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article imageDrugs used for newborns need more study

By Tim Sandle     Dec 15, 2013 in Health
A new study warns that many medications commonly given to newborns have not been officially approved for use for babies.
A new study warns that children and babies have a unique physiology and will not necessarily respond to drugs the way adults do. Specifically, for newborns (infants who are 28 days or younger), most drug labels are still lacking. This creates a problem because many of the drugs used on babies have not been assessed as suitable.
The highlight this study states: "approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. 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 primary risk is that drug labels often do not have information about the correct dose that should be used in newborns. This means that doctors instead make 'best guesses' based on their experience and information from adults and older children.
In terms of future action, a collaboration called the Pediatric Trials Network is collecting information about drugs already been used off-label in infants to increase researchers' understanding of these drugs.
The new study was led by Dr. Matthew Laughon, an associate professor in the Department of Pediatrics at University of North Carolina at Chapel Hill School of Medicine. The study has been published in the journal JAMA Pediatrics. The paper is titled "Drug Labeling and Exposure in Neonates."
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