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Required Registration in iPLEDGE Program to Protect Consumers
Some of the most alarming side effects of Accutane involve use by pregnant women and associated birth defects. According to the Federal Drug Administration (FDA), women who are pregnant or who may become pregnant and women who are breastfeeding should not take the drug. Due to the severity of the potential side effects, the FDA continues to regulate the packaging and distribution of Accutane, even though it is an FDA approved drug.
In 2004, the FDA concluded that the existing Isotretinoin (a synthetic retinoid) risk management program called for some major revisions and improvements. In addition to educational programs and the extended literature included in the packaging, the FDA approved a strengthened risk management program called iPLEDGE. The program is aimed at preventing the use of Accutane during pregnancy.
iPLEDGE is a contract between doctor and patient. Manufacturers of Accutane are currently implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug.
By March 2006, only those doctors and health care providers that are registered in the iPLEDGE program may prescribe Accutane, and only patients who have abided by iPLEDGE's guidelines and who have signed an informed consent form may be prescribed the drug. Isotretinoin may only be dispensed by a pharmacy registered with iPLEDGE, and only wholesalers registered in the program may only make their stock available to those pharmacies.
Additionally, according to iPLEDGE, women who want to take Accutane must undergo two pregnancy tests, both with negative results, before starting the medication. These women may not take Accutane for at least month before they may become pregnant and for at least one month after a pregnancy. Women who are breastfeeding are also at risk for transferring the drug to their infant. While on Accutane, it is advisable that women use two forms of birth control to protect from unwanted pregnancy and from potential exposure to a fetus. Each woman also receives counseling prior to starting a course of Accutane detailing the risks and requirements for safe use of the drug.
Wholesalers and pharmacies must also comply with a separate manufacturers' program that have specific requirements for distributing and dispensing the product. The FDA is in the process of approving this program under the Administration's regulations, known as 21 CFR 314, Subpart H, that require restrictions on the distribution of drugs to assure safe use.
