iPLEDGE, a risk management program to enhance safe use of Isotretinoin for treating severe acne

FDA ( Food and Drug Administration ) has approved a program for Isotretinoin (Accutane and its generics), called iPLEDGE, aimed at preventing use of the drug during pregnancy.
Women who are pregnant or who might become pregnant should not take the drug.
Isotretinoin is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.

The manufacturers are 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.
These measures are designed to guard against pregnancies while using the drug.
Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product.

" This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin." said Steven Galson, Director, FDA's Center for Evaluation and Research. "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of Isotretinoin."

In February 2004, at a joint meeting, FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the existing Isotretinoin risk management programs in effect at that time.

Based upon their review, the joint committee called for major improvements in the restricted distribution program, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug.

To obtain the drug, in addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy testing.

In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing Isotretinoin.

Source: FDA, 2005



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