Pediatric Trials Network Research Contributes to Three Recent Drug Label Changes

Data provided to the FDA by the research network has helped to provide a fuller picture for prescribing these medications to pediatric populations.

Data from the Pediatric Trials Network (PTN) recently contributed to label changes for three different drugs, the culmination of months of research pursued by the NIH-supported research network.

Pediatric Trials Network logo

Label changes occur when the U.S. FDA updates the prescribing information for a drug. In all three of these cases, the FDA added prescribing information to be used when treating children. The PTN, for which the DCRI serves as a coordinating center, is focused on conducting trials to improve drug labeling for children.

The three drugs that can now be used safely and effectively when treating children are:

  • Clindamycin. The label now includes dosing guidelines for children with obesity. While Clindamycin is a commonly used pediatric drug, it is important to consider dosing for children with obesity separately because their bodies may absorb and process drugs differently.
  • Caffeine citrate. The label now includes crucial information about age and dosing. Caffeine citrate is the most commonly used non-antimicrobial medication for premature infants used in the newborn intensive care unit. When given to premature infants, caffeine reduces episodes of apnea (forgetting to breathe) and bradycardia (slowing of the heart rate) that can result from an immature nervous system.
  • Doxycycline. This drug has never been well studied in children younger than 8, but thanks to data from a PTN study called PTN POPS, the label now contains better information on how to use this drug in treating young children. Doxycycline is an antibiotic used to treat diseases such as Rocky Mountain Spotted Fever and methicillin resistant staph aureus.

To date, the PTN has contributed to label changes for 15 drugs.

Kanecia Zimmerman, MD, MPH

“With each label change, the PTN is giving pediatricians more of the critical information they need to improve the lives of their patients and give parents more confidence in their children’s care,” said the DCRI’s Kanecia Zimmerman, MD, MPH, associate professor of pediatrics at Duke University School of Medicine and chair of the PTN steering committee.

Daniel Benjamin

“These label changes reflect the flexible and creative approach that everyone working with the PTN has collectively advanced,” said Danny Benjamin, MD, PhD, principal investigator for the PTN and director of DCRI Pediatrics. “The network is well-positioned for the next several years to continue to improve the health of children, thanks to legislation that supports pediatric research and the quality of our work.”