Dofetilide: is the treatment worse than the disease?

On October 1, 1999, the U.S. Food and Drug Administration (FDA) approved dofetilide (Tikosyn) for the treatment of persistent (nonparoxysmal) atrial fibrillation and flutter. However, the FDA cautioned: “Because Tikosyn can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/flutter is highly symptomatic (1).” Dofetilide is the first new oral antiarrhythmic drug preparation approved for use in the U.S. in seven years, the last being d,l-sotalol in 1992. Unlike its antiarrhythmic cousin, ibutilide—which is approved only for parenteral administration and is used primarily for conversion of atrial tachyarrhythmias in a monitored hospital or emergency department setting—dofetilide is intended for the long-term, outpatient treatment of atrial fibrillation and atrial flutter.