Multaq Side Effects Lawsuits

Multaq® has been linked to potentially fatal liver damage and cardiovascular events

If you or a loved one suffered liver damage, cardiovascular event or death while taking the antiarrhythmic drug Multaq® (dronedarone), you may have cause to file a Multaq lawsuit.

At Napoli Bern Ripka Shkolnik LLP, our attorneys are investigating cases of people who may have reason to file a Multaq lawsuit because they suffered severe Multaq side effects, including reports of Multaq liver damage and an association between Multaq and heart failure in some patients. They are dedicated to helping people injured by prescription drugs. If Multaq side effects have changed your life or the life of your loved one, you can have our attorneys review your case in a free consultation. Contact us today to learn if you have valuable legal rights.

Multaq (dronedarone) is a prescription antiarrhythmic medication.

The U.S. Food and Drug Administration (FDA) approved Multaq in July 2009. As of October 2011, more than 278,000 patients filled prescriptions for the drug. (1)

Physicians prescribe this drug for the prevention of hospitalization in patients who have an abnormal heart rhythm called Paroxysmal or Persistent Atrial Fibrillation (AF) or Atrial Flutter (AFL) who recently experienced an episode of AF or AFL and are in sinus rhythm or will receive treatment to return to regular rhythm. (2)

Atrial Fibrillation (AF), the most common type of arrhythmia, occurs when the heart’s electrical system sends disorganized electrical signals that cause the atria, the heart’s two upper chambers, to contract irregularly and fast. Blood then pools in the atria, and the upper and lower chambers of the heart fail to work together efficiently pumping the blood. (3)

Made by Sanofi-Aventis, Multaq works by helping the heart beat in a normal rhythm.

You may have a Multaq lawsuit if you or a family member suffered these Multaq side effects:

• Liver damage
• Liver failure resulting in death or need for a liver transplant
• Stroke
• Heart failure
• Heart attack
• Death from cardiovascular event
• Other serious Multaq side effects

Multaq Liver Damage

In January 2011, reports of serious Multaq liver damage, including two people that suffered acute liver failure requiring a liver transplant, prompted the FDA to issue a safety announcement to healthcare professionals alerting them of the risk. The FDA also required that Sanofi-Aventis include liver injury as a potential Multaq side effect on the product labeling. (4)

There is an association between Multaq and heart failure, stroke and death in certain patients.

While the FDA approved Multaq for patients with paroxysmal or persistent Atrial Fibrillation (AF) or Atrial Flutter (AFL), physicians may prescribe this medication for uses not approved by the FDA, called off-label use. Physicians may have prescribed Multaq off-label for patients with permanent Atrial Fibrillation (AF), a related population of patients.

In July 2011 however, the FDA announced the agency was reviewing preliminary data from a Sanofi-Aventis sponsored clinical trial studying the effectiveness of Multaq in patients with permanent Atrial Fibrillation that was halted early when results showed the drug doubled the risk of death, stroke and hospitalization for heart failure compared to a placebo. (5)

After completing a review of the PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) clinical trial, the FDA decided in December 2011 that Multaq should carry a new black boxed warning on the product labeling, the agencies most serious type of warning.

Multaq already carried a black boxed warning about the association between Multaq and heart failure when used in patients with heart failure.

Multaq’s new black boxed warning will advise that doctors should not prescribe Multaq for people with heart failure or permanent Atrial Fibrillation (AF) because it doubles the rate of cardiovascular death, stroke and heart failure in these patients. (6)

The FDA recommends that patients taking Multaq receive an electrocardiogram (ECG) at least once every 3 months to monitor their heart rhythm and if the ECG shows an irregular heart rhythm, the patient should receive treatment to restore a normal rhythm if possible or discontinue Multaq. Physicians should also ensure patients on Multaq take the proper antithrombotic therapy, the use of an anticoagulant or antiplatelet drug. (7)

Patients taking Multaq should speak with their doctor if they are concerned about Multaq liver damage, the association between Multaq and heart failure, heart attack, stroke or other Multaq side effects. They should not stop taking Multaq without first speaking with their doctor.

Get help. Find out if you have a Multaq lawsuit today.

The attorneys of Napoli Bern Ripka Shkolnik LLP are offering a free legal consultation to people across the United States who suffered severe Multaq side effects and may have a reason to file a Multaq lawsuit. If you or a loved one took this drug and experienced Multaq liver damage, liver failure, heart attack, stroke, heart failure or a loved one died due to Multaq side effects, you may have valuable legal rights. Contact us now to find out how attorneys of Napoli Bern Ripka Shkolnik LLP can help you get the justice you deserve.

(1) Source: IMS, Vector One®: National (VONA) and Total Patient Tracker (TPT). July 2009 to October 2011. Extracted December 2011.
(2) U.S. National Library of Medicine. (2011, August 15). Dronedarone. Retrieved December 28, 2011, from PubMed Health: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000511/
(3) U.S. Department of Health & Human Services, National Heart Lung and Blood Institute. (2011, July 1). What Is Atrial Fibrillation? Retrieved December 28, 2011, from National Heart Lung and Blood Institute: http://www.nhlbi.nih.gov/health/health-topics/topics/af/
(4) U.S. Department of Health & Human Services, U.S. Food and Drug Administration. (2011, January 14). FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq). Retrieved December 28, 2011, from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/ucm240011.htm
(5) U.S. Department of Health & Human Services, U. F. (2011, July 21). FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events. Retrieved December 28, 2011, from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/ucm264059.htm
(6) Sanofi-Aventis. (2011, 12). MULTAQ (dronedarone) Tablets. Retrieved December 28, 2011, from U.S. Food and Drug Administration: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s013lbl.pdf(7) U.S. Department of Health and Human Services, U. F. (2011, December 19). FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events. Retrieved December 28, 2011, from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/ucm283933.htm#sa