Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset

Stefania Chiappini; Rachel Vickers-Smith; Daniel Harris; Duccio G. Petellier Papanti; John M. Corkery; Amira Guirguis; Giovanni Martinotti; Stefano L. Sensi; Fabrizio Schifano

doi:10.20944/preprints202309.1300.v1

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preprints.org > biology and life sciences > toxicology > doi: 10.20944/preprints202309.1300.v1

Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset

Stefania Chiappini

^* ,

Rachel Vickers-Smith

Daniel Harris

Duccio G. Petellier Papanti

Version 1 : Received: 18 September 2023 / Approved: 19 September 2023 / Online: 20 September 2023 (05:05:11 CEST)

How to cite: Chiappini, S.; Vickers-Smith, R.; Harris, D.; Petellier Papanti, D.G.; Corkery, J.M.; Guirguis, A.; Martinotti, G.; Sensi, S.L.; Schifano, F. Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Preprints 2023, 2023091300. https://doi.org/10.20944/preprints202309.1300.v1 Chiappini, S.; Vickers-Smith, R.; Harris, D.; Petellier Papanti, D.G.; Corkery, J.M.; Guirguis, A.; Martinotti, G.; Sensi, S.L.; Schifano, F. Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Preprints 2023, 2023091300. https://doi.org/10.20944/preprints202309.1300.v1

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MDPI and ACS Style

Chiappini, S.; Vickers-Smith, R.; Harris, D.; Petellier Papanti, D.G.; Corkery, J.M.; Guirguis, A.; Martinotti, G.; Sensi, S.L.; Schifano, F. Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Preprints 2023, 2023091300. https://doi.org/10.20944/preprints202309.1300.v1

APA Style

Chiappini, S., Vickers-Smith, R., Harris, D., Petellier Papanti, D.G., Corkery, J.M., Guirguis, A., Martinotti, G., Sensi, S.L., & Schifano, F. (2023). Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Preprints. https://doi.org/10.20944/preprints202309.1300.v1

Chicago/Turabian Style

Chiappini, S., Stefano L. Sensi and Fabrizio Schifano. 2023 "Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset" Preprints. https://doi.org/10.20944/preprints202309.1300.v1

Abstract

Recent media reports commented about a possible antidiabetics’ misuse issue related to molecules promoted as a weight-loss treatment in non-obese people. We evaluated here available pharmacovigilance misuse/abuse signals related to semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, in comparison to other GLP-1 receptor agonists (albiglutide; dulaglutide; exenatide; liraglutide; lixisenatide; tirzepatide) and the phentermine-topiramate combination. To that aim, we analysed the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AER) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). During January 2018-December 2022, a total of 31,542 AER involving the selected molecules were submitted to FAERS; most involved dulaglutide (n=11,858; 37.6%) and semaglutide (n=8,249; 26.1%). In comparing semaglutide vs the remaining nolecules, the AER ‘drug abuse’, ‘drug withdrawal syndrome’, ‘prescription drug used without a prescription’ and ‘intentional product use issue’ respective PRR values were 4.05, 4.05, 3.60 and 1.80 (all<0.01). The same comparisons of semaglutide vs the phentermine-topiramate combination were not associated with any significant differences. To the best of our knowledge, this is the first study documenting the misusing/abusing potential of semaglutide in comparison with other GLP1 analogues and the phentermine-topiramate combination. Current findings will need to be confirmed by further empirical investigations to fully understand the safety profile of those molecules.

Keywords

semaglutide; drug misuse; drug abuse; pharmacovigilance; image- and performance-enhancing (IPED) drugs; glucagon-like peptide-1 (GLP-1) agonists

Subject

Biology and Life Sciences, Toxicology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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