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U.S. Department of Health and Human Services

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FDA Alert on Crestor (rosuvastatin calcium), 3/2005

FDA ALERT [03/2005] 

Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs.  To date, it does not appear that the risk is greater with Crestor than with other marketed statins.  However, the labeling for Crestor is being revised to 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.   The labeling will also be revised to reflect the results of a large pharmacokinetic study involving a diverse population of Asian patients compared with a Caucasian control group that found drug levels to be elevated approximately 2-fold. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins.  Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins.  At this time, the FDA cannot conclude that recommended doses of Crestor can cause or exacerbate renal failure, but is continuing to carefully evaluate the data.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.