Market Name: Accutane

Generic Name: Isotretinoin

Accutane is an oral treatment for moderate to severe acne. It should only be used for severe, scarring acne or acne present for many years that has not responded completely to antibiotic pills and creams. Studies have shown that the most harmful side effect of Accutane is the possibility of fetal tetragenocity and birth defects.

Because of this risk, Accutane can only be prescribed by health professionals enrolled in the iPledge program, in which they must prove they are not pregnant or planning to become pregnant. A black box warning was added to Accutane’s prescribing information by the FDA in August of 2005.

Black Box Warning Date: August 2005

FDA Link: Accutane