Evidence map›Paper›PMID 32293547›Full record

ArticleBMC pharmacology & toxicology2020

Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices.

Diana Dubrall, Katja S Just, Matthias Schmid, Julia C Stingl, Bernhardt Sachs

Open access · goldAbstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
4.7field-weighted citation impact, top 3% 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

33 citing papers in PubMed, 55 citations in OpenAlex.

  1. Article
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  6. [Recording medication errors in Germany-a workshop report].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026
    Article
  7. Article
  8. Representation of Older Adult Patients in Clinical Trials.Clinical and translational science · 2025
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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 3 institutions in 2 countries.

Diana DubrallInstitute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, North Rhine-Westphalia, Germany. diana.dubrall@bfarm.de.ORCID 0000-0002-8763-051X
Katja S JustInstitute of Clinical Pharmacology, University Hospital of the RWTH Aachen, Aachen, North Rhine-Westphalia, Germany.
Matthias SchmidInstitute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, North Rhine-Westphalia, Germany.
Julia C StinglInstitute of Clinical Pharmacology, University Hospital of the RWTH Aachen, Aachen, North Rhine-Westphalia, Germany.
Bernhardt SachsResearch Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, North Rhine-Westphalia, Germany.
Federal Institute for Drugs and Medical Devices · DERWTH Aachen University · DEInstitut für Medizinische Biometrie, Informatik und Epidemiologie · DE

Funding

Bundesinstitut für Arzneimittel und Medizinprodukte V-16703/68502/2016-2020Universitätsklinikum Bonn V-16703/68502/2016-2020
6 · The paper itself

Abstract

backgroundOlder adults are more prone to develop adverse drug reactions (ADRs) since they exhibit numerous risk factors. The first aim was to analyse the number of spontaneous ADR reports regarding older adults (> 65) in the ADR database of the German Federal Institute for Drugs and Medical Devices (BfArM) and to set them in relation to i) the number of ADR reports concerning younger adults (19-65), and ii) the number of inhabitants and assumed drug-exposed inhabitants. The second aim was to analyse, if reported characteristics occurred more often in older vs. younger adults.

methodsAll spontaneous ADR reports involving older or younger adults within the period 01/01/2000-10/31/2017 were identified in the ADR database. Ratios concerning the number of ADR reports/number of inhabitants and ADR reports/drug-exposed inhabitants were calculated. The reports for older (n = 69,914) and younger adults (n = 111,463) were compared using descriptive and inferential statistics.

resultsThe absolute number of ADR reports involving older adults increased from 1615 (2000) up to 5367 ADR reports (2016). The age groups 76-84 and 70-79 had the highest number of ADR reports with 25 ADR reports per 100,000 inhabitants and 27 ADR reports per 100,000 assumed drug-exposed inhabitants. For both ratios, the number of reports was higher for males (26 and 28 ADR reports) than for females (24 and 26 ADR reports). Fatal outcome was reported almost three times more often in older vs. younger adults. Six out of ten drug substances most frequently suspected were antithrombotics (vs. 1/10 in younger adults). For some drug substances (e.g. rivaroxaban) the ADRs reported most frequently differed between older (epistaxis) and younger adults (menorrhagia).

conclusionsThere is a need to further investigate ADRs in older adults since they occurred more frequently in older vs. younger adults and will likely increase in future. Physicians should be aware of different ADRs being attributed to the same drug substances which may be more prominent in older adults. Regular monitoring of older adults taking antithrombotics is recommended.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overDatabases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleGermanyHumansMaleMiddle AgedRetrospective StudiesYoung AdultADR databaseAdverse drug reactionsAdverse drug reactions older adultsOlder adultsSide effectsSpontaneous reports

Identifiers

PMID32293547
PMCPMC7092423
OpenAlexW3016020774

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.