Roche Laboratories and the U.S. Food and Drug Administration (FDA) have extensively revised the safety labeling for isotretinoin (Accutane). The acne drug’s labeling has changed regarding warnings for psychiatric disorders, warnings for pediatric patients, and a new table to clarify when pregnancy tests and Accutane Qualification stickers are needed.
In a letter to Accutane prescibers, Roche details the additions to the labeling. Under the heading Warnings: Psychiatric, “aggressive and/or violent behaviors have been added to the list of events that Accutane may cause.”
For pediatric patients with a family history of age-related osteoporosis or a personal history of bone metabolism disorders, prescribers are warned to be cautious when prescribing Accutane. In addition, pediatric patients who receive Accutane and participate in repetitive-impact sports may be at risk of fracture, spondylolisthesis with and without pars fractures, and hip growth plate injuries.
The new labeling also notes that “29% of pediatric patients treated with Accutane in the studies developed back pain and 22% experienced arthralgias.”
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