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FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin

The U.S. Food and Drug Administration (FDA) is announcing approval of a strengthened distribution program for isotretinoin, 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 (Accutane and its generics) 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. FDA is approving this program under its regulations, known as Subpart H, that require restrictions on the distribution of a drug to assure safe use.

"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin." said Dr. 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 inform health care providers about iPLEDGE, FDA has issued a Public Health Advisory and revised the Patient and Health Care Provider Information Sheets that detail the tightened restrictions and increased responsibilities under iPLEDGE for prescribing, dispensing, distributing, and obtaining isotretinoin.

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.

A reporting and collection system for serious adverse events associated with the use of istotretinoin has also been implemented. All pregnancy exposures to isotretinoin must be reported immediately to the FDA via the MedWatch 1800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654 or on the iPLEDGE website.

Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE via the internet, beginning August 22, 2005, at or telephone 1-866-495-0654.

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.

Under the program, after October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer. Starting December 31, 2005, all patients and prescribers (doctors) must register and comply with requirements for office visits, counseling, birth control and other responsibilities.

The manufacturers participating in the iPLEDGE program include:

Hoffman-LaRoche manufacturer of Accutane; Genpharm manufacturer of Amnesteem which is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals manufacturer of Sotret; and Barr Laboratories manufacturer of Claravis.

For additional consumer information, visit the following website:

Source: The Food and Drug Administration

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