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Amiodarone

Amiodarone was the first antiarrhythmic drug I was

Amiodarone

given upon being diagnosed with Afib.  I do not know if it would have worked as it made me very nauseous and tired and I had to stop taking it.  In hind site I guess I probably should have maybe given it a little longer as some patients say these symptoms subside after a few days.

Some patients tolerate Amiodarone with no problems at all.  I just did not want to take the risk long term.

Interestingly I was not told about the MANY side effects of Amiodarone at the time and I am glad I went off it when I did.  I then went on to try Tikosyn which helped me for over two years before it failed and I had my ablation.  It should be noted that most cardiologists want you to try - and fail - at least two different drugs before they consider you a candidate for an ablation.  

Amiodarone brand name(Cordarone, Pacerone) is one of the most effective, but certainly the strangest, antiarrhythmic drugs ever developed.  One of the strangest aspects of the drug is its history.  It is a history that explains much about why, to this day, many of the more unusual features of the drug are poorly understood by many doctors who prescribe it.

Amiodarone was developed by a Belgian company in 1961 as a drug for treating angina (chest discomfort related to coronary artery disease), and quickly became a popular anti-angina drug in Europe and South America.

As with a lot of drugs originally intended for another use doctors noticed that amiodarone seemed to reduce cardiac arrhythmias such as Atrial fibrillation. The drug soon being used extensively for heart rhythm disturbances with extraordinary results.  Amiodarone was soon being used all over the world (except in the United States) to treat cardiac arrhythmias of all kinds.  Its reputation soon spread far and wide and amiodarone became the go to antiarrhythmic drug - it almost always worked, and had virtually no side effects.(THEY THOUGHT!)

Both of these assertions, of course, proved false.

Beginning in the late 1970s, American electrophysiologists (heart rhythm specialists) began to get amiodarone from Canada and Europe to use in their patients with life-threatening arrhythmias who did not respond to any other drugs. (The FDA sanctioned this activity on a compassionate-use basis.) The early word from Americans seemed to confirm what was being said all over the world - amiodarone was very safe and very effective.

Within a few years, more than 10,000 American patients with potentially lethal arrhythmias were estimated to be receiving amiodarone.  Of course, because of the way amiodarone was being distributed, nobody really knew how many patients were receiving the drug.  More importantly, because the FDA was not involved in any of this (except to approve of the use of the drug for compassionate reasons), nobody was compiling information on the drug's effectiveness or safety.

Soon American doctors studied the effects of amiodarone on their own patients somewhat more rigorously than the overseas Docs had done.  As a result, within a year or two the view of amiodarone the "wonder drug" began to change.  Amiodarone was indeed more effective at suppressing arrhythmias than any other drug so far (though by no means as effective as had been advertised), but it produced a bizarre series of side effects - including difficult thyroid disorders, skin discoloration (turning BLUE!!), and potentially life-threatening lung toxicity - that doctors around the world seemed to have "missed."  The side effects had been missed, for the most part, because they were so unusual and unexpected, and because their onset tended to be insidious and late.

As the side effects of amiodarone began to be described in medical publications, the FDA became reluctant to approve the drug.  However, the FDA soon had little choice.  In the mid 1980s, the foreign manufacturers of amiodarone threatened to cut off the American supply (not entirely unreasonably, since they had supplied free drug to thousands and thousands of Americans for more than 5 years).  Simply cutting Americans off from the drug would produce a medical (and hence, possibly a political) disaster.  So, in 1985, in sharp contrast to any other drug in modern history, amiodarone became FDA-approved without rigorous, FDA-sanctioned randomized clinical trials.

Respectful of the drug's newly-discovered and very troublesome toxicity, the FDA approved the drug only for life-threatening arrhythmias for which no other treatment was feasible, and required a black-box warning regarding its dangerous side effects. 

Noting that the drug was indeed very effective for non-life-threatening arrhythmias, the FDA urged the manufacturers to conduct randomized clinical trials to gain formal approval for indications such as atrial fibrillation, noting that conducting such trials would reveal much about true incidence and seriousness of the drug's side effects.  Those trials were never done (possibly because such trials are very expensive, and by this time the patent on amiodarone was expiring, opening the door for generic manufacturers to begin selling it), and the original restrictions on the use of amiodarone have persisted to this day.

And as a result, the use of amiodarone for atrial fibrillation (the most common reason it is prescribed today) remains off-label.

The strange history of amiodarone may explain why some doctors who prescribe this drug seem unaware of the scope and the subtle nature of its many side effects - and why some of them do not adequately monitor their patients who take amiodarone, or fully inform their patients as to what to watch out for. 

Everyone taking prescription drugs ought to make themselves aware of possible side effects so they can help their doctors recognize when those side effects may be occurring. This general rule is doubly true for amiodarone.

Stingram.




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