was the first antiarrhythmic drug I was
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
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
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
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
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.
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