Study: Drug Labeling and Exposure in Neonates

From JAMA Pediatrics:

Importance  Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, 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.

Objective  To quantify progress made in neonatal studies and neonatal information in product labeling as a result of recent legislation.

Design, Setting, and Participants  We identified a cohort of drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. We then examined the use of these drugs in a cohort of neonates admitted to 290 neonatal intensive care units (NICUs) (the Pediatrix Data Warehouse) in the United States from 2005 to 2010.

Exposure  Infants exposed to a drug studied in neonates as identified by the FDA website.

Main Outcomes and Measures  Number of drug studies with neonates and rate of exposure per 1000 admissions among infants admitted to an NICU.

I tell friends all the time that they would be shocked and frightened how often we, as pediatricians, are making it up as we go along. This study quantifies some of that with respect to drug use in babies.

Neonates are at special risk for drug problems. They’re so tiny that dosing is difficult. Their livers and kidneys work differently, so they don’t react to drugs the same way. They also can’t report issues themselves. All of this means that we really need to study drugs in infants to know how to use them safely.

This study found 28 drugs that had been researched in neonates in 41 studies. About half these studies weren’t done in the NICU, and premature infants are even more at-risk. Of these 41 studies, though, only 31 had been published.

Hold that in your head as you consider this: in a separate analysis of almost 450,000 hospitalized infants, the researchers identified 399 drugs used in neonates. That means the vast, vast majority of drugs used in the care of neonates have not been studied in neonates.

We need to work on fixing this. Legislation hasn’t done enough.


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