Safety Alerts & Recalls
What does this mean?
Since dronedarone (Multaq) is used to treat the serious condition of abnormal heart rhythms, the benefits of this medicine should continue to outweigh the risks for most patients. If you take dronedarone (Multaq), you should not stop taking your medicine unless told to do so by your healthcare professional. However, please be aware that liver injury is a rare but possible side effect of dronedarone (Multaq). You should 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.
Please talk to your healthcare professional about any concerns you have with dronedarone (Multaq). You can also read the Medication Guide when picking up a prescription for dronedarone (Multaq). It will help you understand the potential risks and benefits of this medication.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of dronedarone (Multaq) to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq)
The Food and Drug Administration (FDA) notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone (Multaq) is being added to the Warnings and Precautions and Adverse Reactions sections of the dronedarone (Multaq) prescribing information.
Dronedarone is sold under the brand name Multaq and is a drug used to treat patients who have had an abnormal heart rhythm during the past six months.
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