Multaq: Does it Still Have a Role in Atrial Fibrillation?

Multaq has had so much bad news lately that the question whether it should play any role in the prevention or treatment of atrial fibrillation seems timely.  Multaq, generic name dronedarone, was brought to the U.S. market about 2 years ago by Sanofi-aventis for the treatment of atrial fibrillation. It had FDA approval for the treatment of paroxysmal atrial fibrillation, permanent atrial fibrillation, and atrial flutter.  I had really forgotten about Multaq as I have very few if any patients that local cardiologists have put on the drug.  It came back to my attention today when drug reps came detailing it at the office.  Somewhat incredulously the reps never even mentioned that the FDA released a warning on July 22, 2011 to physicians not to use Multaq in patients with permanent a-fib because the PALLAS trial was stopped early when patients on Multaq had a two-fold increase in death, stroke and heart failure hospitalization in patients with permanent a-fib.

Since its release Multaq has been in the news frequently as the FDA time after time has released warnings about its use.  Not phased the manufacturer pushed ahead with the PALLAS trial.  This study was undertaken to see if Multaq would reduce the incidence of major cardiovascular events like stroke, arterial embolization, MI, or cardiovascular death in patients with permanent a-fib.  To date no anti-arrhythmic drugs have been shown to improve outcomes in this high-risk group of patients, and there were hints from the initial ATHENA trial of Multaq that it might improve outcomes.  The PALLAS trial appears to have turned out to be a disaster for Sanofi-aventis when instead of improving outcomes in patients with permanent a-fib it appeared to double the rate of the very cardiovascular events Multaq was hoping to prevent.  This led to the premature halt of the trial and the FDA warning of last month.

Multaq has had a really rough first 2 years with a seemingly never-ending litany of FDA warnings about its use.  In early 2010 the FDA warned about the possibility of an increased risk of congestive heart failure (CHF) in patients on Multaq.  On Feb 22, 2010 the FDA changed the warning label of Multaq to note that some patients had worsening of CHF on the drug.  In the second quarter of 2010 the FDA warned about a possible link of Multaq with Torsades de pointes, a potentially lethal and very difficult to treat cardiac arrhythmia.  In the third quarter of 2010 it became apparent that Multaq could interact with warfarin, an anticoagulant used in most a-fib patients to prevent strokes, leading to an increase in the anticoagulation effect and risk of hemorrhage.  Near the end of 2010 cases of severe liver damage due to Multaq began to surface, and on Feb 11, 2011 the FDA warned that Multaq should be stopped if there is a suspicion of liver damage.

Now in a blow that I suspect may lead to the demise of Multaq  the FDA has told patients on Multaq that they should contact their physicians to see if they should stop Multaq.  The warning specifically tells patients not to stop Multaq without consulting their physician, but it appears that with the information we now have that the use of Multaq in patients with persistent atrial fibrillation is contraindicated.  The FDA is telling physicians that they should not prescribe Multaq for patients with persistent a-fib and that the PALLAS data, which is preliminary at this point, is being analyzed to see how to apply this new information to therapy of patients with paroxysmal a-fib and flutter.

MULTAQ is a drug whose primary indication is the potential benefit of reducing hospitalization rates in patients with atrial fibrillation by maintaining a sinus rhythm. the concern of potential risks of hepatic failure, worsening of CHF, drug interactions with warfarin and now higher risk of death, stroke and heart failure hospitalization in patients with permanent atrial fibrillation make it seem less than prudent to start almost any patients on Multaq.  The primary question remaining is whether patients currently on Multaq who are maintaining a regular sinus rhythm without any or many episodes of intermittent a-fib should continue the medication or be taken off Multaq.  My guess is that Multaq will fall into the category of drugs rarely used very quickly if Aventis-sanofi decides to keep the drug on the market at all.  As recommended by the FDA if you are taking Multaq you should contact your physician to see if you are better off continuing to take Multaq, or if you are better off to discontinue the medication.  Don’t stop on your own.

