Amiodarone, also sold under the brand names Cordarone^® and Pacerone ^®, is an extremely dangerous prescription drug that is FDA-approved to treat recurring, life-threatening ventricular fibrillation (VFib) and only as a last resort after all other treatments have failed.

Patient with amiodarone-induced pulmonary fibrosis

This narrowly approved use is because the risk of death from recurrent, life-threatening VFib outweighs the severe and potentially deadly complications from amiodarone. But even then, amiodarone is only to be used as a treatment of last resort after all other treatment measures have failed.

However, the number of individuals suffering from life-threatening VFib, for whom all other forms of treatment have failed, is extremely small. Because of this, the initial brand name manufacturer, Wyeth Pharmaceuticals, began an aggressive campaign to promote the drug to physicians as a “first-line” treatment for atrial fibrillation (AFib), a less severe but far more common form of heart arrhythmia.

In contrast to the small number of individuals suffering from recurrent, life-threatening VFib, more than 6 million Americans suffer from AFib. Despite repeated warnings from the FDA to stop the misleading promotion of amiodarone as a safe and effective treatment for AFib, Wyeth continued its marketing campaign.

Now the generic manufacturers are capitalizing on the market created by Wyeth in continuing the misleading promotion of amiodarone as a treatment for AFib.

This has resulted in millions of AFib sufferers being improperly prescribed amiodarone, unnecessarily exposing them to the potentially deadly complications of amiodarone when several other safer treatment options were available. The most severe complication from amiodarone use is pulmonary fibrosis or toxicity, which causes death in many sufferers. Other serious complications include blindness.

Exacerbating this apparent disregard for safety is the fact that amiodarone was approved under a unique “special needs” approval process, allowing it to bypass the usual clinical trials to show the efficacy and safety of the drug required before FDA approval. This was partly due to the intent that this drug is used only on a very small group of individuals who otherwise would have no treatment for their life-threatening VFib.

Wyeth Pharmaceuticals also failed to perform any post-market clinical trials to show the drug’s safety and efficacy, despite requests to do so by the FDA.

Amiodarone Medication Guide

Amiodarone is one of a few prescription drugs considered so dangerous that the FDA requires a special, direct warning to be given to the consumer at the time of purchase. The FDA requires this warning to come in the form of a “Medication Guide.”

The purpose of the Medication Guide is to ensure a patient is directly warned of a drug’s serious and deadly complications outside of the physician-patient relationship. The manufacturers of amiodarone, along with the distributor and pharmacy, are under a duty to ensure that each patient prescribed amiodarone receives the Medication Guide.

Amiodarone Off-Label Use for AFib

Most amiodarone patients we have spoken to have never received a Medication Guide and were unaware of any serious and potentially deadly complications. Most doctors we have talked to are equally unaware of the history of amiodarone and the fact the FDA never approved the drug for use in the treatment of AFib.

Today, most amiodarone prescriptions are not for FDA-approved use; instead, the drug is prescribed as a “first line” treatment for patients with AFib. These individuals are the opposite of the intended users, which are persons with life-threatening VFib for whom all other treatment options have failed (a treatment of last resort).

These AFib patients, many of whom already have debilitating and deadly lung diseases, should never have been prescribed amiodarone. They might never have taken the drug if they had been given the required Medication Guide.