Drug safety alert issued for dronedarone

The antiarrhythmic dronedarone (Multaq) is again coming under scrutiny from the FDA after review of the company-sponsored PALLAS study of more than 3000 patients, which showed that the drug is associated with an increased mortality rate in patients with atrial fibrillation (AF). Dronedarone currently is approved for treatment of paroxysmal AF and atrial flutter. The new study investigated its use in patients with permanent AF. The study was halted early when the mortality rate in the treatment group was found to be double the rate in the placebo group (32 deaths [2%] in the dronedarone arm vs 14 [0.9%] in the placebo arm). The rate of unplanned hospitalization and stroke also was double in the dronedarone group vs the placebo group. All findings were statistically significant. These findings led the FDA to issue a drug safety alert on July 21, 2011. This follows a January 2011 drug safety alert regarding rare but severe liver injury associated with use of dronedarone. Currently, the FDA is recommending that physicians should not prescribe dronedarone to patients with permanent AF while they further evaluate the data (FDA Drug Safety Communication at www.FDA.gov/drugs/drugsafety).