Oral isotretinoin: The US approach

Abstract

Isotretinoin was initially approved by the US Food and Drug Administration (FDA) in May 1982. The prelaunch enthusiasm driven by key opinion leaders led many dermatologists in the USA to eagerly anticipate the delivery of isotretinoin to local pharmacies. Not only is isotretinoin effective in the narrowly defined approved indication for severe recalcitrant nodular acne, it is also effective in treating more moderate levels of severity, often leading to permanent remissions. Not surprisingly, the numbers of patients exposed to isotretinoin rapidly exceed those predicted by the prevalence of the narrowly defined FDA-approved severe subset of acne patients. Although the most severe subset of acne patients would be predictably mostly males, female patients soon accounted for approximately half of all exposed patients.