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Heart Risks Garner New Restrictions for Multaq

Dec 20, 2011 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) has warned that Multaq should not be used to treat temporary atrial fibrillation because it may place such patients at a higher risk of serious cardiovascular problems, including heart failure, stroke and death.   Multaq was only approved to treat temporary atrial fibrillation when the FDA cleared it for sale in 2009.

Because of findings from its latest review, the FDA announced yesterday that the Multaq drug label has been revised with the following changes and recommendations:

  • Healthcare professionals should not prescribe Multaq to patients with atrial fibrillation who cannot or will not be converted into normal sinus rhythm (permanent atrial fibrillation), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
  • Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in atrial fibrillation, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalization for atrial fibrillation in patients in sinus rhythm with a history of non-permanent atrial fibrillation (known as paroxysmal or persistent atrial fibrillation).
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

This marks the third time this year that the FDA has issued a safety alert for Multaq.  The first warning, issued in January, came after serious cases of liver failure - some requiring transplant - were reported in Multaq patients.  At the time, the label for the drug was updated to state that “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq."

In July, the FDA launched another safety review of Multaq after the PALLAS trial was halted.  PALLAS was studying the use of Multaq in people over 65 with permanent atrial fibrillation, but was shut down after Mutaq-treated subjects experienced a higher-than expected frequency of adverse heart events, including cardiovascular death and stroke.

In yesterday's safety announcement, the FDA said that in addition to PALLAS, it had also taken another look at data from the ATHENA trial, which was used to garner approval for Multaq.  Because patients in that study did not have an increased risk of cardiovascular death, stroke or heart failure, the FDA said it continues to believe that Multaq provides a benefit for patients with non-permanent atrial fibrillation.



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