FDA Drug Safety Alert: Multaq (dronedarone) and Increased Risk of Death and Serious Cardiovascular Adverse Events

The U.S. Food and Drug Administration (FDA) is reviewing data from the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS)  study that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early 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.  The approval of Multaq was based on another trial (ATHENA) in which use of Multaq was associated with a decreased number of deaths compared to placebo.

 The FDA states, "At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation. " 

Additional Information for Patients

• Talk to your healthcare professional about whether you should continue to take Multaq for paroxysmal or persistent atrial fibrillation.
• Do not stop taking Multaq without talking to your healthcare professional.
• Discuss any questions or concerns about Multaq with your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page. 

Additional Information for Healthcare Professionals

• Do not prescribe Multaq to patients with permanent atrial fibrillation.
• FDA is evaluating whether and how the preliminary results of the PALLAS study apply to patients taking Multaq for paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL).
• The PALLAS study results are considered preliminary at this time because the data have not undergone quality assurance procedures and have not been completely adjudicated.
• Report adverse events involving dronedarone to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Facts About Multaq: 

• Multaq was approved  two years ago to treat abnormal heart rhythms.  
• The drug is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted [refer to Multaq label1].
• From approval in July 2009 through June 2011, approximately 1 million Multaq prescriptions were dispensed and approximately 241,000 patients received Multaq prescriptions from U.S. outpatient retail pharmacies. 

Visit the FDA's website to obtain the original July 21 safety alert, which includes PALLAS study data summary.