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

Teriparatide is widely used for osteoporosis treatment in various patients, but its safety profile is not fully documented. This study analyzes the FDA pharmacovigilance database to assess teriparatide’s safety. Data from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2023 were extracted and analyzed for disproportionality between teriparatide and adverse effects (AE). A total of 66,991 AE reports identified teriparatide as the principal suspect medication, aggregating to 222,116 individual AEs. Notably, healthcare professionals authored 16.1% of these reports (<i>n</i> = 10,809), whereas consumers accounted for the majority with 81.3% (<i>n</i> = 54,474). Teriparatide revealed a marked association with an 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 all four employed algorithms. Our study confirms several well-known adverse drug reactions and identifies potential safety issues associated with teriparatide treatment. This contributes to a deeper understanding of the complex relationship between adverse reactions and teriparatide. These findings emphasize the importance of continuous monitoring and ongoing surveillance to promptly identify and effectively manage adverse reactions, thereby enhancing overall patient safety and well-being.

特立帕肽（Teriparatide）目前被广泛应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。本研究借助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。本研究提取并分析了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）之间的不成比例关联。

共计识别出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例次独立不良反应。值得注意的是，医护人员撰写的报告占比16.1%（n=10809），而消费者提交的报告占绝大多数，达81.3%（n=54474）。

在系统器官分类（System Organ Class, SOC）层面，特立帕肽与肌肉骨骼和结缔组织疾病的发生风险升高存在显著关联（报告比值比ROR=3.95；95%置信区间CI：3.91~3.99）。与此同时，共计199个首选术语（preferred terms, PTs）在本次研究所采用的四种算法中均呈现出显著的不成比例性。

本研究不仅验证了数种已明确的药物不良反应，还识别出与特立帕肽治疗相关的潜在安全性问题，有助于更深入地阐明不良反应与特立帕肽之间的复杂关联。本研究结果强调了持续监测与主动监管的重要性，以便及时识别并有效管控不良反应，进而全面提升患者的安全性与健康福祉。