25 Responses to Multaq: Does it Still Have a Role in Atrial Fibrillation?

  1. Dr. Pullen says:

    Linda: I believe so, but you should ask your physician in your particular situation of course. DrP.

  2. Linda hester says:

    Is it safe to go off Multaq without tapering.

  3. Dr. Pullen says:

    Chloe: I am not a cardiologist, and this whole scenario seems a bit unusual. You’ll need to discuss this with the cardiologist involved. DrP.

  4. Chloe says:

    Hello dr pullen. I have a scenario about my relative. 26 years old young man with no underlying medical illness, complains of having palpitations intermittently for past 1month.No other significant signs and symptoms. Non- smoker and non alcoholic. No family history of heart disease. He went to seek treatment from cardiologist. He was diagnosed with pvc.Blood test showed normal hb, normal thyroid, normal rp and normal liver function test. He was prescribed with multaq 400mq. Half tablet bd. after reading your article, I wonder he should start the treatment or not?? I worry about the side effect of multaq greater than the disease itself. And can he stops to take the medication abruptly once his symptoms relieve?!
    Thank you for your attention, dr pullen

  5. Dr. Pullen says:

    Jim McKibben: Lots of questions. I think the key question to ask your cardiologist is whether he believes the risk of use of Multaq outweighs the benefits. If you have permanent a-fib, meaning you are in a-fib and not mostly in a sinus rhythm that from time to time goes into a-fib, it is usually not best to use Multaq. If your cardiologist feels the Multaq prevents episodes of a-fib it may be beneficial. The other side effects you mention are only occasional and you will need to see if they bother you. I do not pretend to be as expert on your situation as your cardiologist and so you need to lean on him for advice specific to your situation. DrP.

  6. Jim McKibben says:

    During a recent checkup with my well respected cardiologist, my heart was found to be in atrial fibrillation. This is the third or fourth time I have had periods of atrial fibrillation during the last 15 plus years. In all cases, I was converted to normal rhythm by drugs or cardioversion. I have been using several different drugs to control my heart rhythm during the last 15 plus years.
    I also have high blood pressure that is difficult to control. My blood pressure has been under control ( 120/70) with the use of several blood pressure medications. I also have a very low pulse rate, usually averaging between 52 and 55 beats per minute. Periodically my pulse rate is in the mid to upper 40’s. My pulse has always been low for nearly 3 decades, well before my blood pressure and atrial fibrillation problems started. A resent 24 hour monitoring of my heart rate found my average pulse was 55 and the lowest rate during the 24 hour monitoring was 35. As a result of the history of a-fib and the slow heart rate, my cardiologist has me on warfarn sodium.
    During this episode of a-fib and most of the past episodes, I have completed an extensive set of heart test including my third or fourth angiogram. The angiograms have found some narrowing of the arteries, but not serious enough to required additional procedures. The series of angiograms have also found my coronary artery disease to be improving or stable.
    Another complicating factor is that I have moderate to severe MS. This has greatly limited my ability to move about and to exercise.
    My cardiologist has recently placed me on Multaq 400 mg tablets twice a day to control the a-fib. I had to change my cholesterol medication to avoid an drug interaction with Multaq.
    My reading about Multag side effect and warnings has raised some concerns. My experience with MS has taught me to ask a lot of questions. What questions should I ask my cardiologist in my next visit?
    Secondly, what is the nature of the weight gain, increased appetite or fluid accumulation? I have a lifelong weight problem.

  7. Dr. Pullen says:

    June: I have no idea. Sounds concerning. Consult your doctor. DrP.

  8. June Edmonds says:

    I haven’t taken Multaq for a few days now. Last night my feet started to feel numb and then I became dizzy and my vision was not clear. My heart was racing and my blood pressure was extremely high. I honestly thought that I was dying. I took several of my Coreg pills and today I am feeling a little better. Still heaviness in my chest. My right arm was hurting and my hand was also numb. Do you feel that stopping the Multaq had something to do with these symtoms or do you believe that Multaq was the cause of these symtoms?

