Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Expert Opin Drug Saf. 2023 Apr;22(4):339-342. doi: 10.1080/14740338.2023.2130891. Epub 2022 Oct 5.
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.
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.
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.
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.
罗莫佐单抗是一种新型骨质疏松症治疗药物。罗莫佐单抗的不良反应仍需探索。美国食品药品监督管理局不良事件报告系统（FAERS）为不良事件（AE）分析提供了大量数据。
本研究收集了 2019 年 1 月至 2020 年 12 月期间 FAERS 中登记的 AE。采用报告比值比（ROR）法分析罗莫佐单抗的 AE。报告 AE 数≥4 例且 ROR 值 95%置信区间（CI）下限>1 被认为具有统计学意义。
本研究共收集了 4413695 例 AE。FAERS 中报告了 1948 例与罗莫佐单抗相关的 AE。经过筛选，有 1851 例 AE 包括 17 个系统分类。注射部位疼痛（ROR=6.89，CI=5.60，8.48）、心力衰竭（ROR=12.62，CI=9.85，16.17）、肾功能损害（ROR=9.11，CI=6.98，11.89）、肺炎（ROR=1.53，CI=1.10，2.21）、碱性磷酸酶血增加（ROR=14.60，CI=9.28，22.97）是罗莫佐单抗应用后的可能 AE。
本研究为罗莫佐单抗的临床应用提供了不良反应警示，并为罗莫佐单抗的可能 AE 提供了真实世界的非比例性分析数据支持。
