In defense of Multaq…not really

It will not last forever, nothing ever does.

Some day I will have to find another big-pharma punching bag.

It’s true; our pal dronedarone (Multaq) is back in the news again.

This time the Multaq news (as reported on Cardiobrief and Pharmalot) is not about its inefficacy or Sanofi-sponsored professors, but rather concerns about it’s safety. This, from the ‘federally certified’ patient safety organization, the Institute of Safe Medication Practices quarterly report, in which multiple Multaq adverse events are highlighted.

Not good.

These days, when medication safety concerns arise, perception changes. And perception is tough to change.

Safety was Multaq’s last remaining lifeline. The Sanofi representatives and paid ‘experts’ would (note the past tense) tell us, “at least our drug is safe.”

And for the most part they were right.

Really?

In this regard I can modestly defend Multaq.  For if we unleashed the fury of the ISMP on any other anti-arrhythmic drug the results would be similar. Let’s take the listed Multaq sins one by one:

  • Multaq might worsen heart failure. This may be true, but consider any ER’s number one cardiac drug: diltiazem. Diltiazem clearly worsens heart failure. So do the commonly used AF-drugs flecanide and propafenone. The idea is not to mis-prescribe drugs.
  • Multaq might trigger or worsen arrhythmia. ”Pro-arrythmia” is a common adverse effect of using anti-arrhythmic drugs. Consider that a not insignificant number of intermittent AF patients treated with other AF drugs (propafenone, flecanide and amiodarone) will develop sustained right atrial flutter. Trading an intermittent problem for a sustained one constitutes worsening. 
  • Multaq might cause excessive heart rate slowing. I remember back ‘in the day’ (and sadly, this is still the case in many non-AF ablation hospitals), a common strategy for treating AF was to medicate a patient to the point that the heart rate was slow enough to require a pacemaker. All AF drugs but one, dofetilide (Tikosyn), may excessively lower heart rates.
  • Multaq might be dangerous to pregnant mothers. Again, it seems really unfair to single out Multaq for this sin. Isn’t going outside dangerous to pregnant mothers? Anti-arrhythmic drugs in pregnancy–are you kidding me?

With Multaq, there are many lessons to be learned.  For one, I learned that the endpoint “reduced hospitalizations” may be code word for: “our efficacy numbers are lousy.”

But another Multaq message that has yet to be emphasized is that the FDA let Sanofi market the drug willy-nilly.  The electrophysiologists–the specialists in treating AF–didn’t even get a chance with Multaq, as Sanofi had the entire medical community prescribing “amio-lite” as if it was a probiotic.

If the FDA had let Pfizer do the same with dofetilide (Tikosyn) years ago, there would have been a slew of disasters.  Dofetilide is a highly effective but little known AF-drug.  Little known because the FDA dramatically restricts its use.  Only specialists, or those doctors who take a special course can prescribe the drug, and then only after starting the drug in the hospital setting. To a lesser degree than dofetilide, but similarly, if doctors used propafenone, flecanide and sotalol like they do Multaq, the safe-Institutes would be very busy.

The issue with Multaq is the same as it was before these safety blemishes. The drug is ineffective, expensive, poorly tolerated and now, in its safety profile it looks the same as other anti-arrhythmic drugs.

Sadly, it seems likely that cath labs and doctors offices are going to loose a prolific provider of free lunches.

But there is Prasugrel and Dabigatran.

JMM

Comments

  1. Seba says

    Liked your post. I'm a newly Flecainide patient and all this info is useful to me. Thanks for your time

  2. Campykid says

    So, does this mean you no longer prescribe Multaq?

    I may have been a Multaq test case for my original EP. It prolonged my QT period and was pro-arrhythmic (funny how these go together). While on it, in addition to frequent random ectopic beats, I had several hours-long bouts of atrial bigeminy (captured twice on an ECG). Being told to "live-with-it" did not engender fondness for the on-duty cardiologist, who'd never seen me before. Not sure why I keep the multiple bottles of non-tolerated arrhythmia meds: Multaq, atenolol, flecainide, and propafenone, but I didn't keep the original EP.

  3. Anonymous says

    Golly Gee Whiz Batman, it only there were enough EPs to ablate AF in every patient in Gotham City (America). No risk there because I know every adverse event from an ablation is reported to Commissioner Gordon (FDA).

  4. DrJohnM says

    Senor Seba, You are my first commenter with a spanish site. That's cool. Thanks.

    Campy, I too keep a bottle of old flecanide around. As a momento, or perhaps, as a token of gratitude that my AF has stayed dormant.

    Anony: I have read that a blog free of contrary snarky comments is likely to have lousy content. So to you, I say thanks for writing. I left the words about medicating AF so much that a pacemaker is required for effect. To emphasize the important AF-treatment axiom: don't make AF treatment worse than the disease.

    JMM

  5. Anonymous says

    Great blog, I really enjoy reading your comments. It really makes me think that we should be reporting all of our side effects with AF medications to the FDA. As medical professionals, isn't it our obligation to contact our pharma representatives for propafenone, flecanide, sotalol, amino and tikosyn when we see side effects to ensure the safety for our patients.
    The real picture of safety might be captured.

  6. Anonymous says

    You did skip one question above, which I realize may have been intentional and certainly is your prerogative, but in case you are willing to answer, I'm curious:

    "So, does this mean you no longer prescribe Multaq?"

    And going further, let's assume your AF recurs, so we are talking about a physically active, generally healthy, middle aged man (um, yeah, ok, so like me): what's your first reaction as to what to reach for as an AAD?

    Mike (in Nashville)

  7. DrJohnM says

    Mike,.

    I have used Multaq a few times. Not recently though. One thing that I try to be, always, is open-minded. There will likely be some limited niche for Multaq.

    If (when) my AF recurs, I will be sad. We will see. Maybe there will be a miracle cure in the years to come. Which AAD for you? That's a question for your AF-doctor.

    JMM