Monitoring Weight Loss in Pediatric Patients Taking Extended-Release Stimulants for ADHD: In Conversation With Stephen Mateka, DO

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CLINICAL CONVERSATIONS

The US Food and Drug Administration (FDA) recently announced its revision of 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.^1,2 Data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment show that 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.Although extended-release stimulants are not approved for children younger than 6 years, clinicians occasionally prescribe them off label to treat ADHD.

In response to this news, Psychiatric Times asked our Child & Adolescent Psychiatry Section Editor a few questions about best practices around prescribing to young patients with ADHD.

Psychiatric Times: Why is this news concerning extended-release stimulants and pediatric weight loss important for practicing child and adolescent clinicians?

Stephen Mateka, DO: It is essential that clinicians treating children and adolescents stay current with the latest evidence and guidelines. The new data significantly shifts the risk-benefit ratio for extended-release psychostimulants in children under 6, requires updates to informed consent discussions, and dosage adjustments due to higher serum levels in this age group.

PT: Do you have any recommendations of how best to monitor weight loss in pediatric patients?

Mateka: Since no weight monitoring guidelines accompany this warning, I recommend using the guidelines for initiation of second-generation antipsychotics. Monitor weight: prior to initiation, monthly for 3 months, and then every 3 months going forward. Monitor as needed if a parent or caregiver raises concern. The pediatrician also needs to be aware of results to track the child’s growth curve.

PT: What alternatives to extended-release stimulants can be considered?

Mateka: If stimulants have shown to help and work best for the child, consider increased dosing frequency of the immediate release formulation. If you are still looking for extended coverage release, the current FDA improved medications are atomoxetine, guanfacine extended-release, clonidine extended-release, and viloxazine.

PT: Thank you!

Dr Mateka is the medical director of psychiatry for Inspira Health and serves as cochair of psychiatry. He is the president of the New Jersey Psychiatric Association (NJPA) and serves on the Inpatient/Partial Hospitalization/Residential Committee and Public Resources Committee for the American Academy of Child and Adolescent Psychiatry (AACAP). Mateka is also psychiatrist adviser for PerformCare, where he works closely with the New Jersey Department of Children and Families and Children’s System of Care.

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. Kuntz L. FDA requires new label warning of weight loss risk in pediatric patients taking extended-release stimulants for ADHD. Psychiatric Times. July 1, 2025. https://www.psychiatrictimes.com/view/fda-requires-new-label-warning-of-weight-loss-risk-in-pediatric-patients-taking-extended-release-stimulants-for-adhd