- iPLEDGE Update (10/22/2010): Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (REMS) in accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. FDAAA required the conversion to REMS of those RiskMAPs approved before FDAAA was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing and agreement to use contraception.
- iPLEDGE Update (10/6/2006): 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’s change will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential (FNCBP). 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, a provision designed to prevent potential exposure to the drug during pregnancy. The elimination of the 23 day lock-out period for males and FNCBP will allow these patients the ability to have a new prescription filled immediately after the 7 day window has expired. This change does not affect female patients of child-bearing potential, and the iPLEDGE call center cannot authorize exceptions.
- Frequently Asked Questions on the iPLEDGE Program These FAQs for prescribers, pharmacy, all users, and patients have been provided by Covance, Inc., contractor for the sponsors of isotretinoin. (10/6/2006)
- FDA Letter to the American Academy of Dermatology (PDF - 56KB) (10/6/2006)
- Dear Healthcare Professional Letter (10/6/2006)
- iPLEDGE Update (3/23/2006)
- FDA Statement on iPLEDGE (2/23/2006)
- FDA ALERT (11/2005): Start Dates Have Been Changed for the iPLEDGE Program. FDA approved a strengthened risk management plan for Accutane and generic isotretinoin on August 12, 2005, to make sure females do not become pregnant while taking this medicine. Isotretinoin causes birth defects. This new plan is called iPLEDGE. The iPLEDGE program was originally scheduled to begin on November 1, 2005. To allow more time for registration and activation, the implementation dates of the iPLEDGE program have been revised. The start date by which wholesalers and pharmacies must be registered /activated in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. The starting date to begin patient registration and qualification in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE will be able to prescribe isotretinoin and only patients registered and qualified in iPLEDGE will be able to be dispensed isotretinoin.
- Public Health Advisory (8/12/2005, updated 10/28/2005)
- FDA News (8/12/2005, updated 10/28/2005)
- Questions and Answers (8/12/2005, updated 10/28/2005)
iPledge Program Accutane (isotretinoin) Questions and Answers
8/12/2005, updated 10/28/2005
Public Health Advisory: Strengthened Risk Management Program for Isotretinoin Public Health Advisory[ARCHIVED]
8/12/2005, updated 10/28/2005
iPLEDGE March 2006 Update[ARCHIVED]
FDA Letter to the American Academy of Dermatology(PDF - 56KB)
Frequently Asked Questions on the iPLEDGE Program(PDF - 68KB)
These FAQs for prescribers, pharmacy, all users, and patients have been provided by Covance, Inc., contractor for the sponsors of isotretinoin. (10/6/2006)
iPLEDGE 2007 Update