Acne? Or birth defects?

Isotretinoin is a relative of vitamin A. The Food and Drug Administration (FDA) approved the first form of the drug, Accutane, in 1982. Since then it has been widely used to treat nodular acne. Other brands of isotretinoin began to enter the market in 2002. All brands of isotretinoin pose the same risk of birth defects.

Nodular acne causes many red, swollen lumps in the skin and can leave permanent scars. Nodular acne sometimes does not respond to treatments other than isotretinoin. The drug clears the skin of most affected individuals for prolonged periods.

Before isotretinoin was approved by the FDA, testing had shown that it could cause birth defects in animals. The manufacturer of Accutane, Roche Pharmaceuticals (a division of Hoffmann-La Roche, Inc.), warned against its use by pregnant women, but pregnancies resulting in birth defects still occurred. As a result, the FDA and the manufacturers of Accutane and other brands of isotretinoin implemented voluntary risk-management plans to prevent pregnant women from using isotretinoin. These programs were not successful in preventing drug exposure during pregnancy, and in 2005 the FDA started a stronger, mandatory risk management program called iPLEDGE. This program aims to assure that no pregnant woman starts taking isotretinoin, and no woman taking isotretinoin becomes pregnant.

What are the risks of using isotretinoin during pregnancy? There is an extremely high risk of birth defects if a woman takes isotretinoin during pregnancy, even if she takes a small amount of the drug for a short period. Birth defects caused by isotretinoin include:

* Hydrocephaly (enlargement of the fluid-filled spaces in the brain)
* Microcephaly (small head and brain)
* Mental retardation
* Ear and eye abnormalities
* Cleft lip/palate and other facial abnormalities
* Heart defects

Isotretinoin can cause these birth defects in the early weeks after conception when a woman often does not know she is pregnant. Even babies without obvious malformations may have mental retardation or learning disabilities. The drug also increases the risk of miscarriage, premature delivery and infant death.