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U.S. Department of Health and Human Services

Safety

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Quillivant XR (Methylphenidate) Extended-release Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Peripheral Vasculopathy, including Raynaud’s phenomenon - Stimulants, including Quillivant XR, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon…