Irregular heart rhythms can be very scary. So too are the drugs that treat these arrhythmias. That’s because anti-arrhythmic medications often come with a long list of serious side effects. This is especially true of amiodarone.
Amiodarone (Cordarone, Nexterone, Pacerone) was approved by the FDA in 1985. It will come as a shock to many health professionals and patients to learn that this powerful drug was allowed on the U.S. market without the usual randomized, double-blind, placebo-controlled trials required for 99% of all medications. That is a tale of woe and intrigue that we won’t go into here.
The FDA has a great number of cautions (including a stringent “black box” warning) about amiodarone. The feds make it clear that 1) the drug has life-threatening side effects and 2) it is a difficult drug to manage. As a result, the FDA states unequivocally that amiodarone should be prescribed only for life-threatening irregular rhythms of the ventricles (“recurrent ventricular fibrillation” or “recurrent hemodynamically unstable ventricular tachycardia”) and then only when other treatments have failed. The FDA also states clearly that patients should only be started on amiodarone in a hospital setting to reduce the likelihood of a life-threatening complication. We suspect that this advice is frequently ignored.
Really Scary Amiodarone Side Effects:
• Lung toxicity is common and can be fatal; symptoms may include wheezing, difficulty breathing, fever, shortness of breath and coughing up blood. Pulmonary fibrosis is a very serious complication of amiodarone therapy.
• Liver damage, liver enzyme elevation, hepatitis
• Worsening of irregular heart rhythms, Torsades de Pointes, slow heart rate
• Thyroid disorders, hyperthyroidism, hypothyroidism, thyrotoxicosis
• Serious visual disturbances, loss of vision, optic nerve damage, blindness
• Dangerous or deadly drug interactions; amiodarone can interact with many other medications in very dangerous ways. No one should ever combine amiodarone with any other drugs without having the prescriber and pharmacist double check for incompatibility reactions.

Cancer?

A study from Taiwan just published in the journal Cancer (online, April 8, 2013) reveals another serious concern about amiodarone. Investigators tracked over 6,000 patients who received amiodarone between 1997 and 2008. There was a modest 12% increased risk of cancer among the patients who took this anti-arrhythmic, but that doesn’t tell the whole story. For men who took amiodarone over at least a year, the elevated risk was 46%. And at the highest dose, the risk increased to 98%. This sort of dose-response effect is worrisome because it suggests that this could be more than a random or coincidental effect.
Doctors will have a hard time making sense of this research. That’s because the FDA doesn’t quite know what to do with such information. You might be surprised to learn that many medications cause cancer in animals. For example, there are notices in the official prescribing information for medications such as omeprazole (Prilosec), which is taken for heartburn or reflux. The drug causes abnormal cell growth and stomach tumors (carcinoids) in rats. No one seems to know whether this constitutes a problem for people.
Spironolactone (Aldactazide, Aldactone) is a blood pressure medicine that is sometimes prescribed for hormonal imbalances and facial hair growth in women. It also causes tumors in rats.
Parents of children with eczema have been worried by reports that the prescription topical skin treatments, Elidel cream and Protopic ointment, are associated with lymphoma and skin cancer. The FDA has warned against using these drugs in children under two years of age. It also states that, “The long term safety of Elidel and Protopic are unknown.”
Such cautions are not reassuring; they leave patients and physicians in a quandary. The same is true for the rheumatoid arthritis injections Cimzia, Enbrel, Humira and Remicade. These very expensive bio-tech drugs have revolutionized the treatment of rheumatoid arthritis and Crohn’s disease. The FDA announced that it was investigating an association between these medications and the development of lymphoma or other cancers.
Another hugely controversial cancer connection has to do with cholesterol-lowering drugs. An article in the Journal of the American Medical Association (Jan. 3, 1996) warned that, “All members of the two most popular classes of lipid-lowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animal exposure close to those prescribed to humans.”
And just recently the FDA has reported that popular diabetes drugs such as Byetta, Januvia, Onglyza and Victoza have been linked to pancreatitis and pre-cancerous cellular changes in the pancreas.
What are we to make of the association between amiodarone and cancer? At this point it is far too preliminary to say this is a cause and effect relationship. We can say, however, that amiodarone is a challenging drug all by itself. In addition to the serious and scary side effects listed above here are some other potential problems:
Other Amiodarone Side Effects:
• Fatigue, tiredness, unsteadiness, dizziness
• Tremor, hand shaking
• Nerve tingling in extremities, burning or pain in fingers and toes
• Digestive distress, nausea, loss of appetite, vomiting, constipation,
• Deposits in the cornea of the eye
• Heart failure
• Discoloration of the skin (a blue-grey tinge)
• Rash, skin reaction (requires immediate medical attention!)
• Pancreatitis, liver damage
• Hallucinations
• Blood disorders

