Evidence map›Paper›PMID 25707393›Full record

ReviewThe pharmacogenomics journal2015

Pharmacogenomic information in drug labels: European Medicines Agency perspective.

F Ehmann, L Caneva, K Prasad, M Paulmichl, M Maliepaard, A Llerena, M Ingelman-Sundberg, M Papaluca-Amati

Abstract readReview
PubMed Publisher
In one paragraph

Review in The pharmacogenomics journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Trial
  4. Review
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  6. Review
  7. Article
  8. Article
  9. Article
  10. Allele frequency of genetic variations related to theJournal of diabetes and metabolic disorders · 2024
    Article
  11. Pharmacogenetic DPYD allele variant frequencies: A comprehensive analysis across an ancestrally diverse Iranian population.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Cardiovascular precision medicine - A pharmacogenomic perspective.Cambridge prisms. Precision medicine · 2023
    Review
  17. Article
  18. Article
  19. Article
  20. Review

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

F EhmannEuropean Medicines Agency, Pharmacogenomics Working Party, London, UK.
L CanevaEuropean Medicines Agency, Pharmacogenomics Working Party, London, UK.
K Prasad1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.
M Paulmichl1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Paracelsus Medical University, Salzburg, Austria.
M Maliepaard1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Medicines Evaluation Board, Utrecht, The Netherlands [3] Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
A Llerena1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Extremadura University Hospital, Faculty of Medicine, Clinical Research Center, Badajoz, Spain.
M Ingelman-SundbergDepartment of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
M Papaluca-AmatiEuropean Medicines Agency, Pharmacogenomics Working Party, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacogenomics (PGx) has a growing impact on healthcare and constitutes one of the major pillars of personalised medicine. For the purpose of improved individualised drug treatment, there is an increasing effort to develop drugs suitable for specific subpopulations and to incorporate pharmacogenomic drug labels in existing and novel medicines. Here, we review the pharmacogenomic drug labels of all 517 medicinal products centrally approved in the European Union (EU) since the establishment of the European Medicines Agency in 1995. We identified all pharmacogenomic-related information mentioned in the product labels and classified it according to its main effect and function on drug treatment, that is, metabolism, transport and pharmacodynamics, and according to the place of the respective section of the Summary of Product Characteristics (SmPC). The labels are preferentially present in drugs having antineoplastic properties. We find that the number of drugs with pharmacogenomic labels in EU increases now steadily and that it will be an important task for the future to refine the legislation on how this information should be utilised for improvement of drug therapy.

Indexed as

Drug LabelingEuropeHumansPharmaceutical PreparationsPharmacogeneticsPharmaceutical Preparations

Identifiers

PMID25707393

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.