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In August 13 2003,
the Food and Drug Administration (FDA) approved
Crestor (rosuvastatin) to lower cholesterol.
Crestor is the sixth cholesterol lowering "statin"
drug on the U.S. market. The other members of the
statin family are atorvastatin (lipitor),
fluvastatin (lescol), lovastatin (mevacor),
pravastatin (pravachol), and simvastatin (zocor).
These drugs are only approved to be used along
with a low-cholesterol diet and an exercise
program to lower cholesterol. Another statin,
cerivastatin (baycol), was removed from the market
because of at least 31 reports of fatal
rhabdomyolysis, an adverse reaction involving the
destruction of muscle tissue that can lead to
kidney failure.
Rosuvastatin will
be sold by
AstraZeneca of Wilmington, DE under
license from Shionogi & Co., Ltd., of Osaka,
Japan.
As reported by
the consumer group Public Citizen, AstraZeneca
originally filed its application with the FDA to
market rosuvastatin in June 2001. The application
was delayed after reports of kidney damage and
muscle weakness (an early signal for
rhabdomyolysis) in clinical trials in patients
taking 80 milligrams of the drug per day. The
company stopped development of the 80 milligram
dose, and rosuvastatin will only be sold in 5, 10,
20, and 40 milligram strengths. There will also be
special restrictions on the distribution of the 40
milligram strength.
Public Citizen
opposed the approval of rosuvastatin because it
alleged that the drug causes abnormal elevations
in urine protein and blood that are signals for
serious kidney toxicity, and is the only statin
that has shown life-threatening rhabdomyolysis in
pre-approval clinical trials.
Rhabdomyolysis is
a potentially life-threatening condition that
occurs when a large number of
skeletal muscle
cells die, resulting in the release of a massive
amount of muscle protein (known as myogloblin)
into the bloodstream. The muscle protein can
become trapped in the kidneys, clogging up the
filtering process of the kidneys and leading to
kidney or renal failure. In addition, potassium
released from the damaged muscle cells can cause
malignant heart rhythms resulting in cardiac
arrest.
Symptoms of
rhabdomyolysis include muscle pain, weakness,
tenderness, malaise, fever, dark urine, nausea,
and vomiting. The pain may involve specific groups
of muscles or may be generalized throughout the
body.
If you are
suffering from rhabdomyolysis or kidney problems,
and have taken Crestor, contact Belluck & Fox for
an immeidate legal evaluation. Drug litigation can
be extremely complex. It is best to seek the
counsel of a personal injury attorney with
experience in this field of law.
Belluck & Fox has substantial experience with
defective product litigation, including
pharmaceutical and medical product cases. | | |
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you been a victim? |
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New York law limits your time to bring a legal claim. To protect your
rights, you need to have your personal injury claim evaluated
immediately. To have your claim evaluated, please fill out this form
or contact us at:
bfinfo@belluckfox.com
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Belluck & Fox, LLP
546 Fifth Ave, 4th Fl
New York, NY 10036
(212) 681-1575
1-877-NYLAW09 |
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