CONTEXT: Elevated total cholesterol (total-C) and low-density lipoprotein 
cholesterol (LDL-C) levels are established risk factors for cardiovascular 
disease (CVD). HMG-CoA reductase inhibitors (statins) are effective 
cholesterol-lowering drugs that are commonly prescribed to treat this condition. 
These drugs are often combined with another class of drugs, fibric acid 
derivatives, to lower both cholesterol and triglyceride levels. Rhabdomyolysis 
is a known, rare serious side effect of statin monotherapy and of statin-fibrate 
combination therapy.
OBJECTIVE: To examine Food and Drug Administration's (FDA's) postmarketing 
database for cases of rhabdomyolysis in relation to monotherapy and combination 
use and calculate reporting rates for this event.
DESIGN: Domestic cases of statin- and statin/gemfibrozil-associated 
rhabdomyolysis were culled from FDA's database and reviewed. Rhabdomyolysis was 
defined by CPK > or = 10,000 IU/L, myopathic signs and symptoms and clinical 
diagnosis of rhabdomyolysis. Reporting rates, consisting of number of reported 
cases/number of prescriptions for each drug, were then calculated to determine 
whether the reporting of rhabdomyolysis cases was commensurate with extent of 
use of each statin in the population.
SETTING: Cases were obtained from the FDA adverse event reporting system (AERS) 
database.
PATIENTS: NA.
MAIN OUTCOME MEASURES: Number of rhabdomyolysis cases were evaluated, along with 
outcomes, such as renal failure, dialysis and death.
RESULTS: Of 866 total reported cases, 482 (56%) were associated with monotherapy 
and 384 (44%) related to combination therapy. More than 80% of reported cases 
for each drug resulted in hospitalization for renal failure and dialysis. 80 
patients expired from events related directly to rhabdomyolysis. Reporting rates 
for all statins, except for cerivastatin, were similar and much lower than 1 per 
100,000 prescriptions. The cerivastatin-reporting rate was much higher at 
4.24/100,000 prescriptions.
CONCLUSIONS: Rhabdomyolysis is a rare, serious side effect of statin monotherapy 
and of statin-fibrate combination therapy. Clinicians need to remain cognizant 
of this potential adverse event and discuss signs and symptoms of muscle 
toxicity with patients in order improve the benefits-to-risks of treating 
dyslipidemia with statins.