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FDA Provides Updated
Patient and Healthcare Provider Information Concerning Crestor
Part of an Ongoing
Agency Effort to Provide Public with Early Access to Emerging Safety
Information
In order to provide Americans with
earlier access to emerging safety information about their medicines,
the Food and Drug Administration (FDA) today issued a public health
advisory, a patient information sheet and a corresponding healthcare
professional information sheet further explaining the identified
risks and benefits of Crestor (Rosuvastatin calcium), a
cholesterol-lowering drug.
"The FDA is committed to providing
Americans with the latest and most comprehensive information on the
medicines they use," said Dr. Steven Galson, Acting Director, Center
for Drug Evaluation and Research (CDER). "Today's FDA advisory on
Crestor is part of an ongoing effort to notify the public of
potentially significant emerging safety data so that they can make
more informed choices about their medical care."
FDA is providing up-to-date information
about the risk of rhabdomyolysis (serious muscle damage) in patients
taking Crestor as well as other statin drugs. This is a well-known,
rare adverse effect of all statins. Extensive review of the large
amount of data available to date from controlled trials as well as
the latest post-marketing safety information indicates that patients
taking recommended doses of Crestor have a similar risk of
rhabdomyolysis as patients on other statin cholesterol treatments.
In addition, Crestor's manufacturer Astra-Zeneca
Pharmaceuticals today revised the package insert for Crestor, based
on discussions with the FDA. These changes re-emphasize
recommendations made in the original label about the need for
physicians to consider using lower starting doses of the drug in
some individuals as a means of reducing the risk of rhabdomyolysis.
The revised labeling notes that this may
be particularly important for treating Asian American patients,
since clinical trial data suggest that they (along with patients on
cyclosporine or patients with severe renal insufficiency) may have
higher drug levels and therefore be at greater risk for muscle
injury due to Crestor than the general population.
Kidney failure of various types has also
been reported in patients treated with Crestor, as well as other
statins. However, patients who are candidates for statin therapy
(e.g., patients with diabetes, hypertension, atherosclerosis, and/or
heart failure) also may be at higher risk for kidney failure even
when they are not prescribed statin therapy. Based on FDAs review of
these cases and the available data from controlled trials, FDA
cannot confirm that recommended doses of statins, including Crestor,
can cause or worsen kidney failure.
Overall, the agency believes that
potential benefits of statin drugs (including Crestor) when used as
labeled and indicated for the treatment of elevated cholesterol
(hypercholesterolemia) outweigh their potential risks and provide an
important treatment option for millions of Americans at risk of
heart disease.
FDA will continue to carefully evaluate
the scientific data on Crestor and the other statin drugs and, when
appropriate, modify the drug label(s) in a timely fashion.
FDA's Public Health Advisory can be
obtained at:
http://www.fda.gov/cder/drug/advisory/crestor_3_2005.htm.
FDA's Patient Information Sheet and Alert
for Healthcare Professionals can be accessed at:
http://www.fda.gov/cder/drug/infopage/rosuvastatin/default.htm
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