Multiple Congenital Malformations Associated with Maternal Isotretinoin Therapy

Isotretinoin (Accutane), an oral synthetic vitamin A derivative, introduced in September 1982 by Roche Laboratories has been widely used in the treatment of recalcitrant cystic acne. Although there is extensive information regarding the teratogenic effects of excessive vitamin A in experimental animals,1 there are few data available on its possible effects in humans. We report a case of a preterm infant with microcephaly, microphthalmia, rudimentary pinnae, cardiac anomaly, and hepatocellular derangement born to a mother on isotretinoin therapy. This constellation of abnormalities mimicks the type of malformations seen in the animal models and is strongly suggestive of the teratogenicity of this drug to the human fetus.