Accutane

isotretinoin

Accutane is a prescription medication taken for the prevention of severe recalcitrant nodular acne, a disfiguring form of acne that causes multiple inflamed cysts and scarring. It is a synthetic form of Vitamin A manufactured by Roche Pharmaceuticals, and of a class of drugs called retinoids because of their relation to Vitamin A.

Since its debut on the market in 1982, Accutane has been linked to severe depression, suicidal thoughts, and suicidal behavior in patients. It has also been linked to severe brain and heart birth defects in children born to women who were pregnant while taking Accutane. In 2001, responding to intense criticism about the safety of Accutane, the FDA instituted a special voluntary restricted distribution program.

Health warnings for Accutane indicate that women who are or may become pregnant should not use Accutane as the risk for serious birth defects is extremely high while taking Accutane in any amount, even for a short period of time. According to the March of Dimes, women who take Accutane while pregnant put their child at risk for microcephaly, hydrocephaly, heart defects, and other problems.

On December 5, 2007, the United States Food and Drug Administration (FDA) announced changes to ease access to the prescription acne medicine Accutane.