The United States Food and Drug Administration is warning doctors that patients taking the drug dronedarone (Multaq) may experience liver injury or in severe cases, complete liver failure. The drug is used to treat abnormal heart rhythm (atrial fibrillation and atrial flutter) and is said to reduce the risk of being hospitalized due to these conditions.
Dronedarone was only approved by the FDA in July, 2009 and since that time, up until October 2010, 147,000 people collected the drug from their pharmacy. An additional number of people were also given the drug in hospital. Patients with heart failure have a two fold increase in death after taking dronedarone.
Liver Failure Requiring Transplantation
Since the drug was approved, the FDA has also received two reports of liver failure that was so severe it required a liver transplant. Both cases involved women who were 70 years of age. In the first case, the woman in question was treated with dronedarone for four and a half months. She began reporting tiredness and exhaustion. Although the medication was discontinued prior to her hospitalization, she was found to have jaundice, coagulopathy and other complications indicative of liver overload. This progressed to liver encephalopathy. All tests done failed to come up with another reason why the woman had liver failure.
In the second case, a woman was given dronedarone treatment for six months and she developed weakness, abdominal pain, coagulopathy, transaminitis and hyperbilirubinemia. She was transplanted one month later.
As a result of this, new adverse reactions are to be listed in the product information.
Advice for Patients Taking Dronedarone
• Signs of liver injury include: itching, yellow eyes or skin, loss of appetite, dark urine and light colored stools. If you have any of these symptoms, see your doctor.
• Talk to your doctor about whether you should still take your medication or not.
• If you suffer any side-effects from taking the medication, report them to the FDA, by phone 1-800-332-1088, or online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm