Isotretinoin
Isotretinoin is a highly effective drug against severe acne; it can cause birth defects if women become pregnant while taking it. It has been sold by Roche since 1982 and goes under the trade names Accutane, Roaccutane, Accure, Oratane, and Isohexal.
In the U.S. more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion. About 160 babies with birth defects were born. The defects include severe brain and heart defects and mental retardations. Doctors normally require two separate methods of birth control for sexually active women taking Accutane and until one month after terminating the drug.
Other common side effects of the drug include dryness of skin, lips and nose, and nosebleeds. Rare side effects may include depression, possibly leading to suicide attempts. Roche has downplayed the psychiatric side effects, and has received three warning letters from the FDA because of this. Because of the serious side effects, the too liberal prescription of Accutane for non-severe cases of acne has been criticized.
Acne results from an interaction of the normal acne bacteria living on the skin with abnormal oils produced by the patient's skin glands (sebaceous glands). While most other acne drugs are antibiotics combating the acne bacteria, Accutane reduces the amount of oil produced, by reducing the activity and size of the sebaceous glands. The exact mechanism of action remains unknown. Isotretinoin occurs naturally in the body as a metabolic product of vitamin A.
