Evidence map›Paper›PMID 36976448›Full record

ArticleDrug safety2023

Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends.

Nelly F Ly, Clare Flach, Thom S Lysen, Emanuil Markov, Hanne van Ballegooijen, Peter Rijnbeek, Talita Duarte-Salles, Carlen Reyes, Luis H John, Leila Karimi and 3 more

Open access · bronzeAbstract read
In one paragraph

Article in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 2% of its field
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Fluoroquinolone-Mediated Tendinopathy and Tendon Rupture.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  14. Article
  15. Fluoroquinolones: what do GPs need to know?The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Article
  16. Review
  17. Safety of fluoroquinolones.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2024
    Review
  18. Estimation of antimicrobial resistance ofEuro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2024
    Article
  19. Article
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

13 authors at 6 institutions in 4 countries.

Nelly F LyIQVIA Ltd, London, UK. francoisenelly.ly@iqvia.com.ORCID 0000-0002-7527-110X
Clare FlachIQVIA Ltd, London, UK.
Thom S LysenIQVIA Solutions B.V., Amsterdam, The Netherlands.
Emanuil MarkovIQVIA, Sofia, Bulgaria.
Hanne van BallegooijenIQVIA Solutions B.V., Amsterdam, The Netherlands.
Peter RijnbeekDepartment of Medical Informatics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Talita Duarte-SallesFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Carlen ReyesFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Luis H JohnDepartment of Medical Informatics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Leila KarimiIQVIA Solutions B.V., Amsterdam, The Netherlands.
Christian ReichIQVIA, Durham, North Carolina, USA.
Sam SalekSchool of Life and Medical Science, University of Hertfordshire, Hatfield, UK.
Deborah LaytonPEPI Consultancy Limited, Southampton, UK.
Erasmus MC · NLInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ESIQVIA (United Kingdom) · GBIQVIA (United States) · USKeele University · GBUniversity of Hertfordshire · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionConcerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, muscles and joints, resulted in the 2018 referral procedure led by the European Medicines Agency (EMA). They advised to stop prescribing fluoroquinolones for infections of mild severity or of a presumed self-limiting course and for prevention of infections, plus to restrict prescriptions in cases of milder infections where other treatment options are available, and restrict in at-risk populations. We aimed to examine whether the impact of EMA regulatory interventions implemented throughout 2018-2019 had an impact on fluoroquinolone prescribing rates.

methodsA retrospective population-based cohort study was conducted using electronic health care records from six European countries between 2016 and 2021. We analysed monthly incident fluoroquinolone use rates overall and for each fluoroquinolone active substance through flexible modelling via segmented regression to detect time points of trend changes, in monthly percentage change (MPC).

resultsThe incidence of fluoroquinolone use ranged from 0.7 to 8.0/1000 persons per month over all calendar years. While changes in fluoroquinolone prescriptions were observed over time across countries, these were inconsistent and did not seem to be temporally related to EMA interventions (e.g., Belgium: February/May 2018, MPC - 33.3%, 95% confidence interval [CI] - 35.9 to - 30.7; Germany: February/May 2019, MPC - 12.6%, 95% CI - 13.7 to - 11.6]; UK: January/April 2016, MPC - 4.9%, 95% CI - 6.2 to - 3.6).

conclusionThe regulatory action associated with the 2018 referral did not seem to have relevant effects on fluoroquinolone prescribing in primary care.

Indexed as

Anti-Bacterial AgentsFluoroquinolonesCohort StudiesEuropean UnionHumansRetrospective StudiesAnti-Bacterial AgentsFluoroquinolones

Identifiers

PMID36976448
PMCPMC10044099
OpenAlexW4361215804

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.