10.6084/M9.FIGSHARE.21285080.V1
Zepeng Chen
Zepeng
Chen
Ming Li
Ming
Li
Shuzhen Li
Shuzhen
Li
Yuxi Li
Yuxi
Li
Junyan Wu
Junyan
Wu
Kaifeng Qiu
Kaifeng
Qiu
Xiaoxia Yu
Xiaoxia
Yu
Lin Huang
Lin
Huang
Guanghui Chen
Guanghui
Chen
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab
<p>Romosozumab is a novel drug for the treatment of osteoporosis. The adverse reactions of romosozumab still need to be explored. The FDA Adverse Event Reporting System (FAERS) provides an enormous dataset for adverse events (AEs) analysis.</p> <p>AEs registered in FAERS between January 2019 and December 2020 were collected for this study. The reporting odds ratio (ROR) method was applied to analyze the AEs of romosozumab. The number of AEs ≥4 cases and ROR value 95% confidence interval (CI) lower limit >1 was considered statistically significant.</p> <p>A total of 4,413,695 AEs were collected for this study. There were 1,948 AEs related with romosozumab reported in FAERS. There are 1851 AEs including 17 system classifications after filtered. Injection site pain (ROR = 6.89, CI = 5.60, 8.48), cardiac failure (ROR = 12.62, CI = 9.85, 16.17), renal impairment (ROR = 9.11, CI = 6.98, 11.89), pneumonia (ROR = 1.53, CI = 1.10, 2.21), blood alkaline phosphatase increased (ROR = 14.60, CI = 9.28, 22.97) were possible AEs after romosozumab application.</p> <p>Our study provides an adverse reaction warning for the clinical application of romosozumab and provides a real-world disproportionality analysis data support for the possible AEs of romosozumab.</p>
Medicine
Genetics
Pharmacology
Biotechnology
Immunology
Biological Sciences not elsewhere classified
Cancer
Science Policy
Infectious Diseases
Taylor & Francis
2022
2022-10-06
2024-02-16
Journal contribution
30495 Bytes
10.6084/m9.figshare.21285080
10.1080/14740338.2023.2130891
CC BY 4.0