Multaq Anyone Else Take It (Page 23)

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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REPORT

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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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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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.
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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.
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**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%
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**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%
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**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%
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**Severity of Liver function test abnormal when taking Multaq : None.
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**Top conditions involved for these people :

1. Atrial fibrillation
2. Back pain
3. Osteoporosis
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**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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"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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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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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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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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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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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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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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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 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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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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The most important drug to put into our body is food. Eating properly prepared unprocessed foods ( organic whenever available) and supplements as your educational beliefs prefer are vital to a healthy healing heart and body. Multag as most drugs are poisons our body does not appreciate....Remember the mind and body go hand and hand. Anxiety is a real killer and a threat to life. Being afraid of your heart stopping and starting is not a good mental exercise. If yoga and mediation help do it....

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Hi Bill,

You really hit it on the nail!! But unfortunately, at times, some of us need to take some medications especially for afib to slow down the rapid heart beats.
I have said a few times in this blog and will say it again that I will not touch Multag (cousin of Amiodarone) or Amiodarone with a ten foot pole. I am getting to sound like a broken record on these two antiarrhyt... drugs but so be it - lots of people are on them, according to this blog - hopefully they have their liver enzymes checked periodically.
I have been on calcium channel blocker and it has been doing a relatively good job keeping the heart beats in check most of the time.
You did not say if you have afib or not!!??
Have a nice evening.

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I agree Bill. The mind is amazing and powerful and can help heal or it can destroy, kind of like Ying & Yang, the principles in Chinese metaphysics.
Negative thinking will always take its toll on the human body. The problem is that everyone is different and there are many who will always be worriers and negative thinkers no matter what.

Not only is anxiety is killer but even more so is constant stress. Various relaxation techniques and positive thinking can help ease these deadly pressures.

Many drugs are dangerous but many times they can be the only choice depending on the circumstances.

There is no known cure for Afib, yet. Somehow if I knew I were going to live 25 more years and had the choice of living them in misery without medication or say 18 to 20 years with medication feeling good, I'll take the meds. And hopefully they will find a cure or a much safer medication during those 18/20 years. But that's just me.

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Tutsi, excellent point about liver enzyme testing.


"What are the recommendations for Multaq users?"

• Before starting treatment with Multaq, doctors should perform liver function tests. Tests should be repeated monthly for six months, at months 9 and 12, and periodically thereafter.

• Doctors should contact patients who are currently receiving Multaq within the next month so that liver function tests can be performed. Thereafter, they should carry out further tests as described above depending on when treatment was started.

• Doctors should stop treatment with Multaq in patients with raised levels of the liver enzyme alanine aminotransferase (more than three times above the upper limit of normal). Appropriate investigation and close observation of patients should continue until the enzyme levels return to normal.

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"Celexa Warning - Abnormal Heart Rhythm Warning"

August 24, 2011
FDA

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

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Hello everyone from Madrid, Spain.

Im a 30 years old Male, diagnosed with a hypertrophic obstructive cardiomyopathy, treated with beta blockers since i was 18 yrs old, and i have been taking Multaq since February, twice a day, had an ablation in last June, in the past 3-4 months i had experienced sort of panic attacks, insomnia, anxiety, gastrointestinal issues, besides, 1 month ago had an AFib, almost passed out, and had to be cardioversioned. I quit drinking alcohol in the beginning of the present year since its a great amount of drugs besides the multaq (fluvastatine, bisoprolol, a bloodthinner called sintrom, aspirine). I felt good when i started taking multaq, but i guess side effects had to come, my heart beat its around 80-110, 110/70 mmhg BP, what really bothers me is the panick attacks, i feel dizzyness, pre-syncopal state, tachycardia, sort of sudden death symptoms, things i never had before, and they began since i started to take multaq, my doc said i have to be at least with that for about 6months or a year, i dont want to take it anymore, i think its getting me worse.
Take care everyone, and sorry for my english :)

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Hello all. First of all I am one of the lucky one that the ablation helped. Except for a little bump now and then,I am great. Was on multag and worked great for me. Had the ablation because doc didn't want me on it for longer that 6 months. But I do have some great new. I have a friend that's a micro biologist,heart surgon. Trials are finished and FDA will OK stem cell treatment in 13 to 14 months. He said the results are amazing!

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