FDA and Manufacturers of Accutane and its Generics to Implement iPLEDGE Program on March 1, 2006

The iPLEDGE program, a strengthened risk management program to educate women about the risk of becoming pregnant while taking isotretinoin (Accutane and its generics), a drug to treat severe recalcitrant nodular acne, will be implemented on March 1, 2006, as planned. This comprehensive program seeks to reduce the risk of inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin.

To date, a large number of prescribers, wholesalers, and pharmacies have registered in the iPLEDGE program in anticipation of the March 1 start date. In addition, over the past few weeks more than 1200 patients per day are registering for the iPLEDGE program.

The iPLEDGE program is a unique risk management program that is unprecedented in size and scope. It has been developed through a cooperative effort of several manufacturers of isotretinoin, a drug that has been marketed for several decades. Isotretinoin is highly effective in the treatment of severe recalcitrant nodular acne, but has known serious side effects, particularly its ability to cause birth defects when pregnant women use the drug, and more recent concerns regarding its potential to be associated with severe depression.

FDA has worked closely with isotretinoin sponsors and their vendor, Covance Inc., to maintain a critical balance between access to the drug by patients who need it and ensuring its safe use. In response to concerns about the operational aspects of the program raised by dermatologists and pharmacists in recent weeks, FDA has ensured that rapid and significant progress has been made by the sponsors and Covance to address them. Specific measures undertaken have included an increase in iPLEDGE call center staffing to handle the expected increases in call volume and user questions in the coming weeks, as well as an enhanced system to process requests for new passwords by users who have forgotten or lost their original passwords.

The iPLEDGE program is aimed at preventing use of the drug during pregnancy. 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 necessary pregnancy testing.

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.

Prescribers and patients who have questions about the iPLEDGE program should contact the iPLEDGE call center at 1-866-495-0654 or on line at https://www.ipledgeprogram.com/

Contact Information

Susan Cruzan

U. S. Food and Drug Administration

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