Researchers looking at neonate drug label changes following recent legislation found only 46 percent of neonatal labeling changes indicated the safety and effectiveness of the drug, according to a study published in JAMA Pediatrics.
The Food and Drug Administration Safety and Innovation Act of 2012 reauthorized two pieces of legislation that increase pediatric drug testing and drug labeling, the Best Pharmaceuticals for Children Act and the Pediatric Equity Research Act.
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Researchers looked at pediatric drug studies to see what progress had been made in neonatal studies and neonatal drug labeling as a result of the legislation.
They found 28 drugs studied for neonate use. Label information was updated on 24 of those drugs, but only 46 percent of those label changes identified the drug as being safe for neonate use.
From 1997 to 2010, a total of 406 label changes were made, but only six percent of those changes included any neonatal information at all, including safety, efficacy and dosage.
Researchers say studying drug information for neonates is challenging due to their unique physiology. Additionally, sample sizes are generally very small, partly due to lack of parental consent for studies. The researchers say there needs to be a higher focus on strategies and efforts to safely and effective study drugs for neonates.
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