Multaq, also known as Dronedarone, is used to treat heart patients that had atrial fibrillation, which is a rhythm disorder that could make the heart beat fast and irregular. It’s also used to treat atrial flutter, which also causes the heart to beat fast, but is still considered regular.
However, this drug is known to sometimes make the heart problems worse – even resulting in death.
In 2011, the FDA terminated a clinical trial of Multaq before the trial was completed. The trial was supposed to test Multaq’s effectiveness as a drug for people whose hearts did not beat in a steady rhythm without stimulation. However, a significant number of participants in the trial suffered from a stroke or heart attack after taking Multaq, while people in a control group who took a placebo instead of Multaq did not have abnormally high rates of these diseases. The data in this clinical trial suggested that taking Multaq can double a patient’s risk of heart attack or stroke if he or she has an abnormal heart rhythm.
Multaq had formerly been approved for use in people with heart conditions, but not people who had the particular condition being studied in the clinical trial. The FDA therefore reviewed data from previous clinical trials and determined that Multaq is safe for its original use, but is not safe for use in patients that have abnormal heart rhythms requiring permanent use of pacemakers or other stimulation devices. Furthermore, all patients that are on Multaq should be closely monitored by their physicians. It’s particularly important to take EKG readings to ensure that the patient’s heart has not developed an abnormal rhythm, as this would indicate that the patient is at risk of stroke or heart attack if he continues on this medication.
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