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Cordarone (Amiodarone Hydrochloride) - FDA Alerts

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FDA Alerts related to Cordarone (Amiodarone)

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.

For complete, up-to-date safety information by the FDA, see MedWatch

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