FDA revises labeling on extended-release stimulants for ADHD to include weight loss risk

FDA revises labeling on extended-release stimulants for ADHD to include weight loss risk | Image Credit: Contemporary Pediatrics

The FDA is set to revise the labeling for all extended-release stimulants that are indicated to treat attention-deficit/hyperactivity disorder (ADHD), to include warnings about weight loss risk in patients younger than 6 years of age taking these medications, among other adverse reactions.¹

In an announcement via the federal agency's Drug Safety Communication website page, the FDA noted that while extended-release stimulants are not approved for children younger than 6 years of age, health care professionals can prescribe them off label to treat ADHD. The agency stated certain formulations of amphetamine and methylphenidate are included in the label revisions.

"To understand the application of the existing Limitation of Use to all extended-release formulations of amphetamine and methylphenidate, the Agency evaluated differences in PK profiles and exposure-response relationships across pediatric age groups and assessed the short- and long-term effects on weight in children 4 to younger than 6 years of age," the FDA stated on its website.

In an assessment of clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment, the FDA found that patients under 6 years of age have higher plasma exposures and higher rates of adverse events than older children. In the assessment, FDA found clinically significant weight loss of at least a 10% decrease in the CDC's weight percentile, was observed in studies with extended-release stimulants.

"For these reasons, the benefits of extended-release stimulants may not outweigh the risks of these products in patients younger than 6 years with ADHD," the FDA stated.

As a result of these findings, the FDA is requiring a Limitation of Use section in the prescribing information of all extended-release stimulants that includes a statement on "higher plasma exposures and higher rates of adverse reactions in children younger than 6 years," the FDA stated.

According to data published by the CDC in November 2024, approximately 7 million of children in the United States aged 3 to 17 years have been diagnosed with ADHD. Boys are more likely to be diagnosed with the disorder than girls (15% vs 8%).²

The FDA recommends health care professionals monitor the child's growth and development and provide necessary interventions to mitigate weight loss if they are on extended-release formulations for ADHD. The agency noted that providers may consider prescribing other ADHD medications such as immediate-release stimulates or provide data or information on ADHD therapy, according to the announcement.¹

Manufacturers of products that do not already have a Limitation of Use section will be required to add one about weight loss risk. For manufacturers that do have a Limitation of Use section, they will be required to revise labeling to "ensure consistent messaging across extended-release amphetamine and methylphenidate formulations."

References:

1. FDA requires labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD. FDA. Drug Safety Communication. June 30, 2025. Accessed July 1, 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. Data and Statistics on ADHD. Centers for Disease Control and Prevention. Data extracted November 2024. https://www.cdc.gov/adhd/data/index.html