In an updated safety communication the FDA announced it was adding new warnings to the dronedarone (Multaq, Sanofi) label. Based on 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 or will not be…
Search Results for: multaq
Dronedarone (Multaq) Gets Another Drubbing in Europe
September 22, 2011 by Leave a Comment
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended new restriction 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. CHMP said that it was recommending that dronedarone…
Guest Post: Multaq’s Off Again, On Again, Then Off Again Ride
July 7, 2011 by Leave a Comment
CardioBrief welcomes this guest post, reprinted with permission, from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes. Today was another tough day for Sanofi’s dronedarone antiarrhythmic…
Dronedarone (Multaq) Study for Permanent AF Stopped Early
July 7, 2011 by 2 Comments
The PALLAS trial of dronedarone (Multaq) for permanent AF has been stopped early, according to a press release (below) 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 comparing dronedarone to placebo in patients with permanent AF. The company said the…
FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)
January 14, 2011 by 4 Comments
The FDA has released a safety communication (reprinted below) about severe liver injury associated with Multaq (dronedarone). The communication confirms and provides additional details about the 2 liver transplant cases that were first reported here on CardioBrief. (Click here for the response from Sanofi-Aventis to the CardioBrief report.) The FDA said that information about the risk…
Sanofi-Aventis Provides More Details About Multaq Letter
January 14, 2011 by 2 Comments
A Sanofi-Aventis spokesperson has confirmed CardioBrief’s story yesterday and has provided further details and clarifications about the Dear Doctor letter. Here is the Sanofi statement:…
Sanofi-Aventis To Inform Doctors About Liver Transplants in 2 Patients Taking Multaq (Dronedarone)
January 13, 2011 by 3 Comments
Sanofi-Aventis is about to send a “Dear Doctor” letter to physicians informing them of two cases of fulminant hepatic failure/necrosis resulting in liver transplanation in two patients taking Multaq (dronedarone), CardioBrief has learned. The two patients were women in their 70’s with no other apparent causes of liver injury or known elevations of liver function…
New Safety Questions Raised About Multaq
November 8, 2010 by 1 Comment
The Institute for Safe Medication Practices has identified a potential drug safety signal for dronedarone (Multaq, Sanofi-Aventis). The potential problem is outlined in QuarterWatch: 2010 Quarter 1, a publication of the ISMP that monitors FDA MedWatch reports, and was written about on the Pharmalot blog. The report concludes: Evidence is accumulating that the risks of the…
A missing piece of the Multaq puzzle finally appears: DIONYSOS published to little fanfare
July 30, 2010 by Leave a Comment
The Greek god Dionysos demanded a great deal of attention. When King Pentheus refused to acknowledge the divinity of Dionysos, the god exacted a terrible and bloody revenge, as recounted in the Bacchae, one of the great tragedies of all time. But the new Dionysos is far less demanding. You might even say he’s shy….
Even more questions about Multaq and Prystowsky, alas
April 15, 2010 by 1 Comment
I’m feeling a bit like Al Pacino in Godfather III: every time I think I’m out of the Multaq story I get pulled back in. A sharp observer forwarded an article posted online in the Journal of Cardiovascular Electrophysiology: “The Impact of New and Emerging Clinical Data on Treatment Strategies for Atrial Fibrillation.” First author:…
More pieces of the Multaq puzzle
April 8, 2010 by 6 Comments
I don’t want to keep harping on Multaq (see the bottom of this post for links to recent stories), but then I keep running across promotions for so-called educational programs that practically beg to be scrutinized. Earlier today I received an email from theheart.org CME Center. At the top of the message was this featured…
Experts disagree on when to use dronedarone (Multaq)
April 6, 2010 by 4 Comments
The billion dollar question is this: when to use Multaq (dronedarone)? A new viewpoint and commentary in JACC from Sanjay Kaul’s group (Singh et al) offers a highly conservative answer to the question. An accompanying editorial by Christian Torp-Pedersen, Ole Dyg Pedersen, and Lars Køber provides a much more liberal view of the drug. It…
UK’s NICE plays a bit nicer with Multaq (dronedarone)
March 30, 2010 by Leave a Comment
The UK’s NICE (National Institute for Health and Clinical Excellence) has eased up a bit on its preliminary recommendations for dronedarone (Multaq). It had previously recommended that the drug not be used to treat atrial fibrillation. The revised draft guidance recommends use of dronedarone in people with AF uncontrolled by first-line therapy (usually including beta-blockers)…
More Multaq: Prystowsky whack-a-mole, ACC responds, Sanofi overtures to EPs
March 26, 2010 by 8 Comments
In response to yesterday’s posting about several problems involving a supposedly independent ACC/HRS website (AFibProfessional.org) supported by Sanofi-Aventis, the manufacturer of Multaq (dronedarone), several new events have transpired: Prystowsky Whack-a-Mole– The Eric Prystowsky lecture has been removed from AFibProfessional.org. An ACC spokesperson told CardioBrief that the ACC, in conjunction with its partner, HRS, was “taking some immediate…
Pieces of a puzzle: Multaq, Sanofi, ACC, HRS, Prystowsky, AF Guidelines
March 25, 2010 by 10 Comments
CardioBrief today dispenses with its usual format. Our post today is a puzzle. Here are the various pieces of the puzzle: Puzzle Piece 1: The commercial prospects of Multaq (dronedarone) appear increasingly cloudy, according to a news report by Jim Edwards on bnet.com. Wall Street estimates for the drug, which some had thought might reach € 3…
Dronedarone (Multaq) gains EU approval for atrial fibrillation
November 30, 2009 by Leave a Comment
Sanofi-aventis announced today that dronedarone (Multaq) received approval for the indication of atrial fibrillation in the European Union. Dronedarone was approved in the US last July. (Click here for our previous coverage of dronedarone.) The approval comes with a contraindication for use in unstable patients with class III and IV heart failure, and a recommendation…
Dronedarone (Multaq) less effective but safer than amiodarone, study suggests
September 8, 2009 by 2 Comments
Dronedarone (Multaq, Sanofi-aventis) is less effective than amiodarone in fighting AF but causes fewer adverse effects, according to a new study. “The critical question for clinical practice,” the study authors write, is whether the safety benefits “justify a retreat from the moderate efficacy afforded by amiodarone.”…
Dronedarone (Multaq) to cost $9/day
July 28, 2009 by 2 Comments
Dronedarone (Multaq) is now available in US pharmacies at a typical retail cost of $9 per day ($4.50 per pill). The drug’s price is significantly higher than earlier Wall Street estimates, according to news stories on Dow Jones and Reuters. Wall Street analysts are now raising their estimates of the drug’s anticipated revenue….
2011 in Review: Rivaroxaban, Sapien, Mark Midei, Conflicts of Interest, and Much More
December 31, 2011 by 4 Comments
Here’s a completely personal review of the past year in cardiology. Please write a comment if you strongly agree, disagree, or think something is missing. Drug of the Year: Rivaroxaban (Xarelto)– Despite a highly negative review from FDA reviewers, rivaroxaban gained FDA approval for the coveted stroke prevention in AF indication. The drug was approved…
PALLAS: Poor Results for Dronedarone in Permanent AF
November 14, 2011 by Leave a Comment
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…
Industry & Medicine: It’s Complicated
October 7, 2011 by 3 Comments
Some people think industry exerts a uniformly negative force on medicine, or at least that’s the only aspect they focus on when they write or talk about the issue. Others focus exclusively on the beneficial effects of industry, and exhibit amnesia in their failure to recall the numerous instances in recent years in which the…
Easy Come, Easy Go? ESC To Review Dronedarone’s Role in AF Guidelines
September 28, 2011 by 5 Comments
Just over a year after speeding with unprecedented haste 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. Responding to an announcement last week from the European Medicines Agency (EMA), the ESC again announced that it…
Easy Come, Easy Go? ESC To Review Dronedarone’s Role in AF Guidelines
August 4, 2011 by 1 Comment
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…
FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone
July 21, 2011 by Leave a Comment
The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis) and the European Medicines Agency (EMA) has provided updates on its reviews of dronedarone and 2 other drugs which 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…
The Heart Rhythm Society Responds to ProPublica’s Questions
May 5, 2011 by Leave a Comment
Editor’s note: The following post is reprinted with permission from ProPublica. It is the latest installment in ProPublica’s Dollars for Doctors: How Industry Money Reaches Physicians, an ongoing investigation. The Heart Rhythm Society Responds to ProPublica’s Questions by Charles Ornstein and Tracy Weber ProPublica, May 5, 2011, 9:45 p.m. Reporters Charles Ornstein and Tracy Weber…
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