A new warning will be added to the label of certain attention deficit-hyperactivity disorder (ADHD) medications over the risk of "significant" weight-loss in young children, the FDA said
Labels of all extended-release stimulants indicated for ADHD -- including certain formulations of amphetamine and methylphenidate -- will be revised to carry a "limitation of use" section about higher rates of weight loss, among other adverse events, in patients younger than 6 years.
Manufacturers of extended-release stimulants will be required to add proper labeling about this risk or revise already existing labeling to ensure consistent messaging across the drug class, the agency noted.
Currently, none of these medications are approved for kids under 6 years of age, but they are sometimes prescribed off-label. Typically taken once daily, they come in various dosage forms, including tablets, capsules, transdermal patches, and liquid suspension.
Following an analysis of clinical trial data, the FDA said it found kids under 6 taking these medications have a higher risk for side effects compared with older children taking the same medications and dosages due to higher plasma exposures. Particularly, clinically significant weight loss -- at least a 10% decrease in the CDC's weight percentile -- was seen in both short- and long-term studies of these drugs.
"For these reasons, the benefits of extended-release stimulants may not outweigh the risks of these products in patients younger than 6 years with ADHD," the agency said.
Healthcare professionals should monitor children's growth and development, provide necessary interventions to mitigate weight loss, and consider stopping the medication or changing to immediate-release stimulants or behavioral ADHD therapies if decreases in weight occur, FDA advised.
The agency asked providers to report side effects involving extended-release stimulants or other medicines to MedWatch.
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