June 1997

Dear Health Care Professional:

Wyeth-Ayerst Laboratories would like to advise you of revised labeling with respect to the Warnings for CORDARONE (amiodarone HCl) TABLETS (see enclosed package insert). Cordarone is an antiarrhythmic agent indicated for the treatment of recurrent ventricular fibrillation and/or recurrent hemodynamically unstable ventricular tachycardia when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.

There have been published reports of optic neuritis and optic neuropathy coincident with amiodarone therapy which were detected after fundoscopic examination of the optic disc and visual field test. In those reported cases where patients were followed for periods of 6 months to 1 year after discontinuation of therapy, visual disturbances and vision loss tended to improve and there was no evidence of progressive visual dysfunction.

In addition, through our postmarketing adverse experience reporting system we have received spontaneous reports of optic neuritis or optic neuropathy coincident with Cordarone therapy. Patients presented with decreased or blurred vision which, in some cases, progressed to permanent blindness. These reports were submitted by health care professionals or consumers to Wyeth-Ayerst Laboratories. It is important to emphasize that, although these events were reported to have occurred during treatment with Cordarone, they were not necessarily caused by it. These events may have been related to an underlying disease, to Cordarone, to other drugs being taken concurrently, or they may have occurred coincidentally during Cordarone use.

In light of the foregoing, please note that the Warnings section of the Cordarone Tablets prescribing information has been revised to include the following:

LOSS OF VISION
Cases of optic neuropathy and/or optic neuritis, usually resulting in visual impairment, have been reported in patients treated with amiodarone. In some cases, visual impairment has progressed to permanent blindness. Optic neuropathy and/or neuritis may occur at any time following initiation of therapy. A causal relationship to the drug has not been clearly established. If symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision, prompt ophthalmic examination is recommended. Appearance of optic neuropathy and/or neuritis calls for re-evaluation of Cordarone therapy. The risks and complications of antiarrhythmic therapy with Cordarone must be weighed against its benefits in patients whose lives are threatened by cardiac arrhythmias. Regular ophthalmic examination, including fundoscopy and slit-lamp examination, is recommended during administration of Cordarone.

Ophthalmic abnormalities including optic neuropathy and/or optic neuritis, in some cases progressing to permanent blindness, papilledema, corneal degeneration, photosensitivity, eye discomfort, scotoma, lens opacities, and macular degeneration have been reported.

We ask health care professionals to help further our understanding of Cordarone Tablets by reporting all adverse events to the Wyeth-Ayerst Laboratories Drug Information Division at 1-800-934-5556 or to the FDA MEDWATCH program by telephone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, or by mail:

Wyeth-Ayerst Laboratories is committed to assisting you in treating your patients who have recurrent ventricular fibrillation and/or recurrent hemodynamically unstable ventricular tachycardia when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. If you have any questions about the new information in the package insert for Cordarone Tablets, please contact our Drug Information Division (1-800-934-5556).

Sincerely,

Marc W. Deitch, M.D.
Senior Vice President, Medical Affairs
and Medical Director

Encl.

See accompanying Prescribing Information.

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