FDA Strengthens Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane)

The U.S. Food and Drug Administration (FDA) has announced 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. 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 www.ipledgeprogram.com or telephone 1-866-495-0654.