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Drug Labels Still Lack Infant-Specific Information Despite Government Legislation

Filed December 11th, 2013 Laurie

Though U.S. government legislation encouraging drug studies involving neonates exist, drug labels still lack infant-specific information, according to the results of a new study.

For the study, researchers studied neonates, who are infants up to 28 days old. Researchers found that neonates are at high risk for harmful effects from drugs. Researchers determined how drugs might affect neonates by analyzing data involving older patients, but pointed out that the responses seen are not appropriate predictors of how the young infants will react due to the unique way in which infant bodies work, according to HealthDay.

Researchers reviewed 28 drug studies that included neonates that were conducted due to federal legislation, as well as 24 related labeling changes. They found that the verbiage of 11 of the 24 labeling changes specified that the drug was approved for use in neonates, HealthDay reported. Researchers also found that of the 28 drugs they analyzed, 13 were not used in neonatal intensive care units (NICU), and that eight of the drugs were used in fewer than 60 neonates, according to HealthDay.

“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,” Dr. Matthew Laughon, of the University of North Carolina at Chapel Hill, and his colleagues wrote online in the December 9 issue of JAMA Pediatrics.

“Education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success,” they added.

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