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multaq, heart attacks, death, liver failure, injury, lawsuit, side effects

Multaq Side Effects Could Lead To Liver Failure, Fatal Heart Problems, Heart Attacks Lawsuits

Multaq | Lawsuits, Side Effects Include: Fatal Heart Problems, Heart Attscks, Liver Damage, Liver Transplants, Severe Liver Injury & Liver Failure

In July 2011 the U.S. Food & Drug Administration (FDA) released a report that Sanofi, the manufacturer of Multaq, halted a trial of the drug showed that there were twice as many heart attacks, strokes and deaths among patients taking the drug. The study involved patients older than 65 with a permanent heart condition known as atrial fibrillation, causing the heart's chambers to pump out of sync.

Multaq (dronedarone) has been associated with liver damage, including severe liver failure. In January of 2011 the U.S. Food & Drug Administration (FDA) announced the label for Multaq (dronedarone) would be updated to warn of this risk. If you or a loved one suffered liver damage while taking Multaq (dronedarone), we want to hear from you today. You may be entitled to compensation for medical bills, lost wages, and pain and suffering.

Lawyers in our firm who practice exclusively in the area of defective pharmaceuticals are investigating Multaq (dronedarone) liver injuries. We are currently offering free case evaluations to victims of Multaq (dronedarone) liver injuries and liver failure. If you or a loved one suffered a liver injury, liver failure, or required a liver transplant while using this drug we urge you to call us today to protect your legal rights.

FDA Multaq (Dronedarone) Liver Injury Warning

Multaq (dronedarone) is used to treat patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) during the past 6 months. Multaq (dronedarone) was designed to be a safer alternative to amiodarone, a generic medicine with serious liver and lung risks that is only approved for life-threatening irregular beating in the heart’s lower chambers. Since its approval in July 2009 through October 2010, around 492,000 Multaq (dronedarone) prescriptions were dispensed and around 147,000 patients filled Multaq (dronedarone) prescriptions.

Multaq (dronedarone) already carried a black box warning, the most severe type of warning, stating the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used in those patients. Common side effects include fatigue, loss of strength, diarrhea, nausea and vomiting.

In January 2011, the FDA issued a drug communication to inform patients and doctors that Multaq (dronedarone) had been associated with liver injuries, including two cases of severe liver failure that required liver transplants. Both patients were female and approximately 70 years of age. In both cases, the patients had had normal liver serum enzymes before starting the drug.

In a letter to health care professionals, Sanofi-Aventis instructed doctors to tell patients to immediately report any symptoms suggestive of liver injury. Such symptoms include:

  • Anorexia
  • Nausea
  • Vomiting
  • Fever
  • Malaise
  • Fatigue
  • Right upper quadrant pain
  • Jaundice
  • Dark urine
  • Itching

Patients should stop taking the drug in cases of suspected hepatic injury, the agency said. If doctors suspect a toxicity issue they should discontinue use of the drug and test the patient's liver enzymes.

The FDA said the "Warning and Precautions and Adverse Reactions sections of the Multaq (dronedarone) label would be modified to reflect the liver injury risk. It is not yet known how often Multaq (dronedarone) liver damage or liver failure may occur. As the FDA's alert pointed out, because adverse reactions to drugs are reported voluntarily, it is not always possible to estimate their frequency.

Help for Victims of Multaq (Dronedarone)

Our firm is offering free case evaluations to victims of Multaq (dronedarone) liver damage. If you or someone you love suffered liver damage, liver failure, or required a liver transplant after treatment with Multaq (dronedarone), we urge you to contact us as soon as possible. Simply fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with us today.

Latest News

July 22, 2011: FDA cites higher death risk in Multaq drug study

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Heart Risks Garner New Restrictions for Multaq

Dec 20, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) has warned that Multaq should not be used to treat temporary atrial fibrillation because it may place such patients at a higher risk of serious cardiovascular problems, including heart failure, stroke and death.   Multaq was only approved to treat temporary atrial fibrillation when the FDA cleared it for sale in 2009. Because of findings from its latest review, the FDA announced yesterday that the Multaq drug label has been revised with...

Study Finds Multaq Doubles Heart Disease Death Risk

Nov 15, 2011 | Parker Waichman LLP
A new study has revealed a connection between Multaq (dronedarone), approved to treat temporary atrial fibrillation, and a two-fold risk of death in those who suffer from permanent erratic cardiac rhythm.The study found that, in addition to the death risk, stroke and heart failure incidences also significantly rose in patients who took Sanofi-Aventis’ Multaq during a clinical trial involving 3,236 patients, wrote Bloomberg Businessweek. The research was halted this July over the increased...

Use of Multaq Should be Curbed, European Regulator Says

Sep 23, 2011 | Parker Waichman LLP
Multaq safety worries have prompted regulators to issue new restrictions for the drug.  According to a report from The Wall Street Journal, concerns about Multaq's impact on the heart, lungs and liver might soon prompt the U.S. Food & Drug Administration (FDA) to take similar steps in the future.Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that Multaq "only be prescribed for maintaining heart rhythm in patients with...

Multaq Losing Favor as Safety Worries Mount

Sep 22, 2011 | Parker Waichman LLP
Mutaq is coming under increasing scrutiny in both the U.S. and Europe as concerns about its safety and effectiveness continue to mount.  At the same time, many doctors appear to be backing away from Multaq because of safety concerns.Multaq is approved to treat temporary atrial fibrillation.  In January, the U.S. Food & Drug Administration (FDA)  announced that the U.S. label for Multaq had been updated, following reports of liver damage, including severe liver failure,...

Multaq Heart Risks Prompt Canadian Review

Jul 26, 2011 | Parker Waichman LLP
Multaq, already under scrutiny in the U.S. and Europe because of a link to potentially serious heart side effects, is being reviewed by regulators in Canada.   As was the case elsewhere, the Health Canada Multaq review was prompted by the halt of a Multaq study because of a high number of severe heart-related problems among patients taking the drug.Health Canada says it's evaluating information on Multaq and the potential for an increased risk of problems such as heart attack and...

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