Acne :: Safe use of isotretinoin – accutane for treating severe acne
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.