Special Alerts:

[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential. For more information visit the FDA website at: [Web], [Web], [Web] and [Web].

REMS:

FDA approved a REMS for isotretinoin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of isotretinoin and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).