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Information for Healthcare Professionals: Crestor (Rosuvastatin Calcium)

 

[For additional information on this drug, see Crestor Information.]

 

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.

To report any serious adverse events associated with the use of Crestor, please contact the FDA MedWatch program using the contact information at the bottom of this page.

Recommendations
Crestor should be used only at doses recommended in the label. Initiation of Crestor therapy with 5 mg daily should be considered in Asian patients.

Data Summary
Crestor, like all statins, has been associated with a low incidence of rhabdomyolysis. The data available to date from controlled trials as well as postmarketing safety information indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins. As with all statins, some individuals taking Crestor will experience muscle side effects, most commonly mild aches and very rarely severe muscle damage. Like all drugs in this class, risks of muscle injury can be minimized by adhering to labeled warnings and precautions, carefully following dosing instructions, and instructing patients to be aware of and to report possible side effects to their healthcare professionals. Finally, like all statins, Crestor should be prescribed at the lowest dose that achieves the goals of therapy (e.g., target LDL-C level).

Various forms of kidney failure have been reported in patients taking Crestor, as well as with other statins. Renal failure due to other factors is known to occur at a higher rate in patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, heart failure). No consistent pattern of clinical presentation or of renal injury (i.e., pathology) is evident among the cases of renal failure reported to date that clearly indicate causation by Crestor or other statins.

Mild, transient proteinuria (non-glomerular in origin), with and without microscopic hematuria, occurred with Crestor, as it has with other statins, in preapproval trials. The frequency of occurrence of proteinuria appeared dose-related. In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure. Nevertheless, dose reduction in addition to other investigations as to the cause should nevertheless be considered if a patient develops unexplained persistent proteinuria.

Ongoing controlled clinical trials of Crestor and other statins, epidemiologic studies of the safety and side effects of Crestor, and ongoing pharmacovigilance by FDA will continue to provide information on the balance of risks and benefits of Crestor and other members of this important class of drugs. This information will be made available and, as appropriate, applied to drug labeling in a timely fashion.
 

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

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-796-3400
druginfo@fda.hhs.gov

 

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