Reuters (6/30, S K, Singh) reports the FDA said Monday it is “revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about the risk of weight loss and other side effects in patients under six years old.” The agency stated “that it is requiring a ‘limitation of use’ section in the prescribing information of all extended-release stimulants to include a statement on higher rates of adverse reactions in children younger than six years.”
Related Links:
— “US FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6,”Sneha S K , Reuters, June 30, 2025