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Multaq Faces Possible Restrictions By The FDA

On September 22, 2011, the European Medicines Agency (EMA) implemented stricter regulations on the already popular heart-rhythm drug Multaq. According to the EMA, there is “an increased risk of Multaq causing injury to the liver as well as the lungs when used in accordance with the currently approved prescribing information.” Subsequently, the U.S. Food and Drug Administration (FDA) is expected to take similar actions of their own, in response to those already taken in Europe.

Multaq (generic: dronedarone hydrochloride), developed by Sanofi, is intended to assist in the treatment of those diagnosed with abnormal heart rhythms such as atrial fibrillation (AFib) and atrial flutter (AFlutter). Accordingly, Multaq may significantly lower the chances that these heart complications result in hospitalization. In doing so, Multaq provides patients with a viable treatment option that promotes normal heart beats in those who are unable to do so themselves. Dronedarone hydrochloride, the active ingredient in Multaq, resides in a classification of medicines known as anti-arrhythmic agents. As an anti-arrhythmic agent, Multaq suppresses abnormal rhythms of the heart.

Unfortunately, evidence provided by the EMA suggests that prolonged Multaq treatment may display a propensity for catastrophic complications. According to the EMA, patients using Multaq may significantly increase their risk of developing severe, life-threatening liver and lung injuries. Furthermore, these findings have obligated European authorities to severely limit the use of Multaq in Europe.

Following actions taken by the EMA, the FDA has already begun an investigation of their own. The Agency has already obtained two clinical studies from Sanofi that will help determine the safety and effectiveness of Multaq. U.S. regulators are currently in the process of reviewing information that will enable them to discern better which Multaq patients might be helped, and which injured or killed. These actions indicate that the FDA expects to take similar, if not stricter approach to the regulation of future Multaq treatment.

The first clinical study, known as Athena, suggests that the benefits of Multaq outweigh the risks. Accorsing to the study, patients with a temporary form of A-fib known as “persistent” tended to be hospitalized less for cardiac conditions if they were using Multaq. However, the second study suggests otherwise. According to the second clinical trial, known as the Pallas trial, Multaq was linked to an increased rate of stroke and death.

Further deliberation, as to whether Multaq portrays a positive risk/benefit profile, is crucial to the FDA process. The task for the FDA is to determine, with precision, whether 10 percent or more of the Athena-type patients were harmed, even if patients in the study overall benefited. Doing so will help determine any future Multaq regulations.

However, news of adverse events associated with Multaq treatment should come as no surprises to the healthcare community. As recently as January 2011, Sanofi added a warning to the Multaq label, indicating that it has been associated with several reported cases of serious liver injuries. Around the same time, Sanofi, in association with the FDA, disclosed two reports of patients on the drug, each of whom developed acute liver failure requiring liver transplantation. The warnings cautioned doctors about the possibility of liver damage, and recommend that patients have their liver function tested both before and during Multaq therapy in order to help reduce the risk and seriousness of liver injury.

Do I Have a Multaq Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Multaq lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by Multaq, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
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