PMID- 36940165
OWN - NLM
STAT- MEDLINE
DCOM- 20230525
LR  - 20230525
IS  - 2724-6442 (Electronic)
IS  - 2724-6051 (Linking)
VI  - 75
IP  - 3
DP  - 2023 Jun
TI  - Is EMA warning on quinolones and fluoroquinolones really assessed? An 
      EudraVigilance database analysis.
PG  - 374-380
LID - 10.23736/S2724-6051.23.05169-8 [doi]
AB  - BACKGROUND: On March 11(th) 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.
FAU - DE Nunzio, Cosimo
AU  - DE Nunzio C
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy - 
      cosimodenunzio@virgilio.it.
FAU - Nacchia, Antonio
AU  - Nacchia A
AD  - Department of Urology, IRCCS Oncological Referrence Center, Rionero in Vulture, 
      Potenza, Italy.
FAU - Lombardo, Riccardo
AU  - Lombardo R
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Franco, Antonio
AU  - Franco A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Cicione, Antonio
AU  - Cicione A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Trucchi, Alberto
AU  - Trucchi A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
FAU - Labella, Mattia
AU  - Labella M
AD  - Section of Statistics, Sapienza University, Rome, Italy.
FAU - Bartoletti, Riccardo
AU  - Bartoletti R
AD  - Unit of Urology, Department of Translational Research and New Technologies, 
      University of Pisa, Pisa, Italy.
FAU - Simonato, Alchiede
AU  - Simonato A
AD  - Section of Urology, Department of Surgical, Oncological and Oral Sciences, 
      University of Palermo, Palermo, Italy.
FAU - Ficarra, Vincenzo
AU  - Ficarra V
AD  - Unit of Urology, Department of Surgery, S. Croce e Carle Hospital, Cuneo, Italy.
AD  - Gaetano Barresi Department of Human and Pediatric Pathology, Section of Urology, 
      University of Messina, Messina, Italy.
FAU - Tubaro, Andrea
AU  - Tubaro A
AD  - Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230320
PL  - Italy
TA  - Minerva Urol Nephrol
JT  - Minerva urology and nephrology
JID - 101777299
RN  - 0 (Fluoroquinolones)
RN  - 0 (Quinolones)
RN  - 5E8K9I0O4U (Ciprofloxacin)
RN  - 6GNT3Y5LMF (Levofloxacin)
SB  - IM
MH  - *Fluoroquinolones/adverse effects
MH  - *Quinolones
MH  - Retrospective Studies
MH  - Ciprofloxacin/adverse effects
MH  - Levofloxacin
EDAT- 2023/03/21 06:00
MHDA- 2023/05/25 06:42
CRDT- 2023/03/20 12:59
PHST- 2023/05/25 06:42 [medline]
PHST- 2023/03/21 06:00 [pubmed]
PHST- 2023/03/20 12:59 [entrez]
AID - S2724-6051.23.05169-8 [pii]
AID - 10.23736/S2724-6051.23.05169-8 [doi]
PST - ppublish
SO  - Minerva Urol Nephrol. 2023 Jun;75(3):374-380. doi: 
      10.23736/S2724-6051.23.05169-8. Epub 2023 Mar 20.