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Multaq Concerns Reverberate through the Cardiology Community

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Washington, DCThe concern over Multaq side effects has, not surprisingly, made it to the pages of Cardiology News (2/12). Ever since the US Food and Drug Administration (FDA) issued a health alert last December with regard to dronedarone (Multaq) and the risk to patients with permanent atrial fibrillation (AF), the cardiology world is proceeding with renewed caution over the Multaq portfolio.

The FDA noted that the only approved used for Multaq is for patients with non-permanent AF. While doctors have always possessed the medical, moral and legal authority to override FDA recommendations as they see fit, a safety review conducted by the health regulator and completed in July 2009 uncovered a risk of death and serious cardiovascular events in those patients with permanent AF.

"The FDA believes that Multaq provides a benefit for patients with non-permanent AF and recommends that health care professionals who prescribe Multaq follow the recommendations in the revised Multaq drug label," the FDA statement said.

While the Cardiology News article was limited to cardiac concerns inherent with Multaq dronedarone, the red flag raised by the FDA last July over the potential for Multaq liver damage constitutes yet another reason for doctors to approach Multaq with caution.

The FDA's analysis was based on a large outcomes study in more than 3,000 patients with a view to determine the effectiveness of the Multaq heart drug. However, the study was terminated early when it became clear that patients with permanent AF taking Multaq were experiencing Multaq problems at a higher rate than those participants taking a placebo.

Often, studies will be terminated early if it is found that study participants are unduly put at risk. Such was the case here, given the Multaq interactions.

Incomplete as it was, the FDA study showed that Multaq heart failure and other cardiovascular events were higher amongst those patients suffering from permanent AF on Multaq dosing v. the control group. The PALLAS study (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) determined that the risk for total death amongst Multaq patients was increased two-fold.

Risk of Multaq death from arrhythmia or sudden death, stroke and hospitalization for heart failure were also increased.

Conversely, when the FDA revisited clinical data from the ATHENA trial that led to the approval of Multaq dronedarone for patients with non-permanent AF, there were no increases in risk associated with those inherent with permanent AF. What's more, the risk for hospitalization was actually reduced.

As a result of concern over Multaq heart for patients with permanent AF, label information has been revised. Multaq lawsuit was not referenced in the article, and so far the manufacturer of Multaq—Sanofi-Aventis—has not issued a Multaq recall.

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READER COMMENTS

Posted by

on
Just for info. My mom has been taking Multaq for about a year now. I was worried about her Liver due to the reports. But her last Liver check about a month ago, her Liver results are all normal, not even raised any. Hopefully it stays that way though, or at least I pray it does.

So not everyone has problems with Multaq/Dronedarone. She has had very little to no side effects also.

Posted by

on
My cardiocologist had me taking Amiodarone for Atrial Fibrulation for many years. On a visit about one year ago he changed the medicatioin to Multaq, stating that Multaq does not have the side effects as Amiodarone. I took the Multaq two nights in a row and horable nightmares, so I stopped taking the medication. It also affected my eating, loosing 30 pounds in three weeks. I went back to my cardocologist and told him that I could not take Multaq. The cardocologist discussed the problem with the cardiocologist who takes care of the Pacemaker and they could not decide on any other medication, so at this time I am not taking medication for Atrial Fibrulation and I feel better without any medication.
I have done research on the medication "Amiodarone" and it leaves you with the impression that you will die without the medication or the medication will kill you because of the side effects.

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