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iPLEDGE program
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<p>The iPLEDGE program is a program by the <a href="/facts/Food_and_Drug_Administration_(United_States)/rCEnh9WB">U.S. Food and Drug Administration</a> (FDA) intended to manage the risk of birth defects caused by <a href="/facts/Isotretinoin/XBKv4fQJ">isotretinoin</a>, a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin. </p><p>Isotretinoin carries a high risk of causing severe <a href="/facts/Birth_defect/ESfzQhTx">birth defects</a> if taken during <a href="/facts/Pregnancy/vEKYGpep">pregnancy</a> (<i>see <a href="/facts/Isotretinoin/XBKv4fQJ">Teratogenicity of isotretinoin</a></i>) and the goals of the iPLEDGE REMS (<a href="/facts/Risk_evaluation_and_mitigation_strategy/J0Lur99P">risk evaluation and mitigation strategy</a>) program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions. </p><p>The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time called the Isotretinoin Products Manufacturing Group (IPMG) under the direction of the <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a>. The program launched on March 1, 2006, at the beginning of the annual meeting of the <a href="/facts/American_Academy_of_Dermatology/SIgvayfV">American Academy of Dermatology</a>. </p><p>According to a study published in 2011, the program has not significantly reduced exposure of pregnant people to the drug in comparison to the previous SMART program. It has been criticized for being overly complicated and difficult for prescribers, pharmacists and patients to navigate successfully. </p>