Crestor (rosuvastatin) - Mar 2, 2005
Audience: Physicians, pharmacists, and other healthcare professionalsFDA issued a public health advisory describing revisions to the WARNINGS, DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY, and PRECAUTIONS sections of the labeling. The revisions include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.
[March 2, 2005 - Public Health Advisory - FDA]
[March 2, 2005 - Drug Information Page - FDA]
[January 2005 - Revised Label - Astra-Zeneca]