If you’re one of the millions of patients with high blood pressure or abnormal heart rhythm (atrial fibrillation), then it’s time to go on high alert. That’s because you’re a prime candidate for one of the worst drugs in history.
The drug is Multaq. And this familiar phrase perfectly defines the problem: “It does more harm than good.”
Seriously. This drug is a potential monster.
So many issues, so little time
“Multaq doubles the rate of cardiovascular death, stroke, and heart failure” in patients with permanent atrial fibrillation (AF).
That staggering statement comes straight from the FDA. You would think it would be enough to shut down a drug and wipe it from the market. But no. That’s what rational people would do. Not the FDA.
But what about patients with non-permanent AF? Here’s how Reuters addressed that question: “The FDA said Multaq is still safe to treat patients with brief bouts of irregular heart rhythm.”
Still safe? Reuters! What are you thinking?
FDA officials would only say they “believe” Multaq is beneficial for non-permanent AF. And they base that belief on just one study mounted by Sanofi-Aventis, the maker of Multaq.
In that study, Multaq was no more dangerous than placebo in patients with non-permanent AF. And yet, the FDA recommends an ECG every three months for anyone who takes Multaq. And… “Patients prescribed Multaq should receive appropriate antithrombotic therapy.”
So this “safe” drug requires constant monitoring and the use of another drug to prevent cardiovascular risks. Does that sound anywhere NEAR safe to you?
Meanwhile, the Multaq website warns that the drug may cause “slowed heartbeat” and “life-threatening liver failure.” And in 2010, an Institute for Safe Medicine Practices investigation linked Multaq to potential impaired kidney function and fatal irregular heartbeats.
The ISMP concluded: “We have seldom seen a drug with so many issues in so many areas of its safety profile.”
Put another way… Multaq is a train wreck!
If you’re taking Multaq, call your doctor. Let him know you want to put as much distance as possible between you and this rock bottom drug.
“FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events” FDA Safety Announcement, 12/19/11, fda.gov
“FDA revises Sanofi Multaq label on heart risks” Anna Yukhananov, Reuters, 12/19/11, reuters.com
“Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation” New England Journal of Medicine, Vol. 360, 2/12/09, nejm.org
“Heartstopping News? More Multaq Safety Signals” Ed Silverman, Pharmalot, 11/8/10, pharmalot.com