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# FDA Expands ER-Stimulant Labeling for Weight Loss
- URL: https://www.fdaweb.com/fda-expands-er-stimulant-labeling-for-weight-loss/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159452

FDA says it is revising the labeling of all extended-release stimulants intended to treat attention-deficit/hyperactivity disorder (ADHD), including certain formulations of amphetamine and methylphenidate, to warn about the risk of weight loss and other adverse reactions in patients younger than age six taking the medications. An agency [notice](https://www.fda.gov/safety/medical-product-safety-information/extended-release-stimulants-adhd-fda-drug-safety-communication-fda-requires-expanded-labeling-about?ref=fdaweb.com) says FDA is requiring a Limitation of Use section in the prescribing information that includes a statement about the higher plasma exposure and higher rates of adverse reactions in children younger than six years.

Although extended-release stimulants are not approved for children younger than six years, the notice says, healthcare professionals can prescribe them off-label to treat ADHD.