New study results indicate that many drug labels still lack specific information pertaining to infants, although Congress passed legislation encouraging drug studies that focus on medications used in children.
The research study, published online yesterday in the journal JAMA Pediatrics, focused on neonates—infants up to 28 days of age—who are at high risk for adverse effects from drugs, HealthDay reports. In a background to the study, the authors note that, in the early days of life, infants’ bodies work in very unique ways. Because of this. analysis of data compiled for older patients does not provide a realistic prediction of how those drugs might affect neonates.
The researchers reviewed 28 drug studies that included neonates and were conducted as a result of federal legislation, along with 24 related labeling changes, according to HealthDay. 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. While a number of label changes have resulted from these policies, “approximately 50 percent of drug product labeling has insufficient information on the safety, efficacy, or dosing appropriate for use in children,” the researchers said, according to Family Practice News.
In a news release about the study, Dr. Matthew Laughon, of the University of North Carolina at Chapel Hill and his colleagues wrote, “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.” The authors further noted that in order to increase success, parents and caregivers must be educated about the need for studies of drugs given to neonates, according to HealthDay.