U.S. FDA Issues Safety Alert for Dronedarone (marketed as Multaq)

The U.S. Food and Drug Administration (FDA) has received several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone (marketed as Multaq), including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 

Information about the potential risk of liver injury from dronedarone is being added to the 'Warnings and Precautions' and 'Adverse Reactions' sections of the dronedarone labels.

Additional Information for Patients

• Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
• Talk to your healthcare professional about any concerns you have with this medication.
• Do not stop taking dronedarone unless told to do so by your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program (1-800-332-1088 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20857)
• Read the Medication Guide when picking up a prescription for dronedarone. It will help you understand the potential risks and benefits of this medication. 

Additional Information for HCPs

• Advise patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching) while taking dronedarone.
• Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. However, it is not known whether routine periodic monitoring of serum liver enzymes (ALT, AST, and alkaline phosphatase) and bilirubin in patients taking dronedarone will prevent the development of severe liver injury.
•  If hepatic injury is suspected, dronedarone should be promptly discontinued and testing of serum liver enzymes and bilirubin should be performed. If hepatic injury is found, appropriate treatment should be initiated.
• Dronedarone should not be restarted in patients who experience hepatic injury without another explanation for the observed liver injury.
• Report adverse events involving dronedarone to the FDA MedWatch program (1-800-332-1088 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20857).

Dronedarone is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent history of AF/AFL and associated cardiovascular risk factors (age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥ 50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.

Additional information is available on the U.S. FDA's website.