Anyone taking amiodarone requires very careful medical monitoring. At the first sign of any symptoms, please contact the prescriber immediately. No one should EVER stop taking amiodarone suddenly. Discontinuation might trigger life-threatening arrhythmias. Should this drug ever need to be discontinued, it should be done so only under the careful supervision of the prescribing physician and in a gradual manner.
Share your experience with this medication below.

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  1. Oscar I.
    Monterey Park, Ca
    Reply

    I’ve been on Amiodarone for a few years prior to my aortic valve replacement surgery on Oct 15, 2014 and went into AFib in the hospital and they gave it to me via IV and I developed a giant black blood blister with swollen hand for over two weeks – I was on 400 mg if Amiodarone for two weeks and now on 200 mg daily – my heart rate is in the high 40’s and 50 I was on Amiodarone for 1 1/2 years prior to my surgery – started with 200 mgs and then, when I was in normal sinus rhythm, decreased to 100 mgs until open heart surgery – my calcium is high 11.0 and they are now going to test my parathyroid after being high on calcium for over 5 years.

    I’m worried about Amiodarone and my cardiologist is not seeing me until a month from now – I guess I’d better make appt with my primary Dr for blood tests…

    Please comment – thank you.
    I’m 75 years old

  2. Donald B.
    South Carolina
    Reply

    I am a long term user of Pacerone. After two heart attacks and emergency bypass surgery on 5 vessels my heart went into severe Vtach. The only thing that helped was very high doses of Pacerone. For over a year I continued to have arrhythmia attacks. Seven emergency treatments later, I found myself having a stent and a heart ablation.

    Still the Vtach continued and that night was a terrible night of fighting to stay alive. The next morning I went to surgery for an implant. A pacer diffibrilator pacemaker was put in and when it was turned on it paced out the arrhythmia and now three years later it has stopped over 200 arrhythmias (Vtach). It has been keeping me from being shocked that many times, if I had lived thru it.

    I have not only been taking Pacerone but Mexilitine. After 4 years I can say by experience, no one should fear having a devise put in. They really can be a life saver. As far as the medicine goes, I am on several other meds for heart and other problems. Only now after 4 years have I had to be removed from taking Pacerone due to hyperthyroidism. I have been checked and show no signs of other issues including cancer or tumors. I am recovering from the hyperthyroidism and am thankful for the diligent care of the VA hospital and doctors who have shown much concern and given so much to keep me alive.

    I am now 63, retired and at times struggle to live as normal a life as I can. If I had not let the specialist and primary care doctors do what they are trained to do I would not be here alive and sharing my story with you. I’m sure that they don’t know everything and that God is still in control, but I am thankful that I did not allow my fears which were many keep them from helping me.

    I still have my struggles but I am still here and looking forward to many more years with my wife children and grands. Without treatment I would not be writing this blog. Thank you for reading and I wish and pray for your health.

