Label Changes Made for Accutane
November 4, 2002
The U.S. Food and Drug Administration and Roche have revised the warnings and precautions sections for the acne medication Accutane. Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on post-marketing safety reports. A new table has been attached to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable.
Information specific to pediatric patients advising physicians to use caution when prescribing Accutane to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism has also been added based on the results of recent studies. A statement is now included regarding the long-term use of Accutane advising that the drug be given at the recommended doses for no longer than the recommended duration. Prescribers are advised to exercise caution when systemic corticosteroids or phenytoin are used with Accutane.
-- Article Courtesy of InjuryBoard.com
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