Multaq was a drug with great promise to help patients with atrial fibrillation, the most common form of irregular heartbeat. However, the drug has been shown to have serious risks, and after two clinical trials were stopped early because of patient deaths and other serious side effects, the FDA has restricted the indications and usage for Multaq. Although investors hoped the drug would become a blockbuster, especially as an aging population would include increasing numbers of patients with atrial fibrillation. Safety concerns, though, have significantly limited the number of patients for whom this treatment seems appropriate.
An early study of possible mortality risk for patients with permanent atrial fibrillation was stopped after patients taking Multaq suffered twice as many deaths as those taking a placebo (pill with no active ingredients). Because of the small sample size and timeframe, this was dismissed as potentially due to chance. Last year, though, another study, this time a larger one, has been halted early because of the high number of deaths in the group taking Multaq. The study, known as PALLAS, reported increases in a number of adverse cardiovascular events, including:
- Death risk overall: 1.94 times more likely in Multaq users
- Death specifically from arrhythmia or sudden death: 3.26 times more likely in Multaq users
- Stroke: 2.32 times more likely in Multaq users
- Hospitalization for heart failure: 1.81 times more likely in Multaq users
As a result of the risks associated with this dangerous drug, the FDA revised its guidelines for the use of the drug. Multaq remains approved for patients with persistent or paroxysmal (occasional) atrial fibrillation, but not permanent atrial fibrillation patients. In addition, doctors are being asked to use an electrocardiogram (ECG) to monitor patients’ heart rhythms every three months.
Sadly, though, it is not known how many people may already have suffered serious heart damage from this dangerous drug. If you have been hurt or lost a loved one due to Multaq, please contact a local personal injury lawyer to learn more about your legal options.