  9. Tim Walker says:

    I had an ablation approx 4 yrs ago with great results. Six months ago I had an afib session that lasted a week but abated by itself. This time I have had it for 3 weeks. My cardio prescribed Multaq, but after reading some things I am almost scared to take it. My afib is not horrible, my HR is about 95 and I don’t notice it when working, but at rest I definitely know its going on. Why would my Dr recommend it as it states in literature not for patients with Afib currently?

  10. Dr. Pullen says:

    June: Your case sounds complex, and it would not be appropriate for me to even try to comment. You just need to get back to your physician(s) to check into these symptoms. DrP.

  11. June Edmonds says:

    I hadan ablation done in September, 2011 and then my heart was shocked back into rhythm a few weeks later. I was already on Plavix from a stent a few years earlier. My doctor that performed the ablation put me on Multaq 400 mg. twice a day and Pradaxa 150 mg. twice a day and the doctor told me to continue the Plavix 75 mg. once a day. I was fine in the beginning and have since had severe pains in the chest and have not been feeling well. I have contributed this to stress, but am now concerned that it may have something to do with the Multaq. Please let me know your thoughts.

  12. David Seyler says:

    I have been on Multag for approximately 6 weeks. I have read the articles on multag and became very concerned with the negatives that I read. I contacted my Doctor who sated that its either Multag or an ablation. I have had 3 attacks of A-Fib in the last year and a half (Aug 2010 to present) lasting about 3 days and a heart rate of 140. Heart rate now is in very low 60′s and high 50′s. Blood pressure is averaging 130 over 75. However the info I read is still very scary and why would a doctor state that it is either multag or and ablation? along with the Multag I am taking pradaxa and bystolic.

  13. Dr. Pullen says:

    Vickie: I cannot give specific individual advice on this blog. I know of no contraindications to stopping Multaq without a taper but you need to call your Mom’s prescribing physician about her problems. DrP.

  14. Vickie Toler says:

    My mother has been on Multaq for 6 days. Last night she didn’t sleep all night because she was having a hard time breathing. She wants to come off it immediately. Will it hurt her since she has only been on it for a short period of time?

  15. Dr. Pullen says:

    I am not aware of Multaq being indicated for V-tach. Maybe an off label use your cardiologist is aware of, so you need to ask them. DrP.

  16. wensel kolarik says:

    Dr Pullen I have V-Tac. My ejection fraction is 54. I was on amiodarone for about 6 months. Suddenly my stamina decreased. When I discontinued it my stamina increased. Now I am on multaq 400 mg twice daily. Is this the right direction I should take. Wensel Kolarik

  17. Gudi says:

    I have been taking Multaq for 11 months. It has helped me so far. Have not had an ‘attack’ of AF since the beg. of taking the drug. I have Paroxysmal AF. I have not gained weight, I am fit, energetic, and healthy and I feel great at my almost 80 years. I am also so grateful to our wonderful health service in Ontario, Canada.
    Thank you. Gudi

  18. Dr. Pullen says:

    Judith: Keep working with your physicians. This can be very difficult. DrP.

  19. Judith says:

    I have been on Multaq for two years. My episodes of arrhythmia have not lessened–I have them every 9 to 23 days and they last anywhere from 8 to 27 hours. I am concerned about the weight gain that I have experienced. I have gained 25 pounds in the two years—I joined SparkPeople, thinking that keeping close track of the calories I consumed would help to take off some of the weight, but the pounds continued to come on–anywhere from 1 to 4 lbs per week. I have had an ablation, but that was not successful.
    The cardiology group that I go to doesn’t seem to have any answers. What should I do about the Multaq?In April I changed doctors in the group and my new doctor prescribed metoprol tar 25 mg, 3x a day along with the Multaq. The next time I had an episode, I experienced a great deal of dizziness, so the drug was cut back to 2x per day. (I still occasionally experience dizziness when having an episode.
    I did see a new procedure that is being performed by Pinnacle Health in Harrisburg, PA, but I’m not sure if they do this procedure on people who are my age–71. I’d appreciate any comments you have to offer.
    Thank you.

