Analysis Of PALLAS Study Data Shows Two-Times Increased Risk Of Death, Stroke, And Heart Attack
(Posted by Tom Lamb at DrugInjuryWatch.com)
[12-19-2011] The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).... FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.
The Multaq drug label has been revised with the following changes and recommendations [see the revised Multaq label for all changes]:...
Public Communication, December 8, 2011
Subject: Information on important new changes on use of Multaq® (dronedarone).
Sanofi-aventis Canada Inc., in collaboration with Health Canada, would like to inform patients of important safety information related to the use of the heart drug Multaq (dronedarone)....
In mid-June 2011 drug regulators first turned their attention to cardiovascular side effects associated with the use of Multaq (dronedarone), soon after Sanofi announced that it was discontinuing the late-stage Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS).
Previously, starting in January 2011, drug-induced liver injury had been the primary safety issue for Multaq.
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More recently, in mid-November 2011 researchers who reviewed the PALLAS study data concluded that Multaq should not be used by patients with permanent atrial fibrillation due to serious cerebrovascular and cardiovascular side effects as well as mortality risks.
As summarized in this November 14, 2011 MedPage Today article, "Dronedarone Hazardous in Permanent Afib":
Analysis of the halted PALLAS trial turned up a 2.29-fold excess in stroke, myocardial infarction, systemic embolism, and death from cardiovascular causes combined among patients on the rhythm control drug (P=0.002).
Hospitalization for heart failure also was elevated a relative 81% compared with placebo (P=0.02)....
These findings were presented by Stuart Connolly, MD, of McMaster University in Hamilton, Ontario, and colleagues in a November 2011 online article published by The New England Journal of Medicine (NEJM), "Dronedarone in high-risk permanent atrial fibrillation", and during the American Heart Association meeting in Orlando, Florida -- PALLAS Presentation Details from AHA Scientific Sessions 2011.
Some additional comments by Dr. Connolly were found in a November 14, 2011 Bloomberg news article, "Sanofi’s Multaq Doubled Deaths From Heart Disease in Study":
“We have had a healthy suspicion of anti-arrhythmic drugs for many years, but we had thought this drug didn’t have the same risks,” Connolly said in a telephone interview. “We are now getting the message that this drug has the potential to harm as well,” he said. “It seems this drug acts very differently depending on which type of patient receives it.”
The negative results of PALLAS -- 21 deaths from cardiovascular causes in the Multaq group, compared with 10 among those getting placebo -- caught many by surprise, as was noted by Stanley Nattel, MD, of the Montreal Heart Institute and University of Montreal, who wrote an NEJM editorial, "Dronedarone in atrial fibrillation -- Jekyll and Hyde?", which accompanied the PALLAS results presentation NEJM article by Dr. Connolly.
We will watch to see what the FDA does about Multaq in light of these new safety findings.
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