What is the best way to reduce birth defects caused by the acne drug isotretinoin?

Isotretinoin is a very effective treatment for severe acne, a condition which can be physically, emotionally, and socially disabling. But the drug can also cause severe birth defects if it is taken by pregnant women. What is the best way to prevent pregnant women from taking the drug, and to prevent women taking it from getting pregnant?

A debate article in PLoS Medicine considers the pros and cons of a new Internet-based system, called iPLEDGE (www.ipledgeprogram.com), which tries to tries to ensure that the drug is dispensed only when there is documentary proof that the patient is not pregnant and is using two forms of birth control.

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Citation: Abroms L, Maibach E, Lyon-Daniel K, Feldman SR (2006) What is the best approach to reducing birth defects associated with isotretinoin? PLoS Med 3(11): e483.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pmed.0030483

PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-03-11-abroms.pdf

Related image for press use: http://www.plos.org/press/plme-03-11-abroms.jpg

- Caption: The iPLEDGE Logo - iPLEDGE is a "comprehensive program to help you get prepared, plan your treatments, and ensure you don't get pregnant during the course of isotretinoin therapy" (https://www.ipledgeprogram.com/). Figure: Covance Inc.

CONTACTS:

Lorien Abroms
George Washington University
Prevention and Community Health
2175 K St, NW, suite 700
Washington, D.C. 20037 United States of America
+1-301-929-6239
lorien@gwu.edu

Edward Maibach
George Washington University
Prevention & Community Health
2175 K St
Washington, D.C. 20037 United States of America
+1 202-467-2286
emaibach@gwu.edu

Katherine Lyon-Daniel
Centers for Disease Control and Prevention
Center on Birth Defects and Developmental Disabilities
1600 Clifton Road
MS D-25
Atlanta, GA 30333 United States of America
+1 404 639-3286
kdl8@cdc.gov

Steven Feldman
Wake Forest University School of Medicine
Department of Dermatology
Winston-Salem, N.C, United States of America
sfeldman@wfubmc.edu

* * * * * * * * EMBARGO: MONDAY, 20 November, 5 P.M. PST * * * * * * *

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About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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