Posts Tagged ‘dronedarone’

January 26th, 2012

Sizing Up Clinical Trials — Quickly and Intuitively

A pharmaceutical sales rep comes to your office bringing lunch. He shows you a graphic stating that Multaq (dronedarone) reduced the primary endpoint in the ATHENA trial by 24%. The fine print shows an impressive P value: <0.0001. You come away satisfied that this drug looks good. You may not realize it, but you also […]

December 19th, 2011

FDA Adds New Warnings to Dronedarone (Multaq) Label

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?

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

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

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

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

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

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

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)

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 […]