USA. The US FDA has approved a strengthened isotretinoin (Accutane and generics) risk management programme (iPLEDGE) in an effort to prevent use of the drug during pregnancy; the agency warns that exposure to isotretinoin during pregnancy may significantly increase the risk of congenital disorders.

According to the FDA, isotretinoin sponsors will be implementing a programme in which prescribers, pharmacies, wholesalers and patients, who agree to accept specific responsibilities, will be required to register in iPLEDGE before receiving authorization to prescribe, dispense, distribute or obtain isotretinoin; the responsibilities are designed to reduce the risk of exposure to isotretinoin during pregnancy.

From 1 November 2005, only iPLEDGE-registered wholesalers will be able to obtain isotretinoin from the manufacturers and only iPLEDGE-registered pharmacies will be able to receive isotretinoin from registered wholesalers. From 31 December 2005, pharmacies will be required to receive iPLEDGE authorization before dispensing an isotretinoin prescription, and only prescriptions from registered prescribers for registered patients will be accepted. Prior to isotretinoin prescription, iPLEDGE prescribers will be responsible for pregnancy counselling of women of childbearing potential, and for obtaining a negative pregnancy test that will be entered into the iPLEDGE system. Using iPLEDGE, isotretinoin sponsors will implement a system for reporting and collecting information on isotretinoin-related serious adverse events, and monitor compliance and pregnancy rates. The FDA has also approved changes to the current isotretinoin warnings, patient information and informed consent document, to help prescribers and patients identify and manage the risks of depression and psychiatric disorders before and after isotretinoin prescription.

References:

1. Public Health Advisory. United States Food and Drug Administration, 12 August 2005 (http://www.fda.gov).

2. Press Release. United States Food and Drug Administration, 12 August 2005 (http://www.fda.gov).