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U.S. Department of Health and Human Services

Drugs

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iPLEDGE 2007 Update

October, 2007

FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne).  Today, FDA approved several changes to the program, including elimination of the 23-day lockout for females of childbearing potential, with the exception of the first prescription to be filled.  In October 2006, the 23-day lockout for males and females of non-childbearing potential was removed.  Previously, all patients prescribed isotretinoin had to fill their prescription within 7 days of their office visit.  Patients who missed this window of opportunity and attempted to fill their prescription after 7 days had elapsed could not receive isotretinoin for another 23 days. 

Other changes to the program that were approved today include linkage of the 7-day prescription window for females of childbearing potential to the date of pregnancy testing rather than the date of the office visit, and extension of the prescription window from 7 days to 30 days for males and females not of childbearing potential.

Changes approved to iPLEDGE were discussed at a joint meeting of the Dermatologic and Ophthalmic Drugs and the Drug Safety and Risk Management Advisory Committees held on August 1, 2007.  The joint committee recommended unanimously to accept the changes proposed.  Additional information can be viewed at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-00-index.htm

FDA believes these changes, due to be implemented by the sponsors in late fall, will enhance the flexibility of the program for users and reduce interruptions in treatment while maintaining the rigor of the iPLEDGE program.    

Questions and Answers on the iPLEDGE update (PDF - 58KB)