  3. Dabraz
    Reply

    Just had my thyroid removed due to Papillary Thyroid Cancer… I was on Amiodarone for over 1 1/2 years and I only found out about this medication when having a Mayo Clinic evaluation on my medications and heart condition after feeling over tired on a daily bases. They immediately took me off this drug and told me it was known for negative thyroid function. After an ultra-sound and biopsy of nodules found on thyroid and now after removal and test the cancer was found in my lymthodes in my neck as well, I guess I will be starting the process of treatment in a few weeks.
    I wish that I knew why I was kept on this last resort drug for affib when it was only present for 6-8 hours after stents were placed on my LAD part of my heart. My affib never showed up again and on the day of my surgery and i was placed on this drug and told that I would never be taken off by my original doctor before getting help at Mayo. Honestly I have my Brother to thank for pushing me to get help at Mayo Clinic. If anyone has any questions on this or anything I have said I will try to look for any comments on this site. Thanks..

  4. kreg
    Reply

    I had a heart attack in September and was put on Pacerone 100mg in the hospital. My doctor told me to stop taking it three days ago, and some of the things I have read have got me kinda scared. I’m 33 years old and went into v-fib in my sleep where I died and had to be shocked back to life. I continued to go into v-fib in the ICCU many more times over the next 24 hours. This is when they
    put me on amiodarone. My doctor says he can’t tell if my heart has actually healed or if it was just the medication doing its job. This is when he told me to stop taking it. Can’t this trigger more arrhythmia problems? Does anyone have any experience? Nist of what I have read has me kinda worried.

  5. kreg
    Reply

    I had a massive heart attack in Sept. I died, and was brought back after ten minutes. I continued to code 5 or 6 times over the next day, and had to recieve 13 shocks with a defibrillator to stabilize me. I was placed on Pacerone in the hospital, and was released after a week and a half in ICCU. I’ve taken it for over three months now, and two days ago I questioned the safety to my cardiologist, and he told me to stop taking it, but that in the next three months I may have another episode as the medication may be solely responsible for my hearts health. Does anyone have any experience with stopping this drug abruptly? Some of the info I am reading has me scared that I’m in for more problems once the drug evacuates my system.
    People’s Pharmacy response: Here is a doctor’s overview of amiodarone (Pacerone): http://www.aafp.org/afp/2003/1201/p2189.html
    We are having trouble finding information on the best way to stop this drug, but apparently other doctors have instructed patients to stop abruptly.
    Amiodarone has a lot of side effects and interacts with many other medications. It should be used only by people whose life-threatening irregular heart rhythms cannot be controlled in other ways. This is from the patient package insert: Because of these possible side effects, Pacerone® Tablets should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.
    Keep in mind that amiodarone stays in the body for rather a long time after it is discontinued, so you will have to put up with the side effects for a while.

  6. SAS
    Reply

    I have been on amiodarone for 22 years…yes, that’s right, 22 years! I was put on it for Vtach. I now have thyroid cancer and I attribute it to the Amiodarone. I had a total thyroidectomy and now need Radioactive Iodine treatment but because of the iodine in the amio, we don’t know what to. It’s my unrest adding that it would take at least 6 months to rid my body of the amio, if I went off of it. But, if I did go off it, what would be a better drug for me? I don’t want to have a pacemaker/defibrillator implanted. I am so upset over this. My Amio levels are routine,y checked and run rather low…about 0.3. Any suggestions?

  7. I Brady
    Reply

    My uncle had been on Amiodarone for 2 years before a tumour was found in the bile duct. His dosage had been upped three months previous to this discovery and had been hospitalised with severe jaundice and kidney failure. The increase in dosage was ‘apparently’ precautionary as his life was not in danger. He died of sudden massive organ failure at 72. He was the first known case of cancer in his family.

  8. Lori
    Reply

    I have psoriatic arthritis, and asked my rheumatologist about Enbrel–advertised on TV by the famous golfer who touts it specifically for psoriatic arthritis. Even though the ad includes a list of scary side effects, I asked my rheumatologist about it. She would not prescribe it for me, because I am a breast cancer survivor. Enbrel and similar drugs are called “biologics;” according to my rheumatologist, all of them are off limits for cancer survivors. Obviously it has been determined that this class of drugs can cause cancer or cancer recurrence. Why is this stuff still on the market?

