Few Legislation-Tied Drug Label Changes Include Neonates
Twenty-eight drugs studied in neonates and 24 related labeling changes identified
WEDNESDAY, Dec. 11, 2013 (HealthDay News) -- Few federal legislation-linked drug labeling changes relate to neonates, and most of the drugs studied are not used or are rarely used, according to a study published online Dec. 9 in JAMA Pediatrics.
Noting that recent federal legislation has led to an increase in pediatric studies submitted to the U.S. Food and Drug Administration, resulting in product labeling with new pediatric information, Matthew M. Laughon, M.D., M.P.H., from the University of North Carolina at Chapel Hill, and colleagues quantified progress made in neonatal studies and neonatal information in product labeling. Using information from the FDA website, a cohort of drug studies were identified from 1997 to 2010 that included neonates; use of these drugs was assessed in a cohort of 446,335 neonates admitted to 290 U.S. neonatal intensive care units (NICUs) from 2005 to 2010.
The researchers identified 28 drugs studied in neonates and 24 related labeling changes on review of FDA databases. The 28 drugs were encompassed in 41 studies, 31 of which were published. Safety and effectiveness were established in 46 percent of the labeling changes. In the cohort of hospitalized neonates, 399 drugs were used and 1,525,739 drug exposures occurred in the first 28 postnatal days. Of the 28 drugs studied in neonates, 46 percent were not used in NICUs and 29 percent were used in fewer than 60 neonates. Ranitidine was the drug most often used (15,627 neonates; 35 exposures per 1,000 admissions).
"Strategies to increase the study of safe and effective drugs for neonates are needed," the authors write.
Two authors disclosed financial ties to the pharmaceutical industry for neonatal and pediatric drug development.