Multaq Side Effects Increase Risk of Heart Disease: Study

The findings of a new study suggest that the side effects of Multaq, a relatively new Sanofi-Aventis heart drug, could double the risk of heart disease for some users. 

The complete results of a Multaq heart study cancelled earlier summer were released on Monday at the American Heart Association’s annual meeting and published by the New England Journal of Medicine. Researchers found a two-fold increase in the risk of cardiovascular problems including heart attacks, strokes and death.

In July, the study, known as PALLAS, was deemed too dangerous to those enrolled and two committees overseeing the safety of the study decided it would have been unethical to continue. More than 3,000 participants, all 65 years of age or older, were told to discontinue use of the drug for the treatment of permanent atrial fibrillation. 

According to the recently released data, Multaq users suffered 21 deaths due to cardiovascular causes, compared to 10 cardiovascular deaths among those given a placebo.

The research, funded by Sanofi, led to the conclusion that Multaq side effects may increase the rates of heart failure, stroke and death from cardiovascular causes in patients with permanent atrial fibrillation, leading researchers to recommend that it not be used in such patients.

Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months. In less than two years since its approval, there have been at least 492,000 Multaq prescriptions in the United States filled by about 147,000 patients at outpatient pharmacies across the country. In addition, the drug can be given to patients being treated in hospitals.

In January, the FDA warned about the potential risk of Multaq liver side effects, indicating that two patients on Multaq suffered acute liver failure that required them to get liver transplant.

A couple weeks after that warning in the United States, the FDA also sent a letter to Sanofi Aventis, admonishing the company for failing to pass on three adverse event reports involving Multaq side effects to the government.