Evidence map›Paper›PMID 30706619›Full record

ArticlePharmacoepidemiology and drug safety2019

Drug-induced anaphylactic reactions in children: A retrospective analysis of 159 validated spontaneous reports.

Bernhardt Sachs, Diana Dubrall, Wilma Fischer-Barth, Matthias Schmid, Julia Stingl

Open access · bronzeAbstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.3field-weighted citation impact, top 9% 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, 26 citations in OpenAlex.

  1. Article
  2. Article
  3. Drug-Induced Anaphylaxis: National Database Analysis.Pharmaceuticals (Basel, Switzerland) · 2024
    Article
  4. Review
  5. Article
  6. Clinical characteristics and risk factors for cefaclor-induced immediate hypersensitivity: a retrospective observation at two university hospitals in Korea.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2021
    Article
  7. Article
  8. 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

5 authors at 2 institutions in 2 countries.

Bernhardt SachsResearch Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.ORCID 0000-0001-8260-0891
Diana DubrallResearch Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.ORCID 0000-0002-8763-051X
Wilma Fischer-BarthResearch Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
Matthias SchmidInstitute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital Bonn, Bonn, Germany.
Julia StinglResearch Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
Federal Institute for Drugs and Medical Devices · DEZimmer Biomet (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe main objective of this study was to analyze validated cases of drug-induced anaphylactic reactions in children with regard to incriminated drugs, clinical characteristics, and associated factors. A further objective was to compare differences in incriminated drugs and characteristics between validated cases and a reference excluding anaphylactic reaction cases (basic dataset).

methodsSpontaneous reports of anaphylactic reactions in children (0-17 years) registered between January 2000 to December 2016 were extracted from the adverse drug reaction database of the German Federal Institute for Drugs and Medical Devices. These reports were restricted to drugs for which at least four cases were found. After case validation, 159 reports remained (validated dataset) and were compared with the basic dataset (n = 12.168 reports) using inferential statistics.

resultsEstimated yearly increase of reports (36.8 vs 0.1), most frequently incriminated drugs (antibiotics 30.2% vs 11%, analgesics/antipyretics 22.0% vs 5.6%; P values less than 0.001) and route of administration (38.4% vs 6.7%) differed between the validated dataset and the basic dataset. Validated cases differed in severity (higher with atracurium), reported symptoms (urticaria leading with analgesics), and associated factors (atopy/allergy rarely reported with antibiotics) depending on the incriminated drug class. In 13.8% (11.3% if excluding repeated readministration in one person) of the cases, the drug had not been tolerated before.

conclusionsA heterogeneous clinical phenotype with differences in associated factors was observed, suggesting different underlying mechanisms triggered by the different drug groups. Occurrence of serious drug-induced anaphylactic reactions in children could be reduced by carefully considering patient history.

Indexed as

AdolescentAdverse Drug Reaction Reporting SystemsAnaphylaxisCefaclorChildChild Health ServicesChild, PreschoolFemaleGermanyHumansIbuprofenInfantInfant, NewbornMalePharmacoepidemiologyReproducibility of ResultsCefaclorIbuprofenadverse drug reactionanaphylactic reactionanaphylaxisatopypharmacoepidemiologyspontaneous reports

Identifiers

PMID30706619
PMCPMC6590409
OpenAlexW2912171001

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.