US EditionUS FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6
UNITED STATES, JUN 30 – The FDA found children under 6 on extended-release ADHD stimulants may lose 10% or more of their CDC weight percentile and face higher rates of side effects.
- On July 7, 2025, the US FDA announced it is revising labels on all extended-release stimulants for ADHD to warn about weight loss risks in children under six.
- This update follows FDA clinical trial data showing higher drug levels and increased side effects, including significant weight loss, in children younger than six years.
- Extended-Release stimulants are not authorized for use in children under six, yet healthcare providers sometimes prescribe them off-label despite the associated risks.
- The FDA is requiring that all extended-release stimulant labels include a specific warning highlighting that children under six may experience higher medication levels in their blood and increased side effects; parents should carefully consider the potential risks and benefits when these medications are used in young children.
- This label revision aims to improve safety awareness and supports careful prescribing decisions, highlighting the need for vigilant monitoring of young patients on these medications.
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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...
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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