ArticleTherapeutic innovation & regulatory science2026
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic Rationale.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Japan, prescription drug labeling has transitioned to a new structured format aimed at improving clarity and consistency, with full implementation in March 2024. Abnormal kidney function, a critical determinant of drug safety, necessitates clear and consistent contraindication labeling. However, current labeling practices have not been comprehensively evaluated.
objectiveTo systematically assess how kidney-related contraindications are described in Japanese package inserts under the new labeling format.
methodsWe reviewed all electronically available prescription drug package inserts as of October 1, 2024. Using 20 kidney-related keywords, we extracted and analyzed statements in Sect. 2 ("Contraindications"), categorizing them into four domains: type of impairment, severity, disease progression, and quantitative criteria. Additionally, a network diagram of co-occurring terms was developed to illustrate the consistency and diversity of terminology.
resultsA total of 233 kidney-related contraindication statements were identified across 182 pharmaceutical ingredients. Type of impairment was mentioned in 81.5%, severity in 54.9%, and quantitative criteria in 38.2%. However, the terminology and threshold values used were inconsistent. Terms such as "severe abnormal kidney function" were used without standardized definitions, and quantitative parameters (e.g., creatinine clearance, estimated glomerular filtration rate) varied across products.
conclusionDespite regulatory efforts to enhance labeling structure, kidney-related contraindication descriptions in Japan remain variable and lack standardization. These inconsistencies may hinder safe prescribing practices and the integration of labeling into clinical decision support systems. Adoption of internationally harmonized terminology, such as KDIGO staging, and clearer regulatory guidance may improve the clinical utility of drug labeling.
Indexed as
Identifiers
40875145What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.