Evidence map›Paper›PMID 30478823›Full record

ArticleDrug safety2019

Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis.

Khac-Dung Nguyen, Hoang-Anh Nguyen, Dinh-Hoa Vu, Thi Thuy-Linh Le, Hoang-Anh Nguyen, Bich-Viet Dang, Trung-Nguyen Nguyen, Dang-Hoa Nguyen, Thanh-Binh Nguyen, Jean-Louis Montastruc and 1 more

Abstract read
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Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

7 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Drug-Induced Anaphylaxis: National Database Analysis.Pharmaceuticals (Basel, Switzerland) · 2024
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Global Trends in Anaphylaxis Epidemiology and Clinical Implications.The journal of allergy and clinical immunology. In practice · 2020
    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

11 authors at 4 institutions in 2 countries.

Khac-Dung NguyenThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Hoang-Anh NguyenThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Dinh-Hoa VuThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Thi Thuy-Linh LeThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Hoang-Anh NguyenThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Bich-Viet DangThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Trung-Nguyen NguyenPoison Control Centre, Bach Mai Hospital, Hanoi, Vietnam.
Dang-Hoa NguyenThe National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Thanh-Binh NguyenDepartment of Pharmacy Management and Pharmacoeconomics, Hanoi University of Pharmacy, Hanoi, Vietnam.
Jean-Louis MontastrucLaboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l'Université Paul-Sabatier (Medical and Clinical Pharmacology Laboratory, Faculty of Medicine, Paul-Sabatier University) and Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Information sur le Médicament (Midi-Pyrenees Centre for Pharmacovigilance, Pharmacoepidemiology and Drug Information), UMR INSERM 1027, Toulouse, France.
Haleh BagheriLaboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l'Université Paul-Sabatier (Medical and Clinical Pharmacology Laboratory, Faculty of Medicine, Paul-Sabatier University) and Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Information sur le Médicament (Midi-Pyrenees Centre for Pharmacovigilance, Pharmacoepidemiology and Drug Information), UMR INSERM 1027, Toulouse, France. haleh.bagheri@univ-tlse3.fr.
Hanoi University of Pharmacy · VNBạch Mai Hospital · VNCentre Hospitalier Universitaire de Toulouse · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite the numerous studies investigating drug-induced anaphylaxis (DIA), understanding and quantitative data analysis in developing countries remain limited. The aim of our study is to describe and quantify DIA using the National Pharmacovigilance Database of Vietnam (NPDV).

methodsSpontaneous reporting of adverse drug reactions (ADRs) recorded between 2010 and 2016 were retrospectively analysed to identify DIA reports. The trend and characteristics of DIA cases were described. Multivariate disproportionality analysis was used for signal generation.

resultsOverall, 4873 DIA cases (13.2% of total ADRs) were recorded in the NPDV, 111 of which resulted in death (82% of total ADR-induced deaths) over a 7-year period. There was a remarkable increase in DIA reporting over time (p < 0.001). The incidence rates of DIA reporting per total ADRs and per 100,000 inhabitants remained high (mean rates [95% CI] of 12.06 [9.88-14.24] and 0.77 [0.33-1.20], respectively). Concerning suspected drugs, systemic antibiotics (n = 3318, 68%) were mostly reported with a reporting odds ratio (ROR) and 95% CI of 2.35 [2.20-2.51]. In the case of antibiotic-induced anaphylaxis, the third-generation cephalosporins were predominant (n = 1961, 40.2%, ROR 2.39 [2.24-2.55]). We also noted drugs generally associated with DIA such as contrast agents (ROR 2.43 [2.04-2.88]) and anaesthetics (ROR 4.02 [3.30-4.89]). Furthermore, unexpected signals were observed for alpha-chymotrypsin (ROR 1.75 [1.23-2.44]) and amoxicillin/sulbactam (ROR 1.59 [1.18-2.10]), uncommonly reported in western countries.

conclusionIn recent years, cases of drug-induced DIA have increased in Vietnam, mostly due to antibiotics and third-generation cephalosporins. The inappropriate use of these drugs should be taken into account. Our findings also highlighted typical Vietnamese signals for alpha-chymotrypsin- and amoxicillin/sulbactam-induced anaphylaxis, which may relate to a specific sociological context in resource-limited countries.

Indexed as

Adverse Drug Reaction Reporting SystemsDatabases, FactualPharmacovigilanceAnaphylaxisHumansVietnam

Identifiers

PMID30478823
OpenAlexW2903476223

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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.