FDA Approves Changes to iPledge Program
The U.S. Food and Drug Administration has made a number of changes to iPledge, the program instituted to prevent fetal exposure to Accutane (isotretinoin). Isotretinoin is a potent prescription drug intended to treat severe or cystic acne.
Enrollment in iPledge is required for all isotretinoin users, prescribers, and pharmacies that dispense the medication. Patients taking the drug undergo ongoing education, and sign an agreement stating they understand the risks associated with isotretinoin. Women must also submit to regular pregnancy tests and use two forms of birth control while using this medication.
Changes to the iPledge program include the elimination of the 23-day lockout period for women of childbearing potential. Previously, all patients had to fill their prescriptions within 7 days of their doctor's office visit. If this window was missed, women of childbearing potential were required to wait 23 days before obtaining a new prescription. This change will allow women who do not get their prescriptions filled within 7 days to receive a new prescription without having to wait until the next month. The 23-day lockout period for men and women of non-childbearing potential was removed from the program in October 2006.
Other approved changes include the linkage of the 7 day window to the last pregnancy test rather than the last office visit, and an extension of the prescription window from 7 to 30 days for men, and women of non-childbearing potential.
Registration in iPledge became mandatory in March 2006, in an attempt to reduce the number of women who become pregnant while taking isotretinoin. The drug causes severe birth defects in children whose mothers took isotretinoin while pregnant. This risk continues for up to one month after a woman stops using the drug.
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