January 19, 2012 — Though several clinical trials suggest Multaq risks may outweigh its benefits, researchers are poised to conduct yet another trial. This time, they will combine Multaq with another medication, Ranexa.
The makers of Multaq (dronedarone) are facing Multaq lawsuits brought by patients who contacted a Multaq lawyer after suffering from serious cardiovascular side effects after taking the medication. Conflicting results from several clinical trials have left doctors unsure whether it is safe.
The safety information on Multaq, also known by its drug-name dronedarone has been conflicted, leading cardiologists to question whether the medication is safe to prescribe to their patients. This confusion has prompted the drug-company to conduct yet another safety study.
The newest study of Multaq will be called HARMONY. It will be a randomized, double-blind, placebo-controlled clinical trial that will examine the safety and efficacy of a combination of Multaq and another drug, Ranexa (ranolazine) for people who suffer from atrial fibrillation.
The doctors responsible for conducting the research say that pre-trial information suggests that the combination of the two medications could effectively treat people who suffer from atrial fibrillation. Many people who suffer from this disease, a type of irregular heartbeat, also known as an “atrial flutter” or “paroxysmal atrial fibrillation.” When people have this disorder, the upper chambers of the heart beat out of sync with the lower chambers. One of the biggest dangers is that blood will pool in the upper chambers, form a blood clot, and the heart will pump this clot to the brain, causing a stroke.
- EURIDIS / ADONIS: Found that Multaq increased the time until a patient experienced their first recurrence of atrial fibrillation.
- ANDROMEDA: This study was terminated early because researchers found that Multaq doubled the mortality rate in patients taking the medication
- ATHENA: This study found that Multaq reduced mortality and cardiovascular hospitalizations
- PALLAS: This study was prematurely terminated after finding a two-fold increase in the risk of stroke and heart failure in patients taking Multaq compared with a placebo
FDA Adds Safety Warning to Multaq Label
In December 2011, the FDA added new safety warnings to the label of Multaq, following the conclusion of research that found patients may be twice as likely to suffer cardiovascular events, including a stroke, heart attack (myocardial infarction), systemic embolism, or death. The increased risk of these serious, life-threatening side effects was only increased for people who were taking Multaq who suffered from permanent atrial fibrillation, prompting the FDA to warn that patients with non-permanent atrial fibrillation should be monitored regularly, and if they develop permanent atrial fibrillation, they should stop taking Multaq.