Could this be the rock-bottom worst drug ever?
Hitting rock bottom
In 2010 I asked, “Could this be the rock-bottom worst drug ever?”
In 2012 the answer is: “Good chance it is.”
The drug is Multaq, a treatment for patients with abnormal heart rhythm — also known as atrial fibrillation. More than two million people in the U.S. have AF, and millions more are at increased risk due to high blood pressure.
A few days ago, Michele sent you a Code Red message to alert you about a new Multaq safety review from the FDA.
But as usual, the FDA only got it partly right, leaving the impression that this drug is still safe for hundreds of thousands of patients.
Wrong. Multaq 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 AF.
That’s a staggering statement. And it comes straight from the FDA. And 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.
This past July — eight months after I nominated Multaq to the Must-To-Avoid Hall of Fame — the FDA informed healthcare professionals that a clinical trial had been halted when Multaq was linked to a two-fold increase in the deadly conditions listed above.
But that was just the FDA letting doctors know they were reviewing the study.
Finally, last month, the FDA confirmed Multaq’s overwhelming dangers in patients with permanent AF. (Why it took them five months to review a study I reviewed in half an hour I’ll never know.)
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 smoking?
FDA officials would only say they “believe” Multaq is beneficial for non-permanent AF. That’s based on a single 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 that anyone who takes Multaq should be given an ECG “at least once every 3 months,” and “Patients prescribed Multaq should receive appropriate antithrombotic therapy.”
So this “safe” drug requires constant monitoring AND the use of another drug to prevent potential 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 immediately and let him know you want to put as much distance as possible between you and this rock bottom drug.
Sources:
“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
