Adverse events with concomitant amiodarone and statin therapy.

The authors reviewed adverse events (AEs) reported to the United States Food and Drug Administration to determine the percentage of statin-associated AE reports with concurrent amiodarone use for simvastatin, atorvastatin, and pravastatin. AEs affecting the following organ systems were analyzed: muscle, liver, pancreas, and bone marrow. The percentage of simvastatin reports with concurrent amiodarone use was 1.0%, compared with 0.7% of the atorvastatin-associated reports (p = not significant). The percentage of pravastatin reports with concurrent amiodarone use was 0.4% (p < 0.05 for pravastatin vs. simvastatin). Muscle toxicity was the most commonly reported statin-amiodarone AE, accounting for 77% of the reports. AEs tended to occur in older male patients (mean age, 76 years), who were on multiple other medications (mean number of other medications, five). Clinicians should be vigilant about muscle-related complaints in patients concomitantly taking amiodarone, especially in elderly patients on multiple medications. Use of a statin not metabolized through the cytochrome P450-3A4 system may be appropriate in this setting.