FDA adverse event reports on statin-associated rhabdomyolysis.
OBJECTIVE
To determine the number of cases of statin-associated rhabdomyolysis reported to the Food and Drug Administration for 6 statins and to profile the cases.


METHODS
A retrospective analysis of all domestic and foreign reports of statin-associated rhabdomyolysis between November 1997 and March 2000 was conducted. Outcome measures included the total number of reports (initial plus follow-up), the number of unique cases, age, gender, percentages of report codes and role codes, and frequencies of concomitant interacting drugs that may have precipitated rhabdomyolysis, outcomes codes, and report source codes.


RESULTS
There were 871 reports of statin-associated rhabdomyolysis in the 29-month time frame examined, representing 601 cases. The following number of cases were associated with each of the individual statins: simvastatin, 215 (35.8%); cerivastatin, 192 (31.9%); atorvastatin, 73 (12.2%); pravastatin, 71 (11.8%); lovastatin, 40 (6.7%); and fluvastatin, 10 (1.7%). Drugs that may have interacted with the statins were present in the following number of cases: mibefradil (n = 99), fibrates (n = 80), cyclosporine (n = 51), macrolide antibiotics (n = 42), warfarin (n = 33), digoxin (n = 26), and azole antifungals (n = 12). The reports of 62.1% of cases were classified as expedited. Statins were designated as the primary suspect in 72.0% of the cases. Death was listed as the outcome in 38 cases. The majority of reports (n = 556) were from health professionals.


CONCLUSIONS
Compared with the other statins, simvastatin and cerivastatin were implicated in a relatively higher number of reports. Because of the various limitations of a spontaneous reporting-system database, caution is urged when interpreting the relative number of cases reported.
Omar
Mohamed A
MA
Division of Pharmacy Practice and Administration, College of Pharmacy, University of Texas at Austin, Austin, TX, USA. mohamed.omar@pharma.novartis.com
Wilson
James P
JP
D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D008297:Male; D012206:Rhabdomyolysis / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration
D000960:Hypolipidemic Agents