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FDA issues Multaq Warnings

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susan_harr6 years ago

A new study indicates that Multaq– and its generic version dronedarone- may cause death in patients who use it to treat permanent atrial fibrillation. The study was being conducted to determine whether or not the drug, which was approved for treating short term abnormal heart rhythms (non-permanent atrial fibrillation) could be prescribed to patients with permanent atrial fibrillation. According to a Food and Drug Administration (FDA) safety announcement, “the study was stopped short 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.”

In 2009, Multaq (manufactured by Sanofi) was approved for treatment of short-term arrhythmia lasting less than six months. Since then, the FDA estimates 1 million Americans have received prescriptions for the drug.

FDA Warnings

  • “Patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation.”
  • “Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.”

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