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4.3.3. Fluoroquinolones:
ciprofloxacin (NAP), enoxacin (NAP), flumequine (NAP), lomefloxacin (NAP), levofloxacin (NAP),
moxifloxacin (NAP), norfloxacin (NAP), ofloxacin (NAP), pefloxacin (NAP), prulifloxacin (NAP),
rufloxacin (NAP)
Signal of retinal detachment
Regulatory details:
PRAC Rapporteur: Martin Huber (DE)
Administrative details:
EPITT 15914 – Follow-up April 2013
MAH(s): Bayer, Sanofi, various
Background
For background information, see PRAC minutes of 8-11 April 2013.
Following the last discussion at PRAC further epidemiological studies on the association between
fluoroquinolones and retinal detachment had been published 10 and the EMA secretariat had conducted
an analysis in The Health Improvement Network (THIN) database as previously recommended by the
PRAC. The newly published literature and the outcome of the THIN analysis were critically reviewed by
the Rapporteur.
Discussion
The PRAC discussed the assessment of the newly available studies and agreed that they had limitations
with regard to their ability to address the complex situation of ophthalmologic confounding factors and
concurrent risk factors for retinal detachment.
Furthermore, most studies were based on secondary analyses of health care data with limited
information on confounders. However, two studies 11 had found a statistically significant increased risk
of retinal detachment in association with fluoroquinolone treatment.
Since October 2012, new cases of retinal detachment with fluoroquinolones were reported, some of
them assessed as at least ‘possibly related’ to fluoroquinolone use.
The PRAC concluded that a causal relationship between fluoroquinolone intake and retinal detachment
could neither be established nor firmly excluded based on the available data. Therefore, as a
precautionary measure, a warning on visual disorders should be included in the product information of
systemic fluoroquinolones, when no such warning exists.
10 Kuo SC, Chen YT, Lee YT, Fan NW, Chen SJ, Li SY, Liu CJ, Chen TL, Chen TJ, Fung CP. Association between recent use of
fluoroquinolones and rhegmatogenous retinal detachment: a population-based cohort study. Clin Infect Dis. 2014
Jan;58(2):197-203.
Fife D, Zhu V, Voss E, Levy-Clarke G, Ryan P. Exposure to oral fluoroquinolones and the risk of retinal detachment:
retrospective analyses of two large healthcare databases. Drug Saf. 2014 Mar;37(3):171-82.
Chui CS, Man KK, Cheng CL, Chan EW, Lau WC, Cheng VC, Wong DS, Yang Kao YH, Wong IC. An investigation of the
potential association between retinal detachment and oral fluoroquinolones: a self-controlled case series study. J Antimicrob
Chemother. 2014 May 15. pii: dku145.
Kapoor KG, Hodge DO, St Sauver JL, Barkmeier AJ. Oral Fluoroquinolones and the Incidence of Rhegmatogenous Retinal
Detachment and Symptomatic Retinal Breaks: A Population-Based Study. Ophthalmology. 2014 Jan 28. pii: S0161-
6420(13)01181-0. doi: 10.1016/j.ophtha.2013.12.006.
11 Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment.
JAMA. 2012 Apr 4;307(13):1414-9.
Kuo SC, Chen YT, Lee YT, Fan NW, Chen SJ, Li SY, Liu CJ, Chen TL, Chen TJ, Fung CP. Association between recent use of
fluoroquinolones and rhegmatogenous retinal detachment: a population-based cohort study. Clin Infect Dis. 2014
Jan;58(2):197-203
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 20/75