Amiodarone (Cordarone, Pacerone) is approved by the FDA for two very serious irregular heart rhythms: “1. Recurrent ventricular fibrillation and 2. Recurrent hemodynamically unstable ventricular tachycardia.” The FDA is very clear that “there is no evidence from controlled trials that the use of amidarone favorably affects survival.” The agency makes it quite clear that amiodarone side effects are very serious so the drug should only be prescribed 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 sometimes ignored.
No where in the prescribing information is atrial fibrillation mentioned as an approved indication for amiodarone. As you read some of the stories below you will discover that it is being prescribed for this arrhythmia. This reader shares a poignant story:
Q. My husband has been taking amiodarone for several months. Over the last few weeks, he has been experiencing extreme nausea and vomiting. He has also developed a severe cough that seems to be getting worse. He has extreme shortness of breath, fatigue and weakness and numbness in his fingers and hands.
He was placed on amiodarone because he has congestive heart failure and went into cardiac arrest. My husband now has liver and kidney problems along with everything else, and I firmly believe this medication is the root cause.
I intend to take him off it beginning today. He currently takes two tabs daily. I am going to lower his dosage to one tablet daily beginning today and after one week, lower it to one half tab daily.
I also want to take him off of Coumadin and atorvastatin. I believe that all these drugs are killing him faster than the illness itself. I will keep him on the blood pressure medication, and the medication for his stent but nothing else.
A. We urge you to get in touch with your husband’s physician. His symptoms are concerning and could well be due to amiodarone, which can cause lung damage (Clinical Medicine Insights. Case Reports, Oct. 9, 2016).
Discontinuing amiodarone or any of your husband’s medicines is NOT a do-it-yourself project. Once his physician hears about the serious symptoms he is experiencing, we suspect that his regimen will be adjusted. Never stop any medicine without very careful medical supervision!
Amiodarone Side Effects:
The FDA could not be any clearer than this:
“Amiodarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.”
The FDA goes on to describe “potentially fatal toxicities” including lung damage, liver injury and heart rhythm disturbances.
- Lung toxicity is common (between 10 and 17%) 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
- 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 (note that the patient above was getting amiodarone partly for heart failure)
- Discoloration of the skin (a blue-grey tinge)
- Rash, skin reaction (requires immediate medical attention!)
- Pancreatitis, liver damage
- Blood disorders
Amiodarone Drug Interactions:
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.
Making Sense of Amiodarone Side Effects:
Did your eyes glaze over halfway down that long list. We wouldn’t blame you for zoning out. Most people cannot read a long list of side effects without fading. Real stories from visitors to this site put side effects into a more personal light:
Katherine in Seattle, Washington shared a tragic story:
“Just read your response to a query about the use of amiodarone. My husband almost died while taking this drug. We noticed that he couldn’t even walk up the stairs after taking amiodarone for awhile. I read on the internet that if one is taking this drug he should be under constant doctor care. We talked to the doctor and he denied that the drug would have caused the symptoms but took my husband off any way and gave him an alternative drug. My husband improved immediately. Not everyone can take this particular drug.”
Don in Dallas says:
“Thank you for your article about bad drugs–especially Amiodarone–which has been described to me as one of the 10 most toxic drugs in the U. S.
“I am 78 years old. In May, 2009, I had a bout with atrial fibrillation. My cardiologist put me on several heart drugs including Amiodarone. I went to see him in Sep 2009 and advised him that I had concerns about this drug. He assured me that I had nothing to be concerned about. In Oct 2009, I had a problem with my left eye. I went to see my doctor. He just passed this by. On 12-18-09, I woke up one morning and thought I was going blind. Everything was very dark and I had lost my side vision.
“I went to my eye doctor who referred me to a neurologist. She misdiagnosed me with optic neuritis and gave ma a weeks round of intravenous steroids. A doctor friend suggest I get a second opinion since optic neuritis is mainly found in females age 20-40 who have MS–which was not me. I went to an eye specialist at SW Medical Center here in Dallas, He said I have optic neuropathy (damage to the optic nerve). Said it was most likely caused by the Amiodarone, and called my heart doctor and told him to take me off it. He is now my FORMER cardiologist.
“After that, I developed osteoporosis (most likely caused by the steroids) and had to have 3 kyphoplasties to repair three different vertebrae fractures. My back is ok now but my eyes will never improve. Everything is too bright outside and too dark inside. Best thing I see is a computer screen due to the back light. In any event, most of my activities have been curtailed.
