Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy -
Department of Urology, IRCCS Oncological Referrence Center, Rionero in Vulture, Potenza, Italy.
Minerva Urol Nephrol. 2023 Jun;75(3):374-380. doi: 10.23736/S2724-6051.23.05169-8. Epub 2023 Mar 20.
On March 11 2019, European Medicines Agency (EMA) issues a warning after a review of serious, disabling and potentially permanent adverse events (AEs), particularly on musculoskeletal and nervous system, with quinolone (QN) and fluoroquinolone (FQ) antibiotics. Aim of this study was to evaluate the effect of the EMA warning on the rate of AEs after QN and FQ treatments, reported in the EudraVigilance (EV) database.
EV database is the system for managing and analyzing information on suspected AEs to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We retrospectively explored the effect of FQs and QNs on musculoskeletal and nervous system from the EMA warning up to now (21 months) and compared these results with the 21 months before the EMA warning.
Main part of AEs in EV database were reported for ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin. Ciprofloxacin total AEs before 21 months till 12 months of EMA warning were 2763. 12 months before EMA Warning they were 2935. Twelve months after EMA Warning they were 3419. Between 12 months till 21 months they were 3174. Musculoskeletal disorders were respectively 574 (21% of the total) 21 months before, 558 (19%) 12 months before, 1048 (31%) after 12 months, 540 (17%) after 21 months of EMA Warning. Nervous system disorders were respectively 606 (22% of the total) 21 months before, 517 (18%) 12 months before, 680 (20%) after 12 months, 560 (18%) after 21 months of EMA Warning (respectively OR 1,16 95%CI 1,10 -1,22, P 0,12 ; OR 0,76 95%CI 0,69-0,83, P 0,27 ; OR 1,01 95%CI 0,96-1,06 P 0,05).
Our analysis clearly showed no significant differences before and after EMA warning, opening new insights in the role of the EMA warning in clinical practice.
2019 年 3 月 11 日，欧洲药品管理局（EMA）在审查了喹诺酮（QN）和氟喹诺酮（FQ）抗生素的严重、致残和潜在永久性不良事件（AE）后发布了警告，特别是在肌肉骨骼和神经系统方面。本研究的目的是评估 EMA 警告对 EudraVigilance（EV）数据库中报告的 QN 和 FQ 治疗后 AE 发生率的影响。
EV 数据库是管理和分析在欧洲经济区（EEA）获得授权或正在临床试验中研究的药物可疑 AE 信息的系统。我们回顾性地研究了自 EMA 警告发布以来（21 个月）至现在 FQ 和 QN 对肌肉骨骼和神经系统的影响，并将这些结果与 EMA 警告前的 21 个月进行了比较。
EV 数据库中的主要 AE 报告为环丙沙星、左氧氟沙星、莫西沙星、诺氟沙星和氧氟沙星。在 EMA 警告前的 21 个月内，环丙沙星的总 AE 为 2763 例，在 EMA 警告前 12 个月内为 2935 例，在 EMA 警告后 12 个月内为 3419 例，在 EMA 警告后 12 个月内为 3174 例。肌肉骨骼疾病分别为 574 例（总病例数的 21%）、21 个月前为 558 例（19%）、12 个月前为 1048 例（31%）、EMA 警告后 21 个月为 540 例（17%）。神经系统疾病分别为 606 例（总病例数的 22%）、21 个月前为 517 例（18%）、12 个月前为 680 例（20%）、EMA 警告后 21 个月为 560 例（18%）（分别为 OR 1.16，95%CI 1.10-1.22，P 0.12；OR 0.76，95%CI 0.69-0.83，P 0.27；OR 1.01，95%CI 0.96-1.06，P 0.05）。
我们的分析清楚地表明，EMA 警告前后没有显著差异，这为 EMA 警告在临床实践中的作用提供了新的见解。
