Research shows the anti-arrhythmic drug dronedarone—sold under the brand name Multaq—causes liver injuries and heart-related side effects. The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you’ve taken Multaq and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Multaq recalls and Multaq class action lawsuits. We might be the Multaq law firm you are looking for.
What Is Multaq and What Is Prescribed For?
Multaq is the brand name for the drug dronedarone. Made and sold by French pharmaceutical giant Sanofi S.A. (formerly Sanofi-Aventis), this prescription medication is used to prevent arrhythmia (irregular heartbeat) episodes that require hospitalization in 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 often compared to the generic anti-arrhythmic amiodarone, which has many 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 Causes 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:
- Yellow eyes or skin (jaundice);
- 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—the agency’s most serious kind—advising doctors not to prescribe Multaq to patients who have been diagnosed with New York Heart Association (NYHA) 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 side effect or a Multaq heart injury side effect, the Rottenstein Law Group would like to hear from you.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Multaq lawsuit on your behalf if necessary. RLG will also keep you up to date on any Multaq class action lawsuits, FDA Multaq warnings, and Multaq FDA recall announcements.
If you have taken Multaq and believe it harmed you, contact RLG today.