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What is the iPLEDGE Program for Accutane?
The iPLEDGE Program was initiated in 2005 and encompasses all FDA-approved isotretinoin. The Food and Drug Administration regulates it as part of a U.S. gov. program. The goal of iPLEDGE is to prevent birth defects and ensure proper monitoring and prescribing of isotretinoin. iPLEDGE is a centralized system for physicians, pharmacists, and patients to manage the medication and minimize any potential risks.
Women of childbearing potential who participate in the iPLEDGE program to take Isotretinoin therapy for recalcitrant cystic acne must have two documented negative pregnancy tests before the medication can be prescribed. They must also sign an agreement indicating they will use two forms of contraception or maintain abstinence while taking Isotretinoin. Birth control pills are considered an excellent method of pregnancy prevention while on Accutane. The combination birth control pill is recommended over the mini-pill since it contains estrogen and progesterone. All women must have a monthly negative pregnancy blood test to continue with Isotretinoin.
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