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CRESTOR Safe and Effective When Used According to Prescribing
Information
- AstraZeneca says complete analysis of Crestor safety data refutes findings
reported in 'Circulation' -
WILMINGTON, Del., May 23 /PRNewswire/ -- Conclusions from a review published
in Circulation today regarding CRESTOR are misleading, and unfortunately create
unnecessary alarm for patients who need this medication to lower their
cholesterol.
Conclusions from the Circulation review, based on adverse event reporting
system (AERS) data gathered through September 2004, stand in direct contrast to
an FDA document issued on March 14, 2005, in response to a citizen's petition.
A copy of the FDA's document can be found at:
http://www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf
The FDA has access to the most complete data set and according to their
conclusion, "[o]ur review of all of the available evidence (including
preclinical data, pre-marketing clinical studies, Phase 4 clinical studies, and
post-marketing adverse event reports) indicates that CRESTOR does not pose a
risk of muscle toxicity greater than the other approved statins, and that with
respect to renal toxicity, there is no convincing evidence that CRESTOR poses a
risk of serious renal injury."
The Circulation report attempts to draw conclusions that simply cannot be drawn
from adverse event reporting data. The FDA's own disclaimer on the front page
of the AERS states, "the information contained in these [adverse event] reports
has not been scientifically or otherwise verified as to a cause and effect
relationship and cannot be used to estimate the incidence of adverse drug
reactions."
It is important to note that the results of this study represent the
conclusions of the authors only and do not represent the official position of
the AHA.
CRESTOR has been prescribed almost 22 million times for more than 4.7 million
patients. AstraZeneca stands fully behind the safety and effectiveness of
CRESTOR when the product is used according to the prescribing information.
About CRESTOR
CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use
as an adjunct to diet in the treatment of various lipid disorders including
primary hypercholesterolemia, mixed dyslipidemia and isolated
hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase
inhibitors) class of drug therapy. CRESTOR has not been determined to prevent
heart disease, heart attacks, or strokes. For patients with
hypercholesterolemia and mixed dyslipidemia, the usual recommended starting
dose of CRESTOR is 10 mg. Initiation of therapy with 5 mg once daily should be
considered for patients requiring less aggressive LDL-C reductions or who have
predisposing factors for myopathy. For patients with marked
hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg
starting dose may be considered. AstraZeneca licensed worldwide rights to
CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
Important Safety Information
CRESTOR is contraindicated in patients with active liver disease or unexplained
persistent elevations of serum transaminases, in women who are pregnant or may
become pregnant, and in nursing mothers. It is recommended that liver function
tests be performed before and at 12 weeks following both the initiation of
therapy and any elevation of dose, and periodically (e.g., semiannually)
thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported with CRESTOR and with other drugs in this
class. The 40-mg dose of CRESTOR is reserved for those patients who have not
achieved LDL-C goal at 20 mg. CRESTOR should be prescribed with caution in
patients with predisposing factors for myopathy, such as renal impairment.
Patients should be advised to promptly report unexplained muscle pain,
tenderness, or weakness, particularly if accompanied by malaise or fever.
CRESTOR is generally well-tolerated. Adverse reactions have usually been mild
and transient. The most frequent adverse events thought to be related to
CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal
pain (1.3%) and nausea (1.3%).
A full copy of the prescribing information for CRESTOR is available at
http://www.astrazeneca-us.com/pi/crestor.pdf or by calling 1-877-420-7249.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the world's
leading pharmaceutical companies with healthcare sales of over $21.4 billion
and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology and neuroscience products. In the United States,
AstraZeneca is a $9.6 billion healthcare business with more than 12,000
employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global)
as well as the FTSE4Good Index. For more information about AstraZeneca, please
visit: http://www.astrazeneca-us.com/
DATASOURCE: AstraZeneca
CONTACT: Kellie Caldwell, +1-302-885-1435, or Steve Lampert,
+1-302-886-7862, both of AstraZeneca LP
Web site: http://www.astrazeneca-us.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html