  9. MA
    Reply

    From article: Another hugely controversial cancer connection has to do with cholesterol-lowering drugs. An article in the Journal of the American Medical Association (Jan. 3, 1996) warned that, “All members of the two most popular classes of lipid-lowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animal exposure close to those prescribed to humans.”
    My father developed prostate cancer and just had his prostate removed. His levels for TS (blood test to detect cancer) started going up 4 or 5 years ago, and he started taking a statin type cholesterol lowering medication 6 or 7 years ago. I’m wondering if this could have some correlation; and if there are any safer alternatives (natural and medicinal) to explore?
    Thank you!

  10. Janet
    Reply

    Following aortic valve replacement surgery in 1997, I experienced fibrillations and was prescribed Amiodarone for about a month. In 2001 I was diagnosed with thyroid cancer and had my thyroid completely removed surgically. For a long time I have suspected that the Amiodarone played a part in the development of my thyroid cancer. (The endocrinologist said that he suspected that the cancer was a result of radiation treatment for acne that I may have had as a teen. However I never had such treatment.)

  11. Anetta
    Reply

    I’ve taken Amiodarone for several years and have never had any problems and this article scares me. I kinda question whether I should keep taking it.
    PEOPLE’S PHARMACY RESPONSE: As with all medicines prescribed for serious conditions, we don’t recommend you discontinue on your own. Do discuss the issue with your physician.

  12. M
    Reply

    I was prescribed Amiodarone by the Cleveland Clinic about a week after after my double heart valve operation in 2009. I was released from the hospital one day later and returned to my home, which is about 4 hours away. I developed extremely debilitating pain when I moved any muscle, had difficulty breathing, dizziness, and nausea so bad that I could not eat anything. I was too ill for the return trip to Cleveland, so I had to go to a local hospital. That hospital, of course, did not have my records and did not believe my account of the drug’s side effects. They kept me on Amiodarone for another week.
    Long story short, I was hospitalized for another two weeks while they experimented with another drug and then I was rehabilitated in a nursing home for another month. I thought Cleveland Clinic was such a wonderful a place for the surgery–but I continue to be shocked and angry that they released me with such a dangerous drug.

  13. Katherine C.
    Reply

    One year ago my husband was hospitalized for four days after fainting in the kitchen, hitting his head on a heavy wooden chair and a table. He was in neuro intensive care for two days. Amiodarone was believed to be the primary culprit. His inability to be stabilized on Coumadin was another factor. Despite Afib and the acknowledged risks, he feels much better without either drug.

