The 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.
The FDA is 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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