The U.S. Food and Drug Administration announced Monday it will require revised labeling for all extended-release stimulants used to treat attention-deficit hyperactivity disorder, adding specific warnings about weight loss and other adverse effects in patients younger than six years old.
The regulatory action mandates a "limitation of use" section in prescribing information for all extended-release stimulants, highlighting higher rates of adverse reactions in children under six compared to older pediatric patients.
Clinical Evidence Drives Safety Update
The FDA's decision stems from its assessment of clinical trial data examining extended-release formulations of amphetamine and methylphenidate for ADHD treatment. The analysis revealed that patients younger than six years demonstrate higher drug concentrations in their bodies and experience increased rates of side effects compared to older children.
"For these reasons, the benefits of extended-release stimulants may not outweigh the risks in patients younger than six years," the FDA stated.
Off-Label Prescribing Practices
While extended-release stimulants lack FDA approval for children under six, healthcare professionals can prescribe these medications "off label" to treat ADHD in this age group. The new labeling requirements aim to ensure prescribers have comprehensive safety information when considering treatment options for younger patients.
Extended-release stimulants are available in various dosage forms, including tablets, capsules, and liquid suspensions, and serve as primary initial therapy for ADHD treatment.
Market Impact and Industry Response
The labeling changes affect stimulants sold under various brand names, including Ritalin manufactured by Novartis and Concerta from Johnson & Johnson's Janssen unit. However, a Johnson & Johnson spokesperson confirmed that the new FDA requirement does not apply to Concerta.
These stimulant medications work by increasing brain levels of dopamine and norepinephrine, neurotransmitters associated with motivation, attention, and impulse control.
Clinical Context and Patient Population
ADHD affects approximately seven million children in the United States between ages three and 17, according to FDA data. The disorder impacts patients' ability to pay attention, follow directions, and complete tasks.
The American Psychiatric Association acknowledged the regulatory update, stating: "Stimulants are a proven treatment for children and adolescents with ADHD... As with any medications, parents need to weigh the risks and benefits for their child."
The FDA has approved two medication categories for ADHD symptom management: stimulants and non-stimulants, with stimulants being commonly prescribed by healthcare professionals for their established efficacy in treating the condition.
