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FDA Medwatch Alert: FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger Than 6 Years Taking Extended-Release Stimulants for ADHD

FDA Drug Safety Communication - June 30, 2025 What safety concern is FDA announcing?The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated...

FDA Medwatch Alert: Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine...

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Attention-Deficit Hyperactivity Disorder (ADHD)

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