ArticleThe pharmacogenomics journal2017
Health regulatory communications of well-established safety-related pharmacogenomics associations in six developed countries: an evaluation of alignment.
Article in The pharmacogenomics journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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.
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.
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Who cites it
6 citing papers in PubMed.
- Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies.The pharmacogenomics journal · 2024Article
- Genophenotypic Factors and Pharmacogenomics in Adverse Drug Reactions.International journal of molecular sciences · 2021Review
- Pharmacogenetic information in Swiss drug labels - a systematic analysis.The pharmacogenomics journal · 2021Article
- Pharmacogenomics Implementation and Hurdles to Overcome; In the Context of a Developing Country.Iranian journal of pharmaceutical research : IJPR · 2021Article
- Clinical Relevance of CYP2D6 Polymorphisms in Patients of an Austrian Medical Practice: A Family Practice-Based Observational Study.Drugs - real world outcomes · 2020Article
- Applications of pharmacogenomics in regulatory science: a product life cycle review.The pharmacogenomics journal · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recommendations on genetic testing are typically conveyed by drug regulatory authorities through drug labels, which are legal requirements for market authorization of drugs. We conducted a cross-sectional study of drug labels focusing on three crucial aspects of regulatory pharmacogenomics communications: (i) intent; (ii) interpretation in the local context; and (iii) implications of the genetic information. Labels of drugs associated with well-established safety-related genetic markers for adverse drug reactions across six developed countries of United States, Canada, United Kingdom, Australia, New Zealand and Singapore were reviewed. We found differing medical advice for genotype-positive HLA-B*15:02, HLA-A*31:01, UGT1A1*28 and CYP2D6 ultra-rapid metabolisers in breastfeeding women. This raises questions on implications to clinical practice between these countries. Varying ways of presenting at-risk population and allele frequencies also raises question in incorporating such information in drug labels. An international guidance addressing these crucial aspects of regulatory pharmacogenomic communications in drug labels is long overdue.
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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.