Asuntos regulatorios farmacéuticos: acceso abierto

Labeling of medicines commonly administered to children and adults

Abstract

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

Obesity is a major public health problem that can impact drug disposition and dosing, particularly in vulnerable pediatric populations. Despite the potentially harmful consequences of inappropriate drug dosing in children with obesity, drug product labels largely fail to include dosing or guidelines specific to this population. The lack of this information results in a higher incidence of adverse events and concerns by treating physicians regarding their ability to provide appropriate care to children with obesity. Using data from the Pediatric Trials Network (PTN) funded by the National Institute of Child Health and Human Development, we explored potential ways to improve drug labeling in children with obesity. To improve health outcomes for children with obesity, carefully designed and executed pharmacokinetic trials and comprehensive pharmacokinetic analysis strategies are needed. Early collaboration with the Food and Drug Administration may be helpful in developing studies and analyses that are most beneficial to child health. This collaboration is particularly important for drugs treating life-threatening diseases, where inclusion of pharmacokinetics and dosing in the drug label is vital. We hope that increasing knowledge about drug dosing in children with obesity will open the door to regulatory guidance based on extrapolation or population-specific pharmacokinetic 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.