Drug labels often lack infant-specific information, despite U.S. government legislation encouraging drug studies involving children, a new study finds.
The research focused on neonates, who are infants up to 28 days of age. They are at high risk for harmful effects from drugs. The unique ways in which their bodies work makes it difficult to determine how drugs might affect them by analyzing data involving older patients, according to background information in the study.
"The scientific and clinical research community will need to work together with the FDA to conduct essential neonatal studies," said Dr. Matthew Laughon, of the University of North Carolina at Chapel Hill, and colleagues.
The researchers reviewed 28 drug studies that included neonates and were conducted as a result of federal legislation, along with 24 related labeling changes.
The results showed that 11 of the 24 neonatal labeling changes made it clear that the drug was approved for use in neonates.
The investigators also found that 13 of the 28 drugs were not used in neonatal intensive care units and that eight of the drugs were used in fewer than 60 neonates, according to the study published online Dec. 9 in the journal JAMA Pediatrics.
"Because of these challenges of performing clinical trials in infants, few labeling changes have included infant-specific information. Novel trial designs need to be developed and appropriate study end points must be identified and validated," Laughon and colleagues wrote in a journal news release.
"Education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success," they added.
-- Robert Preidt