  20. Dr. Pullen says:

    Bob S: I’d suggest you discuss this with your primary care doctor. DrP.

  21. Bob Schumann says:

    I tried to post from my iPhone, with not much luck. I have been on Multaq for a month after a 10 day hospital stay after collapsing on the kitchen floor on 09/09/2011. My PCP admitted me with a diagnosis of AFib. During my stay in the hospital, I was given a stress test which prompted a heart cath. There were 2 arteries found to have 45% blockage, so no action was taken. Long story short, I am now on Multaq 400 mg twice a day and Pradaxa 150 mg twice a day. I take Uroxatrol, which seems to be a major problem with Multaq. Multaq also seems to be an issue with some of my other meds, but not as significent as Uroxatrol My cardiologist doesn’t seem concerned with these issues and said we will monitor them. In the same breath, he said, “see you in 6 months”.

    Taking Multaq along with Pradaxa concerns me along with some of the other meds I am on, especially the Uroxatrol. I take Lisinopril and an occational Percoset for cronic back pain. What do I do, get the Dr. to take me off Multaq, or just hope for the best with both meds? I thought Pradaxa was designed for AFib, so why the Multaq! Thanks, Bob………

  22. Bob S says:

    I have been on Multaq for a month after a 10 day hospital stay. I calapsed on the kitchen floor on 09/09/11. The PCP admitted me with a diagnosis of AFib. During my stay they performed a stress test that prompted a heart cath procedure. They found 2 blocked arteries. They were only at 40% so no action was taken. Long story short, I am now on Multaq 400 mg twice a day along with Pradaxa 150 mg twice a day. I use Epocrates app to check interactions a d found Multaq seems to have an issue with most of the meds I currently taking; Uroxatrol seems to be a major problem with Lisinopril and Percoset only a slight issue. Strangely enough, it shows a reaction between Multaq and Pradaxa. Bottom line, my cartioliigest is not concerned about any of this, but I am. Especialy the Uroxatrol! He indicated he would monitor the interactions, and in the next breath said “see you in 6 mo”.

    Taking Multaq and Pradaxa concerns me. I have no reaccurance of AFib since being admitted, my cholesterol has been in the 130′s for years so why both of these drugs? Percoset is for cronic back pain and only taken now and then, Uroxatrol is taken every night. what should I do? Thanks Bob..

  23. Dr. Pullen says:

    Dan Hoff: This is a direct quote from the FDA web site:

    “At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.” (1)

    You are right in that Multaq does not have an FDA approval for permanant a-fib. I think my facts are correct. DrP.

  24. Dan Hoff says:

    Multaq was never indicated for permanent AFib in the U.S. Recent, hullabaloo surrounding a prospective permananent AFib trial that was halted should not affect current paroxysmal or persistent AFib patients taking Multaq. You also seem to have the FDA and EMA confused. The FDA has not suggested that patients see their doctors to consider stopping Multaq. The FDA has issued nothing since July. The EMA told doctors to quit prescribing Multaq for rate control in patients with Permanent AFib. Multaq was indicated for rate control in Europe but not the U.S. Get your facts straight.

  25. Adrian Jiminnez says:

    I’ve been on Multaq since shortly after it came out and it seems like it has been pretty good for me. I used to have these really long attacks of a-fib that often led to having to go the the emergency room and sometimes even have shock treatments to bring back the normal heart beat. Since I’ve been on the Multaq I have only had to go to the ER once, and then the normal heart beat came back with just some IV medication.
    It is certainly scary to read all the bad news about Multaq, but it’s even more scary for me to think of having to stop the Multaq and go back to the alternative of more attacks. If I never have to be shocked again for a-fib I’ll be ecstatic. I’ll take the risks of the drug any day. I hope your article does not frighten away anyone who might get the same great results that I’ve had.

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