MONDAY, Oct. 9 (HealthDay News) -- The U.S Food and Drug Administration and the iPLEDGE program of Conshohocken, Penn., has announced a change to its iPLEDGE risk management program for isotretinoin that will make it easier for some patients to fill repeat prescriptions of the acne treatment. The program, which aims to reduce the risk of fetal exposure to isotretinoin, has eliminated its 23-day lock-out period for males and females of non-childbearing potential.
The change does not affect women of childbearing potential and there have been no changes to prescribing criteria for the drug. The change will enable males and females who are not of childbearing potential to start the qualification process for continuation of treatment after the seven-day window period, rather than having to wait for 23 days.
"This change has no affect on pharmacy requirements. Pharmacists must continue to authorize every isotretinoin prescription using the iPLEDGE system," the FDA statement notes. A further change that will affect the 23-day lock-out period for women of childbearing potential is in the pipeline for roll-out in 2007 and details will be announced at a later date.
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