Multaq Side Effects

In recent months, the US Food and Drug Administration (FDA) has issued two warnings about potential Multaq side effects. Those side effects reportedly include an increased risk of Multaq liver failure and Multaq heart failure. Multaq is known generically as dronedarone and is made by Sanofi Aventis.

Multaq was approved in the US in July 2009 for the treatment of atrial flutter and paroxysmal or persistent atrial fibrillation, both of which can result in stroke. It was not approved for permanent atrial fibrillation, which was the focus of the PALLAS study (below). Multaq is made by Sanofi Aventis. According to the FDA, between July 2009 and October 2010, more than 600,000 dronedarone prescriptions were filled.

In July, 2011, the FDA issued a warning to doctors and patients regarding the potential risk of liver damage associated with Multaq. According to the FDA news release (07/21/11), the agency received reports of liver damage in patients who took Multaq pills, including two reports of patients undergoing liver transplant. Both patients who required liver transplantation were over 70 years old, had no preexisting liver problems and had taken Multaq for between four and six months.

Symptoms of severe liver injury include weakness, shortness of breath, stomach pain, difficulty breathing, rapid weight gain and diarrhea.

In December 2011, the FDA announced that trials on Multaq linked the medication to a serious risk of cardiovascular problems, which included an increased risk of death. As a result, the FDA has altered the warning label to include information about those risks. Specifically, the label will now carry the warning:

"Healthcare professionals should not prescribe Multaq to patients with Permanent Atrial Fibrillation who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke and heart failure in such patients."

Furthermore, FDA warned that patients should have their heart rhythm monitored every three months and treatment with Multaq should stop if the patient is in AF.

In 2011, the FDA announced that it was reviewing data from a clinical trial that studied the effects of Multaq in patients with permanent atrial fibrillation (AFib). The Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, undertaken by Sanofi Aventis, was halted early after an analysis of data found a two-fold increase in death, stroke and hospitalization in patients who took Multaq when compared with patients who took a placebo.

The FDA is now evaluating whether the preliminary results of the PALLAS study apply to patients who take Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter.

In July 2011, Health Canada announced it was also reviewing information regarding the risk of Multaq side effects. In making its announcement, Health Canada noted that in Canada, "Multaq is authorized only for the treatment of patients with a history of, or who currently have various forms of intermittent atrial fibrillation ('non-permanent atrial fibrillation')."

Symptoms of worsening heart failure include shortness of breath at rest, wheezing at rest, chest tightness, trouble sleeping, weight gain, foot or leg swelling and trouble breathing while asleep.

According to the Multaq website (www.multaq.com), common Multaq side effects include stomach problems, nausea, diarrhea, vomiting, indigestion, tiredness, weakness, rash and itching.

Multaq can interact with:

• Nefazodone
• Voriconazole
• Ritonavir
• Telithromycin
• Ketoconazole
• Clarithromycin
• Itraconazole
• Cyclosporine

Furthermore, when the following medications are taken with Multaq, patients can experience a dangerous abnormal heart rhythm:

• Phenothiazines
• Tricyclic antidepressants
• Certain medicines used to treat abnormal heart rhythm or fast heartbeat
• Certain antibiotics

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Last updated on Dec-19-11