From Our 2011 Archives
FDA Warning on Atrial Fibrillation Drug Multaq
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Doubling of Deaths Halts Multaq Study; FDA Mulls Risk to Current Users
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
July 22, 2011 -- If you're taking the atrial fibrillation drug Multaq, the FDA wants you to call your doctor right away.
Don't stop taking the drug -- that could be dangerous. But the FDA wants patients to be aware that a clinical trial of Multaq, called PALLAS, was halted when the drug doubled the risk of death, stroke, and heart failure hospitalization in heart patients with permanent atrial fibrillation.
Multaq is approved to treat paroxysmal atrial fibrillation (intermittent), persistent atrial fibrillation, or atrial flutter. The big question -- now the subject of an FDA investigation -- is exactly how the PALLAS findings apply to current patients.
Multaq was approved in 2009 after the ATHENA clinical trial showed it decreased deaths in patients with non-permanent atrial fibrillation and atrial flutter.
But this is now the fifth time the FDA has reported signals of possible risk from Multaq:
The FDA is telling patients:
The FDA is telling doctors:
SOURCES: News release, FDA.FDA web site.Heart.org: "Deaths doubled with dronedarone in PALLAS: FDA and EMA updates," "Dronedarone makes FDA watch list five straight times." ©2011 WebMD, LLC. All Rights Reserved.
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