Multaq-Associated Cardiovascular Events Stops Clinical Trial Early

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New York, NY: The FDA has notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq, (dronedarone) in patients with permanent atrial fibrillation.

The Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo.

The FDA is evaluating whether and how the preliminary results of the PALLAS study apply to patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter. The PALLAS study results are considered preliminary at this time because the data have not undergone quality assurance procedures and have not been completely adjudicated. FDA will update the public when more information is available. Earlier this month, the European equivalent of the FDA, The European Medicines Agency, said it will review Sanofi's drug for atrial fibrillation, based on early data from PALLAS.

Multaq was approved in the United States in July 2009 for treatment of flutter and paroxysmal or persistent atrial fibrillation, but not permanent atrial fibrillation. Also known as donedarone, Multaq, was being studied in patients with permanent atrial fibrilliation in the PALLAS trial. When Sanofi found severe cardiovascular events occurring in some patients they stopped the trial early.

Multaq is also associated with reports of liver failure and in January the FDA and Sanofi warned of reports they had received of patients experiencing of acute liver injury while on the drug. However, the decision to halt the PALLAS trial was not related to liver-related adverse events.

Multaq Drug Use Restricted in Europe

In September 2011, European regulators reportedly limited the use of Multaq because of safety concerns. The move could mean that the FDA will take similar action shortly. According to reports, the European Medicines Agency said Multaq should not be used in patients who have permanent problems with their heartbeat, but it can still be used in patients with intermittent heartbeat problems. European doctors are recommended to consider other treatments before using Multaq. The FDA has reportedly asked for details on patients from two clinical trials to help make a decision about the drug's risk-benefit profile.

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Last updated on Dec-19-11

ARTICLES AND INTERVIEWS

FDA Adds Risk for Death and Serious Cardiovascular Events to Multaq Label

Washington, DC: The Food and Drug Administration (FDA) has revised the labeling for Multaq (Dronedarone) to include the increased risk for death and serious cardiovascular events when the drug is taken by patients with permanent atrial fibrillation. Multaq, made by Sanofi-Aventis, is indicated for treatment of atrial flutter and paroxysmal or persistent atrial fibrillation, but not permanent atrial fibrillation [READ MORE]

Multaq Gets Restricted Indication in Europe, FDA Could Do Same

Paris, France: Sanofi's heart-rhythm drug Multaq, has been given a new indication by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), essentially limiting the drug's use for safety reasons. The Food and Drug Administration (FDA) is expected to take similar steps shortly. Multaq, also know as dronedarone, has been associated with an increased risk of liver, lung, and cardiovascular adverse events [READ MORE]

Post-Market Clinical Trial for Multaq Halted amongst Concerns

Washington, DC: A clinical trial designed to assess the effectiveness of a drug to treat abnormal heart rate has been stopped early following a discovery by a data-monitoring committee of a two-fold increase in death, according to a communiqué from the US food and Drug Administration (FDA). The drug agency is reviewing the data from Multaq, manufactured by Sanofi Aventis—as is Health Canada north of the border.

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