FDA Requires New Label Warning of Weight Loss Risk in Pediatric Patients Taking Extended-Release Stimulants for ADHD

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The US Food and Drug Administration (FDA) today announced it is revising the label of all extended-release stimulants indicated 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 effects in patients younger than 6 years of age.¹ Although extended-release stimulants are not approved for children younger than 6 years, clinicians occasionally prescribe them off label to treat ADHD.

According to analysis of data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment, patients younger than 6 years have higher plasma exposures and higher rates of adverse effects than older children taking the same medication at the same dosage. Notably, investigators observed clinically significant weight loss (at least 10% decrease in the Centers for Disease Control and Prevention weight percentile) in both short- and long-term studies with extended-release stimulants.² As a result, they believe the benefits of extended-release stimulants may not outweigh the risks of these medications in patients with ADHD who are younger than 6 years.

The FDA will require a Limitation of Use section in the prescribing information of all extended-release stimulants that includes a statement about the higher plasma exposures and higher rates of adverse reactions in children younger than 6 years. Manufacturers of extended-release stimulants that currently do not have a Limitation of Use section in the labeling will be required to add one about this risk, and manufacturers that do already have a Limitation of Use section will be required to revise the labeling to ensure consistent messaging.

For psychiatrists and mental health clinicians, the FDA strongly advises watching the weight of pediatric patients taking these medications: “Health care professionals should be aware that extended-release stimulants are not indicated to treat ADHD in children younger than 6 years because these products have a greater risk of weight loss and other adverse reactions than in older children taking the same dose of the same medication,” the FDA advised. “If a child younger than 6 years is taking an extended-release stimulant and experiencing weight loss or other adverse events, consider stopping the medication and/or switching to an alternative treatment (eg, immediate-release stimulant). Health care professionals should monitor the child’s growth and development and provide necessary interventions to mitigate weight loss.”

In order to help the FDA track safety issues with medicines such as this one, they recommend reporting adverse effects from extended-release stimulants or other medicines to the FDA MedWatch program.

This news could impact millions of US children with ADHD. According to a national survey, an estimated 7 million (11.4%) US children aged 3-17 years have ever been diagnosed with ADHD and approximately half of children with ADHD (53.6%) received ADHD medication.³

References

1. FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD. FDA Drug Safety Communication. June 30, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-expanded-labeling-about-weight-loss-risk-patients-younger-6-years-taking-extended

2. CDC Growth Charts. National Center for Health Statistics; Centers for Disease Control and Prevention. September 2024. Accessed July 1, 2025. https://www.cdc.gov/growthcharts/cdc-growth-charts.htm

3. Danielson ML, Claussen AH, Bitsko RH, et al. ADHD prevalence among U.S. children and adolescents in 2022: diagnosis, severity, co-occurring disorders, and treatment. J Clin Child Adolesc Psychol. 2024;53(3):343-360.