Food and Drug Administration Update for Pediatric Health Care Professionals

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2006;12(5) 

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An FDA expert panel on March 24, 2006 voted against the approval of modafinil for the treatment of children and adolescents with ADHD.[9] Modafinil is currently approved for the treatment of narcolepsy and is sold under the trade name Provigil.® The request from the manufacturer, Cephalon, was supported by recent studies demonstrating the efficacy of modafinil in patients with ADHD.[12,13] While the panel agreed on the efficacy of the treatment, the concern for severe dermatologic reactions, including Stevens Johnson syndrome (SJS), drove the 12-1 vote against approval. One case of SJS was reported during the ADHD clinical trials. The FDA's Adverse Event Reporting System has received another four reports. The panel recommended further clinical trials, enrolling at least 3,000 patients, to demonstrate the drug's safety.

In addition to these changes, on January 18,th the FDA announced a new format for prescribing information. This format is designed to highlight important safety information, making it more useful to prescribers. More information about the Final Rule on the Content and Format of Prescription Drug Labeling, as well as the new drugs and safety alerts, may be found on the FDA CDER website.[1]

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