Multaq Anyone Else Take It (Page 20)
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Okay I will start off by saying this drug scares me because it has not been out for very long. I have Afrial Fib which is not behaving I can be 70 beats one min and regular and the next I will be at 190 and in atrial fib and flutter. this is my last chance at a med I have tried all the others I usually end up in the ER two or three times a week. I have had one ablation so far. If anyone else takes it please let me know what it is like. I am starting it on Tuesday.

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many of you indicate that you are taking supplements (gary - thanks for that great list!) are you also taking prescription meds at the same time?
thanks

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Hi Randy,

Besides taking a high potency multivitamin and a few other things. The particular one's I take for the heart are as follows.

CoQ10 capsules
Magnesium Citrate capsules
Hawthorn (herb) capsules
Omega-3 Fish Oil
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Other things equally good for the heart are:

Potassium (also in many foods, bananas have plenty)
Taurine
Acetyl-Carnitine
I stopped taking the above three capsules because taking all this stuff at once was causing me to get the runs, lol.

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Here is a link to the article which has a link to the warning letter sent out. You will see that Multaq is not being taken off the market.
drug-injury.com/druginjurycom/2011/01/multaq-liver-failure-warning-fda-dear-doctor-letter-sanofi-aventis.html

They refer to it as a "Dear Doctor" letter, not "Dear John". Copy the letter and show it to your EP and that his remark about Multaq is incorrect.

I always thoroughly research everything, especially when some doctor says it.

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Hi maebellino,

Actually they are not taking Multaq off the market. I just posted the letter you're referring to but this site has to review my post first before it goes up. It's not a "Dear John" letter, it's the August Multaq update drug warning that was sent to all European Cardiologists. A 70 year old woman in Germany had drug related liver failure

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Hi maebellino,

Actually they are not taking Multag off the market. They sent another warning letter due to one 70 year-old woman in Germany who developed a drug-induced liver injury.

The letter below is the one you're referring to that doctors just received ----

Multaq: August 2011 Update:

Important Drug Warning

Increased Cardiovascular Risk in Permanent AF Patients Treated with Multaq® (dronedarone)

Dear Healthcare Provider:

Sanofi-aventis, US LLC would like to inform you of the premature discontinuation of the PALLAS
(Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) phase
IIIb clinical trial due to an excess of cardiovascular death, stroke and cardiovascular hospitalization,
primarily heart failure hospitalization, in those patients receiving dronedarone. This indicationseeking
trial enrolled patients with permanent atrial fibrillation (AF), a different, but related,
population than that for which Multaq is indicated. Permanent AF was defined by the presence of
AF/atrial flutter (AFL) for at least 6 months prior to randomization and patient/physician decision to
allow AF to continue without further efforts to restore sinus rhythm. The trial had two composite coprimary
endpoints: 1). Major cardiovascular events (stroke, systemic arterial embolism, myocardial
infarction or cardiovascular death); 2). Cardiovascular hospitalization or death from any cause. The
currently available data from the PALLAS trial is preliminary; a full and comprehensive analysis of
these data is ongoing.


Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and
associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular
accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus
rhythm or who will be cardioverted.


Multaq should not be prescribed for patients with permanent AF. Healthcare professionals are
advised to monitor patients regularly (at least every six months) in order to ensure that they remain
within the approved indication and do not progress to permanent atrial fibrillation or new or
worsening heart failure. Additionally, please be aware of, and refer to, the BOXED WARNING,
CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections of the Multaq
Prescribing Information for further information about the appropriate patient population.


Sanofi-aventis is in communication with the FDA and additional analyses are being conducted. The
Prescribing Information for Multaq will be revised to include this information and will be distributed
once it has been reviewed and approved by the FDA (the link to the current Prescribing Information
has been provided below for your information). For additional information, please contact sanofiaventis
Medical Information Services at 1-800-633-1610 (option 1).


Healthcare professionals should report adverse events suspected to be associated with the use of
Multaq to sanofi-aventis at 1-800-633-1610 (option 2).


Alternatively, report this information to FDA’s MedWatch reporting system by phone (1-800-FDA-
1088), by facsimile (1-800-FDA-0178), online (https:/­/­www.accessdata.fda.gov/­scripts/­medwatch/­)
or mailed, using the MedWatch for FDA 3500, to the FDA Medical Products Reporting Program,
5600 Fishers Lane, Rockville, MD 20852-9787.

We will continue to monitor the safety profile of Multaq, both the liver injury and the various heart-related problems, going forward.


Sincerely,

Paul H. Chew, MD
US Chief Science Officer/Chief Medical Officer
sanofi-aventis U.S.

