FDA MedWatch - Cordarone (amiodarone HCl) and new Medication Guide

  1. MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    FDA and Wyeth notified pharmacists and physicians of a new Medication Guide
    for Cordarone (amiodarone hydrochloride tablets). The FDA regulation 21CFR
    208 requires a Medication Guide to be provided with each prescription that
    is dispensed for products that FDA determines pose a serious and significant
    public health concern. A list of currently approved Medication Guides are
    available at http://www.fda.gov/cder/Offices/ODS/labeling.htm.

    Read the 2005 safety summary, including links to the Dear Healthcare
    Professional Letter, Dear Pharmacist Letter, current Prescribing
    Information, and new Medication Guide:

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