The Food and Drug Administration has forced Roche Pharmaceuticals to update their Accutane label numerous times. Due to birth defects and other serious side effects, Accutane has been before the FDA over twenty times. Despite the increase in warnings, birth defects remain one of the most startling side effects of Accutane. Roche's current label reads- CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by women who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining, after Accutane exposure, which fetus has been affected and which fetus has not been affected.

Major fetal abnormalities associated with Accutane use in women have been reported. There is an increased risk of premature births and spontaneous abortion (miscarriage).

Documented physical abnormalities include: skull, ear, and eye abnormalities, facial deformities, and cleft palate.

Documented internal abnormalities include: Central nervous system abnormalities (including cerebral abnormalities, cerebella malformation, hydrocephalus, cranial nerve deficit); cardiovascular and gland abnormalities.

In particular cases death has been a result of some of the previously mentioned abnormalities.

Cases of IQ scores below the legal cutoff for mental retardation whether the child did or did not have evident CNS abnormalities have also occurred.