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I was on Multaq for a year and then it tanked. 3 weeks ago I was put in the hospital for 2 days of monitoring to switch to Flecainde. So far so good. I am personally not looking at an abaltion at any time - great for those it works for but even my own EP said 2 days ago........" I wouldn't even have an ablation myself til we ( meaning Drs. ) get our sh..t together. The success rate is not where it should be". He also said - not to alarm anyone here - that Cardiologists have received their "Dear John " letter and Multaq is soon to be taken off market. Thats too bad - so many of us were so hopeful.

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multaq did not work for me. is anyone taking another anti-arrhythmia drug? my doc is talking ablation and i'm still skeptical of trying that. i've read many responses here where some folks are satisfied with the results but many of you also talked of the need for multiple ablations cause they didn't always work.

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Gary:

I had a similar experience with a cardiologist here in Denver. It was a woman, which surprised me. She ignored my abnormal EKG and my inability to breathe and told me I was out of shape and had metabolic syndrome. She totally ignored my statement that I had been to Europe with 22 teenagers just 2 months prior.

I then ended up in a (male) PCP's office, who, after listening to my heart, sent me to the ER immediately. I was in Vtach. My doctors at the University of Colorado were wonderful. I, too, had never heard of an electrophysiologist until then.

I agree that if a doctor ignores your symptoms, or won't talk to you, you need to go immediately to someone else. It could mean your life.

Debbie

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Gary,

Glad to hear you are doing well on the Multaq. I have been taking it for over a year with excellent results but have concerns about the long term effects on the liver. I am interested in what vitamins and herbs you have found to be beneficial for Afib. Can you describe what they are and how long you have been using them and the results. I have not had an episode of over a year but woul like top get off any presription drug. I don't take any other meds,, just the Multaq. Any info you provide is appreciated.

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"Multaq (dronedarone) – Association with Severe Liver Injury"

Irish Medical Times
March 1, 2011

Dronedarone is indicated in clinically stable adult patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

Since Dronedarone was licensed in 2009, there have been reports of liver function test abnormalities and hepatocellular liver injury in patients taking dronedarone, including two cases of acute liver failure requiring transplantation. Some of these cases occurred early after the start of treatment, "with the two cases requiring liver transplantation occurring at 4.5 and 6 months after initiation of treatment in patients with normal baseline liver function tests." In one case the liver injury was not reversible after discontinuation of dronedarone. Although both patients were taking concomitant medications, a causal relationship with dronedarone could not be excluded.

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eHealthMe

A real world approach for drugs: many side effects, drug interactions, and effectiveness can not be detected when drugs are approved. They may be found only after drugs have been used by millions of people and for a long time. On eHealthMe, you can study 30 million latest drug outcomes since 1977 from FDA and community, and personalize the study to any gender or age.
-------------------------------------------
Based on 18 reports from the FDA

"Multaq and liver function tests"

**On Aug, 8, 2011: 948 people reported to have side effects when taking Multaq. Among them, 18 people (1.90%) have Liver Function Test show Abnormal.
----------------------------------------------------

**Time on Multaq when people have Liver function test show abnormal :

Liver function test abnormal: 1 month - 57.14%

Liver function test abnormal: 1 - 6 months - 42.86%

Liver function test abnormal: 6 - 12 months - 0.00%

Liver function test abnormal: 1 - 2 years - 0.00%
----------------------------------------------------

**Gender of people who have Liver function test abnormal when taking Multaq:

Liver function test abnormal: Female - 89.47%

Liver function test abnormal: Male - 10.53%
----------------------------------------------------

**Age of people who have Liver function test abnormal when taking Multaq :

Liver function test abnormal: 1 to 59 - 0.00%

Liver function test abnormal: 60+ - 100.00%
----------------------------------------------------

**Severity of Liver function test abnormal when taking Multaq : None.
----------------------------------------------------

**Top conditions involved for these people :

1. Atrial fibrillation
2. Back pain
3. Osteoporosis
----------------------------------------------------

**Top co-used drugs for these people :

1. Verapamil
2. Sotalol
3. Coumadin
4. Simvastatin
5. Vytorin

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider.

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This has been known about Multaq for the last six months. It is just as dangerous as the other heart arythmia drugs. It is suppost to have the fewest side affects but does cause liver dammage like the other ones.

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Is everyone aware that a notice came out today from the FDA and Health Canada that Multaq is causing liver failure! Apparently several people on Multaq have gone into liver failure, the one thing they said Multaq wouldn't cause. I've been on it for 19 months, am having my first ablation the end of September. This really scares me and I'm speaking to my doctor tomorrow about this. I want to find out what the alternative is. Please everyone, google this about Multaq so you can read up on it. I will let you know what I've been able to find out.

