Safety Assessment of Glucagon-Like Peptide 1 Receptor Agonists Based on the FAERS Database: Focus on Tumorigenic Risk in Subpopulations.

Abstract

GLP-1 receptor agonists (GLP-1RAs) are extensively used in treating Type 2 diabetes due to their therapeutic benefits. However, clinical reports have highlighted adverse events, particularly the underexplored association with tumor development. This study investigates GLP-1RA-related adverse events, focusing on tumorigenic risks, using data from the FDA Adverse Event Reporting System (FAERS). FAERS data from Q1 2005 to Q4 2023 were analyzed using the proportional reporting ratio (PRR) method to identify GLP-1RA-associated adverse events. Detailed analyses examined event distribution across genders, ages, and body weights, with an emphasis on tumor-related risks in vulnerable subpopulations. A total of 195,250 GLP-1RA-related adverse event reports were identified, spanning 25 system organ classes (SOCs). The most reported SOCs were gastrointestinal disorders (n = 110,451, PRR 2.44), investigative findings (n = 80,126, PRR 2.46), and metabolism and nutrition disorders (n = 25,236, PRR 2.21). Notably, 7457 cases involved benign, malignant, and unspecified tumors (PRR 0.5). Further analysis revealed that the risk of GLP-1RA-associated tumorigenesis varied by age, sex, and weight, suggesting that tumorigenesis risk differed in specific subpopulations. These findings underscore the need for vigilance regarding GLP-1RA-related adverse events, particularly tumor risks in specific subgroups. Clinicians should consider patient-specific factors, such as age, gender, and body weight, to ensure safe and effective GLP-1RAs therapy.