FDA

FDA mandates new labeling on ADHD stimulants to warn of weight loss risk in children under 6

July 1, 2025

FDA announced a labeling update for all extended-release stimulant medications used to treat ADHD, including amphetamine and methylphenidate formulations. Although these medications aren't approved for children under 6, they are frequently prescribed off label in this age group. FDA’s review of clinical trial data revealed that younger children experience higher plasma drug levels and a significantly greater risk of adverse effects—particularly clinically meaningful weight loss—compared with older children receiving the same dosage.

To address these concerns, FDA is requiring manufacturers to include a “Limitation of Use” section in the prescribing information for all extended-release stimulants, explicitly warning about the elevated risks in patients under 6. This move aims to harmonize safety messaging across the drug class and ensure that clinicians are fully informed when considering treatment options for very young children with ADHD. The agency also encourages clinicians and caregivers to consider alternative therapies, including immediate-release stimulants, which may offer more flexible dosing and potentially lower risk profiles in this population.

Source:

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