WASHINGTON The Food and Drug Administration announced that Covance, the developer of the iPLEDGE risk management program has fully implemented the program revisions approved by the FDA on Oct. 3.
The program is designed to reduce the risk of fetal exposure to isotretinoin, or Accutane, a drug used to treat severe recalcitrant nodular acne. Those changes include eliminating the 23-day lockout period, a period when new prescriptions cannot be filled, for females of childbearing potential, with the exception of the first prescription to be filled. Changes to the iPLEDGE program, which were proposed by the FDA, Covance and the manufacturers of isotretinoin, were subsequently endorsed at a joint meeting of the Dermatologic and Ophthalmic Drugs and the Drug Safety and Risk Management Advisory Committees on Aug. 1.
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 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.
Isotretinoin and its generic equivalents are approved by the FDA for the treatment of severe recalcitrant nodular acne. This type of acne does not respond to other drug treatments. The iPLEDGE program was implemented on March 1, 2006, to minimize fetal exposure to the drug while providing a system to closely monitor patients taking the medication and their access to the drug. The monitoring system is further supported by trained prescribers, pharmacists and other health care providers