Medication Guide for Amiodarone

The U.S Food and Drug Administration (FDA) has mandated a medication guide for amiodarone. In 2004, approximately 3 million prescriptions were dispensed for amiodarone, a drug for heart arrhythmia. More than The U.S Food and Drug Administration (FDA) has mandated a medication guide for amiodarone. In 2004, approximately 3 million prescriptions were dispensed for amiodarone, a drug for heart arrhythmia. More than 90 percent of amiodarone prescriptions are filled with generic amiodarone. The medication guide was published by a manufacturer of branded amiodarone at the request of the FDA. The complete medication guide can be found online at http://www.wyeth.com/content/ShowLabeling.asp?id=470 and http://www.upshersmith.com/PDFs/PaceroneMedGuide.pdf.

Several factors may have led to the publication of the medication guide, including:

• The risks of using amiodarone as an antiarrhythmic agent. Serious side effects are associated with this agent (e.g., lung damage, liver damage, worse heartbeat problems) that can lead to death.

• Off-label prescribing for atrial fibrillation. The FDA has not approved amiodarone for the treatment of atrial fibrillation. Amiodarone is approved only for use in adults with ventricular arrhythmias (life-threatening heartbeat problems), for which other treatments did not work or were not tolerated.

• Concern that prescribing physicians and patients receiving amiodarone may not be fully informed of the risk of using this drug.

Physicians and patients may seek information about alternative medications to amiodarone that are approved by the FDA for the treatment of symptomatic atrial fibrillation without structural heart disease. Older patients may be at higher risk, because atrial fibrillation most commonly affects persons who are 50 years and older.