Accutane (Isotretinoin) Indications
Isotretinoin is indicated for severe recalcitrant nodular acne, and critically, for any acne causing psychosocial burden or active scarring regardless of objective severity, as well as for patients who have failed standard oral and topical therapies. 1, 2, 3
FDA-Approved Indication
- Severe recalcitrant nodular acne is the only FDA-approved indication, defined as "many" inflammatory lesions ≥5 mm in diameter that may become suppurative or hemorrhagic, unresponsive to conventional therapy including systemic antibiotics. 3
Expanded Clinical Indications (AAD Guidelines)
The American Academy of Dermatology significantly broadens the indication criteria beyond the FDA label:
Primary Indications
- Severe acne of any type (not limited to nodular acne). 1, 2
- Any acne causing psychosocial burden should be considered severe acne and qualifies for isotretinoin, even if objectively "moderate" by lesion count. 1, 4, 2
- Any acne with active scarring or high risk of scarring qualifies for isotretinoin regardless of traditional severity grading. 1, 4, 2
- Treatment-resistant acne that has failed standard oral and topical therapies. 1, 2
Specific Clinical Scenarios
- Gram-negative folliculitis presenting as eruptive uniform pustules to nodules in periorificial areas (obtain lesion culture to confirm diagnosis). 2
- Acne fulminans (typically requires concurrent oral corticosteroids). 1, 2
Critical Pitfalls to Avoid
- Do not delay isotretinoin in patients with scarring acne while waiting for them to "fail" multiple therapies first—the presence of scarring itself qualifies them as candidates. 2
- Do not dismiss patients with "moderate" acne who have significant psychosocial impact; these patients should be considered as having severe acne for treatment purposes. 2
- Do not withhold isotretinoin due to concerns about neuropsychiatric conditions or inflammatory bowel disease—population-based studies have not identified increased risk. 1, 4, 2
Dosing Considerations
- Standard dosing: 0.5-1 mg/kg/day divided into two doses with food for 15-20 weeks. 4, 3
- Moderate acne: 0.3-0.5 mg/kg/day. 4
- Daily dosing is preferred over intermittent dosing for optimal outcomes. 1, 4
Absolute Contraindications
- Pregnancy (isotretinoin causes life-threatening birth defects). 4, 3
- Breastfeeding. 4
- Hypersensitivity to isotretinoin or vitamin A. 4
Mandatory Requirements for Persons of Childbearing Potential
- Two forms of effective contraception must be used simultaneously starting 4 weeks before therapy, throughout treatment, and continuing for 3 years after discontinuation. 4
- Pregnancy testing required within 2 weeks prior to starting and monthly during treatment. 4
- Avoid alcohol completely as it converts isotretinoin to etretinate, which has a significantly longer elimination half-life. 4