May 2006
Volume 47, Issue 13
ARVO Annual Meeting Abstract  |   May 2006
Amiodarone–Associated Optic Neuropathy: A Review of 294 Cases From the Research on Adverse Drug Events and Reports (RADAR) Project
Author Affiliations & Notes
  • L.N. Johnson
    Mason Eye Institute, University of Missouri–Columbia, Columbia, MO
  • R.S. Passman
    Northwestern University Medical School, Chicago, IL
  • C.L. Bennett
    Northwestern University Medical School, Chicago, IL
  • Footnotes
    Commercial Relationships  L.N. Johnson, None; R.S. Passman, None; C.L. Bennett, None.
  • Footnotes
    Support  RPB
Investigative Ophthalmology & Visual Science May 2006, Vol.47, 765. doi:
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      L.N. Johnson, R.S. Passman, C.L. Bennett; Amiodarone–Associated Optic Neuropathy: A Review of 294 Cases From the Research on Adverse Drug Events and Reports (RADAR) Project . Invest. Ophthalmol. Vis. Sci. 2006;47(13):765.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To report 294 cases of amiodarone–associated optic neuropathy (AON), representing the largest number of cases reported with this toxicity.

Methods: : Reports of AON were identified from the Food and Drug Administration’s Adverse Event Reporting System (FDA–AERS) and published cases identified through Medline search.

Results: : A total of 294 cases of AON were identified: 214 from the FDA–AERS, 57 from published case reports, and 23 from adverse events reports for patients enrolled on clinical trials. Based on a priori criteria, 80 cases were characterized as having definitive AON. The mean age was 63 (± 10) years and 84% were male. The mean duration of amiodarone therapy before vision loss was 9 months (range 1–84 months). Insidious onset AON (44%) was the most common presentation. Other presentations included acute onset optic neuropathy (21%), retrobulbar optic neuropathy (29%), pseudotumor cerebri/raised intracranial pressure (8%), and delayed–progressive onset optic neuropthay (6%). In some cases, ocular presentation varied between eyes in the same patient. Nearly one–third of the patients were asymptomatic. Optic disc edema was present in 85% of cases, with median duration of 3 months (range, 1 to 8 months). Visual acuity at presentation ranged from 20/15 to light perception. In follow–up, 58% had improved visual acuity, 21% had unchanged visual acuity, and 21% had further decreased visual acuity. Legal blindness (20/200 or worse) was noted in at least one eye in 20% of cases.

Conclusions: : The clinical presentations of AON can be acute onset and unilateral, and does not have to be insidious and bilateral. Visual improvement occurs in 58% of cases following amiodarone discontinuation.

Keywords: drug toxicity/drug effects • neuro-ophthalmology: optic nerve • visual impairment: neuro-ophthalmological disease 

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