Earlier in the year we told you how a popular heart drug could injure your liver. Now…the latest research shows it may also cause heart failure…and possibly death.
The research comes directly from the drug maker itself…as part of a post-marketing study. But the drug maker cut the study short…because of “a significant increase in major events” including “cardiovascular death.”
A European health committee has taken one look at their findings…and has ordered the drug be restricted.
A spokesman for the committee says…”events shown in the study mean an increased risk of cardiovascular side effects.”
But it’s a different story in the US. So far the drug remains in wide use. The FDA has yet to take action…while they review the study. And FDA public affairs officer Sandy Walsh advises patients to continue taking the drug in the meantime.
But many leading US doctors say this isn’t good enough.
“The drug is dangerous,” says Dr. Steven Nissen.
He’s the past president of the American College of Cardiology…and is one of TIME Magazine’s “100 most influential people in the world.” He’s published over 300 articles for the most credible medical journals…and leads heart research at Cleveland Clinic.
Dr. Nissen says the new findings come as no surprise. Initial studies showed the drug was risky before it was even released.
“The increased risk of death in heart patients (was shown) in pre-approval studies,” he says.
So if this drug is so dangerous…how did it get approval in the first place? And why is it still available? Stay with us as we uncover the truth about this drug…
Origins of the Drug
The drug is called dronedarone. But it’s better known by its street name…Multaq. It’s made by Sanofi-Aventis and treats heart fibrillation and flutter. Heart fibrillation is fast and irregular beating. Flutters are the fast but regular beating of the heart. So…in other words…Multaq treats irregular heartbeat and maintains normal rhythm.
People dealing with these problems experience rapid heart rate, palpitations and a fluttering feeling.
And it affects about 2.5 million Americans and 4.5 million people in the EU.
Doctors used an older drug to treat the condition called amiodarone. But studies showed it caused serious side effects including organ toxicity. So…the drug maker developed Multaq to avoid these problems. And it was promoted as a safer option. That promotion made the drug maker $179 million in the first half of 2011 alone.
But this is far less than what they were expecting. They’d originally hoped it would make them billions each year.
So why the shortfall?
It’s because ever since its release…report after report shows it to be…
Dangerous…and Not Much Use
“Safety issues (were) apparent even prior to launch,” says Dr. Nissen.
An initial study showed that the drug “doubled the death rate compared to placebo.” It was called the ANDROMEDA study and the results were so bad it was shut down early.
The FDA told the drug maker to put a warning on its website about it. And if you visit the Multaq site you’ll see…
“In a placebo-controlled study patients given (the drug) had a greater than two-fold increase in mortality.”
But a second study – ATHENA – showed better results. This study took patients in generally good health…that had only mild heart conditions.
The results seemed pretty good. And so the drug went ahead.
But within a year reports linked the drug to liver and lung problems…the same problems that the drug was created to avoid.
The first reports came in a trickle.
Two older women both suffered acute liver failure while on the drug.
Neither one had a history or other causes of liver injury. In fact…their blood work showed their liver function to be good. But after taking the drug for six months…they both wound up in hospital with liver failure.
And related cases began to build. Finally…the FDA issued a press release early this year.
“FDA has received several case reports of liver failure in patients treated with dronedarone. (These) include two post-marketing reports of acute failure requiring transplantation.”
So…the European Medicines Agency (EMA) responded by telling the drug maker to conduct further safety studies. And that’s what’s led to the new study…which shows the drug doesn’t just harm your liver…but also the organ it’s meant to protect…your heart.
What the Latest Study Shows
The drug maker launched the PALLAS study and planned to look at 10,800 people. The study would run through August 2013. It would include over 585 sites, with 185 sites in the US and at least 20 in Canada.
But after just a couple of months…and with only 3,149 people enrolled…the study was cut short.
The drug maker won’t say much about the details. But researchers say they saw a big increase in heart “events” in people taking the drug, as opposed to the placebo.
Dr. Stuart Connolly of McMaster University led the study. He told Heartwire he couldn’t give specific details about it.
“Suffice it to say,” he says, “there was a significant increase in major cardiovascular events. In our study that was stroke, systemic embolism or death. These were pretty important events.”
The drug maker told the researchers to stop the study…and tell their subjects to quit the drug.
But according to a press release by the drug maker…this doesn’t apply to anyone not being studied. Everyone else “should not stop their therapy and should consult their physician if they have questions.”
Dr. Connolly says this isn’t suspicious. He says only certain people need be concerned.
He says the patients in the PALLAS study were a “high risk group.” Whereas people in the earlier ATHENA study had “mild risk factors,” such as being over 75.
“There’s strong evidence from ATHENA that patients benefit from (the drug),” he says. “That is, the patients who are ATHENA-like patients. I would say that it’s reasonable to stay on the drug. And I don’t think they should be worried.”
But there are many other doctors – not connected with the drug maker – who don’t agree.
Breaking Down Multaq
Dr. Jonathan Piccini leads heart research at Duke University Medical Center. He’s seen the PALLAS findings and says what triggered the study is no longer the big concern.
He says that liver problems are fairly rare. But the real problem now is that the drug causes heart failure, hospitalization and death. And that’s in patients with mild heart problems. He says the findings should make heart doctors think twice about prescribing the drug.
Dr. John Mandrola agrees. He’s a heart doctor from Louisville.
“I’m surprised that the drug has persisted,” says Dr. Mandrola. He says the drug has a long history littered with…”dubious scientific trials, inefficacy, and now safety concerns.”
And it’s not just that it’s dangerous…
“It just doesn’t work,” he says.
Dr. Nissen agrees.
“I have significant concerns about the efficacy of (it),” he says. “The drug is substantially less efficacious compared with (older drugs).” (xiv)
They both say earlier trials show this to be true.
Two earlier studies – ADONIS and EURIDIS – showed that the drug didn’t do much to fix irregular heart rhythm.
And Dr. Steven Singh also confirms this. He’s the chief of cardiology at the VA Medical Center in Washington, DC.
He says that those two studies show that Multaq is “barely better than placebo.”
So Why is Multaq Still on the Market?
“How (did) Multaq (ever) get promoted to the first line of treatment?” asks Dr. Mandrola.
He answers his own question…
“Substantial and persistent marketing,” he says.
And Dr. Nissen agrees…and blames mainstream medicine.
“The drug has been aggressively promoted, often through professional medical societies,” he says. “Over-promotion of a risky drug during its initial launch (is) a historical harbinger of serious safety concerns.”
Now…the FDA has spoken about the most recent study.
“The study was stopped early after the committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo.”
But the FDA has yet to take action…pending its review.
We’ll continue to follow this story and keep you updated on developments as they happen.
In the meantime we’ve completed an in-depth report that looks at many aspects of heart health…and offers expert guidance on the best ways to improve it.
It’s filled with just-released research and findings on the subject…from the most credible doctors.
We’ll be telling you how you can get this report soon…so keep an eye on your inbox.
Wishing you good health,
Editorial Director, NHD “Health Watch”