Trends in Adherence to a Revised Risk Management Program Designed to Decrease or Eliminate Isotretinoin-Exposed Pregnancies

Abstract
Isotretinoin (Accutane; Hoffmann-La Roche Inc, Nutley, NJ), first approved in the United States in 1982, is indicated to treat severe, recalcitrant, nodular, cystic acne. This form of acne is painful, permanently disfiguring, and does not respond to other acne treatments. Isotretinoin is uniquely effective for this condition, but its use carries significant potential risks, including birth defects and intrauterine fetal death.