FDA Continues to Warn Public About Multaq on Warning Labels

While the FDA recently warned the public about how dangerous Multaq (made by Sanofi-Aventis) is, the agency also has issued a major warning against using Multaq (dronedarone) as a treatment for permanent atrial fibrillation (AF).

The FDA’s safety warning against Multaq states that the drug “increases the risk of serious cardiovascular events — including death — when used by patients in permanent atrial fibrillation (AF).” This new warning comes on the heels of a recent safety review of dronedarone, which was conducted because of events that happened during the halted PALLAS study and the ATHENA clinical trials.

The PALLAS study was halted by Sanofi after patients started dying of heart complications. The study was conducted to see if Multaq could be used safely and effectively as a treatment for permanent AF, since the drug had proven effective at treating temporary AF. What the study found instead was that Multaq not only caused liver failure, it also caused AF symptoms to get worse for some patients.

Now that the FDA has issued new warnings against Multaq, the new label states that “healthcare professionals should not prescribe dronedarone to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF) because the medication doubles the rate of cardiovascular death, stroke and heart failure in those patients.”

The FDA is also calling for medical professionals to keep a close watch on AF patients’ heart rhythms by using electrocardiogram screenings every three months or so. The warning also states that AF patients should not take Multaq if the clinical tests show that their heart rhythms are worsening and that they should be cardioverted if it’s clinically indicated.

Finally, the new label states “dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF. In addition, patients prescribed dronedarone should receive proper antithrombotic therapy.”

If you or a loved one have suffered from liver failure or a worsening of your heart condition after taking Multaq to treat your AF, contact attorney Greg Jones for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.

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