Background: On March 11th 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. Methods: 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. Results: 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). Conclusions: 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.

Is EMA warning on quinolones and fluoroquinolones really assessed? An EudraVigilance database analysis / DE Nunzio, Cosimo; Nacchia, Antonio; Lombardo, Riccardo; Franco, Antonio; Cicione, Antonio; Trucchi, Alberto; Labella, Mattia; Bartoletti, Riccardo; Simonato, Alchiede; Ficarra, Vincenzo; Tubaro, Andrea. - In: MINERVA UROLOGY AND NEPHROLOGY. - ISSN 2724-6442. - (2023). [10.23736/S2724-6051.23.05169-8]

Is EMA warning on quinolones and fluoroquinolones really assessed? An EudraVigilance database analysis

DE Nunzio, Cosimo;Nacchia, Antonio;Lombardo, Riccardo;Franco, Antonio;Cicione, Antonio;Trucchi, Alberto;Labella, Mattia;Tubaro, Andrea
2023

Abstract

Background: On March 11th 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. Methods: 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. Results: 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). Conclusions: 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.
2023
ema; quinolones; warning
01 Pubblicazione su rivista::01a Articolo in rivista
Is EMA warning on quinolones and fluoroquinolones really assessed? An EudraVigilance database analysis / DE Nunzio, Cosimo; Nacchia, Antonio; Lombardo, Riccardo; Franco, Antonio; Cicione, Antonio; Trucchi, Alberto; Labella, Mattia; Bartoletti, Riccardo; Simonato, Alchiede; Ficarra, Vincenzo; Tubaro, Andrea. - In: MINERVA UROLOGY AND NEPHROLOGY. - ISSN 2724-6442. - (2023). [10.23736/S2724-6051.23.05169-8]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1676057
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