  14. EH
    Reply

    In April 2011 I had open heart surgery with aortic valve replacement and CABG X 3 two of which were double blocked. Legs & carotid arteries excellent but heart severely calcified. All four valves damaged. The Mitral valve is very insufficient, but they don’t like to do two artificial valves in the same person. Pulmonary valve showed pulmonary hypertension in Sept. 2012 for which they did a second catherization which showed I had fluid in lungs.
    I had SOB after 2011 surgery while still in the hosp. They treated me with Amiodarone/Pacerone and for six month post surgery. Lately I have been advised by a friend of mine that this is a very dangerous drug. I see in the above info that you should not stop this drug all at once.
    No one at the hospital or my surgeon or cardiologist told me any of these risks. I had not had AF before the surgery but the cardiologists conferred on my case and said that it’s not unusual for someone to develop AF after surgery as it’s the hearts way of protesting them having their hands where no one should put their hands and makes the heart irritable. The cardiologists told me that they didn’t think I needed a pacemaker which I was very thankful for, but I was released from the hospital on this drug for six months then told I could stop it.
    I was very high risk going into heart surgery due to rheumatic fever in my 20s three times. But being a very active person I believe this kept me from developing the problem sooner. Afterwards I had SOB even by the time I got to cardiac rehab. The nurse there checked my lungs down the left side and said she wasn’t hearing the whooshing sound an expanding lung makes. In the hospital they said in my report that I had some start of pneumonia in the left lung but didn’t make that much of it. However at three weeks I was admitted to our local hospital with extreme shortness of breath and also internal bleed from the counmadin they put me on temporarily.
    Had two pints of blood, and found to have a urinary tract infection for which they gave me Ciprofloxin which I have since found I do not tolerate well and have a sensitivity to on my list of things I cannot take. I feel like the surgeons were not very upfront with me as to what to expect after surgery. I was taken off Coumadin and told I could not take it, but that was alright as I had chosen the bio-prosthetic artificial valve which does not require the follow up like the metal valve does. They also did thorocenticis taking nearly 1 1/2 liters of bloody fluid through my back.
    Nearly two years and numerous echos and five TEEs after the heart surgery I am still having some muscle symptoms and eye problems, but the drs say this is not from the Amiordarone. But they don’t know what is causing the problem. I have read much on Amiodarone/Pacerone and other generics of this drug and have mentioned it to my current cardiologist just recently and she admitted that they were using this drug a lot, but have cut back on the usage in light of these findings.
    Now she has ordered blood tests and radiologic test including DDimmer, CPR which were showing quite high readings leading her to order deep vein and chest test for blood clots which were negative, but we are waiting to have EMG, then maybe test for auto-immune problems as to the high readings of the blood tests and my recent findings for my eyes which the eye dr. says he doesn’t have answers for but doesn’t think the Amiodarone is a connection to the eye problem I have which is double vision in both eyes, a slight fold in the cornea, an eye specialist they sent me to from the local dr. said he thinks I have a problem with the tear ducts and oil glands around the eyes mixing and puddling on the surface of my eyes causing a prism effect. Treatment was washing my eyelids each morning with diluted baby shampoo and using artificial tears up to four times daily. I did that for two weeks with no change. He said not to use eye makeup during that time. I discontinued this treatment with the exception of the artificial tears which my local eye dr. said to continue after the two weeks was up and no change. But he said he didn’t have any answers as to what has caused this problem and to come back in a year if nothing changes. I asked how will it affect driving my car. He said the brain adjusts and I haven’t had a problem doing things except working on my computer is more difficult.
    Reviewing things that might cause a problem like this for the eyes, I see Amiodarone may cause neuritis problems and others, and if you have this problem you would probably have crusting of the lids and eyelashes which I did not. I did not have that much discomfort in my eyes. I noticed the double vision and called it to the drs. when I had my annual vision test. Both eyes are 20/30 and clear vision, but closing each eye individually still shows double vision which they tell me is unusual.
    I have a pinched nerve in my C5-6 neck area which was found affecting both arms and hands on an EMG in 1988. I did not want neck surgery all this time as they go through the front of the neck along the voice box to get to the back to fix it. As a singer/musician I have done several sessions with physical therapy over the years to keep from having the surgery, but it is escalating in the last year. and left arm, neck and right arm aching and spasms and tingling and numbness in my hands to the pinched nerve, but now wonder if this problem has been aggravated by the Amiodarone.
    As to statins, I have been on gemrofibrcil, Lipitor, Vytorin, and now Pravastatin. I don’t think my readings are that high, but the cardiologist/surgeons swear by the info that they read that statins make a difference in keeping cholesterol levels down in everyone. I don’t believe everyone can tolerate these. And the symptoms I have point to that fact and some of the literature I have found also indicates that. At 77 years old, I have to wonder whether taking the statin is beneficial to me at this age and/or just taking fish oil 1200 MG daily and watching diet will be just as beneficial for whatever time I have left. I still play music and sing as professional musician for nearly 63 years.
    I am so skeptical of what drugs can do and do not believe everything I hear from the drugs companies. I am a Type II diabetic for over 25 years, but my A1c has been in the 5.4 range for the last 1 1/4 years and my primary dr. cut my Glimnaperide in half down to 1 MG daily. I do have some kidney issues that have been mostly resolved also. This is long, but if you don’t have enough info about me, how could you get any idea of how to define my problem. Thank you. EH

  15. Ark
    Reply

    Wow! This seems like a very potent drug. Is anyone, if there is an alternative to this?

  16. E L L
    Reply

    My arrhythmia went away when I quit drinking anything with caffeine.

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