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Prescription labelling

Prescription labels have little dosing guidance for children with obesity

. The study used search terms related to weight and size to determine the current incorporation of obesity as a covariate in paediatric drug development

Despite the US Congress providing incentives to drug manufacturers to encourage the study of medications in children, few approved drugs include safe dosing information for obese kids, according to researchers from the Children’s National Health System in conjunction with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research.

The study surveyed paediatric medical and clinical pharmacology reviews under the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act of 2012. The study used search terms related to weight and size to determine the current incorporation of obesity as a covariate in paediatric drug development. 

Janelle Vaughns (Credit: Children's National Health System)

The paper, ‘Obesity and Pediatric Drug Development’, published in The Journal of Clinical Pharmacology, noted that of the 89 product labels identified, none provided dosing information related to obesity – and the effect of BMI on drug pharmacokinetics was mentioned in only four labels.

Data from the Centers for Disease Control and Prevention indicate that one in six children and adolescents in the US is obese. Obesity increases the percentage of fat tissue more than it boosts the percentage of lean body mass and enlarges kidney size, factors that impact how the body takes up medicine, where it retains it and how quickly it is excreted.

“We are making progress in expanding the number of medicines with paediatric labelling, but we need to do more concerning providing dosing guidelines for children with obesity,” said Dr Janelle D Vaughns, director of bariatric anaesthesia at Children's National and the lead study author. “Moving forward, regulators, clinicians and the pharmaceutical industry should consider enrolling more obese patients in paediatric clinical trials to facilitate the safe and effective use of the next generation of medicines by obese children and adolescents.”

Study co-authors include Children’s Gastroenterologist Dr Laurie Conklin, and Children’s Division Chief of Clinical Pharmacology Dr Johannes N van den Anker; Dr Ying Long, University of Southern California; Dr Panli Zheng, University of North Carolina at Chapel Hill; Dr Fahim Faruque, University of Maryland; and Drs Dionna Green and Gilbert Burckart, both of the FDA.

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