Drug Labeling and Exposure in Neonates
(Ivanhoe Newswire) –A new study at the University of North Carolina at Chapel Hill shows that federal legislation encouraging the study of drugs in pediatric patients has resulted in very few labeling changes that include new infant information.
For the study, researchers reviewed drug studies that included neonates and analyzed the types of drug labeling changes that were made. They reviewed the FDA databases and identified 28 drugs studies in neonates and 24 related labeling changes.
They found 11 (46 percent) of the 24 neonatal labeling changes made clear the drug was approved for use in neonates on the basis of safety and effectiveness. Then, researchers discovered that most of the drugs studied were not used in neonatal intensive care units (NICUs), with 13 (46 percent) of the 28 drugs studied in neonates not used and 8 (29 percent) of the drugs used in fewer than 60 neonates.
For more information, go to: http://media.jamanetwork.com/news-item/study-examines-drug-labeling-exposure-infants/
SOURCE: JAMA Pediatrics, December 2013
Click Here for a free weekly email with Ivanhoe's latest Medical Breakthroughs.