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

The U.S. Food and Drug Administration (FDA) is revising labeling on all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD), stating that patients younger than 6 years of age taking these medications are at greater risk of weight loss and other side effects compared with older children taking the same medication at the same dosage.

Extended-release stimulants are not approved for use in children younger than 6 years, but health care professionals may prescribe them “off label” to treat ADHD.

We are requiring the Limitation of Use section of the prescribing information of all formulations of extended-release amphetamine and methylphenidate to include a statement about these side effects in children younger than 6 years. Manufacturers of products that do not currently have a Limitation of Use section will be required to add one about this risk. Manufacturers of products that already have a Limitation of Use section will be required to revise their labeling to ensure consistent messaging across extended-release amphetamine and methylphenidate formulations. 

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