FDA Issues Alert to Crestor Users

posted on:
March 2, 2005

author:
Staff

 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.

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