International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs' product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels. Pediatric prescribing information regarding indication, approved age, formulations, and safety was insufficient in Korean drug labels compared with those in the FDA. Most important, the adverse events frequently reported in Korean children were not sufficiently presented in drug labels. In conclusion, this study highlights the urgent need for the Korean regulatory agency to encourage and accelerate research and development to increase the extent of pediatric prescribing information to be added to drug labels to promote appropriate drug prescribing for children.