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U.S. Department of Health and Human Services

Safety

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Accutane (isotretinoin) November 2002

Audience: Dermatologists and other healthcare professionals

FDA and Roche revised the WARNINGS: Psychiatric Disorders, Boxed CONTRAINDICATIONS AND WARNINGS, DOSAGE AND ADMINISTRATION, and PRECAUTIONS: Drug Interactions sections of the prescribing information. Changes in pediatric labeling were made to the CLINICAL PHARMACOLOGY: Special Patient Populations: Pediatric Patients, WARNINGS: Skeletal: Bone Mineral Density, and PRECAUTIONS: Pediatric Use:sections.

Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on post-marketing safety reports. No mechanism of action has been established for these events. A new table has been added to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable. Information specific to pediatric patients has been added based on the results of recent studies conducted in this patient population. A statement has been added regarding the long-term use of Accutane advising that Accutane be given at the recommended doses for no longer than the recommended duration. Prescribers were advised to exercise caution when systemic corticosteroids or phenytoin are used with Accutane.

[September 2002 - Letter - Roche Laboratories]
[June 2002 - Full, Revised Label - Roche Laboratories]