Dronedarone is used to treat patients with heart rhythm disorders that could prove extremely serious. It is an antiarrhythmic medication that is given to people with atrial fibrillation or atrial flutter. Dronedarone is known by the brand name Multaq and was marketed to be a safe alternative to amiodarone. In one year, there were 147,000 prescriptions filled for the drug. The drug is manufactured and marketed by the French company, Sanofi, S.A.
Before 2011, Dronedarone carried a black box warning stating that the drug should not be taken by patients who have recently experienced heart failure. In a study which looked at 627 patients with symptoms of heart failure, 310 of them were given Multaq, while 317 took a placebo. Within 63 days, researchers found that twice as many patients in the Multaq group had died (25 patients, or 8.2 percent) as opposed to the placebo group (12 patients, or3.8 percent). It was also found through this study that Multaq patients spent more time in the hospital.
In 2011, the FDA issued another warning about Dronedarone. The FDA warned about serious side effects such as severe liver injuries. One study linked Dronedarone to liver toxicity, and referred to two cases of severe liver failure that required liver transplants. Of the two patients, both were women approximately 70 whose liver serum enzymes were normal before beginning Dronedarone.
Serious side effects may include:
- Severe dizziness, fainting, fast or pounding heartbeats
- Slow heart rate, feeling like you might pass out
- A new or a worsening irregular heartbeat pattern
- Feeling short of breath, even with mild exertion, swelling in your ankles or feet, rapid weight gain
- Wheezing, cough, chest pain , trouble breathing, coughing up mucus
- Nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
- Breathing problems while lying down trying to sleep
- Low electrolytes (confusion, jerky muscle movements, uneven heartbeats, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling)
Less serious side effects may include:
- Mild stomach pain, diarrhea, upset stomach
- Feeling weak or tired
- Mild skin rash or redness