With the introduction of oral isotretinoin 20 years ago, an incredible triumph was achieved in the treatment of acne vulgaris. Much has been learned of the pathogenesis of acne and the mechanism by which isotretinoin affects acne. The teratogenicity of isotretinoin has cast a shadow on this effective drug with recent concern about the regulation of its use. The S.M.A.R.T. program has been implemented to address this concern. Alleged depressive mood effects of isotretinoin have resulted in further controversy. The efficacy of and indications for isotretinoin use are discussed here, with elaboration on the reported side effects. Given its established risks, treatment with isotretinoin may become severely curtailed if caution is not exercised.
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