Adverse events associated with teriparatide:a real-world disproportionality analysis of the Fda adverse event reporting system (faers)

Teriparatide iswidely used for osteoporosis treatment in various patients, but its safetyprofile is not fully documented. This study analyzes the FDA pharmacovigilancedatabase to assess teriparatide’s safety. Data from thefirst quarter (Q1) of 2004 to the third quarter (Q3) of 2023 were extracted andanalyzed for disproportionality between teriparatide and adverse effects (AE). A total of66,991 AE reports identified teriparatide as the principal suspect medication,aggregating to 222,116 individual AEs. Notably, healthcare professionalsauthored 16.1% of these reports (<i>n</i> = 10,809), whereas consumers accounted for themajority with 81.3% (<i>n</i> = 54,474). Teriparatide revealed a marked association withan increased propensity for musculoskeletal and connective tissue disorders (ROR,3.95; 95% CI, 3.91–3.99) at the System Organ Class (SOC) level. Concurrently,199 preferred terms (PTs) displayed significant disproportionality across allfour employed algorithms. Our studyconfirms several well-known adverse drug reactions and identifies potentialsafety issues associated with teriparatide treatment. This contributes to adeeper understanding of the complex relationship between adverse reactions andteriparatide. These findings emphasize the importance of continuous monitoringand ongoing surveillance to promptly identify and effectively manage adversereactions, thereby enhancing overall patient safety and well-being.

特立帕肽（Teriparatide）被广泛用于多种患者的骨质疏松症治疗，但其安全性特征尚未得到完整记录。本研究依托美国食品药品监督管理局（FDA）药物警戒数据库，对特立帕肽的安全性展开评估。研究提取并分析了2004年第一季度（Q1）至2023年第三季度（Q3）的相关数据，以探究特立帕肽与不良反应（AE）之间的报告比例失衡情况。最终共纳入66991份以特立帕肽为主要可疑药物的不良反应报告，累计涉及222116例次个体不良反应。值得注意的是，医护人员撰写的报告占比为16.1%（n=10809），而消费者贡献了绝大多数报告，占比达81.3%（n=54474）。在系统器官分类（SOC）层面，特立帕肽与肌肉骨骼及结缔组织疾病的发生风险显著升高存在明确关联（报告比值比ROR=3.95；95%置信区间CI：3.91~3.99）。同时，本研究采用的四种算法均显示，有199个首选术语（PTs）存在显著的报告比例失衡情况。本研究验证了数种已知的药物不良反应，并识别出与特立帕肽治疗相关的潜在安全问题，有助于进一步深化对不良反应与特立帕肽之间复杂关联的认知。本研究结果凸显了持续监测与动态监管的重要性，以便及时识别并妥善处置不良反应，进而全面提升患者的安全与健康水平。