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Drug labeling and exposure in neonates
Matthew M Laughon1, Debbie Avant2, Nidhi Tripathi3
1Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill.
JAMA Pediatrics
|December 11, 2013
Summary
Pediatric legislation increased drug studies, but neonatal drug information remains scarce. Most studied drugs are rarely used in neonatal intensive care units (NICUs), highlighting a need for better neonatal drug research strategies.
Area of Science:
- Neonatal pharmacology
- Pediatric drug development
- Regulatory science
Background:
- Federal legislation has spurred pediatric drug studies, improving product labeling.
- Despite progress, about 50% of drug labels lack adequate pediatric information.
- Neonatal drug labeling is particularly limited due to study challenges and vulnerable populations.
Purpose of the Study:
- To assess the impact of recent legislation on neonatal drug studies.
- To quantify improvements in neonatal drug information within product labeling.
Main Methods:
- Identified neonatal drug studies from 1997-2010 linked to pediatric legislation using FDA data.
- Determined study publication status and resulting labeling changes.
- Analyzed drug usage in a cohort of 446,335 infants admitted to US neonatal intensive care units (NICUs) from 2005-2010.
Main Results:
- 28 drugs were studied in neonates, leading to 24 labeling changes; 46% established safety and efficacy.
- 13 of the 28 studied drugs were not used in NICUs, and 8 were used in fewer than 60 neonates.
- Ranitidine was the most frequently used studied drug in neonates within NICUs.
Conclusions:
- Legislation has yielded limited improvements in neonatal drug labeling.
- Many drugs studied in neonates are infrequently used in clinical practice.
- Novel strategies are required to enhance the study and use of safe, effective neonatal drugs.
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