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The Food and Drug Administration (FDA) has announced updates to the labeling of all extended-release stimulant medications indicated for attention-deficit/hyperactivity disorder (ADHD) because of a known risk of significant weight loss in children under 6 years of age. Clinically significant weight loss (at least a 10% decrease in the Centers for Disease Control and Prevention weight percentile) was observed in both short- and long-term studies with extended-release stimulants. The revised labeling will apply to extended-release formulations of amphetamines and methylphenidate, which are currently not approved for use in children younger than 6 but may be prescribed off-label. In its announcement, FDA concluded that the potential benefits of extended-release stimulants may not outweigh the risks in this population. Manufacturers will be required to update or revise their product labeling, and providers are asked to monitor the weight of children taking ADHD stimulants.
Large population: According to the FDA, an estimated 7 million (11.4%) U.S. children aged 3 to 17 have been diagnosed with ADHD, with boys (15%) more frequently diagnosed than girls (8%).
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