The US FDA has approved 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, FDA said in a release.
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.
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 programme, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counselling before receiving the drug, FDA release added.