Alert for Healthcare Professionals
Amiodarone (marketed as Cordarone)

FDA Alert [05/2005]: Pulmonary toxicity, Hepatic Injury, and Worsened Arrhythmia
Amiodarone may cause potentially fatal toxicities, including pulmonary toxicity, hepatic injury, and worsened arrhythmia.

Amiodarone should only be used to treat adults with life-threatening ventricular arrhythmias when other treatments are ineffective or have not been tolerated.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Recommendations

Because of its potentially life-threatening side effects and the difficulties associated with managing its use, amiodarone should be prescribed for the treatment of only the following documented, life-threatening, recurrent ventricular arrhythmias when these arrhythmias have not responded to other antiarrhythmic agents or when alternative agents have not been tolerated:           

• Recurrent ventricular fibrillation

• Recurrent hemodynamically unstable ventricular tachycardia

Patients must be hospitalized while the loading doses of amiodarone are administered. Amiodarone should be prescribed only by physicians experienced in the treatment of life-threatening arrhythmias who are thoroughly familiar with amiodarone’s risks and benefits and have access to laboratory facilities capable of adequately monitoring the effectiveness and side effects of amiodarone treatment. 

Data Summary

Amiodarone has several potentially fatal toxicities.  The most important of these is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis). This has occurred as clinically manifest disease at rates as high as 17 percent in some series of patients with ventricular arrhythmias given doses of around 400 mg daily, as abnormal diffusion capacity without symptoms in a much higher percentage of patients.  Pulmonary toxicity is fatal about 10 percent of the time. 

Hepatic injury is common with amiodarone, but is usually mild and evidenced only by abnormal liver enzymes.  Overt liver disease can occur, however, and has been fatal in a few cases. 

Amiodarone can exacerbate the ventricular arrhythmia being treated by, for example, making the arrhythmia less well-tolerated or more difficult to reverse.  This has occurred in approximately 2 to 5 percent of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5 percent of patients.  Although the frequency of such proarrhythmic events does not appear greater with amiodarone than with other antiarrhythmic agents, the effects are prolonged when they occur, because amiodarone is very slowly metabolized and excreted (over months). 

FDA Amiodarone Patent Information Sheet
http://www.fda.gov/cder/drug/infosheets/patient/amiodaronePIS.pdf 

Report serious adverse events to FDA's MedWatch at 1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
druginfo@fda.hhs.gov

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Date created: May 2005

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