“Amiodarone messed me up really bad. I sent a copy of your article to my former cardiologist; I recently read an article that said that a Mayo Clinic study indicated that about 1.5% of people who take Amiodarone for a period of time will develop a vision problem.”
Karen in LA:
“Joe, I read in the LA Times about a Father’s Death due to lung damage from Amiodarone. My father also died from drug-induced pulmonary toxicity. He was only on 200mg for 10 months.
“Since his death, I have been notified by many people who have lost loved ones due to pulmonary toxicity and most were on low dose, for a very short time, less than a year, with close to the same story…all were on it for atrial fib (“Off Label”). He was fine one day, woke up the next with flu symptoms, fever, cold, cough, immediate diagnosis, pneumonia. He was hospitalized, got a lung biopsy after not responding to antibiotics; diagnosis amiodarone-induced pulmonary toxicity.
“He was put on a ventilator; no improvement because the half life of the drug is so long. Then he died because there was nothing that could be done.
“There is a website called amiodaronetoxicity.com where family members are sharing their stories. We fear that many are dying from “Pneumonia” and it really could be from amiodarone. Lots of people are on amiodarone for Atrial Fib, Off Label. The pharmaceutical companies withheld stronger warnings for a year in 2003, until finally at the end of 2004 they finally sent out stronger warnings. Too late for my Dad, a retired Doctor, who would have known that his little cough was a huge warning that he was developing lung damage.
“My Dad was a patient of a reputable cardiology group in Los Angeles. I feel that had that warning gone out, the doctors also would have been more in tune to his very slight symptoms. Sadly, the warnings aren’t strong enough, and I continue to hear stories too often. I want the public to be more aware of the symptoms of amiodarone-induced pulmonary toxicity, in the hope that one life can be saved.”
Paula offered a somewhat similar story:
“Hi: I listen to your radio show every Saturday. My husband was given the drug amiodarone which was not monitored by lung function or other tests. He began feeling that he had asthma/pneumonia-like symptoms and visited his cardiologist, local clinic, and general practitioners. He entered three hospitals and still his condition was not treated.
“After 40 days in the hospital, mostly in intensive care, he died of what was diagnosed as cryptogenic organizing pneumonia. I have all his records and several of the doctors who treated him were knowledgable that he was taking amiodarone but never treated him with steroids. No one should have to go what he went through until he died. I hope this information will help someone.”
Delores in Evansville, IN
“I wasn’t to share the story about the death of my husband on Dec. 28, 2008. His death certificate said cause of death was pneumonia and congestive heart failure.
“His Dr. had ordered a cardioversion because of an irregular heart beat. We both understood that this was not a dangerous thing and could be done any number of times. The benefits lasted six months and my husband felt fine.
“His heart again lost its rhythm and the Dr. said he needed to go into the hospital in order to take medicines that could possibly extend the time in normal rhythm. My husband asked several times why he could not just have another cardioversion. The Dr. indicated it was unethical to not try to extend the time. He was given amiodaarone and died within 7-10 days.”
Kathy in Seattle:
“My husband took this one medication for his heart and he, too, couldn’t function. He was an avid hiker, in his 70s at the time, and couldn’t even walk up the basement steps. He went to his prescribing doctor, who questioned the cause but my husband insisted he wanted to quit taking amiodarone.
“Three months later (it took that long to get it out of his system) he was back to hiking. We think the drug almost killed him. I looked it up on the internet at the time and it said you should be under constant doctor’s care because 1 out of 7 people have this bad reaction to it! I read your column every Sunday and usually cut out the articles because they affect me or someone I know. Thank you for what you do.”
Bev in Georgia:
“I fully believe my 53-yr-old son died a horrible death from amiodarone after heart surgery. He had a short run of atrial fib which is not unusual and is why he went home with a prescription for amiodarone.
“He had clear lungs that went to shortness of breath and cough and interstitial pneumonia. It was wrongly diagnosed as double pneumonia. His oxygen saturation went down to 70%. He died December 20, 2015. He was intubated and on a ventilator. It was a horrible death.”
The People’s Pharmacy Bottom Line on Amiodarone:
Amiodarone IS appropriate for people with life threatening ventricular heart rhythms. It doubtless helps patients when other options have been exhausted. But this is a drug that requires very careful monitoring and supervision. At the first signs of any of the amiodarone side effects listed above, patients and their families should notify the prescriber immediately. No one should EVER stop amiodarone without medical supervision.