Table1_Indications and adverse events of teriparatide: based on FDA adverse event reporting system (FAERS).XLSX

BackgroundTeriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.ObjectiveTo investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for key AEs, and explore potential applications to provide clinical reference.MethodsFAERS data from 2004 to 2023 were analyzed. Reports where teriparatide was the primary suspect drug were included. Adverse events were mapped to System Organ Classes and Preferred Terms. Disproportionality analysis using ROR, PRR, BCPNN and EBGM algorithms was conducted to detect safety signals.ResultsOut of 107,123 reports with teriparatide as the primary suspect, key AEs identified included pain in extremity (PRR: 4.54), muscle spasms (PRR: 5.11), fractures (PRR range: 17.67–552.95), and increased calcium levels (PRR: 50.73). Teriparatide exhibited a stronger association with increased calcium levels (PRR: 50.73) compared to fractures (PRR range: 17.67–552.95). Notably, only 10.86% of AE reports were submitted by physicians and another 10% by other health professionals. Subset analyses showed a higher consistency of reported AEs from health professionals compared to the general dataset. Off-label uses were noted in conditions such as arthritis (0.57%) and cancer (0.12%). For osteoporosis, main AEs were pain (18.2%), fractures (12.4%), muscle spasms (7.7%), and nausea (6.5%), while glucocorticoid-induced osteoporosis AEs included fractures (24.1%), pain (13.2%), decreased bone density (9.8%), and nausea (5.1%).ConclusionOur findings provide real-world safety data on teriparatide, revealing key AEs and their association strengths. The low proportion of reports by healthcare professionals suggests the need for cautious interpretation. Continuous vigilance and further research are imperative to guide teriparatide’s clinical use.

背景：特立帕肽获准用于治疗骨质疏松症。鉴于其广泛应用，上市后监测至关重要。目的：本研究旨在利用FAERS数据库调查特立帕肽相关的不良事件（AEs），比较关键AEs的关联强度，并探讨其临床应用的可能性。方法：分析了2004年至2023年的FAERS数据。纳入了以特立帕肽为主要嫌疑药物的报告。不良事件被映射到系统器官类别和优选术语。采用ROR、PRR、BCPNN和EBGM算法进行不均衡性分析，以检测安全性信号。结果：在107,123份以特立帕肽为主要嫌疑药物的报告中发现，关键AEs包括肢体疼痛（PRR：4.54）、肌肉痉挛（PRR：5.11）、骨折（PRR范围：17.67–552.95）和钙水平升高（PRR：50.73）。特立帕肽与钙水平升高（PRR：50.73）的关联强度强于与骨折（PRR范围：17.67–552.95）的关联。值得注意的是，仅有10.86%的AE报告由医师提交，另有10%由其他卫生专业人员提交。子集分析显示，来自卫生专业人员的报告与一般数据集相比，报告的AEs一致性更高。在关节炎（0.57%）和癌症（0.12%）等条件下存在非标签使用。对于骨质疏松症，主要AEs包括疼痛（18.2%）、骨折（12.4%）、肌肉痉挛（7.7%）和恶心（6.5%），而糖皮质激素诱导的骨质疏松症AEs包括骨折（24.1%）、疼痛（13.2%）、骨密度降低（9.8%）和恶心（5.1%）。结论：我们的研究结果提供了特立帕肽的真实世界安全性数据，揭示了关键AEs及其关联强度。由医疗保健专业人员提交的报告比例较低，这表明需要谨慎解读。持续警惕和进一步研究对于指导特立帕肽的临床应用至关重要。