Statin Drugs |
Bad Supplements |
Crestor, is a member of a
class of cholesterol-lowering drugs commonly referred to as “statins”.
It 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
Pharmaceuticals has released a revised package insert for
Crestor (rosuvastatin) for use in the European Union (EU). The
changes to the European labeling are in response to
postmarketing spontaneous adverse event reports in patients
receiving Crestor and highlight certain patient populations who
may be at an increased risk for serious muscle toxicity (myopathy)
associated with Crestor use, especially at the highest approved
dose of 40 mg.
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