Class Action Litigation Blog

FDA Orders Ischemic Event Warning For Multaq Label

Patients who have experienced suffering pain and injury from unsafe pharmaceuticals  need to be properly treated medically for all adverse conditions that developed and fairly compensated for any financial loss, national class action product liability attorney Keith T. Belt says

The FDA has revised the label of dronedarone (Multaq), an antiarrhythmic drug, to reflect its increased risk of death or serious cardiovascular events when taken by patients with permanent atrial fibrillation. Dronedarone is approved to treat atrial flutter and paroxysmal or persistent atrial fibrillation, but not permanent Afib.

The drug’s maker, sanofi-aventis, had tested dronedarone in patients with permanent atrial fibrillation but the trial, called PALLAS, was stopped early because of increased cardiovascular events in those taking the drug.

A full analysis of the data, presented at the 2011 American Heart Association meeting, confirmed the excessive risk — almost double compared with placebo — of cardiovascular events including stroke, myocardial infarction, systemic embolism or death from cardiovascular causes.

Dronedarone had been approved to treat atrial flutter and paroxysmal or persistent atrial fibrillation on the strength of the ATHENA trial, reported in 2009. The benefit of the drug in this trial was mainly from a reduced rate of hospitalization from atrial fibrillation.

Following the discontinuation of PALLAS, however, the FDA announced that it was reviewing the drug’s safety in patients with permanent atrial fibrillation.

The new label changes for the drug include the following:

• Dronedarone should not be prescribed to patients with permanent atrial fibrillation (those who cannot or will not be converted into normal sinus rhythm) because of the twofold risk of cardiovascular death, stroke, and heart failure in such patients.
• Patients on the drug should be monitored via ECG every three months and patients in atrial fibrillation should discontinue the drug or be cardioverted if that is clinically indicated.
• Patients prescribed dronedarone should receive appropriate antithrombotic therapy.

In January, the FDA alerted healthcare professionals to the potential for liver damage from dronedarone based on two reported post-marketing case reports of acute liver failure that required transplantation. The agency recommended periodic liver enzyme tests, especially in the first six months of treatment.

About Belt Law Firm, P.C.

Belt Law Firm, P.C., has more than 70 years of combined experience, and has the resources and experience to take on class action lawsuits of any size and against any opponent. In the past, our class action lawyers have participated in several large-scale class and mass joiner actions and have secured millions of dollars for our clients. Class-action lawsuits are an efficient and calculated way to take on large, well-represented organizations, and also to help the maximum number of people.  Class action lawsuits offer a number of advantages because they are able to aggregate a large number of what are often smaller individualized claims into one class action lawsuit. Our class action attorneys’ main mission is to bring powerful representation and justice to the individual or small business. In the process, class actions provide the necessary impetus to change laws for the better and to help thousands of people who have been injured, oppressed or have suffered injustice.  We put our reputation on the line in every case.

If you believe that you have been cheated or defrauded by a common corporate plan or scheme, you should contact us immediately at Belt Law Firm by filling out this form or by calling us toll free at 1-888-933-1514 for your Free Class Action Consultation

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