Evidence map›Paper›PMID 37004083›Full record

ArticleBMC pharmacology & toxicology2023

Selective serotonin reuptake inhibitors and suicidality in children and young adults: analyses of pharmacovigilance databases.

Diana Dubrall, Stefanie Fekete, Sarah Leitzen, Lena Marie Paschke, Marcel Romanos, Matthias Schmid, Manfred Gerlach, Bernhardt Sachs

Open access · goldAbstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 2% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
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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

8 authors at 5 institutions in 2 countries.

Diana Dubrall *Institute for Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany.
Stefanie Fekete *Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Centre for Mental Health, Margarete-Höppel-Platz 1, 97080, Würzburg, Germany. Fekete_S@ukw.de.
Sarah LeitzenFederal Institute for Drugs and Medical Devices (BfArM), Research Division, North Rhine-Westphalia, Bonn, Germany.
Lena Marie PaschkeCentral Research Institute of Ambulatory Health Care in Germany, Berlin, Germany.
Marcel RomanosDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Centre for Mental Health, Margarete-Höppel-Platz 1, 97080, Würzburg, Germany.
Matthias SchmidInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany.
Manfred Gerlach *Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Centre for Mental Health, Margarete-Höppel-Platz 1, 97080, Würzburg, Germany.
Bernhardt Sachs *Federal Institute for Drugs and Medical Devices (BfArM), Research Division, North Rhine-Westphalia, Bonn, Germany.
Universitätsklinikum Würzburg · DEFederal Institute for Drugs and Medical Devices · DEUniversity Hospital Bonn · DEUniversity of Southern Denmark · DKZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince the warnings by the United States (US) and European regulatory authorities in 2004 and 2005 it had been discussed whether there is some link between selective serotonin reuptake inhibitors (SSRIs) and suicidality in the pediatric population. The aim of our study was to describe trends and patterns in spontaneous reporting data referring to suicidality in children, adolescents and young adults treated with SSRI after the warnings.

methodsDescriptive analyses of reports for 0-24 year olds referring to suicide/suicidal ideations, self-harms and overdoses with SSRIs reported as suspected submitted to the US (FAERS) and the European (EudraVigilance) adverse drug reaction databases until 2019 were performed. The causal relationship was assessed in accordance with the WHO criteria for the European reports. For Germany, prescription data for SSRIs were provided and reporting rates (number of reports/number of prescriptions) were calculated for the reports with possible causal relationship (so called "confirmed reports").

resultsSince 2004, the number of reports referring to suicide/suicidal ideations, self-harm and overdoses increased steadily in the US and EU. However, only a slight increase was seen for the confirmed EU reports. After 2008, the proportion of reports informing about suicidal ideations increased, while the proportion of fatal suicide attempts decreased. Reporting rates were higher for females and adolescents (12-18 years).

conclusionsOur results demonstrate the importance of further monitoring suicidality in 0-24 year olds treated with SSRI in order to recognize suicidality early avoiding fatal suicide attempts. The higher reporting rates for females and adolescents should be further investigated.

Indexed as

Selective Serotonin Reuptake InhibitorsSuicideAdolescentChildFemaleHumansPharmacovigilanceSuicidal IdeationSuicide, AttemptedUnited StatesYoung AdultSelective Serotonin Reuptake InhibitorsAdverse drug reactionAntidepressantsChildDepressionSuicide

Identifiers

PMID37004083
PMCPMC10067298
OpenAlexW4362523560

What OpenQuestion holds

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LicenceCC BY
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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.