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Randy - the Multaq and alcohol also worked for me for about 6 months. No AFIB and my same lifestyle - drink or two at night with my husband - champagne for special occasions - beer with pizza, etc - we just kept up the same routines as if I did not have AFIB. Then, the AFIB started sneaking back but I was in denial about the alcohol. When I had an episode on a day when I had no alcohol the night before, I convinced myself it was NEVER alcohol. As the Multaq finally tanked and I was in AFIB 80% of the time - I even said "what the heck".....already in AFIB so might as well have a glass of wine. Last week I was in the hospital for 3 days to transfer to Flecinade and my husband and I are now committed to a permanent change. NO alcohol for me. It isn't easy - habits die hard. Patterns are hard to break. I am 59 but hope for years on Flec and I need to help that along as much as possible.
I hope you never have anymore AFIB but please know, in my opinion and my Drs. - alcohol and Multaq ( and most other drugs ) are looking for trouble. Good luck to you - sounds like you are upbeat and that is half the battle.

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Hi Greg,
I could not help but answer to this one. Hope you did your research on Amiodarone - the most effective drug for A-Fib and the most toxic drug for arrhythmias - it is suppose to be the last drug anyone is put on for A-Fib. I would not touch it with a ten foot pole. This drug can affect ones heath way beyond when one has stopped taking it.
Multaq is the cousin of this drug and I also would not touch Multaq with a ten foot pole.
One of the websites to check this out is:
heartdisease.about.com/od/drugsforheartdisease/a/amiodarone_lung.htm
I don't take any drugs be it antibiotic or anything else until I have done my research on them.
I wish you good luck!!

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I am a 48 Yr 190 lb male and have been on 400 mg twice/day for over a year with excellent results. No AF since I started the drug and have no side effects at all. Moderate and sometime more than modrate use of alcohol has not been a problem. For those of you with severe AF and have had ablations I would strongly reccommend the Maze procedure at the Inova heart center in Fairfax, VA. This procedure has worked on many and cured them for life. I had the procedure with good results for a year but went back into occasional AF, one in a million according to the doctors. They say another ablation to solve the fluter will help. Maybe consider it when I am tired of taking the Multaq. Good luck.

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I just had an ablation and am on amiodarone right now. I am still in and out of sinus rythem. What I found out is eating healthier helps a lot. Otherwise none of the medicines have really worked for me. I am just waiting to see if the ablation worked.

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i didn't get the news i had hoped for today...my holter moinitor did not show improvement in my premature atrial beats so the multaq doesn't seem to be working. yuk!

doc is now talking about trying amiodarone and/or ablation. not looking forward to any of this.

someone on this site mentioned a future radical change in treatment - no drugs or ablation. please respond with more info.
thanks

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I just had an ablation by Dr. wilbur a month ago. I don't know if it has worked yet. It was on my left side of my heart and a few years ago on my right side at South central. That one worked but it took a few months to.

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I totally agree maebellino. If a Dr./Cardiologist does not return a call within a day, move on.

When I first got Afib last year I saw a general Cardiologist that dealt with a variety of many of heart conditions. He had no time to talk to me when questioned (in his office yet!). He only wanted to give me tests and try some meds, without explaining what the meds did.

There were 2 Cardiologists working out of the office, both Oriental and I could barely understand what I being told. After my third visit he wanted to try another med without explaining what it did. He wanted to give me a beta blocker of some type but I said NO! I'm on another med that doesn't work well with certain blockers and he already knew this but didn't even bother to check. So I told him no, not until I research it myself.

Obviously I was taking up too much of his time (2 doctors and an average of 10+ patients all at once all doing different things, this was the norm for his office).

So he said, "I'm only a Cardiologist, let me send you to an Arrhythmia specialist". I didn't even know Arrhythmia specialists existed!

So I went to this big new facility in NJ (where I am) which believe it or not was called "New Jersey Arrhythmia Associates" (in W. Orange)

The Doc I saw there was incredible and only worked with Arrhythmia patients. He spent about a half an hour discussing things with me and answering ALL my questions. With the first drug he started me on, he spent about 10 minutes online making sure my other med would not have any issues with the med he wanted to try on me first. Unbelievable. I feel totally safe with him and finally felt I found someone who could really help. Most Doctors today will not sit down with you and have an actual discussion (like in the old days).

Whatever area your in, you might want to try looking up a Cardiologist that only works in, or specializes in Arrhythmia's. They are out there. And it now seems to be a growing specialization.

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