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Multaq Label Change Reveals Increased Cardiovascular Risk

New evidence lends weight to the long-suspected link between Multaq, a popular heart medication, and adverse cardiovascular events. Subsequently, the U.S. Food and Drug Administration (FDA) acknowledged that significant changes have been made to the labels of Multaq products. According to two clinical trials, Multaq may be responsible for several severe cardiovascular events. Patients diagnosed with permanent atrial fibrillation (AF) may exhibit a propensity for fatal circumstances when receiving Multaq treatment.

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 and atrial flutter. 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 and promote a healthy heart beat. Unfortunately, the mechanism of action tasked with doing so may be responsible for adverse events in patients. According to clinical trials, Multaq increases the risk of serious cardiovascular events, including death, when used by patients with permanent AF.

The PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) trial was designed to evaluate the effectiveness of Multaq in patients with permanent AF. However, the trial was terminated prematurely due to the significant amount of cardiovascular events that had taken place. Tests were deemed too dangerous to continue Multaq treatment.

Contradictory to what the PALLAS trial revealed, a second trial showed a reduction in the risk of hospitalizations for AF in patients with non-permanent AF who were randomized to receive Multaq. Otherwise known as ATHENA, this second trial was conducted to determine whether the increased risks observed in the PALLAS study population applied to patients for whom the drug is intended for.

After having reviewed the data from these two trials, the FDA has acknowledged that Multaq provides a benefit for patients with non-permanent AF and recommends that healthcare professionals who prescribe Multaq follow the recommendations in the revised Multaq drug label. However, the FDA has recently changed the labels on Multaq products to indicate that severe, life-threatening cardiovascular complications may occur in patients with permanent atrial fibrillation.

The Multaq drug label has been revised with the following changes and recommendations:

  • Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
  • Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

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.

If you or a loved one has been injured by Multaq, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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