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Alert for Healthcare
Professionals
Crestor (Rosuvastatin Calcium)
FDA ALERT [03/2005]: Rhabdomyolysis (serious muscle
damage) has been reported in patients taking Crestor as well as
other statin drugs. To date, it does not appear that the risk is
greater with Crestor than with other marketed statins. However,
the labeling for Crestor is being revised to highlight important
information on the safe use of Crestor to reduce the risk for
serious muscle toxicity (myopathy/rhabdomyolysis), especially at
the highest approved dose of 40 mg. The labeling will also be
revised to reflect the results of a large pharmacokinetic study
involving a diverse population of Asian patients compared with a
Caucasian control group that found drug levels to be elevated
approximately 2-fold. Kidney failure of various types has also
been reported in patients treated with Crestor as well as other
statins. Patients who are candidates for statin therapy (e.g.,
patients with diabetes, hypertension, atherosclerosis, and/or
heart failure) may also be at higher risk for kidney failure even
when they are not taking statins. At this time, the FDA cannot
conclude that recommended doses of Crestor can cause or exacerbate
renal failure, but is continuing to carefully evaluate the data.
This information
reflects FDA’s preliminary analysis of data concerning this drug.
FDA is considering, but has not reached a final conclusion about,
this information. FDA intends to update this sheet when additional
information or analyses become available.
To
report any unexpected adverse or serious events associated with the
use of Crestor, please contact the FDA MedWatch program at
1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Recommendations
Crestor should be used only at doses recommended in the label.
Initiation of Crestor therapy with 5 mg daily should be considered
in Asian patients.
Data Summary
Crestor, like all statins, has been associated with a low incidence
of rhabdomyolysis. The data available to date from controlled trials
as well as postmarketing safety information indicate that the risk
of serious muscle damage is similar with Crestor compared to other
marketed statins. As with all statins, some individuals taking
Crestor will experience muscle side effects, most commonly mild
aches and very rarely severe muscle damage. Like all drugs in this
class, risks of muscle injury can be minimized by adhering to
labeled warnings and precautions, carefully following dosing
instructions, and instructing patients to be aware of and to report
possible side effects to their healthcare professionals. Finally,
like all statins, Crestor should be prescribed at the lowest dose
that achieves the goals of therapy (e.g., target LDL-C level).
Various forms of kidney failure have been reported in patients
taking Crestor, as well as with other statins. Renal failure due to
other factors is known to occur at a higher rate in patients who are
candidates for statin therapy (e.g., patients with diabetes,
hypertension, atherosclerosis, heart failure). No consistent pattern
of clinical presentation or of renal injury (i.e., pathology) is
evident among the cases of renal failure reported to date that
clearly indicate causation by Crestor or other statins.
Mild, transient proteinuria (non-glomerular in origin), with and
without microscopic hematuria, occurred with Crestor, as it has with
other statins, in preapproval trials. The frequency of occurrence of
proteinuria appeared dose-related. In clinical trials with doses
from 5 to 40 mg daily, this effect was not associated with renal
impairment or renal failure. Nevertheless, dose reduction in
addition to other investigations as to the cause should nevertheless
be considered if a patient develops unexplained persistent
proteinuria.
Ongoing controlled clinical trials of Crestor and other statins,
epidemiologic studies of the safety and side effects of Crestor, and
ongoing pharmacovigilance by FDA will continue to provide
information on the balance of risks and benefits of Crestor and
other members of this important class of drugs. This information
will be made available and, as appropriate, applied to drug labeling
in a timely fashion.
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Date created: March 2, 2005 |
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