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U.S. Department of Health and Human Services

Safety

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Isotretinoin - Accutane and generic isotretinoin

Audience: Dermatological, other healthcare professionals and patients

[Posted 08/12/2005] FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane. In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin.

[August 12, 2005 - Public Health Advisory - FDA]
[August 12, 2005 - Press Release - FDA]
[August 12, 2005 - Drug Information Page - FDA]
[August 12, 2005 - Healthcare Professional Information Sheet - FDA]
[August 12, 2005 - Label - Roche]