Evidence map›Paper›PMID 34117617›Full record

ArticleDrugs - real world outcomes2021

Risk of Bleeding Associated with Antidepressant Drugs: The Competitive Impact of Antithrombotics in Quantitative Signal Detection.

René Zeiss, Christoph Hiemke, Carlos Schönfeldt-Lecuona, Bernhard J Connemann, Maximilian Gahr

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. 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 1 country.

René ZeissDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany. rene.zeiss@uni-ulm.de.ORCID http://orcid.org/0000-0002-2471-8004
Christoph HiemkeDepartment of Psychiatry and Psychotherapy, University Medical Center of Mainz, Mainz, Germany.
Carlos Schönfeldt-LecuonaDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Bernhard J ConnemannDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Maximilian GahrDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Universität Ulm · DEJohannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo date, disproportionality analysis has been unable to demonstrate the increased bleeding risk associated with antidepressant drugs, especially selective serotonin reuptake inhibitors.

objectiveWe hypothesised that a potential signal for an increased bleeding risk may be mitigated by the effects of agents other than antidepressant drugs that are strongly associated with haemorrhages, especially antithrombotics. In addition, we investigated if the use of more specific search terms of the Medical Dictionary for Regulatory Activities facilitates the detection of signals.

methodsPharmacovigilance data from the Uppsala Monitoring Centre were used to calculate substance-specific reporting odds ratios (RORs) for all types of bleeding and gastrointestinal bleeding. Reporting odds ratios were calculated with and without antithrombotic comedication.

resultsRegarding any type of bleeding, no signals were found in association with antidepressant drugs. Concerning upper gastrointestinal bleeding, signals were found related to citalopram (ROR: 1.56 [95% confidence interval 1.11-2.20]) and escitalopram (ROR: 1.52 [95% confidence interval 1.03-2.25]). After removal of reports related to antithrombotics, these signals could no longer be detected, but a new signal related to St. John's Wort associated with haemorrhages was found (ROR: 1.50 [95% confidence interval 1.21-1.86]).

conclusionsAntithrombotics seem unlikely to have a major impact on the detection of the bleeding risk of antidepressant drugs. The different categorisation of adverse drug reactions regarding the strength of a causal relationship between a drug and an event in the database may be relevant for this negative finding.

Identifiers

PMID34117617
PMCPMC8605951
OpenAlexW3166837930

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.