FDA Updates ADHD Medication Labels to Highlight Weight Loss Risks

The U.S. Food and Drug Administration (FDA) has announced a revision to the labeling of all extended-release medications used for treating attention-deficit/hyperactivity disorder (ADHD). This update specifically addresses the potential for weight loss and other adverse effects in young children under 6 years old. While these medications, which include certain formulations of amphetamine and methylphenidate, are not approved for children under 6, healthcare providers sometimes prescribe them off-label for this age group.

Clinical research indicates that children under 6 may experience higher drug concentrations in their system, leading to an increased incidence of side effects, including significant weight loss. As a result, the FDA is requiring a new Limitation of Use statement to be added to the prescribing information of all extended-release stimulant medications. This section will explicitly mention the elevated plasma exposure levels and the higher risk of adverse reactions in this young age group.

Healthcare providers are advised to monitor the growth and development of children using these medications regularly. They should be alert to weight loss and take timely actions to manage or mitigate such effects. Alternatives such as immediate-release stimulants or behavioral therapies may be considered if concerns arise. If parents or caregivers notice unexplained weight loss in a child on an extended-release stimulant, consulting a healthcare professional is recommended to evaluate the ongoing benefits and risks of treatment.

This regulatory change aims to enhance safety measures for young children receiving ADHD treatment and ensure more informed prescribing practices.

Source: https://medicalxpress.com/news/2025-07-fda-adhd-medication-weight-loss.html