PMID- 15860984 OWN - NLM STAT- MEDLINE DCOM- 20050609 LR - 20191109 IS - 1520-037X (Print) IS - 1520-037X (Linking) VI - 8 IP - 2 DP - 2005 Spring TI - Adverse events with concomitant amiodarone and statin therapy. PG - 95-7 AB - 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. FAU - Alsheikh-Ali, Alawi A AU - Alsheikh-Ali AA AD - Department of Medicine, Division of Cardiology, Preventive Cardiology Center, Tufts-New England Medical Center, Boston, MA 02111, USA. FAU - Karas, Richard H AU - Karas RH LA - eng PT - Journal Article PL - United States TA - Prev Cardiol JT - Preventive cardiology JID - 9813731 RN - 0 (Heptanoic Acids) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Pyrroles) RN - A0JWA85V8F (Atorvastatin) RN - AGG2FN16EV (Simvastatin) RN - KXO2KT9N0G (Pravastatin) RN - N3RQ532IUT (Amiodarone) SB - IM MH - Adverse Drug Reaction Reporting Systems MH - Aged MH - Amiodarone/administration & dosage/*adverse effects MH - Atorvastatin MH - Drug Therapy, Combination MH - Female MH - Heptanoic Acids/administration & dosage/adverse effects MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/*adverse effects MH - Male MH - Pravastatin/administration & dosage/adverse effects MH - Pyrroles/administration & dosage/adverse effects MH - Simvastatin/administration & dosage/adverse effects MH - United States MH - United States Food and Drug Administration EDAT- 2005/04/30 09:00 MHDA- 2005/06/10 09:00 CRDT- 2005/04/30 09:00 PHST- 2005/04/30 09:00 [pubmed] PHST- 2005/06/10 09:00 [medline] PHST- 2005/04/30 09:00 [entrez] AID - 10.1111/j.1520-037x.2005.4060.x [doi] PST - ppublish SO - Prev Cardiol. 2005 Spring;8(2):95-7. doi: 10.1111/j.1520-037x.2005.4060.x.