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US FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
- The FDA announced on July 4, 2025, it will revise labeling of all extended-release stimulants treating ADHD to warn about weight loss risks in children under 6 years old.
- The revision follows evidence that children younger than six have higher drug levels and more adverse effects, though the medications are not approved for this age group but may be prescribed off-label.
- The updated label will include a "limitation of use" section that addresses the increased risk of significant reductions in body weight and additional adverse reactions identified in both short-term and long-term clinical studies.
- Research indicated a minimum 10% reduction in CDC weight percentile among affected children, and the FDA cautioned that, for patients under six years old, the potential harms of extended-release stimulants could exceed their therapeutic advantages.
- This action aims to ensure clinicians monitor weight closely in young patients and may influence prescribing practices for millions of US children diagnosed with ADHD.
60 Articles
60 Articles
FDA Will Now Require Labeling of ADHD Medication to Indicate Weight Loss Risk
WEDNESDAY, July 2, 2025 (HealthDay News) -- The U.S. Food and Drug Administration is revising the labeling of all extended-release attention-deficit/hyperactivity disorder (ADHD) medications, including certain formulations of amphetamine and methylphenidate, to warn about the medication's risk for weight loss…
MedPage Today
Bioethics.comSome ADHD Meds Can Cause Significant Weight Loss in Young Kids, FDA Warns
(MedPage Today) -- A new warning will be added to the label of certain attention deficit-hyperactivity disorder (ADHD) medications over the risk of "significant" weight-loss in young children, the FDA said. Labels of all extended-release stimulants...
More than meds: why easier access to ADHD treatment has to be part of a whole-system approach
Thom Leach/Getty ImagesNew Zealanders with attention-deficit hyperactivity disorder (ADHD) will now have easier access to diagnosis and medication after the government changed prescribing rules. But there is still so much we don’t know about ADHD in Aotearoa. And while these changes will help many, easier access to medication alone won’t fill the gaps in other supports people with ADHD need to live well. From February 2026 trained GPS and nurse …
FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
The Food and Drug Administration 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 6 years old.
US FDA to revise label of ADHD stimulants to add weight loss risk in patients younger than 6
The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants to treat attention-deficit hyperactivity disorder (ADHD) to warn about the risk of weight loss and other side effects in patients younger than six years.
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