Multaq® Liver Damage
The heart rhythm drug Multaq® has been linked to severe liver damage, liver failure, and the need for a liver transplant in some users. Multaq has also been linked to an increased risk of heart failure, stroke, and even death.
Following a safety review of the drug, the U.S. Food and Drug Administration (FDA) warned that Multaq increases the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).
Do I have a case?
If you took Multaq and were hospitalized with liver damage or liver failure, if you required a liver transplant, or if a loved one took Multaq and died from liver problems, contact our firm immediately.
What is Multaq used for?
Multaq (dronedarone) is in a class of medications called antiarrhythmics, which are designed to help the heart to beat normally.
Multaq is used to treat people who have had atrial fibrillation (a heart rhythm disorder that may cause fast and irregular heartbeat) or atrial flutter (a heart rhythm disorder that may cause the heart to beat very fast) within the past six months and who also have other conditions that increase the risk that they will develop heart problems.
Multaq is marketed as decreasing the risk that people who have these conditions will need to be hospitalized to treat heart problems.
Is Multaq dangerous?
The FDA warned that some patients using Multaq have suffered severe liver injury and liver failure leading to liver transplant.
The FDA has also notified healthcare professionals that a Multaq safety study was halted early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving the drug compared to patients taking a placebo.
What does Multaq look like?
Multaq is a white film-coated tablet that should be taken by mouth, usually two times a day with a meal. The standard dose is 400 mg twice a day, regardless of age or weight. There is no generic version.
How many people have taken Multaq?
The FDA reported that around 492,000 prescriptions were dispensed, and around 147,000 patients filled Multaq prescriptions at outpatient retail pharmacies in the United States since 2009.
What is being done to protect consumers?
The FDA said it would add a new warning about the risk for liver damage to the label of Multaq.
The agency recommended patients should contact their doctor if they experience signs of liver injury, including nausea, vomiting, and fever. If doctors suspect toxicity issues, the patient should discontinue Multaq use and undergo a liver enzyme test.
Multaq® is a registered trademark of Sanofi-Aventis and is used here only to identify the product in question. This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Sanofi-Aventis.