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.
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.
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.