Amiodarone, also sold under the brand names Cordarone® and Pacerone,® are extremely dangerous drugs that were FDA approved for the limited purpose of treating recurring, life-threatening ventricular fibrillation (VFib) but only as a last resort after all other treatments have failed.
The reason for this narrowly approved use is the risk of death from recurrent, life-threatening V-Fib 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 serious 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. The Generic manufacturers not only capitalized on the market created by Wyeth but continued 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 a large number of much safer treatment options were available. The most serious complication from Amiodarone use is pulmonary fibrosis/pulmonary 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 due in part to the intent that this drug be used only on a very small group of individuals who otherwise would have no treatment for their life-threatening VFib. Nor did Wyeth Pharmaceuticals perform any post-market clinical trials to show the drug’s safety and efficacy, despite requests to do so by the FDA.
Amiodarone is also one of a small number of drugs considered so dangerous that the FDA requires a special, direct warning 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 the patient is warned of the 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.
Most Amiodarone patients we have spoken to have never received a Medication Guide, were not aware of any of these serious and potentially deadly complications, and were not aware the drug was never approved for use in the treatment of AFib. Indeed, the vast majority of Amiodarone prescriptions are not for the FDA approved use, but instead it is prescribed as a “first line” of 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 for VFib). These AFib patients, many of whom have debilitating and deadly lung diseases, should never have been prescribed Amiodarone, and if they had been given the required Medication Guide, would never have taken the drug. We have filed a number of lawsuits on behalf of AFib patients who developed pulmonary fibrosis/toxicity or blindness after being prescribed Amiodarone for treatment of the AFib.
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