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

• Published in: Biomedicines Vol. 12; no. 5; p. 1124
• Main Authors: Butuca, Anca, Dobrea, Carmen Maximiliana, Arseniu, Anca Maria, Frum, Adina, Chis, Adriana Aurelia, Rus, Luca Liviu, Ghibu, Steliana, Juncan, Anca Maria, Muntean, Andrei Catalin, Lazăr, Antonina Evelina, Gligor, Felicia Gabriela, Morgovan, Claudiu, Vonica-Tincu, Andreea Loredana
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01-05-2024
• Subjects: Analysis; Body mass index; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes therapy; Drugs; Evidence-based medicine; Exercise; FDA approval; Glucagon; Glucagon-like peptide 1; Glucose; Hypertension; Hypoglycemic agents; Insulin; Life expectancy; Metabolism; Obesity; off-label use; Overdose; Overweight; Peptides; Safety; semaglutide; Sibutramine; Type 2 diabetes; underdose; Weight control; weight loss; United Kingdom; Romania; overdose; off-label use; EudraVigilance; GLP-1; underdose; weight loss; obesity; semaglutide
• DOI: 10.3390/biomedicines12051124
• EISSN: 2227-9059

Some glucagon-like peptide-1 receptor agonists (GLP-1 RAs), first used in the treatment of type 2 diabetes mellitus (T2DM), have been approved for the treatment of obesity in patients with or without T2DM (liraglutide-LIR, semaglutide-SEM, and tirzepatide-TIR). Social media had an important influence on the off-label use of GLP-1 RAs for obesity, especially for SEM. We analyzed 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. The 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 hi3gh tendency for overdose reports. The most frequent off-label use was reported for SEM and TIR. In order to lower the risks of ADRs, the off-label use should be reduced and carefully monitored.