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Some research has shown the anti-arrhythmic drug dronedarone, which is sold under the brand name Multaq, can cause liver injuries and heart-related side effects. We are zealous advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you or a loved one has taken Multaq and believe it has caused harm, contact us for a free, confidential legal consultation oday. We will evaluate your case for free and if it has merit we will take it on a contigency fee basis.

Multaq Lawsuit Frequently Asked Questions

Multaq is the brand name for the drug dronedarone. This drug is produced by French pharmaceutical giant Sanofi S.A. (formerly Sanofi-Aventis). This medication is used to prevent arrhythmia (irregular heartbeat) episodes that can result in hospitalization of people who have already suffered an atrial fibrillation or atrial flutter within the last six months. The U.S. Food and Drug Administration (FDA) approved the drug in July 2009, and Sanofi sells it in 400 mg oral tablets. According to the FDA, from Multaq’s approval date until October 2010, 147,000 people filled 492,000 Multaq prescriptions.

Multaq is sometimes compared to the generic anti-arrhythmic amiodarone, which has also can have adverse side effects. Like amiodarone, Multaq is chemically a benzofuran derivative. However, according to the FDA, Multaq’s mechanism of action is unknown. Unlike amiodarone, Multaq has lower levels of iodine, which causes pulmonary fibrosis and thyroid disease in amiodarone users. Multaq is also less soluble in fats, making it less likely to cause neurotoxic side effects.

Multaq May Cause Liver Injury Side Effects

On January 14, 2011, the FDA issued a Drug Safety Communication warning the public and healthcare professionals that Multaq had caused several cases of hepatocellular liver injury and hepatic failure. In two of these cases, the patients required liver transplants after using the drug for four-and-a-half months and six months even though their livers were healthy before they began Multaq treatment; their explanted livers showed evidence of extensive hepatocellular necrosis. The Drug Safety Communication lists the following symptoms:

  • Malaise/fatigue;
  • Itching;
  • Yellow eyes or skin (jaundice);
  • Nausea;
  • Vomiting;
  • Fever;
  • Light-colored stools;
  • Dark urine;
  • Anorexia/Loss of appetite; and
  • Right upper quadrant pain.

The FDA recommends Multaq users who experience these symptoms report them to their doctors, who should then conduct tests of their livers for injuries. The FDA has updated the “Warnings and Precautions” section of Multaq’s drug label to reflect these concerns.

Two weeks after its January Drug Safety Communication, the FDA sent Sanofi a Warning Letter because it found that the drug-maker had failed to comply with FDA postmarketing regulations, specifically, “inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events”; “failure to submit serious and unexpected adverse drug experience (ADE) reports within 15 calendar days to FDA”; and “failure to include all postmarketing studies in the Annual Report to FDA.”

After the FDA issued the drug safety communication, health officials in Canada and Europe also began reviewing adverse reports of Multaq liver injury side effects. In July 2011, shortly after Sanofi halted the PALLAS Multaq trial on the drug’s efficacy for treating permanent atrial fibrillation, the European Medicines Agency announced it would initiate a new review of Multaq atrial fibrillation side effects.

The FDA now requires that Multaq’s drug label contain a black box warning advising doctors not to prescribe Multaq to patients who have been diagnosed with New York Heart Association Class IV heart failure. NYHA Class IV heart failure refers to a patient who is mostly bedridden and shows symptoms of heart failure even when at rest. The FDA advises against prescribing Multaq for those with NYHA Class II and III heart failure after a recent hospitalization or referral to a specialized heart failure clinic.

The black box Multaq warning exists because of the results of a study that tested 627 people with symptoms of heart failure. The researchers gave 310 of them Multaq and the remaining 317 a placebo. After 63 days, they discovered that twice as many people in the Multaq group, 25 (8.1%), had died as opposed to 12 (3.8%) in the placebo group. More Multaq users required hospitalization as well.

If you suffered a Multaq liver injury or a Multaq heart injury, we would like to hear from you

New Jersey Multaq Law Firm

With a lawsuit against the manufacturer of Multaq we may be able to help to compensate you for your pain and suffering and other damages. To learn more about a Multaq lawsuit, you should contact our New Jersey Multaq Lawyers immediately as the statutes of limitations restrict the time frame in which you may be able to pursue your claims. If you believe that you or a loved one has been seriously injured due to any of these drugs, and you are interested in learning more about how we can help, please contact our New Jersey Multaq Attorneys today.

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