Postmarket Drug Safety Information for Patients and Providers > Isotretinoin (marketed as Accutane) Capsule Information

Postmarket Drug Safety Information for Patients and Providers > Isotretinoin (marketed as Accutane) Capsule Information

	The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

Please be advised that the isotretinoin manufacturers have informed FDA that the iPLEDGE REMS Program website will undergo maintenance on March 17 and March 18, 2018.  During this time, their website will be completely unavailable; therefore, no updates can be made to their database, meaning no interactions can take place with their system.  During this time, the iPLEDGE Program Contact Center will be open during their normal hours of operation (9:00 AM to 12:00 midnight ET, Monday through Saturday) to answer general information questions. Specifically, Prescribers will not be able to interact with the iPLEDGE Program, Patients will not be able to complete Patient Monthly Comprehension Questions, and Pharmacies will not be able to obtain a Risk Management Authorization (RMA) number. Prescriber Action: Prescribers and their designees should ensure that any patient whose isotretinoin prescription Risk Management Authorization (i.e., RMA or iPLEDGE authorization) expires March 17 or March 18, 2018 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on March 16, 2018.  The isotretinoin manufacturers anticipate that their system will be available again starting Monday, March 19, and FDA will update this posting accordingly. Patient Action: Any patient whose isotretinoin prescription Risk Management Authorization (i.e., RMA or iPLEDGE authorization) expires during the weekend of March 17-18, 2018 must obtain their prescription before 11:59 p.m. (Eastern) on Friday March 16, 2018.  If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again.  The isotretinoin manufacturers anticipate that the iPLEDGE system will be available again starting Monday, March 19, 2018 and we will update the FDA’s isotretinoin webpage accordingly. Isotretinoin is a retinoid medication used to treat severe recalcitrant nodular acne.  While isotretinoin is beneficial for some patients, there are risks associated with this drug.  Specifically, isotretinoin is highly teratogenic (i.e., causes severe birth defects) and, therefore, is approved for marketing only under a restricted-distribution REMS, called the iPLEDGE Program.  The goals of the iPLEDGE Program are to minimize fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions.