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: dronedarone
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…
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…
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…
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…
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 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…
Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines
December 20, 2010 by Leave a Comment
A focused update on the guidelines for the management of atrial fibrillation has been released by the ACC, AHA, and HRS. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights of the document:…
Dronedarone and ticagrelor speed into ESC guidelines
August 30, 2010 by 1 Comment
Getting into the guidelines can be a slow and laborious process. Some critics complain that it takes too long for new therapies to receive the guideline seal of approval. But with the new guidelines released at the ESC it’s unlikely that anyone will complain about such dawdling. With unprecedented speed, dronedarone and ticagrelor have achieved…
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)…
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….
Dronedarone approved by FDA for atrial fibrillation or atrial flutter
July 2, 2009 by 1 Comment
Following a contentious FDA advisory panel meeting and considerable discussion about the ultimate clinical role of the drug, dronedarone (Multaq) has finally been approved by the FDA for the treatment of atrial fibrillation or atrial flutter. Sanofi-Aventis said it planned to launch the drug this summer. According to the FDA, the drug’s label will contain…
Dronedarone debut: will it be successful?
April 29, 2009 by 6 Comments
In the wake of dronedarone’s successful but controversial advisory panel meeting in March, a perspective in the New England Journal of Medicine by Peter Zimetbaum reviews the complicated history of the drug and makes a cautious forecast that the drug may be accepted into clinical practice when and if it gains FDA approval: “So where…
Dronedarone gets cautious nod from FDA advisory panel
March 18, 2009 by 2 Comments
The FDA’s Cardiovascular and Renal Advisory Committee voted 10 to 3 in favor of approval for Sanofi’s dronedarone. By all accounts it was a difficult decision for the committee. CardioBrief has received statements from panel members Sanjay Kaul (yes, he did make it to the meeting) and Darren McGuire….
FDA reviewers give green light for dronedarone
March 16, 2009 by 2 Comments
Ahead of Wednesday’s meeting of the Cardiovascular and Renal Advisory Committee meeting, FDA reviewers have recommended approval of Sanofi’s dronedarone to delay recurrence of and hospitalization for atrial fibrillation. FDA observers will be pleased to learn that Sanjay Kaul is listed on the roster as a committee member. CardioBrief is willing to bet that Sanjay…
Dronedarone, rivaroxaban, post-MI hyperoxygenation system, face FDA panels next week
March 10, 2009 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee and Circulatory System Devices Panel are each set to meet next week, when they will evaluate the drugs rivaroxaban and dronedarone and the TherOx Aqueous Oxygen System for infarct size reduction….
FDA advisory committee to consider dronedarone in March
February 13, 2009 by Leave a Comment
Following fast on the heels of the publication of the ATHENA trial in the NEJM, the FDA has announced that it will hold a hearing of the Cardiovascular and Renal Drugs Advisory Committee on March 18 to consider “the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for…
ATHENA published in NEJM: dronedarone benefits AF patients
February 11, 2009 by 1 Comment
The ATHENA trial, originally presented last May at the Heart Rhythm Society meeting, has been published in the New England Journal of Medicine. The trial found that “dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.” The ATHENA slide set is available on ClinicalTRialResults.Com….
Cholesterol Wars: The Reimbursement Battle Begins
August 28, 2015 by 1 Comment
(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…
Growing Popularity Of Dabigatran Leads To Increased Complications
June 7, 2012 by 1 Comment
Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…
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