Evidence map›Paper›PMID 32353167›Full record

ArticleBritish journal of clinical pharmacology2020

Amoxicillin-induced crystal nephropathy: A nationwide French pharmacovigilance databases study.

Laure Thomas, Christine Le Beller, Thierry Trenque, Joëlle Michot, Marie Zenut, Emmanuel Letavernier, Nicolas Mongardon, Dominique Vodovar

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. The role of oral amoxicillin/clavulanic acid in the treatment of osteomyelitis: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. The Crystalline Nephropathies.Kidney international reports · 2021
    Review
  8. Acute Kidney Injury After High Doses of Amoxicillin.Kidney international reports · 2021
    Article
  9. Article
  10. 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

8 authors at 4 institutions in 1 country.

Laure ThomasCentre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Hôpitaux Universitaires Henri Mondor, Créteil, France.ORCID 0000-0003-4777-5690
Christine Le BellerCentre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Hôpital Européen Georges Pompidou, F-75014, Paris, France.
Thierry TrenqueCentre Régional de Pharmacovigilance et de Pharmacoépidémiologie, Centre Hospitalier Universitaire, Reims, France.ORCID 0000-0002-5645-8366
Joëlle MichotCentre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Centre Hospitalier Universitaire Saint-Antoine, Paris, France.
Marie ZenutCentre Régional de Pharmacovigilance, Centre Hospitalier Universitaire, Clermont-Ferrand, France.
Emmanuel LetavernierInstitut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche_S1155, Rare and Common Kidney Diseases, Matrix Remodeling and Tissue Repair, Paris, France.
Nicolas MongardonService d'anesthésie-réanimation chirurgicale, DMU CARE, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Créteil, France.
Dominique VodovarCentre Anti-Poison et de Toxicovigilance de Paris - Fédération de toxicologie, Assistance Publique des Hôpitaux de Paris, Hôpital Fernand-Widal, Paris, France.ORCID 0000-0002-8196-5511
Assistance Publique – Hôpitaux de Paris · FRInserm · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Reims · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAmoxicillin (AMX)-induced crystal nephropathy (AICN) is a rarely reported adverse drug reaction (ADR) but its increase has been recently reported in the Paris area. Our aim was to investigate the incidence, characteristics and outcome of AICN in France.

methodsRetrospective analysis of all AICN cases reported to the French National Pharmacovigilance Database and the Marketing Authorization Holders Pharmacovigilance Database. AICN notification rate was compared to intravenous AMX and AMX-clavulanate sales.

resultsIn total, 101 AICN cases were included. Intravenous AMX/AMX-clavulanate was prescribed as surgical prophylaxis (32 surgical patients) or to treat infection (69 medical patients). AKI KDIGO stage 3 was observed in 70 patients and 24/70 patients required renal replacement therapy and/or intensive care unit admission. The annual notification rate of AICN was increased by a factor of 13 since 2010 (6 [0;7] and 77 [24;111] cases per 100 000 patient-years of exposure, before and after 2010 respectively; P < .001). In surgical patients, the increase in AICN has been reported since 2010 and was mainly related to inadequate AMX administration. In medical patients, the increase in AICN was observed since 2014. After 2014, medical patients were older (67 [42;77] vs 74 years [64;84] respectively; P < .05) and were treated more frequently for endocarditis (0/20 vs 15/49 respectively; P < .01). A contributing factor was observed or suspected in 62 patients.

conclusionAICN is a severe ADR that dramatically increased in France since 2010. Assessment of AICN contributing factors and AMX drug monitoring in patients receiving high dose of AMX could reduce the risk of AICN.

Indexed as

AmoxicillinPharmacovigilanceAmoxicillin-Potassium Clavulanate CombinationFranceHumansRetrospective StudiesAmoxicillinAmoxicillin-Potassium Clavulanate Combinationacute kidney injuryadverse drug reactionamoxicillincrystalsrenal replacement therapy

Identifiers

PMID32353167
PMCPMC7576614
OpenAlexW3022815980

What OpenQuestion holds

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Registered trials

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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.