Jiang Wanting, Yin Shudan, Li Lingmin, Teng Menghao
Department of Ultrasound Imaging, Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an, Shaanxi, China.
Department of Sports Medicine and Joint Surgery, Xi'an Ninth Hospital), Xi'an, Shaanxi, China.
PLoS One. 2025 Aug 29;20(8):e0331444. doi: 10.1371/journal.pone.0331444. eCollection 2025.
Definity significantly enhances the diagnostic accuracy of echocardiography but raises ongoing safety concerns. This study aimed to explore potential adverse events (AEs) associated with Definity in real-world settings by analyzing data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
We retrospectively extracted AE reports from the FAERS database between 2004 and the first quarter of 2024. Disproportionality analyses using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were conducted to identify signals potentially associated with Definity. Univariate and multivariate logistic regression analyses were performed as sensitivity analyses to assess potential risk factors for Definity-related AEs.
A total of 4460 reports with Definity as the "primary suspected" drug were included. We identified 104 statistically significant signals at PT level, including common AEs such as back pain and muscle spasms, as well as exploratory signals not listed on the drug label, such as eye movement disorder and renal pain. It is noteworthy that 21 signals did not retain significance following Bonferroni correction. These AEs spanned 25 System Organ Classes (SOCs). In reports with available time-to-onset data, most events occurred within 30 days of administration, while some were reported at longer intervals. Moreover, logistic regression analysis indicated that both gender and body weight were independent risk factors associated with Definity-related AE.
This study provides exploratory insights into potential AEs associated with Definity based on real-world pharmacovigilance data. While most signals are consistent with known safety profiles, several emerging signals warrant further investigation and clinical awareness. These findings may contribute to ongoing risk management and pharmacovigilance efforts.
Definity显著提高了超声心动图的诊断准确性，但引发了持续的安全担忧。本研究旨在通过分析美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）的数据，探索现实环境中与Definity相关的潜在不良事件（AE）。
我们回顾性提取了2004年至2024年第一季度FAERS数据库中的AE报告。使用报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）进行不成比例分析，以识别可能与Definity相关的信号。进行单变量和多变量逻辑回归分析作为敏感性分析，以评估Definity相关AE的潜在风险因素。
共纳入4460份以Definity为“主要怀疑”药物的报告。我们在PT水平上识别出104个具有统计学意义的信号，包括背痛和肌肉痉挛等常见AE，以及药物标签上未列出的探索性信号，如眼球运动障碍和肾痛。值得注意的是，21个信号在Bonferroni校正后不再具有显著性。这些AE涵盖25个系统器官类别（SOC）。在有可用发病时间数据的报告中，大多数事件发生在给药后30天内，而有些事件报告的间隔时间更长。此外，逻辑回归分析表明，性别和体重都是与Definity相关AE的独立风险因素。
本研究基于现实世界的药物警戒数据，对与Definity相关潜在AE提供了探索性见解。虽然大多数信号与已知的安全概况一致，但一些新出现的信号值得进一步调查和临床关注。这些发现可能有助于正在进行的风险管理和药物警戒工作。
