PTN’s Caffeine, Doxycycline research results in two new FDA label changes

Research conducted by the Pediatric Trials Network (PTN) has led the U.S. Food and Drug Administration (FDA) to update the prescribing information, or drug label, of two medications: Caffeine citrate and Doxycycline.

Newborn baby in incubator

Caffeine citrate is the most commonly used non-antimicrobial medications for premature infants used in the in the newborn intensive care unit. When given to premature infants, caffeine reduces episodes of apnea and bradycardia. In lay terms, premature babies have a central nervous system that is immature, and part of that immaturity is that they forget to breathe. This apnea then leads to slowing of the heart rate and that can be life threatening. However, the label for this medication was missing crucial information about the correct age, dosing, and other information. PTN completed several studies and worked with the FDA to get new, important information into the label.

Doxycycline colorful word on white background with stethoscope

Doxycycline, which was studied as part of PTN POPS, is an antibiotic used to treat some diseases such as Rocky Mountain Spotted Fever and methicillin resistant staph aureus.  This drug has never been well studied in children under 8 years of age. PTN research has led to a label change that now gives pediatricians better information when using this drug to treat children.

“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, an NIH-supported research network conducting trials to improve drug labeling for children. “The network is well-positioned for the next several years to continue to improve the health of children, thanks to legislation that supports pediatric and the quality of our work.”

“With each label change, 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 Kanecia Zimmerman, MD, associate professor of pediatrics at Duke University School of Medicine and Co-PI for the PTN.

To learn more about PTN’s work regarding Caffeine and Doxycycline and associated data, you may access the related Caffeine NICHD Data and Specimen Hub (DASH) and Doxycycline DASH pages.


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