Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity


Zimmerman KO, Benjamin Jr. DK, Becker ML, Anand R and Hornik CP

Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early collaboration with the Food and Drug Administration may be helpful in developing studies and analyses that are most beneficial for child health. This collaboration is particularly important for drugs that treat potentially life-threatening diseases, where inclusion of PK and dosing on the drug label is vital. We hope that increasing the body of knowledge on drug dosing in children with obesity will open the door to regulatory guidance based on extrapolation or population-specific PK studies, similar to other currently-recognized special populations. Given the magnitude of the pediatric obesity pandemic, recognition as a special population will offer substantial public health value.


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