Multaq Liver Side Effects Leads Group To Warn Against Use of Heart Drug

The watchdog group Public Citizen is warning consumers to avoid use of the heart drug Multaq, due to potential side effects that may increase the risk of liver injury and liver failure. 

Following the release of information that Sanofi-Aventis has received at least 155 reports of liver problems from Multaq, Public Citizen classified Multaq as a “DO NOT USE” drug. The consumer advocacy group is urging the public to avoid the medication if they can, and talk to their doctor about getting off of it as quickly as possible if they are already using Multaq.

Sanofi-Aventis sent a letter to Canadian health care professionals (pdf) and a letter to Canadian Multaq patients (pdf) in March alerting them to the potential risk of liver injury from side effects of Multaq.

According to the letter to sent to Canadian doctors, 87 of the cases involved serious liver injury from Multaq, including rare cases of liver failure. This comes after only 16 months of Multaq being on the market, and the number of reports are much larger than prior estimates of Multaq problems, which ranged from three to nine known incidents.

Similar letters have not been sent to doctors or consumers in the United States.

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 U.S., 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.

A quarterly report by the Institute for Safe Medication Practices published the same month identified nine reported cases in the FDA adverse event database that linked Multaq use to serious liver damage and injury.

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.

Public Citizen warned that anyone who took Multaq should be aware of any symptoms of potential liver injury, including loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, and itching. The group, which opposed the approval of Multaq, warned that patients currently on the drug should seek periodic liver function tests and should consult with their health care professionals before discontinuing use of Multaq.