Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2016-01-08

Product

Oral fluoroquinolones

Potential Safety Issue

Retinal detachment

Key Messages

  • Oral fluoroquinolones are antibiotics used to treat bacterial infections.
  • Health Canada's follow-up safety review on the link between the use of oral fluoroquinolones and retinal detachment was carried out to assess new evidence since the completion of Heath Canada's initial review on this issue in 2013.
  • Health Canada's follow-up safety review concluded that a potential link between the use of oral fluoroquinolones and retinal detachment could not be ruled out at this time. Given that retinal detachment is a medical emergency, the recommendations of the Health Canada review were that the current labeling for oral fluoroquinolones be revised to highlight the urgency to consult a health care professional if patients experienced vision problems during or following oral fluoroquinolone's administration.

Overview

A Health Canada safety review was carried out as a follow-up assessment on the potential risk of retinal detachment with the use of oral fluoroquinolones. Health Canada's previous safety review examined the risk of retinal detachment with oral fluoroquinolones and had concluded that limited evidence was available to support a link at that time. Since Health Canada's initial review, many other studies have been conducted regarding the potential link between the use of oral fluoroquinolones and retinal detachment triggering this follow-up safety review.

Retinal detachment is a painless separation of the retina from the layer of support tissue and blood vessels at the back of the eye that provides the retina with oxygen and nourishment. Symptoms related to retinal detachment depend on the location and extent of the detachment, and may include the sudden appearance of debris in the field of vision (look like spots, hairs or strings and seem to float across one's vision -- floaters), the perception of flashes of light in the affected eye, the sensation that a shadow or curtain has come down over a portion of the visual field, or even sudden and complete loss of vision in the affected eye. Retinal detachment is considered a medical emergency and requires immediate attention to prevent permanent visual damage.

Use in Canada

  • Oral fluoroquinolones are medicines widely used to treat bacterial infections (antibiotics), especially infections of the respiratory and the urogenital system (genitourinary tract).
  • There are five different oral fluoroquinolone drugs marketed in Canada by different companies: ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin a.

Safety Review Findings

  • At the time of the second Health Canada review, there were 3 reports of retinal detachment in Canada b that were linked to the use of oral fluoroquinolones. A causal relationship between the use of fluoroquinolones and the development of retinal detachment could not be established from these Canadian reports.
  • At the time of the second Health Canada review, 22 reports c of retinal detachment linked with oral fluoroquinolones were reported internationally.
  • Two publications (of four observational studies) found a modest link between the occurrence of retinal detachment and the use of fluoroquinolones (8 to 365 days after completion of treatment).

Conclusions and actions

  • Health Canada's follow-up safety review concluded that a link between the use of fluoroquinolones and the occurrence of retinal detachment cannot be ruled out at the present time.
  • Given that retinal detachment is a medical emergency, the recommendations of the review were that the current labeling for oral fluoroquinolones be revised to highlight the urgency to see a health care professional if patients experienced vision problems during or following oral fluoroquinolone administration.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Etminan M, Forooghian F, Brophy JM, Bird ST and Maberley D, (2012), Oral fluoroquinolones and the risk of retinal detachment, JAMA 307:1414-1419.
  2. Chui CS, Man KK, Cheng CL, et al, (2014), An investigation of the potential association between retinal detachment and oral fluoroquinolones: a self-controlled case series study, J Antimicrob Chemother 69:2563-2567.
  3. Eftekhari K, Ghodasra DH, Haynes K, et al, (2014), Risk of retinal tear or detachment with oral fluoroquinolone use: a cohort study, Pharmacoepidemiol Drug Saf 23:745-752.
  4. Fife D, Zhu V, Voss E, Levy-Clarke G, Ryan P, (2014), Exposure to oral fluoroquinolones and the risk of retinal detachment: retrospective analyses of two large healthcare databases, Drug Saf 37:171-82.
  5. Kapoor KG, Hodge DO, St Sauver JL, Barkmeier AJ, (2014), Oral fluoroquinolones and the incidence of rhegmatogenous retinal detachment and symptomatic retinal breaks: A population-based study, Ophthalmology S0161-6420.
  6. Kuo SC, Chen YT, Lee YT, et al, (2014), Association between recent use of fluoroquinolones and rhegmatogenous retinal detachment: a population-based cohort study, Clin Infect Dis 58:197-203.
  7. Pasternak B, Svanström H, Melbye M, Hviid A, et al, (2013), Association between oral fluoroquinolone use and retinal detachment, JAMA 310:2184-2190.

Footnotes

  1. Gatifloxacin was one of the oral fluoroquinolones identified in Etminan et al study and therefore was considered along with the other marketed FQs. However, oral gatifloxacin is no longer marketed in Canada (since June 29, 2006).
  2. Canadian reports can be accessed through the Canada Vigilance Online Database.
  3. International reports were retrieved from the Eudravigilance database.
  4. This list of references is not intended to be exhaustive. References have been selected as suggestions for further reading and reflect the most current information at the time of the safety review.

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