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