Crestor won FDA
approval in August 2003 in 5, 10, 20, and 40 mg. doses, but not the 80 mg.
dosage. In recent months there have been reports of serious side effects of Crestor use. Statins,
like Crestor, work by reducing production of cholesterol in the liver and by
increasing the ability of the liver to remove LDL (bad) cholesterol from the
blood. Statins reduce the level of LDL cholesterol in the blood and can reduce
triglyceride levels and increase levels of HDL (good) cholesterol.
As a result of
Crestor side effects, two major healthcare insurers with over 15 million
patients have refused to reimburse for Crestor. Still reeling from 31 cases of
fatal rhabdomyolysis caused by Baycol which was removed from the market in
2001, healthcare companies are taking a more cautious and conservative
approach. Other companies are placing Crestor in the highest tier of three
out-of-pocket categories to discourage Crestor prescriptions due to the risk of
Rhabdomyolysis. Crestor rhabdomyolysis causes
muscle fibers to begin to break down, releasing a protein called myoglobin,
which can damage the kidneys as they attempt to filter it out of the
bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness,
stiffness, pain or spasms.
After a damaging delay over safety concerns, Crestor
superstatin finally won FDA approval in August 2003. AstraZeneca’s CEO has
pledged to do whatever it takes to persuade doctors to prescribe Crestor
superstatin, including launching an estimated $1 billion first-year promotional
campaign. The
80 mg. dose of Crestor was withdrawn by AstraZeneca because of safety concerns.
Critics are even anxious about the 40 mg. dose. All statins have been
found to carry a risk of muscle injury, known as myopathy, and rhabdomyolysis
is the most severe form, potentially causing severe kidney damage, kidney
failure and death. All statins currently contain a warning that myopathy and
rhabdomyolysis are rare possible side effects. With statins being among the
best selling prescription drugs in America, the number of injuries and lawsuits
is sure to rise.

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