Pregnancy prevention programs for medications used in dermatology

Abstract

Certain drugs used in dermatology carry a high risk of teratogenicity after maternal as well as paternal exposure. The birth of an offspring with impairments or disabilities is an emotionally distressing situation for parents, often resulting in lifelong liability for the family as well as the society. An obligation to prevent such pregnancies exposed to teratogenic agents has resulted in the development of pregnancy prevention programs. United States Food and Drug Administration in cooperation with drug manufacturers has developed a Risk Evaluation and Mitigation Strategies for a biologic or a drug to ensure that its benefit outweighs the risk. These complex but comprehensive programs were established to ensure that fetal exposure to teratogenic agents does not occur by controlling their prescription and usage. This article will review the organization, application and ethical issues raised by the mandatory standardized drug distribution programs for drugs used in dermatology, namely, thalidomide, isotretinoin, and acitretin.