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

[Brian, ASN, RN]

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:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Cordarone