In two separate cases, patients taking dronedarone (Multaq) experience acute liver failure resulting in needing a liver transplant. Since then, the FDA is requiring additional risks be added to drug labels.
Used to treat atrial fibrillation, dronedarone has also been used as a treatment for atrial flutters in attempts to restore a normal heart rhythm. Prior to receiving medication, many patients experienced additional medications for electric shock treatments.
Approved in 2009, the drug was never approved to reduce death. In fact, a study of patients experiencing irregular heartbeats actually found that the drug Multaq increased death risk by more than 200 percent.
Since being approved, nearly 200,000 have taken Multaq. Makers of the drug, Sanofi-Aventis, explain no known link exists between Multaq and acute liver failure.
Still, the FDA remains cautious, asking doctors to monitor patients taking the medication. Warning signs and symptoms include reduce appetite, dark urine, fever, fatigue, jaundice, nausea, and vomiting. Patients taking the medication and experiencing any of these symptoms are urged to contact a health professional.