Multaq Heart Side Effects Being Reviewed in Europe

European regulators are taking a new look at the side effects of Multaq on the heart, after reports have linked a potential risk of cardiovascular problems to the popular Sanofi Aventis drug. 

The European Medicines Agency (EMA) announced this week that it will start a new review of the risk of Multaq heart problems. The new review comes even as other EMA experts prepare to report on the findings of an ongoing review of an increased risk of liver problems with Multaq.

Last week, Sanofi announced that it was discontinuing a study on the use of Multaq to treat permanent atrial fibrillation, a form of abnormal heart rhythm, after spotting a significant increase in the number of cardiovascular events suffered by participants in the study who had been given Multaq. Similar increases were not seen among those given a placebo.

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. Multaq is already approved to treat non-permanent atrial fibrillation.

Both Sanofi and the EMA have noted that the population in the PALLAS study is different from the population who use Multaq for its currently approved indications.

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.

On July 18-21, the EMA’s Committee for Medicinal Products for Human Use (CHMP) will reveal the findings of their review of Multaqu liver problems, which began in January.