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Crestor, a member of a class of
cholesterol-lowering drugs commonly referred to as “statins”, was
approved in the U.S. in August 2003, based on review of an extensive
clinical database involving approximately 12,000 patients. At that time,
the FDA identified in the WARNINGS section of the product label those
patients whose increased baseline risk for myopathy warranted more careful
monitoring when prescribed Crestor. The U.S. approved labeling included a
specific section titled, “Myopathy/Rhabdomyolysis”, which states that
patients who are of advanced age (³ 65 years), have hypothyroidism,
and/or renal insufficiency should be considered to have a greater risk for
developing myopathy while receiving a statin. Physicians are warned to
prescribe Crestor with caution in these patients, particularly at higher
doses, as the risk of myopathy increases with higher drug levels.
In addition, the U.S. approved labeling for Crestor states that increased
rosuvastatin drug levels were observed in certain sub-populations of
patients (e.g., subgroups of Asians, patients concomitantly using
cyclosporine and gemfibrozil), conferring increased risk of myopathy.
Because of these findings, the FDA required Astra-Zeneca to make available
in the U.S. a 5-mg dose that could be used in patients requiring less
aggressive cholesterol-lowering or who were taking concurrent
cyclosporine. The maximum recommended dose in the FDA-approved label is
limited to 10 mg daily in patients with severe renal impairment or who are
also taking gemfibrozil.
FDA has received reports of rhabdomyolysis in association with Crestor, as
it has with other drugs in the statin class. In ongoing fashion, we are
evaluating these reports of adverse muscle effects with regard to clinical
severity and apparent relationship to the drug. FDA is comparing the
frequency of reporting of muscle injury with Crestor to that with other
statins, given differences in prescribing rates for the different drugs.
Pending the evaluation of the recent Crestor safety experience, FDA is not
proposing to change the US labeling for Crestor, but does want to
re-emphasize to physicians to the importance of carefully following the
recommendations in the current product label. Analysis of accumulating
safety data in the U.S. and worldwide will be considered in any future
labeling changes for Crestor, and to make recommendations on risk
management plans for Crestor.
Additional Crestor News and information:
FDA issues new crestor warning
Crestor health warning from March 5, 2005
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