The American Academy of Dermatology isued an Update to a position paper on Isotretinoin, reiterating the Academy's commitment to the safe and responsible use of isotretinoin.

Isotretinoin, commonly referred to by the original brand name Accutane, is no longer manufactured by Roche, and is sold as generic formulations.


Position Statement on Isotretinoin (download the pdf file here).

(Approved by the Board of Directors December 9, 2000;
Amended by the Board of Directors March 25, 2003, March 11, 2004 and
November 13, 2010)


1. 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. 1 -4

2. 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.1

3. 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.

4. 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


5. 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 web site (www.ipledgeprogram.com) to prevent fetal exposure during
treatment with isotretinoin.1


6. 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. 1 5 6

7. 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. 7, 8 While some recent studies have suggested such a
relationship 9,10, 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.

8. 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.


1. Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC,
Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R. American
Academy of Dermatology. Guidelines of care for acne vulgaris management. J
Am Acad Dermatol 2007 Apr;56(4):651-63.
2. Strauss JS, Rapini RP, Shalita AR et al. Isotretinoin therapy for acne: results of a
multicenter dose-response study. J Am Acad Dermatol 1984; 10: 490-6.
3. Strauss JS, Leyden JJ, Lucky AW et al (2001) Safety of a new micronized
formulation of isotretinoin in patients with severe recalcitrant nodular acne: A
randomized trial comparing micronized isotretinoin with standard isotretinoin. J
Am Acad Dermatol 45:196–207
4. Goulden V, Clark SM, Mcgeown C, Cunliffe WJ (1997) Treatment of acne with
intermittent isotretinoin. Br J Dermatol 137:106–108
5. Hahm BJ, Min SU, Yoon MY, Shin YW, Kim JS, Jung JY, Suh DH. Changes of
psychiatric parameters and their relationships by oral isotretinoin in acne
patients. J Dermatol. 2009 May;36(5):255-61.
6. Kaymak Y, Taner E, Taner Y. Comparison of depression, anxiety and life quality
in acne vulgaris patients who were treated with either isotretinoin or topical
agents. Int J Dermatol. 2009 Jan;48(1):41-6.
7. Bernstein CN, Nugent Z, Longobardi T, Blanchard JF. "Isotretinoin Is Not
Associated with Inflammatory Bowel Disease: A Population-Based Case-Control
Study." Am J Gastroenterol. 2009 Nov;104(11):2774-8.
8. Crockett SD, Gulati A, Sandler RS, Kappelman MD.A causal association
between isotretinoin and inflammatory bowel disease has yet to be established.
Am J Gastroenterol. 2009 Oct; 104(10):2387-93.
9. Reddy D, Siegel CA, Sands BE, Kane S. Possible association between
isotretinoin and inflammatory bowel disease. Am J Gastroenterol.
2006;101:1569–1573
10. Crockett SD, Porter CQ, Martin CF, Sandler RS, Kappelman MD. "Isotretinoin
Use and the Risk of Inflammatory Bowel Disease: A Case-Control Study." Am J
Gastroenterol. 2010 Mar 30 online

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