Leaving Out the Littlest Patients in Rx Labeling

Medication labeling for newborns lacked sufficient evidence for guiding doctors

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) When medications are approved by the FDA, the process involves identifying age groups who can take the medication. But that means studies are needed for those age groups.

One of the most difficult age groups to study for medication usage includes children — especially newborns.

When there are too few studies available involving the youngest patients, there is less guidance available for administering medications to these young patients.

In the past decade, a variety of laws in the US have been passed to try to improve labeling of medications for children.

A recent study, however, found that few of these changes involved medications for newborns. More studies involving babies are needed, the researchers found.

"Ask the pharmacist to explain your newborn's treatment."

This study, led by Matthew M. Laughon, MD, MPH, of the Department of Pediatrics at the University of North Carolina at Chapel Hill, looked at what changes have occurred in medication product labeling for infants since new laws came into effect.

Dr. Laughon and colleagues conducted their study in several parts. First, they looked for studies involving newborns that had been published between 1997 and 2010 due to new laws related to medication labeling for newborns.

These researchers identified 41 studies (31 that were published) which involved 28 different medications studied in newborns.

Then they specifically looked at what labeling changes were made as a result of these medication studies.

They found 24 medication labeling changes had been made following these studies' results, including 11 changes that related to safety and effectiveness.

Next, the researchers looked at how those specific medications were used between 2005 and 2010 among nearly half a million babies at 290 US neonatal intensive care units (NICUs).

Overall, 399 medications were used for 446,335 hospitalized babies, totaling about 1.5 million exposures to medication in the babies' first month in the NICU.

Nearly half (13 medications) of the 28 medications in the originally identified studies were not used on any newborns in the NICUs.

Another eight medications — just under a third of those identified — were only used in a very small number of newborns (60 babies).

The most commonly used medication in the newborns that showed up in the identified studies was ranitidine, a medication used to treat stomach problems such as reflux.

Of the babies studied, 15,627 were given ranitidine, which worked out to be about 35 out of every 1,000 babies in the NICUs.

Yet only a small percentage of the medications identified in the studies were used for newborns at all.

The researchers therefore concluded that the various laws passed that affected pediatric medication labeling did not involve many medications for newborns.

"Most drugs studied are either not used or rarely used in US NICUs," these researchers wrote. "Strategies to increase the study of safe and effective drugs for neonates are needed."

"It can be a nightmare for parents and caregivers trying to navigate the jungle of medical information (and mis-information)," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky. "Drug-related information obtained on the internet can also be vexing, making treatment decisions even more difficult for parents of newborns or babies."

Carter recommended that consumers speak with their pharmacist.

"Develop a relationship with and work to mine the wealth of information that is available to them from these medication experts," he said. "Pharmacists are easily accessible and are well-equipped to provide the answers to the perplexing questions many parents have when it comes to choosing and administering proper medications to their little ones."

This study was published December 9 in the journal JAMA Pediatrics. The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health and Thrasher Research Fund.

One author has received research funding from Pfizer, Cempra, Diomorph, Aptiv Solutions, GlaxoSmithKline, Janssen Research and Development, Special Products Ltd, Tetraphase Pharmaceuticals and The Medicines Company.

Another has received research funding from Astellas Pharma US, Cubist Pharmaceuticals, Johnson & Johnson, Pfizer, Pangen Biosystems Inc and CV Therapeutics Inc.

The other authors reported no other potential conflicts of interest.

Review Date: 
December 9, 2013
Last Updated:
January 2, 2014