New Clinical Trial of Multaq Moves Forward

January 19, 2012 — Yet another clinical trial of Multaq (dronedarone) is set to move forward, despite the Multaq lawsuits brought against the drug-company by people who contacted a Multaq lawyer following serious, life-threatening side effects.

Though the medication has been linked to deadly cardiovascular side effects, prompting two clinical studies to halt prematurely, a new trial will see whether Multaq combined with Ranexa can help people who suffer from atrial fibrillation.

Cardiologists have been unsure whether it is a good idea to prescribe Mutlaq to their patients who suffer from atrial fibrillation, after several studies had conflicting results. Two studies concluded that Multaq was beneficial; two studies were halted early because researchers found substantial increases in the rate of death and other cardiovascular side effects.

The Multaq studies that have been conducted already are:

• EURIDIS / ADONIS: This study found that when a patient who had atrial fibrillation took Multaq, there was an increased amount of time until they suffered a recurrent episode.
• ANDROMEDA: This study was prematurely aborted when doctors prescribing Multaq found that the mortality rate was twice as high compared to a placebo.
• ATHENA: This study found that Multaq reduced the overall death rate and hospitalizations related to cardiovascular events.
• PALLAS: This study was prematurely aborted when doctors found that Multaq increased the rate of stroke and heart failure by a two-fold rate, compared with a placebo.

This inconclusive safety profile has some cardiologists concerned that the drug may not be safe or effective. Some people still have hope for a use for the medication, however, which is why there will be another study of Multaq: HARMONY will be a randomized, double-blind, placebo-controlled clinical that will combine Multaq with Ranexa (ranolazine). The trial is intended to see whether the combination of these two drugs can help people who suffer from atrial fibrillation.

Atrial fibrillation is a type of abnormal heart rhythm, also known as irregular heartbeat, “atrial flutter,” “paroxysmal atrial fibrillation,” or “persistent atrial fibrillation.” There is a difference between persistent/permanent atrial fibrillation; the FDA has updated the safety label on Multaq to warn that patients who have permanent atrial fibrillation should not take Multaq.

When a person has atrial fibrillation, they are at an increased risk of developing blood clots in their heart. If these blood clots break loose, the heart may pump the clots to a person’s brain, causing a stroke. Strokes can be debilitating or deadly.

FDA Adds Safety Warning to Multaq Label

The FDA added new safety warnings to the Multaq safety label after the agency reviewed research that found Multaq users with permanent atrial fibrillation may have double the risk of suffering life-threatening cardiovascular events — these include stroke, heart attack (also known as “myocardial infarction”), systemic embolism, or death. As a result of this information, the safety label on Multaq now warns that people who have permanent atrial fibrillation should not take the medication, and people with non-permanent atrial fibrillation should be monitored by their health-care provider in case the permanent version develops.