FDA Requires New Label Warning of Weight Loss Risk in Pediatric Patients Taking Extended-Release Stimulants for ADHD
Psychiatric Times
JULY 1, 2025
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.
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