatric disturbance, and educate their patients about these and other potential risks. Physicians also should monitor their patients for any indication of IBD and depressive symptoms.

Source: American Academy of Dermatology