iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)

The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. It is a “shared system” REMS, meaning that it includes all FDA-approved isotretinoin products. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.

In an effort to provide timely isotretinoin information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on isotretinoin and the iPLEDGE REMS on this page.

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AAD Suggests Halting iPLEDGE Program

A scheduled change to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) has led to a delay in isotretinoin prescriptions. Physicians and their teams have been unable to access the iPLEDGE site during an update to incorporate an FDA-approved modification to the iPLEDGE REMS that took effect

iPLEDGE Must Abstain from Abstinence

Isotretinoin has unmatched efficacy in the treatment of acne. However, because isotretinoin is a teratogen that can cause profound birth defects, the iPLEDGE program regulates the drug’s distribution in the United States. To minimize fetal exposure to isotretinoin, the program requires that female patients capable