Drug labels often lack infant-specific information, despite US government
legislation encouraging drug studies involving children, a new study finds.
The research focused on neonates, who are infants up to 28 days of age. They
are at high risk for harmful effects from drugs.
The unique ways in which their bodies work makes it difficult to determine
how drugs might affect them by analysing data involving older patients,
according to background information in the study.
Essential neonatal studies
"The scientific and clinical research community will need to work
together with the FDA to conduct essential neonatal studies," said Dr
Matthew Laughon, of the University of North Carolina at Chapel Hill, and
The researchers reviewed 28 drug studies that included neonates and were
conducted as a result of federal legislation, along with 24 related labelling
The results showed that 11 of the 24 neonatal labelling 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, according to the study published online in the journal JAMA
"Because of these challenges of performing clinical trials in infants,
few labelling changes have included infant-specific information. Novel trial
designs need to be developed and appropriate study end points must be
identified and validated," Laughon and colleagues wrote in a journal news
"Education of parents and caregivers regarding the need for studies of
drugs being given to neonates will also increase trial success," they
The US National Library of Medicine has more about children and medicines.