Acne drug's iPLEDGE program updated for more flexibility

December 7, 2007

Changes made to isotretinoin iPLEDGE program

The risk management program to reduce the risk of fetal exposure to isotretinoin, iPLEDGE from Covance, has fully implemented program updates approved by the FDA in October. The revision will eliminate the 23-day lockout period when new prescriptions cannot be filled for females of childbearing age, and will thereby reduce interruptions in treatment while maintaining the rigor of the program. Changes to iPLEDGE were endorsed at a joint meeting of the agency's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management Advisory Committees in August 2007. The iPLEDGE program was implemented in March 2006 to minimize fetal exposure to the drug and closely monitor patients and their access to isotretinoin. The new changes can be viewed on-line at