kfay said:
"Many Doctors take the 'easy way out' and put their patients on the SLEDGE HAMMER of antiarrhythmics, Amiodarone, in spite of it's laundry list of dangerous side effects (if taken in too large a dose and / or for too long) and the fact that it takes MONTHS to be eliminated from the body once it is discontinued"
Can I just add to this thread that I am really tired of reading the constant dire warnings about how bad and horrible it is to be on this drug? After reading for months on VR.com about how awful it is and how dangerous it is, when I was coherent enough after surgery to realize they had put me on it, needless to say I was less than pleased. I questioned 3 very well respected, obviously well trained and knowledgable Dr.'s from the Mayo clinic not to mention my local cardio after I got home, about the wisdom of putting me on such a powerful, dangerous drug when others are available that might be able to do the job. They all assured me that they knew what they were doing, had much experience (much more than me one told me) in dealing with patients after heart surgery and how to most effectively keep them from entering what can be potentially deadly heart rhythms. They all assured me that a three month course of this drug far outweighs any harm that may come from it. Please be aware that sometimes when you pinpoint a specific drug or valve as having "dangerous side effects", you may cause some one to go against their doctors specific advice or turn down something that may actually save their life.
Just my opinion
Kim
You raise a good point Kim. For Short Term Use (6 months MAXIMUM) with Proper and Regular Monitoring, Amiodarone is 'usually' safe.
We have read reports on VR.com where patients were "inadvertently" continued on Amiodarone for way longer than intended resulting in permanent injuries.
I have 2 concerns about using Amiodarone as the First Treatment for post-op Atrial Fibrilation.
First, the FDA has issued a WARNING that it should ONLY be used after other treatment options have proven inadequate. So why is it used as the First Choice so often?
Second, is that I suspect that patients are NOT fully informed about the treatment options and possible consequences of those options. Whatever happened to "Informed Concent"?
At the Very Least, it is MY belief that patients should be advised of the treatment plan, including Dose and Duration, along with potential side effects to watch for and report if observed.
Do these patients know what needs to be watched for?
An uninformed patient and overworked medical providers is a recipe for disaster. How many times have patients been continued on the High Loading Dose because someone 'forgot' to lower the dose after X weeks?
"Trust me, I am a Doctor" equates Doctors with GOD and PERFECTION.
I won't elaborate on those issues.
When I did a Google Search for "Amiodarone" I came up with 1,600,000 links.
Here are a few from the First Page, starting with the FDA ALERT:
Search
Amiodarone hydrochloride (marketed as Cordarone) Information
FDA ALERT [05/2005] – Pulmonary toxicity, Hepatic Injury, and Worsened Arrhythmia
Amiodarone may cause potentially fatal toxicities, including pulmonary toxicity, hepatic injury, and worsened arrhythmia.
Amiodarone should only be used to treat adults with life-threatening ventricular arrhythmias when other treatments are ineffective or have not been tolerated.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
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from :
http://www.rxlist.com/cgi/generic/amiodarone_wcp.htm
WARNINGS
Cordarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
Cordarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time. Liver injury is common with Cordarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Like other antiarrhythmics, Cordarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with Cordarone than with many other agents used in this population, the effects are prolonged when they occur.
Even in patients at high risk of arrhythmic death, in whom the toxicity of Cordarone is an acceptable risk, Cordarone poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.
The difficulty of using Cordarone effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of Cordarone is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15 to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when Cordarone must be stopped will be made difficult by the gradually, but unpredictably, changing amiodarone body burden. A similar problem exists when Cordarone is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried.
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SIDE EFFECTS
Adverse reactions have been very common in virtually all series of patients treated with Cordarone for ventricular arrhythmias with relatively large doses of drug (400 mg/day and above), occurring in about three-fourths of all patients and causing discontinuation in 7 to 18%. The most serious reactions are pulmonary toxicity, exacerbation of arrhythmia, and rare serious liver injury (see “WARNINGS”), but other adverse effects constitute important problems. They are often reversible with dose reduction or cessation of Cordarone treatment. Most of the adverse effects appear to become more frequent with continued treatment beyond six months, although rates appear to remain relatively constant beyond one year. The time and dose relationships of adverse effects are under continued study.
Neurologic problems are extremely common, occurring in 20 to 40% of patients and including malaise and fatigue, tremor and involuntary movements, poor coordination and gait, and peripheral neuropathy; they are rarely a reason to stop therapy and may respond to dose reductions or discontinuation (see “PRECAUTIONS”).
Gastrointestinal complaints, most commonly nausea, vomiting, constipation, and anorexia, occur in about 25% of patients but rarely require discontinuation of drug. These commonly occur during high-dose administration (i.e., loading dose) and usually respond to dose reduction or divided doses.
Ophthalmic abnormalities including optic neuropathy and/or optic neuritis, in some cases progressing to permanent blindness, papilledema, corneal degeneration, photosensitivity, eye discomfort, scotoma, lens opacities, and macular degeneration have been reported. (See “WARNINGS”.)Asymptomatic corneal microdeposits are present in virtually all adult patients who have been on drug for more than 6 months. Some patients develop eye symptoms of halos, photophobia, and dry eyes. Vision is rarely affected and drug discontinuation is rarely needed.
Dermatological adverse reactions occur in about 15% of patients, with photosensitivity being most common (about 10%). Sunscreen and protection from sun exposure may be helpful, and drug discontinuation is not usually necessary. Prolonged exposure to Cordarone occasionally results in a blue-gray pigmentation. This is slowly and occasionally incompletely reversible on discontinuation of drug but is of cosmetic importance only.
Cardiovascular adverse reactions, other than exacerbation of the arrhythmias, include the uncommon occurrence of congestive heart failure (3%) and bradycardia. Bradycardia usually responds to dosage reduction but may require a pacemaker for control. CHF rarely requires drug discontinuation. Cardiac conduction abnormalities occur infrequently and are reversible on discontinuation of drug.
The following side-effect rates are based on a retrospective study of 241 patients treated for 2 to 1,515 days (mean 441.3 days).The following side effects were each reported in 10 to 33% of patientsGastrointestinal: Nausea and vomiting.
The following side effects were each reported in 4 to 9% of patients
Dermatologic: Solar dermatitis/photosensitivity.Neurologic: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias.Gastrointestinal: Constipation, anorexia.
Ophthalmologic: Visual disturbances.
Hepatic: Abnormal liver-function tests.
Respiratory: Pulmonary inflammation or fibrosis.The following side effects were each reported in 1 to 3% of patients
Thyroid: Hypothyroidism, hyperthyroidism.Neurologic: Decreased libido, insomnia, headache, sleep disturbances.
Cardiovascular: Congestive heart failure, cardiac arrhythmias, SA node dysfunction. Gastrointestinal: Abdominal pain.Hepatic: Nonspecific hepatic disorders.
Other: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities.
The following side effects were each reported in less than 1% of patients
Blue skin discoloration, rash, spontaneous ecchymosis, alopecia, hypotension, and cardiac conduction abnormalities.
In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with Cordarone, the adverse reactions most frequently requiring discontinuation of Cordarone included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.
Other symptoms causing discontinuations less often included visual disturbances, solar dermatitis, blue skin discoloration, hyperthyroidism, and hypothyroidism. Postmarketing ReportsIn postmarketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, renal impairment, renal insufficiency, acute renal failure, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pulmonary alveolar hemorrhage, pleuritis, pseudotumor cerebri, syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, hallucination, confusional state, disorientation, delirium, epididymitis, impotence, and parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversable with discontinuation of therapy), also have been reported with amiodarone therapy.
