US EditionUS FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
- The US FDA announced on Monday, 2025-07-03, it is revising labels of all extended-release stimulants for ADHD to warn about weight loss risks in children under 6 years old.
- The label revision follows FDA clinical trial data showing higher drug levels and more adverse effects in children under 6 compared to older children, raising safety concerns.
- Extended-Release stimulant medications, such as those containing amphetamine and methylphenidate, are officially labeled for use in children aged 6 and older, but healthcare providers sometimes prescribe them off-label to younger children.
- The FDA requires a 'limitation of use' section in prescribing information to note higher plasma exposures and higher adverse reaction rates in children under 6, with observed weight loss of at least 10% CDC weight percentile.
- The FDA highlighted that in children under six, the potential risks associated with extended-release stimulant medications could surpass the therapeutic advantages, emphasizing the importance of careful consideration by both parents and healthcare providers.
57 Articles
57 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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