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.