United states of America - A revised package insert has been published by the manufacturer of rosuvastatin (Crestor®). Changes to the label reflect results from a Phase IV pharmacokinetic study in Asian-Americans and highlight important information to reduce the risk for myopathy and rhabdomyolysis, especially at the highest approved dose of 40 mg.
Rosuvastatin is a statin approved in August 2003 for use in lowering serum cholesterol. All statins rarely cause serious muscle damage. Physicians are warned to prescribe rosuvastatin with caution, particularly at higher doses, as the risk of myopathy increases with higher drug levels.
In a pharmacokinetic study involving a diverse population of Asians residing in the United States, rosuvastatin drug levels were found to be elevated approximately 2-fold compared with a Caucasian control group. As a result of these findings, the label now states that the 5 mg dose of rosuvastatin should be considered as the start dose for Asian patients and any increase in dose should take into consideration the increased drug exposure in this patient population.
It also emphasizes that the 40 mg dose is not an appropriate start dose and should be reserved only for those patients who have not achieved their cholesterol goals with the 20 mg dose.
Reference: FDA Public Advisory, 2 March 2005 http://www.fda.gov/cder/foi/label/2005/21366slr005lbl.pdf