The U.S. Food and Drug Administration (FDA) has announced a significant update to the labeling of all extended-release medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). The change specifically targets the use of these drugs in children younger than six, warning about the risk of weight loss and other adverse reactions.What Is ADHD?ADHD is a common neurodevelopmental disorder that typically begins in childhood. It is characterized by symptoms such as inattention, hyperactivity, and impulsivity that can interfere with a child's development and daily functioning. Treatment usually involves a combination of behavioral therapy and medication, including stimulants like amphetamines and methylphenidate.Labeling Change Reflects Off-Label Prescribing TrendAlthough extended-release stimulants are not approved for use in children under six, the FDA notes that healthcare professionals sometimes prescribe them “off-label” to younger patients. This is typically done in cases where other treatments have failed or when symptoms are especially severe. However, the FDA warns that clinical trials have shown young children process these drugs differently from older children, often resulting in higher concentrations of the medication in the body.These higher drug levels have been associated with an increased likelihood of side effects, including clinically significant weight loss. As a result, the FDA is requiring drug manufacturers to include a new “Limitation of Use” section in the prescribing information for all extended-release stimulant medications.This section will outline the risks specific to children under six, including:Higher plasma concentrations of the drugGreater rates of side effects, including reduced appetite and weight lossThe fact that extended-release formulations are not approved for this age groupMonitoring and Alternative Options RecommendedFor young children already taking extended-release ADHD stimulants, the FDA advises healthcare providers to closely monitor the patient’s growth and development. Pediatricians should regularly chart weight and height to detect early signs of weight loss. If weight loss becomes a concern, alternative treatments should be considered.These may include:Switching to immediate-release stimulants, which may be easier to manage in younger childrenExploring non-medication interventions, such as behavioral therapies and parent training programsReevaluating the overall treatment plan to ensure it aligns with the child’s developmental needs and physical healthWhat Should Parents and Caregivers Do?Parents and caregivers are encouraged to stay alert for signs of weight loss in children taking extended-release stimulants. If any concerning changes in appetite or weight are noticed, it’s essential to consult the child’s pediatrician. The doctor can then weigh the benefits and potential harms of continuing the current medication and discuss safer alternatives if needed.The FDA's move comes as part of its ongoing effort to improve pediatric medication safety and ensure that drug use in children is backed by evidence, especially when used outside of official guidelines.