Major Warning on Amiodarone

[John & Joann]

Knight-Rider recently published a report regarding Amiodarone. It is not approved for Atrial Fib/Flutter. Read the attached article and also the link.

Use of amiodarone comes with substantial risks

Knight Ridder Newspapers



What are amiodarone's risks?


The drug's FDA-approved prescribing label for doctors, which patients rarely see, warns that the drug comes with "substantial toxicity." About three-fourths of all patients taking a 400 mg dose experienced some side effects. Some can be fatal:


-Lung toxicity, which has harmed as many as 17 percent of patients in some studies and has been fatal about 10 percent of the time.


-Liver injury is common. While usually mild, it too can be fatal.


-Worsening of the heart rhythm problem.


-When given to pregnant women, the drug has caused serious harm to the fetus. Other side effects include thyroid problems and neurological disorders. Vision problems and blindness also have been reported.


Should patients take amiodarone for atrial fibrillation?


The FDA hasn't approved amiodarone to treat atrial fibrillation. However, as with all drugs, doctors are free to prescribe it "off label" after weighing the risks and benefits.


According to the latest research, particularly a major National Institutes of Health study called AFFIRM, experts say amiodarone generally isn't the first drug a patient should try for atrial fibrillation. A patient should first try a drug to regulate how fast the heart beats.


Other options include a procedure to destroy the misfiring electrical connection in the heart. Patients also can be treated with various rhythm-control drugs.


What can patients do?


Talk with your doctor. Ask why he or she chose rhythm control over rate control. For more information about the AFFIRM study, go to www.nhlbi.nih.gov/new/press/02-12-04.htm.


Don't stop taking amiodarone without a doctor's supervision.


Make sure your doctor regularly monitors you for signs of lung, liver and thyroid problems.


Ask your pharmacist for a copy of the official, FDA-approved prescribing label - not just the one-page sheet that pharmacies often hand out with drugs. Or read the label online at www.cordarone.com.

http://www.nhlbi.nih.gov/new/press/02-12-04.htm

There has been a significant amount of information released in the past 3 weeks.

Do NOT stop with your medication until you have consulted with your physician. They may NOT have read this latest information. This information is VERY RECENT NEWS!!!

The ambulance chasers already have sites on the internet to find clients.

 

[JimL]

Amen!

When I read the pages in the Physician's Desk Reference (not normally available to patients -- it weighs more than you're supposed to lift so soon after surgery) shortly after I was prescribed amiodarone, my initial reaction was, "I'm going to die!" Of course I'm going to die eventually, but I meant (1) According to the PDR amiodarone is only to be prescribed in a life-threatening situation, and (2) the side effects were so many and so prevalent.

For me, magnesium works better than amiodarone anyway.

Thanks for posting this story.

 

[perkicar]

Amiodarone

Amiodarone

I need to print this off and take it to work. I work on a Bone Marrow Transplant unit,but our patients sometimes have atrial fib/flutter (in fact we have a patient right now who has a textbook flutter strip). I wondered why we hadn't been giving it to these patients--maybe the docs are paying attention, because I was initially taught that it was the drug of choice for a-fib. The last few folks we've been giving esmalol (a beta blocker).
Hmmmm-I just learn more and more in this place!
Carolyn

 

[Marty]

Betapace

Betapace

My wife has been on an antiarrythmic drug called Betapace. (generic name is sotalol.) She's stayed in normal sinus rythym now for over three years. I asked the cardiologist if Betapace is a beta-blocker and he said "No, it is an anti arrythmic." She's had no side-effects.

 

[Nancy]

Amiodarone has been discussed a great deal on this site. If you want to see former posts do a search on it. We have a family friend in another country whose card. put her on Amiodarone (Cordarone) and left her on it for several years, never checking out any side effects. She now has irreversible pulmonary fibrosis, and it did not even take care of her afib. She finally had the Maze procedure done, and her afib is better.

I am sure others will come along with stories that they know about. Unfortunately, it started becoming the drug of choice for first line of defense in treating afib/flutter, instead of the drug of last resort which it should have been.

My husband had afib and flutter for many, many years. His cardiologists have never suggested putting him on Amiodarone, not that we would ever agree to it. He has never been cardioverted either. They chose to let it go. Can't tell why, but several of them felt the same way. Maybe it was because he has so many other issues.

