New label requirement for ADHD stimulants warns of weight-loss risk in young children

The US Food and Drug Administration (FDA) is requiring new labeling of all extended-release stimulants used to treat attention deficit hyperactivity disorder (ADHD). The warnings must be included in the “limitation of use” section of the product labeling and warn of the risk of weight loss and other adverse reactions in patients younger than 6 years.

Although extended-release stimulants are not approved for children under 6 years, healthcare professionals can prescribe them off-label to treat ADHD, according to the FDA.

Labeling now must include a statement about the higher plasma exposures and higher rates of adverse reactions in children younger than 6 years. Manufacturers of extended-release stimulants that currently do not have a limitation of use section in the labeling will be required to add information about this risk.

This action was prompted by data from clinical trials evaluating formulations of amphetamines and methylphenidate. The FDA examined differences in pharmacokinetic (PK) profiles and exposure-response relationships across various pediatric age groups. The assessment focused on the short- and long-term effects of these drugs on weight in children aged 4 years to younger than 6 years.

The analysis revealed that children under the age of 6 years experience higher plasma drug levels and experience more pronounced side effects compared to older children. Notably, a “clinically significant” weight loss was observed in both short-term and long-term studies of extended-release stimulants. FDA said that “for these reasons, the potential benefits of extended-release stimulants may not outweigh the risks for patients under 6 years old with ADHD.” The Centers for Disease Control and Prevention (CDC) defines a decrease of at least 10% of body weight as a significant weight loss.

Healthcare professionals were advised to monitor the child's growth and development and consider stopping the medications or switching to an alternative treatment for patients younger than 6 years who experience weight loss.

FDA estimates that 7 million children, or 11.4% of U.S. children 3-17 years old have been diagnosed with ADHD, with boys more likely to be diagnosed than girls.

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New label requirement for ADHD stimulants warns of weight-loss risk in young children

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