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.
