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FDA Drug Safety Podcast for Healthcare Professionals: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On July 21, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that FDA is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq, active ingredient dronedarone, in patients with permanent atrial fibrillation. The 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. Currently Multaq is approved for use in a different, but related patient population. The approval of Multaq was based on another trial (ATHENA) in which use of Multaq was associated with a decreased number of deaths compared to placebo.

The Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy study, also known as the PALLAS study, sponsored by Sanofi Aventis (the maker of Multaq), was being conducted to assess the potential clinical benefit of Multaq in patients over 65 years of age with permanent atrial fibrillation in the reduction of:

  • Major cardiovascular events, such as stroke, systemic arterial embolism, myocardial infarction or cardiovascular death, or
  • Unplanned cardiovascular hospitalization or death from any cause

A critical question is whether and how the unfavorable results of the PALLAS study, obtained in patients with permanent atrial fibrillation, apply to patients who use Multaq for the approved indications (non-permanent atrial fibrillation, also known as paroxysmal or persistent atrial fibrillation).

FDA previously issued a Drug Safety Communication in January 2011 regarding cases of rare but severe liver injury that have been reported with the use of Multaq.

Today's communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. FDA will update the public when more information is available.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. They should not prescribe Multaq to patients with permanent atrial fibrillation.
  2. 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.
  3. 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.
  4. Adverse events involving dronedarone should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete Data Summary detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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