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Jul 27, 2011

FDA Warns Against Dronedarone (Multaq) in Treating Permanent Atrial Fibrillation

A new drug, dronedarone (Multaq), may increase risk for death, stroke and hospitalization in patients with permanent atrial fibrillation.

On July 21, the U.S. Food and Drug Administration issued a safety alert regarding the use of dronedarone (Multaq), a drug to treat abnormal heart rhythms, for patients with permanent atrial fibrillation. This alert is based on initial study findings from a study conducted by Sanofi-Aventis, the maker of Multaq. Initial data showed that patients taking Multaq for permanent atrial fibrillation were at significantly increased risk for death, stroke and hospitalization, causing the study to be stopped early.

Multaq is a relatively new drug approved in 2009 to treat patients with atrial fibrillation — the most common cardiac arrhythmia. It is estimated that about 1 million Multaq prescriptions have been filled since then to treat over 240,000 patients. However, this drug was only approved for the treatment of paroxysmal atrial fibrillation and atrial flutter — cardiac conditions that come and go, and are present for less than 6 months.

Based on study findings, Multaq should not be prescribed to patients with permanent atrial fibrillation. Furthermore, those currently taking Multaq should consult with their physicians about whether they should continue this treatment for non-permanent atrial fibrillation. However, patients should not stop taking the drug without consulting with their doctor first.

The FDA hopes to provide final study results soon, and further research will be conducted to confirm the safety of Multaq in patients with non-permanent atrial fibrillation.

Questions for You to Consider

  • What is Multaq?

  • Multaq is the brand name for dronedarone, a drug made by the pharmaceutical company Sanofi-Aventis. It was initially approved in July 2009 to reduce the risk of cardiovascular hospitalization in patients with non-permanent atrial fibrillation or atrial flutter with a recent arrhythmic episode and other cardiovascular risk factors.
  • Should I stop taking Multaq for non-permanent arrythmia?

  • If you are currently taking Multaq, do not stop taking this drug without consulting with your physician. Any side effects should be reported to the FDA MedWatch Program, and all questions or concerns should be discussed with your healthcare provider.


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Guidance from the Agency for Healthcare Research and Quality (AHRQ) in making health decisions

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