Medication Guide for Cordarone (amiodarone HCl) (June 2005)
FDA is notifying physicians and pharmacists that a Medication Guide for patients must be distributed with each prescription for Cordarone tablets, or generic amiodorone. This is an anti-arrhythmic drug used to treat severe ventricular arrhythmias. FDA requires these guides for drugs that pose a serious public health concern. The guide explains to patients that Cordarone can cause lung damage and liver damage, and in some cases can worsen the heart rhythm problems that the drug is intended to treat. It describes the warning symptoms that should lead patients to seek medical attention, and explains that the drug should only be used when other agents did not work. In a letter to health care professionals, Cordarone's manufacturer, Wyeth Laboratories, cautions that the Medication Guide should not be used as a substitute for talking to patients about the risks and benefits of the drug.
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