I was prescribed this back when my pacemaker went in, but I had such a bad reaction to it, I stopped after three doses. After a lot of research, I realized that I made a very good choice to stop taking it. First of all I wasn’t comfortable with what I read about the research. Second, I don’t have, and never have had, atrial fibrillation. I should never have been considered a candidate.
Sanofi-Aventis To Inform Doctors About Liver Transplants in 2 Patients Taking Multaq (Dronedarone)
Sanofi-Aventis is about to send a “Dear Doctor” letter to physicians informing them of two cases of fulminant hepatic failure/necrosis resulting in liver transplanation in two patients taking Multaq (dronedarone), CardioBrief has learned. The two patients were women in their 70′s with no other apparent causes of liver injury or known elevations of liver function tests (LFTs) prior to the acute liver failure. Liver failure developed after the women were taking dronedarone for four to six months.
Wow…
The FDA originally rejected Multaq in 2006, but then approved it in July 2009.
UPDATE: The FDA has issued a safety communication regarding liver damage associated with Multaq. Honestly, the closer you look, the worse it seems to get. It would be nice if this means the drug gets pulled, but it doesn’t appear to be the recommendation at this point. From the link above Larry Husten quotes Steve Nissen:
Steve Nissen provided the following comment to CardioExchange about Multaq:
I have significant concerns about the safety, efficacy and tolerability of dronedarone. Although liver toxicity was not anticipated, other safety issues have been apparent even prior to launch. The increased risk of death in heart failure patients represented a particularly concerning finding in pre-approval studies. The drug is substantially less efficacious compared with amiodarone and the GI tolerability is poor. Despite these warning signs, the drug has been aggressively promoted, often through industry-sponsored CME offered by professional medical societies. Over-promotion of a risky drug during its initial launch period has been a historically important harbinger of serious safety concerns. Dronedarone may be headed for trouble.
Yup, I guess the important thing is to listen to your body. Take care, sending good thoughts to you and your family (hope he is doing better).
Oh, one last thing, is always let your doctor know when you stop something and why you stopped it, as not doing so could become problematic in the event of an emergency.
I did let him know. Immediately. I plan to ask him at my next visit if, in light of this “doctors letter” that is going out, if he is going to continue to prescribe it to his patients.
My doctor has repeatedly insisted I should never be anxious to be among the first to use a medication or undergo a procedure or form of theraphy.
“Bleeding edge,” you know.
My cardiologist is a good EP. But his one foray in prescribing meds for me was not a happy ending!
It’s the crap like this, that’s go me worried.
Fortunately, what you’re on has been around for quite awhile. Remember all the research you and I were doing on this way back in Nov 2009?