J&J Concerta Psychiatric Adverse Event Labeling Change Proposed By FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Post-marketing adverse event reports spur the labeling change for Concerta and other methylphenidate ADHD therapies. The agency is also examining adverse event reports for amphetamine ADHD therapies and Lilly's Strattera to determine if there is a similar risk.
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FDA's pediatric committee is hesitant to recommend a labeling change for attention deficit/hyperactivity disorder drugs based on current data. FDA should, however, communicate concerns about psychiatric events to the public, possibly through Drug Watch website.