December 19th, 2011
FDA Adds New Warnings to Dronedarone (Multaq) Label
Larry Husten, PHD
In an updated safety communication, the FDA announced on Monday that it is adding new warnings to the dronedarone (Multaq, Sanofi) label. On the basis of results from the PALLAS trial, which was discontinued early due to safety concerns, the drug label will now warn: Healthcare professionals should not prescribe Multaq to patients with AF who cannot […]
November 14th, 2011
PALLAS Intrigue: What Role Remains for Dronedarone?
CardioExchange Editors, Staff
John Mandrola, Eric Prystowsky, and Sanjay Kaul weigh in on PALLAS and the present and future of Multaq.
November 14th, 2011
PALLAS: Poor Results for Dronedarone in Permanent AF
Larry Husten, PHD
After a brief announcement earlier this year that the trial had been terminated early, the full results of PALLAS (Permanent Atrial Fibrillation Outcomes Study Using Dronedarone on Top of Standard Therapy) have now been presented at the AHA and published simultaneously in the New England Journal of Medicine. PALLAS shows that dronedarone (Multaq, Sanofi) should not be used in patients […]
September 22nd, 2011
Dronedarone (Multaq) Gets Another Drubbing in Europe
Larry Husten, PHD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended new restrictions on dronedarone (Multaq), Sanofi’s embattled and controversial antiarrhythmic drug. CHMP says that dronedarone should only be used for maintaining sinus rhythm in patients with paroxysmal or persistent AF after successful cardioversion. The drug should no longer be used in […]
August 4th, 2011
Easy Come, Easy Go? ESC to Review Dronedarone’s Role in AF Guidelines
Larry Husten, PHD
Less than a year after speeding into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered. “The ESC will produce a focused update of the AF Guidelines when the full results of PALLAS have been published and regulatory authorities […]
July 21st, 2011
FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone
Larry Husten, PHD
The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication about […]
July 9th, 2011
Will You Still Use Multaq (Dronedarone)? A CardioExchange Panel
CardioExchange Editors, Staff
Our panel responds to the what the cessation of the PALLAS trial means for dronedarone. Will you still use this drug?
July 7th, 2011
Dronedarone (Multaq) Study for Permanent AF Stopped Early
Larry Husten, PHD
The PALLAS trial of dronedarone (Multaq) for permanent AF has been stopped early, according to a press release issued by Sanofi. PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) was a double-blind, placebo-controlled, phase IIIb trial of dronedarone in patients with permanent AF. The company said the discontinuation of the trial […]
January 14th, 2011
FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)
Larry Husten, PHD
The FDA has released a safety communication about severe liver injury associated with Multaq (dronedarone). The FDA said that information about the risk of liver injury would be added to the dronedarone label. The drug’s manufacturer, Sanofi-Aventis, has also sent a letter to healthcare professionals informing them of the warning. The FDA is recommending that doctors advise […]
September 21st, 2010
See Everything
John Mandrola, MD, FACC
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog Dr John M. Do you see anything wrong with this picture? (Hint: see the right column) I guess the European electrophysiologists couldn’t wait for us in North America. They have published their own 54,000 word Euro-specific guidance […]
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