Rosuvastatin safety: lessons from the FDA review and post-approval surveillance

Abstract

Rosuvastatin is the first statin approved by the regulatory authorities since the withdrawal of cerivastatin. Although highly efficacious, this new statin has generated considerable controversy regarding its safety. Rosuvastatin was approved for clinical use based on the largest pre-approval database for all statins prior to commercial use. In this database, rosuvastatin had a similar safety profile to other approved statins up to the highest approval dose of 40 mg. As with all statins, there is a marked increase in adverse effects when the dose is titrated from 40 to 80 mg, and rosuvastatin demonstrates a similar dose/toxicity relationship. In the pre-approval data trials on 80 mg, there was a 1.0% (n = 16) incidence of myopathy and 7 patients developed rhabdomyolysis. However the <or= 40 mg doses had a myopathy rate similar to other statins. In the post-marketing surveillance for rosuvastatin, there have been reports of rhabdomyolysis, but the incidence rate, when corrected for prescription utilisation, is similar to other statins following initial approval.