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.
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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.