FDA Issues Warning about Serious and Fatal Side Effects with Multaq Antiarrhythmia Drug

July 21, 2011

The U.S. Food and Drug Administration (FDA) issued a warning today about Multaq (dronedarone) after a clinical trial of the drug was halted due to dangerous cardiovascular side effects with the drug.

The clinical trial, sponsored by the Multaq’s maker Sanofi Aventis, was to study the safety and effectiveness of Multaq in patients over 65 years of age with permanent atrial fibrillation. When the data monitoring committee reviewed early trial data, they found patients taking Multaq were twice as likely to suffer death and twice as likely to suffer stroke and hospitalization for heart failure compared to patients taking a placebo.

The FDA approved Multaq (dronedarone) in 2009, based on another study that did not find these risks, for the prevention of cardiovascular hospitalization in certain patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL). Multaq is in a class of drugs called antiarrhythmics, which help a heart with an abnormal heart rhythm beat normally.

Nearly 250,000 patients used Multaq in 2009.

The FDA is reviewing this clinical trial data to evaluate if patients taking the drug for paroxysmal or persistent atrial fibrillation are at risk for the same Multaq side effects.

“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,” the FDA advised. “Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.”

The FDA recommends patients taking Multaq:

• 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.

The FDA advised 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.

In January, the FDA warned of reports of serious liver damage, including liver failure, with Multaq.