Isotretinoin and iPledge: a view of results

UMMS Affiliation

Department of Medicine, Division of Dermatology

Publication Date


Document Type



Abnormalities, Drug-Induced; Adverse Drug Reaction Reporting Systems; Dermatologic Agents; Female; Humans; Isotretinoin; Pregnancy; Pregnancy Complications; Program Development; Program Evaluation; United States; United States Food and Drug Administration


Dermatology | Maternal and Child Health | Skin and Connective Tissue Diseases | Women's Health


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.

DOI of Published Version



Maloney ME, Stone SP. Isotretinoin and iPledge: a view of results. J Am Acad Dermatol. 2011 Aug;65(2):418-9. doi: 10.1016/j.jaad.2011.04.006.

Journal/Book/Conference Title

Journal of the American Academy of Dermatology

Related Resources

Link to Article in PubMed

PubMed ID