Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
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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 and other adverse reactions in patients younger than 6 years of age.<\/p>\n
Extended-release stimulants are currently not approved for children younger than 6 years, but health care professionals do prescribe them “off label” to treat ADHD.<\/p>\n
Clinical trials have shown that compared with older children, patients younger than 6 years have higher levels of the drug in their bodies and higher rates of side effects. Children younger than 6 years can also suffer clinically significant weight loss.<\/p>\n
The FDA is requiring a Limitation of Use section be added to the prescribing information of all extended-release stimulants. This section will include a statement about the higher plasma exposures and higher rates of adverse reactions observed in children younger than 6 years.<\/p>\n
For children taking an extended-release stimulant, health care providers should regularly chart the patient’s growth and development, be aware that interventions may be needed to address and mitigate any weight loss, and consider prescribing other ADHD medications, such as immediate-release stimulants, or recommend behavioral therapies.<\/p>\n
If parents or caregivers observe weight loss in their child who is taking an extended-release stimulant, they should contact their pediatrician or another health care provider to review the benefits and harms of continuing treatment.<\/p>\n