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Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis

Amira Guirguis Orcid Logo, S Chiappini Orcid Logo, GD Papanti P, R. Vickers-Smith Orcid Logo, D Harris Orcid Logo, JM Corkery Orcid Logo, D Arillotta Orcid Logo, G. Floresta Orcid Logo, G Martinotti, F Schifano

European Neuropsychopharmacology, Volume: 82, Pages: 82 - 91

Swansea University Author: Amira Guirguis Orcid Logo

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DOI (Published version): 10.1016/j.euroneuro.2024.02.003

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IntroductionThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).AimThe aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin a...

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Published in: European Neuropsychopharmacology
ISSN: 0924-977X
Published: Elsevier BV 2024
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>65564</id><entry>2024-02-02</entry><title>Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis</title><swanseaauthors><author><sid>b49270b9a0d580cf4f31f9a1b6c93f87</sid><ORCID>0000-0001-8255-0660</ORCID><firstname>Amira</firstname><surname>Guirguis</surname><name>Amira Guirguis</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2024-02-02</date><deptcode>PHAR</deptcode><abstract>IntroductionThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).AimThe aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.MethodsDescriptive and pharmacovigilance disproportionality analyses was performed.ResultsA total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 ‘serious’ cases related to selected ADRs were registered during 2005–2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).DiscussionSuicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations.ConclusionsWith the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders.</abstract><type>Journal Article</type><journal>European Neuropsychopharmacology</journal><volume>82</volume><journalNumber/><paginationStart>82</paginationStart><paginationEnd>91</paginationEnd><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0924-977X</issnPrint><issnElectronic/><keywords>Pharmacovigilance; Glucagon-like peptide-1 receptor agonists; Adverse drug reactions; Suicide</keywords><publishedDay>1</publishedDay><publishedMonth>5</publishedMonth><publishedYear>2024</publishedYear><publishedDate>2024-05-01</publishedDate><doi>10.1016/j.euroneuro.2024.02.003</doi><url/><notes/><college>COLLEGE NANME</college><department>Pharmacy</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>PHAR</DepartmentCode><institution>Swansea University</institution><apcterm>SU Library paid the OA fee (TA Institutional Deal)</apcterm><funders>This research received no external funding. Institutional Review Board Statement: Not applicable. Informed Consent Statement: Not applicable. Data Availability Statement: The FDA Adverse Event Reporting System data are publicly available and can be found here: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-eventreporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard (accessed on 4 July 2023).</funders><projectreference/><lastEdited>2024-04-07T13:06:39.6218827</lastEdited><Created>2024-02-02T14:58:43.1593437</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Pharmacy</level></path><authors><author><firstname>Amira</firstname><surname>Guirguis</surname><orcid>0000-0001-8255-0660</orcid><order>1</order></author><author><firstname>S</firstname><surname>Chiappini</surname><orcid>0000-0002-6810-1540</orcid><order>2</order></author><author><firstname>GD Papanti</firstname><surname>P</surname><order>3</order></author><author><firstname>R.</firstname><surname>Vickers-Smith</surname><orcid>0000-0002-7224-8916</orcid><order>4</order></author><author><firstname>D</firstname><surname>Harris</surname><orcid>0000-0001-9139-3433</orcid><order>5</order></author><author><firstname>JM</firstname><surname>Corkery</surname><orcid>0000-0002-3849-817x</orcid><order>6</order></author><author><firstname>D</firstname><surname>Arillotta</surname><orcid>0000-0002-8843-0595</orcid><order>7</order></author><author><firstname>G.</firstname><surname>Floresta</surname><orcid>0000-0002-0668-1260</orcid><order>8</order></author><author><firstname>G</firstname><surname>Martinotti</surname><order>9</order></author><author><firstname>F</firstname><surname>Schifano</surname><order>10</order></author></authors><documents><document><filename>65564__29748__8f7285639133476998568ab42d8956ed.pdf</filename><originalFilename>65564_VoR.pdf</originalFilename><uploaded>2024-03-19T12:16:22.4134001</uploaded><type>Output</type><contentLength>884800</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>©2024 The Authors. 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spelling v2 65564 2024-02-02 Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis b49270b9a0d580cf4f31f9a1b6c93f87 0000-0001-8255-0660 Amira Guirguis Amira Guirguis true false 2024-02-02 PHAR IntroductionThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).AimThe aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.MethodsDescriptive and pharmacovigilance disproportionality analyses was performed.ResultsA total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 ‘serious’ cases related to selected ADRs were registered during 2005–2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).DiscussionSuicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations.ConclusionsWith the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders. Journal Article European Neuropsychopharmacology 82 82 91 Elsevier BV 0924-977X Pharmacovigilance; Glucagon-like peptide-1 receptor agonists; Adverse drug reactions; Suicide 1 5 2024 2024-05-01 10.1016/j.euroneuro.2024.02.003 COLLEGE NANME Pharmacy COLLEGE CODE PHAR Swansea University SU Library paid the OA fee (TA Institutional Deal) This research received no external funding. Institutional Review Board Statement: Not applicable. Informed Consent Statement: Not applicable. Data Availability Statement: The FDA Adverse Event Reporting System data are publicly available and can be found here: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-eventreporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard (accessed on 4 July 2023). 2024-04-07T13:06:39.6218827 2024-02-02T14:58:43.1593437 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Pharmacy Amira Guirguis 0000-0001-8255-0660 1 S Chiappini 0000-0002-6810-1540 2 GD Papanti P 3 R. Vickers-Smith 0000-0002-7224-8916 4 D Harris 0000-0001-9139-3433 5 JM Corkery 0000-0002-3849-817x 6 D Arillotta 0000-0002-8843-0595 7 G. Floresta 0000-0002-0668-1260 8 G Martinotti 9 F Schifano 10 65564__29748__8f7285639133476998568ab42d8956ed.pdf 65564_VoR.pdf 2024-03-19T12:16:22.4134001 Output 884800 application/pdf Version of Record true ©2024 The Authors. This is an open access article under the CC BY license. true eng http://creativecommons.org/licenses/by/4.0/
title Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
spellingShingle Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
Amira Guirguis
title_short Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
title_full Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
title_fullStr Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
title_full_unstemmed Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
title_sort Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis
author_id_str_mv b49270b9a0d580cf4f31f9a1b6c93f87
author_id_fullname_str_mv b49270b9a0d580cf4f31f9a1b6c93f87_***_Amira Guirguis
author Amira Guirguis
author2 Amira Guirguis
S Chiappini
GD Papanti P
R. Vickers-Smith
D Harris
JM Corkery
D Arillotta
G. Floresta
G Martinotti
F Schifano
format Journal article
container_title European Neuropsychopharmacology
container_volume 82
container_start_page 82
publishDate 2024
institution Swansea University
issn 0924-977X
doi_str_mv 10.1016/j.euroneuro.2024.02.003
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Pharmacy{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Pharmacy
document_store_str 1
active_str 0
description IntroductionThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).AimThe aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators.MethodsDescriptive and pharmacovigilance disproportionality analyses was performed.ResultsA total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 ‘serious’ cases related to selected ADRs were registered during 2005–2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide).DiscussionSuicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations.ConclusionsWith the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders.
published_date 2024-05-01T13:06:36Z
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