ArticleClinical pharmacology and therapeutics2020
International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.
Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
3 citing papers in PubMed.
- A comparison of the labeling of antineoplastic and supportive medicines in China, Japan, and the US based on the WHO essential medicines list.Frontiers in medicine · 2025Article
- Age-related off-label drug prescribing in pediatric patients in South Korea and consistency of labeling compared to the United States, Europe, and Japan.Clinical and translational science · 2024Article
- Evaluation of off-label medication use and drug safety in a pediatric intensive care unit.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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