Drug Recalls -Multaq Label Changed to Include an Increased Risk of Death

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Multaq Label Changed to Include an Increased Risk of Death

Tuesday, 20 December 2011 18:27 | Written by Drug Recall Lawyer |

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Multaq (dronedarone) was found to increase the risk of death or serious adverse cardiovascular events if used by patients in permanent atrial fibrillation (AF).

The safety review completed by the FDA sparked the following revisions to the Multaq label:

Healthcare professionals should not prescribe Multaq to patients with AF
Healthcare professionals should monitor the heart rhythm of a patient on Multaq at least once every three months
Patients prescribed Multaq should receive antithrombotic therapy

Originally, Multaq was approved "to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL)." After this safety review, however, the FDA recommends that "patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation."

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