Exploring the association between suicidal thoughts, self-injury, and GLP-1 receptor agonists in weight loss treatments: Insights from pharmacovigilance measures and unmasking analysis. Guirguis, A, Chiappini, S, Papanti P, G., Vickers-Smith, R., Harris, D, Corkery, J., Arillotta, D, Floresta, G., Martinotti, G, & Schifano, F European Neuropsychopharmacology, 82:82–91, May, 2024.
Paper doi abstract bibtex Introduction The study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA). Aim The 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. Methods Descriptive and pharmacovigilance disproportionality analyses was performed. Results A 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). Discussion Suicide/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. Conclusions With 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.
@article{guirguis_exploring_2024,
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},
volume = {82},
issn = {0924-977X},
shorttitle = {Exploring the association between suicidal thoughts, self-injury, and {GLP}-1 receptor agonists in weight loss treatments},
url = {https://www.sciencedirect.com/science/article/pii/S0924977X24000385},
doi = {10.1016/j.euroneuro.2024.02.003},
abstract = {Introduction
The study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).
Aim
The 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.
Methods
Descriptive and pharmacovigilance disproportionality analyses was performed.
Results
A 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).
Discussion
Suicide/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.
Conclusions
With 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.},
urldate = {2024-09-02},
journal = {European Neuropsychopharmacology},
author = {Guirguis, A and Chiappini, S and Papanti P, GD and Vickers-Smith, R. and Harris, D and Corkery, JM and Arillotta, D and Floresta, G. and Martinotti, G and Schifano, F},
month = may,
year = {2024},
keywords = {Adverse drug reactions, Glucagon-like peptide-1 receptor agonists, Pharmacovigilance, Suicide},
pages = {82--91},
}
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Aim The 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. Methods Descriptive and pharmacovigilance disproportionality analyses was performed. Results A 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). Discussion Suicide/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. Conclusions With 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.","urldate":"2024-09-02","journal":"European Neuropsychopharmacology","author":[{"propositions":[],"lastnames":["Guirguis"],"firstnames":["A"],"suffixes":[]},{"propositions":[],"lastnames":["Chiappini"],"firstnames":["S"],"suffixes":[]},{"propositions":[],"lastnames":["Papanti","P"],"firstnames":["GD"],"suffixes":[]},{"propositions":[],"lastnames":["Vickers-Smith"],"firstnames":["R."],"suffixes":[]},{"propositions":[],"lastnames":["Harris"],"firstnames":["D"],"suffixes":[]},{"propositions":[],"lastnames":["Corkery"],"firstnames":["JM"],"suffixes":[]},{"propositions":[],"lastnames":["Arillotta"],"firstnames":["D"],"suffixes":[]},{"propositions":[],"lastnames":["Floresta"],"firstnames":["G."],"suffixes":[]},{"propositions":[],"lastnames":["Martinotti"],"firstnames":["G"],"suffixes":[]},{"propositions":[],"lastnames":["Schifano"],"firstnames":["F"],"suffixes":[]}],"month":"May","year":"2024","keywords":"Adverse drug reactions, Glucagon-like peptide-1 receptor agonists, Pharmacovigilance, Suicide","pages":"82–91","bibtex":"@article{guirguis_exploring_2024,\n\ttitle = {Exploring the association between suicidal thoughts, self-injury, and {GLP}-1 receptor agonists in weight loss treatments: {Insights} from pharmacovigilance measures and unmasking analysis},\n\tvolume = {82},\n\tissn = {0924-977X},\n\tshorttitle = {Exploring the association between suicidal thoughts, self-injury, and {GLP}-1 receptor agonists in weight loss treatments},\n\turl = {https://www.sciencedirect.com/science/article/pii/S0924977X24000385},\n\tdoi = {10.1016/j.euroneuro.2024.02.003},\n\tabstract = {Introduction\nThe study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA).\nAim\nThe 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.\nMethods\nDescriptive and pharmacovigilance disproportionality analyses was performed.\nResults\nA total of 209,354 ADRs were reported, including 59,300 serious cases. 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