Two cases of acute liver failure in which the patients taking heart medication dronedarone (Multaq) needed liver transplants have resulted in an FDA communication informing that data on the potential risk of liver injury are being added to the drug’s labels.

Dronedarone (Multaq) is used to treat atrial fibrillation and atrial flutter in individuals whose hearts either returned to normal rhythm or who underwent drug therapy for electric shock treatment – the drug helps maintain normal rhythm. The FDA (Food and Drug Administration) approved dronedarone in July 2009, and it is available as 400mg tablets in 60 count bottles. The FDA did not approve the medication for reducing deaths. A study of patients with irregular heartbeats found that Multaq treatment more than doubles the risk of death.

Since its launch, approximately 200,000 people have taken Multaq. According to the FDA, “Since dronedarone’s approval in July 2009 through October 2010, around 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States.”

French pharmaceutical company, Sanofi-Aventis, the makers of Multaq, informs that no causal link has been established between taking the drug and acute liver failure.

The FDA is asking doctors to remember to tell their patients (who are on dronedarone) to contact a healthcare professional whenever they experience hepatic injury or toxicity signs and symptoms, which may include:

  • anorexia (markedly reduced appetite)
  • dark urine, or itching)
  • fatigue
  • fever
  • jaundice (yellow staining of the skin and the whites of the eyes)
  • malaise (general feeling of being unwell, discomfort)
  • nausea
  • right upper quadrant pain
  • vomiting

The FDA adds that perhaps doctors should consider getting occasional hepatic serum enzymes during the first six months of dronedarone therapy.

Patients and healthcare professionals should report side effects and adverse events linked to this medication to the Agency’s MedWatch Safety Information and Adverse Event Reporting Program.

A letter was sent to US doctors from Sanofi-Aventis about the two cases of acute liver failure.

Jean-Marc Podvin, a company spokesman, said in an interview with Dow Jones Newswires:

“Patient safety is Sanofi’s priority,(we are) working with European health authorities and in the countries where Multaq is approved and those where it is submitted for review.”

Individuals with severe liver problems should not take Multaq, the company informs on its web site.

Source: FDA

Written by Christian Nordqvist