Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database

• Published in: Scientific reports Vol. 15; no. 1; pp. 4104 - 11
• Main Authors: Zhao, Shuai, Wang, Yan, Deng, Xiaoli, Chen, Xi, Lu, Zhaoyi
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 03.02.2025; Nature Publishing Group; Nature Portfolio
• Subjects: 631/67; 692/499; 692/700; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Adverse drug reactions (ADRs); Adverse events; Adverse events (AEs); Algorithms; Antineoplastic Agents, Immunological - adverse effects; Bayes Theorem; Bayesian analysis; Cetuximab; Cetuximab - adverse effects; Databases, Factual; Discitis; Disseminated intravascular coagulation; Drug metabolism; Drug-Related Side Effects and Adverse Reactions - epidemiology; Female; Glomerulonephritis; Head and neck cancer; Humanities and Social Sciences; Humans; Lymphatic system; Male; Metastases; Monoclonal antibodies; multidisciplinary; Neoplasms - drug therapy; Neural networks; Nutrition; Nutrition disorders; Patient safety; Preferred terms (PTs); Retrospective Studies; Science; Science (multidisciplinary); Side effects; System organ class (SOC); Targeted cancer therapy; United States; United States Food and Drug Administration; United States; Head and neck cancer; Adverse events (AEs); System organ class (SOC); Preferred terms (PTs); Cetuximab; Adverse drug reactions (ADRs)
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-025-88838-z

This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as ‘primary suspected (PS)’ AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab.