Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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 (n = 10,809), whereas consumers accounted for the majority with 81.3% (n = 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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 (n = 10,809), whereas consumers accounted for the majority with 81.3% (n = 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.
UNASSIGNED: 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.
摘要：
■特立帕肽广泛用于各种患者的骨质疏松症治疗，但它的安全档案没有完全记录。本研究分析FDA药物数据库以评估特立帕肽的安全性。
■提取并分析了2004年第一季度（Q1）至2023年第三季度（Q3）的数据，以确定特立帕肽与不良反应（AE）之间的不相称性。
■共有66,991例不良事件报告确定特立帕肽为主要可疑药物，总计222116个个体不良事件。值得注意的是,医疗保健专业撰写了这些报告的16.1%(n=10,809)，而消费者占大多数，占81.3%(n=54,474)。特立帕肽显示出明显的关联，并增加了肌肉骨骼和结缔组织疾病的倾向（ROR，3.95；95%CI，3.91-3.99）在系统器官类（SOC）水平。同时,199个首选术语(PT)在所有四种采用的算法中都显示出显著的不相称性。
我们的研究证实了几种众所周知的药物不良反应，并确定了与特立帕肽治疗相关的潜在安全性问题。这有助于更深入地理解不良反应与特立帕肽之间的复杂关系。这些发现强调了持续监测和持续监测的重要性，以迅速识别和有效管理对手行为，从而提高整体患者的安全和福祉。
■提取并分析了2004年第一季度（Q1）至2023年第三季度（Q3）的数据，以确定特立帕肽与不良反应（AE）之间的不相称性。
■共有66,991例不良事件报告确定特立帕肽为主要可疑药物，总计222116个个体不良事件。值得注意的是,医疗保健专业撰写了这些报告的16.1%(n=10,809)，而消费者占大多数，占81.3%(n=54,474)。特立帕肽显示出明显的关联，并增加了肌肉骨骼和结缔组织疾病的倾向（ROR，3.95；95%CI，3.91-3.99）在系统器官类（SOC）水平。同时,199个首选术语(PT)在所有四种采用的算法中都显示出显著的不相称性。
我们的研究证实了几种众所周知的药物不良反应，并确定了与特立帕肽治疗相关的潜在安全性问题。这有助于更深入地理解不良反应与特立帕肽之间的复杂关系。这些发现强调了持续监测和持续监测的重要性，以迅速识别和有效管理对手行为，从而提高整体患者的安全和福祉。
