FDA requires expanded labeling about weight loss risk in patients younger than 6 years for extended-release stimulants

Abstract

The Food and Drug Administration (FDA) is revising the labeling 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 reactions (side effects) in patients younger than 6 years taking these medications.