At the end of September, the European Medicines Agency (EMA) announced that it is going to restrict Multaq use to patients with paroxysmal or persistent atrial fibrillation due to the drug’s adverse safety risks. This has many wondering if the FDA will soon follow suit.
The official announcement from the EMA’s Committee for Medicinal Products for Human Use (CHMP) stated, “Multaq (dronedarone) should be restricted to patients with paroxysmal or persistent atrial fibrillation when sinus rhythm is obtained and should not be used when atrial fibrillation is still present. It should not be used in permanent atrial fibrillation or in patients with heart failure or those with left ventricular systolic dysfunction. It should also not be used in patients with a previous lung or liver injury following treatment with amiodarone. Patients with nonpermanent atrial fibrillation treated with dronedarone should be monitored by a specialist and have their lung, liver and heart-rhythm function checked regularly.”
In February, the EMA had requested that doctors wishing to prescribe Multaq for atrial fibrillation patients issue them a liver functions test first due to the drug’s link to liver failure. For its part, the FDA has already issued a warning that Multaq can cause liver damage, and they have made Sanofi-Aventis, the makers of Multaq, update its warning labels to include liver failure risks. The FDA has even gone so far as to request that healthcare professionals issue periodic liver enzyme tests to Multaq patients as a safeguard within the first six months of Multaq treatment.
Earlier this year, Sanofi had to halt a clinical trial of Multaq because patients were dying. The trial, known as the PALLAS Study, was conducted to see if Multaq could be used as a treatment for permanent atrial fibrillation (the drug was already approved for temporary a-fib); however, the drug was causing abnormal heart rhythms in the patients. With the EMA restricting Multaq use, and adverse effects reports coming in to the FDA’s MedWatch, some feel that it is just a matter of time before the U.S. regulators issue a similar restriction on Multaq.
If you or a loved one have developed liver failure after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced with Multaq lawsuits and may be able to get you money for your injuries.