He was put on Tracleer for his pulmonary hypertension and while that was working on the PH, his heart eventually returned, on its own to NSR. Perhaps less stress on his heart.

 

[DuchessBear]

Sotalol (BetaPace and BetaPaceAF) is, among other things, a beta blocker. Here's some info from rxlist.com:

BETAPACE AFTM, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties.

Mechanism of Action: BETAPACE AFTM (sotalol hydrochloride) has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. BETAPACE AFTM (sotalol hydrochloride) is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above.

I have been on sotalol for nearly 3 years, with no ill effects.

By the way, rxlist.com is a great resource for drug information -- it has the full prescribing information for each drug.

 

[Jeff Summers]

I have been on amioderone for close to 4 years. I have a yearly chest x-ray, various blood tests every 6 mths for the liver and thyroid functions. It works great for me. I took rythmol for 6 months after surgery, but it made every thing (including H2O) taste metallic. My 2 biggest complaints about Amioderone-severe sensitive to sunlight, and hair loss (on my head-I wouldn't mind if it was on back, ears, or other places hair seems to pop up after 40) My cardio calls this the Cadillac of antirhythym drugs. It has worked great with my INR, and you only have to take it once a day. I am currently investigating alternative antirhythym drugs to discuss with my PCP. Any other antiraythymetic drug suggestions out there?

 

[bvdr]

Hi Jeff,

I've been on flecainide for the last couple of years and it works better than digoxin and/or combinations of digoxin and cardiazem, atenolol, sotolol, or verapamil. It has a cloud over it's use from when it was first introduced and prescribed for any arrhythmia. Now it is generally used for only rapid atrial arrhythmias and is known to be quite effective. I hate being on any medication but this seems to have fewer side effects for me than any of the others did. Now that I am on a rather high dose I no longer have episodes of rapid atrial fib.

 

[Harpoon]

You know, I suspect that amiodarone is a drug that can be much more effective in some patients than in others where other anti-arhythmics aren't working well.

I was on it for about 6 months or so after getting home and I was never really comfortable with it after reading up on all the medications I was on. For the record, there is a "layman's" version of the PDR that can be purchased at various places. Called the "Pill Book," I got mine at my pharmacy. I'd recommend it to anyone who's going to be on a number of medications for a long time or for someone who's been switching a lot of medications.

I'll also add that I was on about half the regular "maintenance dose" of the medication and that it really took over a year post-op before my heart rhythm settled to the point where it is now.

 

[JimChicago]

Personally I think Drs should be required to advise patients when prescribing a med for an 'off label' use. There have been eye sight problems also associated with this med.

A site by a man who had severe side effects from this med is:
http://www.coyote-howls.com/

 

[hensylee]

My brother was on it for 1 yr, 4 months. It was to prepare him for cardioversion, but the dr forgot about it and just left him on it. This was several yrs ago. He eventually developed Parkinson-like symptoms - we complained to the dr that he was getting worse and worse, but the guy didn't even recognize these symptoms and was trying to check each medicine out, but never even examined the fact that it might be amiodarone and never took him off it. It was amiodarone. Brother is now in assisted living, has non-classical Parkinson's. His eyesight is messed up. His lungs seem clear.

A few weeks ago, brother had a bleed that couldn't be stopped (coumadin) and his bp was way up there, so we took him to ER where he was in a-fib. The dr wanted to put him on amiodarone - and don't you know I had a fit!! He was shocked but agreed to use toprol, digoxin instead. Brother is in a-flutter so the meds are controlling it, I guess.

In past posts, you will find one from me in probably every thread. I am verbose about this subject.

 

[sylviayasgur]

hi all,
joey has been on a very low maintenance dose of amiodarone. every time he tries to wean off, consistently, about 4-6 months later (it has a long half life) he goes into afib. so he and his cardio have decided that this is a safe dose and he goes for annual pulmonary testing. he has hypothyroidism and takes synthroid which is also monitored very closely since the amiodarone affects this as well.
he took betapace/sotolol prior to his surgery, but it no longer worked after his surgery. they decided that since joey didn't respond to a bolus of the betapace, it was considered unreliable in controlling his afib.
amiodarone really does work well for him, but i get nervous that he is on it at all. he and his cardio are very comfortable with their decision to keep him on it for now. i adore his cardio and feel he is one of the most conservative and smartest doctors i know and trust him wholeheartedly when it comes to joey's health and well-being.

hope you are all well,
sylvia