Since its approval by the Food and Drug Administration (FDA) in 1982, isotretinoin has positively affected the lives of countless patients. Of course, any pharmaceutical agent has both its desired effect as well as undesirable side effects. The prescription of any given drug for any individual patient depends on the risk-benefit analysis for that patient. The side effect of teratogenicity has naturally moved to the forefront of safety standards for isotretinoin. It is important to remember that fetal exposure is the problem, not pregnancy itself, and all attention and efforts should be focused on preventing such exposure.

In the United States, 4 programs have been developed over time in an effort to prevent fetal exposure. These programs have been evaluated in terms of the numbers of pregnancies that occur, which is used as a proxy for potential fetal exposure. As we discuss the problem of teratogenicity with isotretinoin and the various programs to protect against it, we will use the term “pregnancies” as a representation of fetal exposure.