December 25, 2013
Little Progress Made in Labeling Drugs for Neonates

Chapel Hill, NC—Despite federal legislation promoting the study of pharmaceuticals in pediatric patients, drug labels still have a dearth of information on appropriate prescribing in new infants.

That’s according to a new study led by researchers from the University of North Carolina at Chapel Hill.

The report, published recently in JAMA Pediatrics, points out that neonates—up to 28-days-old—are at high risk of drug-related adverse events, but that their unique physiology makes it hard to extrapolate data on drugs even from older infants.

The problem, according to the study background, is that few drug trials occur in infants that small.

“Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end-point development is lagging and studies are more challenging,” the authors write.

For the article, researchers reviewed drug studies that included neonates from 1997 to 2010 to assess the types of drug labeling changes, if any, that followed legislation.

Of the 24 labeling changes occurring as a result of 28 drug studies used in neonates, only 11—46%—made clear that the drug was approved for use in neonates based on safety and effectiveness studies.

Researchers also found that 13, 46%, of the studied drugs were not used in neonatal intensive care units and that another eight, 39%, were rarely used, i.e., used in fewer than 60 newborns.

“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 study concludes.

The authors add that “education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success. The scientific and clinical research community will need to work together with the FDA to conduct essential neonatal studies.”

U.S. Pharmacist Social Connect