Side Effects of Multaq Lead to Restrictions in Europe, US Likely to Follow

Concerns over potential side effects of Multaq, a relatively new heart drug, have lead European health officials to restrict use of the drug and similar actions are expected soon in the United States as well. 

On September 22, the European Medicines Agency (EMA) said that Sanofi’s drug Multaq should only be used to treat paroxysmal or persistent atrial fibrillation, a form of abnormal heart rhythm, and then only after alternative treatment options should be considered.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) made the recommendations after analyzing the health risks of Multaq, which have been linked to liver damage and cardiopulmonary problems.

The EMA recommended that every patient in Europe currently on Multaq have their treatment evaluated by their doctor at their next available appointment.

The decision comes as the U.S. and Canada are still analyzing data from a number of studies that suggest Multaq side effects may cause serious health risks when prescribed for unapproved uses on certain types of heart patients, particularly those who have permanent atrial fibrillation.

According to a recent report by the Wall Street Journal, sources inside the FDA say that the U.S. can expect similar or tougher restrictions on Multaq to be announced in the near future. 

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.

New concerns arose this summer when Sanofi tried to test to see if Multaq could work for patients with permanent forms of atrial fibrillation. In July, the company discontinued clinical trials testing Multaq for that use due to safety reasons. Researchers spotted 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.