The U.S. Food and Drug Administration (FDA) has announced that the heart medication dronedarone (brand name Multaq) has been associated with rare but severe liver injuries—including two cases of acute liver failure leading to liver transplant.
Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Dronedarone can reduce the risk of being hospitalized for these heart problems.
Previous warnings about the drug were directed at people with recent severe heart failure; for those patients, Multaq carried a risk of death. Other than that, however, the FDA reported few serious side effects, and list the most common reactions as diarrhea, nausea, vomiting, and loss of strength. (For the 2009 FDA approval announcement click here: FDA Approves Multaq)
The FDA gives the following recommendations:
- 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; MEDWATCH)
- Read the Medication Guide when picking up a prescription for dronedarone. It will help you understand the potential risks and benefits of this medication.
To read the full FDA safety announcement for Multaq, click here: Severe liver injury associated with the use of dronedarone
If you believe you have developed liver damage as the result of taking Multaq and would like to explore your legal options, please feel free to contact HensonFuerst Attorneys at 1-800-4LAW-MED. Or, visit our site at https://www.hensonfuerst.com/.
If you have questions, HensonFuerst has answers.