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February 1997

Potential Subversion of Pregnancy Prevention Program in the Managed Care Setting

Author Affiliations

Director, Division of Dermatologic and Dental Drug Products Center for Drug Evaluation and Research US Food and Drug Administration HFD-540 5600 Fishers Ln Rockville, MD 20857

Arch Dermatol. 1997;133(2):243-244. doi:10.1001/archderm.1997.03890380117023

The article by Brodell1 on micromanaged care in a recent issue of the Archives contained several disconcerting revelations about managed care guidelines that may undermine the safety of a drug frequently prescribed by dermatologists: Accutane (Roche Laboratories, Nutley, NJ) (isotretinoin). Isotretinoin is effective in treating acne, but it is also teratogenic. The manufacturer, in conjunction with the Food and Drug Administration and with input from the Dermatologic Drugs Advisory Committee, implemented a multicomponent program designed to reduce the risk of pregnancy among women prescribed Accutane.2

The Pregnancy Prevention Program is supported by materials distributed to all dermatologists and to those nondermatologists who are recognized prescribers of Accutane.3 The Accutane package insert provides the informational elements on which this program is based. Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed

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