When a Uniquely Effective Drug is Teratogenic

Abstract

Isotretinoin is a uniquely effective oral agent for the treatment of severe cystic acne.¹ Typically a patient uses the medicine for 20 weeks, and in most cases enters a prolonged remission. First marketed in the United States in 1982, isotretinoin had been used by more than 800,000 people by the end of 1987. About 40 percent of these were women.^{2 , 3} The substantial teratogenic effect of retinoic acid in animals has been known for many years. As a result, the package insert for isotretinoin included from the beginning a warning against its use during pregnancy. In spite of this precaution, within . . .