Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database

Anca Butuca
ORCID logo ,
Carmen Maximiliana Dobrea
ORCID logo ,
Anca Maria Arseniu
,
Adina Frum
ORCID logo ,
Adriana Aurelia Chis
ORCID logo ,
Luca Liviu Rus
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Steliana Ghibu
* ,
Anca Maria Juncan
ORCID logo ,
Andrei Catalin Muntean
* ,
Antonina Evelina Lazăr
,
Felicia Gabriela Gligor
ORCID logo ,
Claudiu Morgovan
,
Andreea Loredana Vonica-Tincu
ORCID logo
Version 1 : Received: 29 April 2024 / Approved: 29 April 2024 / Online: 30 April 2024 (10:14:22 CEST)

How to cite: Butuca, A.; Dobrea, C. M.; Arseniu, A. M.; Frum, A.; Chis, A. A.; Rus, L. L.; Ghibu, S.; Juncan, A. M.; Muntean, A. C.; Lazăr, A. E.; Gligor, F. G.; Morgovan, C.; Vonica-Tincu, A. L. An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database. Preprints 2024, 2024041954. https://doi.org/10.20944/preprints202404.1954.v1 Butuca, A.; Dobrea, C. M.; Arseniu, A. M.; Frum, A.; Chis, A. A.; Rus, L. L.; Ghibu, S.; Juncan, A. M.; Muntean, A. C.; Lazăr, A. E.; Gligor, F. G.; Morgovan, C.; Vonica-Tincu, A. L. An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database. Preprints 2024, 2024041954. https://doi.org/10.20944/preprints202404.1954.v1

Abstract

Some glucagon-like peptide-1 receptor agonists (GLP-1 RAs), first used in the treat-ment of type 2 diabetes mellitus (T2DM), have been approved for the treatment of obe-sity in patients with or without T2DM (liraglutide – LIR, semaglutide - SEM, and tir-zepatide - TIR). Social media had an important influence on the off-label use of GLP-1 RAs for obesity, especially for SEM. We analysed the Google queries related to SEM to assess people's interest in this drug. We also investigated the occurrence of adverse drug reactions (ADRs) by searching the EudraVigilance database (EV) for Individual Case Safety Reports (ICSRs) that reported SEM as the suspected drug and performed a descriptive and a disproportionality analysis. Data obtained for SEM were compared to other GLP-1 RAs. SEM had the highest proportions of searches on Google associated with the term “weight loss” and presented the lowest number of severe ADRs, but it also had the highest number of ICSRs reported in EV. Even though no unexpected safety issues have been reported for it until now, SEM has a high tendency for overdose reports. The most frequent off-label use was reported for SEM and TIR. In order to lower the ADRs’ risks, the off-label use should be reduced and carefully monitored.

Keywords

semaglutide; obesity; weight loss; overdose; underdose; off-label use; EudraVigilance; GLP-1

Subject

Medicine and Pharmacology, Pharmacology and 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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