Eye disorders during amiodarone treatment
Eye disorders during amiodarone treatment
Various ocular side effects can occur during amiodarone treatment: Corneal microdeposits, ocular changes connected with thyroid dysfunction, optic neuritis/optic neuropathy, scotoma, macular degeneration, photosensitivity, corneal degeneration. Very frequently (almost without exception) microdeposits form on the cornea when a sufficient tissue concentration of the medicinal product is reached.
These are generally localised beneath the pupil, asymptomatic and are not in any way a contraindication to continued treatment. They may be accompanied by the perception of coloured rings around dazzling lights or by blurred vision. These corneal microdeposits are made up of complex lipid structures and can be reversed on discontinuation of treatment.
In rare cases, serious optic neuritis/optic neuropathy may occur during amiodarone treatment, causing bilateral blindness and, as a result, discontinuation of treatment (Ref. 1).
Amiodarone, ocular side effects, corneal deposits, optic neuritis, optic neuropathy
Incident data |
Description |
Case: 2011
Age: 44
Sex: Male
Medicinal products: Cordarone
Active substances: amiodarone
Indication: Symptomatic atrial fibrillation
ADR: Corneal deposits
Outcome: Unknown |
Some time after commencing amiodarone treatment, the patient consulted his GP because he was experiencing impaired vision. Ophthalmological examination revealed deposits typical of those associated with amiodarone, but no signs of optic neuritis. Amiodarone treatment was subsequently discontinued. No reports on the further course of the reaction were received. |
Case series: 13 patients
Age: 60-85
Sex: 11 male, two female
Active substances: amiodarone
Indication: Arrhythmia
ADR: Optic neuropathy
Outcome: Not systematically recorded |
A retrospective case series described 13 patients (11 men and two women) aged 60 to 85 who developed optic neuropathy after treatment with amiodarone (four patients in one eye, nine in both) (Ref. 2). The amiodarone dosage was 1 g/week in one case, 1.4 g/week in ten cases and 3 g cumulative by intravenous administration in one case. No dosage was documented in one case. In all cases, the indication for amiodarone was ventricular or supraventricular arrhythmia. The ophthalmological symptoms were regressing in some cases, but the course was not systematically recorded. Among other things, the authors mention the difficulty of diagnosing clinically distinct “amiodarone-associated optic neuropathy (AAON)“, where a causal relationship between the optic neuropathy and treatment amiodarone is assumed (Ref. 2). |
Summary and recommendation
Regular ophthalmological examinations, including fundoscopy and slit lamp examinations, are recommended during treatment with amiodarone. If visual acuity gradually declines and the visual field becomes impaired, an ophthalmological examination that includes fundoscopy must be carried out without delay. If optic neuropathy/optic neuritis occur, amiodarone treatment must be discontinued owing to possible progression to bilateral blindness (Ref. 1).
Statutory duty of healthcare professionals to report adverse drug reactions (ADRs)
In Switzerland, healthcare professionals who are authorised to dispense or administer medicinal products are obligated to report severe and/or previously unknown side effects. Reports to Swissmedic can be entered and sent in the Electronic Vigilance Reporting Portal “ElViS”.
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References
[1] Information for healthcare professionals (www.swissmedicinfo-pro.ch)
[2] Fasler K, Traber GL, Jaggi GP, Landau K. Amiodarone-associated Optic Neuropathy-A Clinical Criteria-based Diagnosis?. Neuroophthalmol 2017;42(1):2-10.
Note for marketing authorisation holders
If articles in this section refer to individual cases, these cases are already recorded in the Swiss spontaneous reporting system and have been transmitted to all responsible institutions. We ask affected marketing authorisation holders not to report these cases again (“back report”) to Swissmedic.
