Black Box Warning
Amiodarone is intended for use only in patients with life-threatening arrhythmias because its use is accompanied by substantial toxicity. (1) Pulmonary toxicity, including potentially fatal interstitial pneumonitis and pulmonary fibrosis, occurs in 10-17% of patients on doses around 400 mg/day. (2) Hepatotoxicity ranging from asymptomatic enzyme elevation to hepatic failure has been reported. (3) Proarrhythmic effects, including worsening of existing arrhythmia, torsades de pointes, and new-onset ventricular arrhythmias, have occurred. Initiate therapy in a hospital setting with continuous ECG monitoring.
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Amiodarone.