Patients with permanent atrial fibrillation who take Multaq (dronedarone), an antiarrhythmic medication, have double the risk of death and double the risk of being hospitalized for heart failure or developing stroke compared to those on a placebo, the FDA announced after the evaluation of a clinical trial. The trial was halted early because of these findings.
Multaq was originally approved by the FDA (Food and Drug Administration) for a different, but related use. Its approval was based on a previous (ATHENA) study in which the medication was linked to a lower risk of death when compared to placebo.
This latest study, called PALLAS, was looking at the benefits of Multaq for individuals with permanent atrial fibrillation aged 65+ years. Researchers were specifically looking out for reductions in unplanned cardiovascular hospitalization or death from any cause, as well as major CV (cardiovascular) events. Examples of major CV events include cardiovascular death, myocardial infarction (heart attack), stroke, or systemic arterial embolism. PALLAS stands for Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy.
The FDA wants to determine what the implications might be of the PALLAS results with regard to Multaq's approved use - patients with paroxysmal or persistent atrial fibrillation (non-permanent atrial fibrillation).
If you are currently taking Multaq for non-permanent atrial fibrillation you should discuss your medication therapy with your doctor, do not stop taking it without consulting him/her, the FDA said.
The FDA is also telling doctors not to prescribe Multaq for those with permanent atrial fibrillation.
In January this year the FDA issued a Drug Safety Communication about some cases of uncommon but serious liver complications in patients taking Multaq.
According to the FDA, patients should:
Talk to their doctor about continuing Multaq for paroxysmal or persistent atrial fibrillation. They should not stop without talking to their doctor first.
Direct any questions or concerns regarding Multaq with their doctor.
Inform the FDA MedWatch program of any side effects they may experience. Telephone number 800-332-1088.
According to the FDA, doctors should:
Not prescribe Multaq to individuals with permanent atrial fibrillation.
Stay informed about the FDA's current ongoing evaluation of Multaq. The Agency is evaluating how the PALLAS preliminary results might impact on Multaq therapy for those with paroxysmal atrial fibrillation, persistent atrial fibrillation, or atrial flutter.
Be aware that the PALLAS study results are preliminary ones.
View drug information on Multaq.