FDA Updates Crestor Warning Information
Asian-Americans Among Groups More at Risk of Serious Muscle Damage
March 3, 2005 -- The FDA has issued a public health advisory to further
explain the risks and benefits of the cholesterol-lowering drug Crestor. The
drug will now carry a new label that includes new recommended doses for
patients at a higher risk of muscle damage, including Asian patients.
"The FDA is committed to providing Americans with the latest and most
comprehensive information on the medicines they use," says Steven Galson, MD,
MPH, acting director of the Center for Drug Evaluation and Research (CDER), in
a news release." 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."
Serious Muscle Damage
The FDA is providing up-to-date information about the risk of serious muscle
damage - called rhabdomyolysis -- in patients taking Crestor as well as
This is a
well-known, rare side effect of all statins, it says.
Rhabdomyolysis is a condition in which muscle cells break down. This floods
the blood with muscle proteins, sometimes leading to fatal kidney failure.
In June 2004, the FDA advised doctors to be
in January 2005, Crestor's manufacturer, AstraZeneca Pharmaceuticals, reported
The FDA says extensive review of the large amount of available data
indicates that patients taking recommended doses of Crestor have a similar risk
of rhabdomyolysis as patients taking other statin drugs. Other available
statins include Lipitor, Pravachol, and Zocor.
Crestor's manufacturer is also reminding doctors that they should consider
using lower starting doses of Crestor in some individuals. AstraZeneca today
revised the package insert to re-emphasize these recommendations.
3 Groups of Patients More at Risk
Data show that certain people may have higher drug levels and therefore be
at greater risk for muscle injury due to Crestor. The drug's new label
recommends that those at higher risk start with a dose of only 5 mg. The
higher-risk groups include:
- People taking the immune suppressing drug cyclosporine, such as organ
- Patients with severe kidney failure
Kidney failure of various types has also been reported in patients treated
with Crestor, as well as other statins.
However, the FDA says it's difficult to establish the exact association
between kidney failure and statins. People who often need statins to lower
their cholesterol include patients with diabetes, high blood pressure, heart
disease, and heart failure. These same people are already at a higher risk of
developing kidney failure.
Therefore, the FDA says it cannot confirm that recommended doses of statins,
including Crestor, can cause or worsen kidney failure.
Overall, the FDA says the potential benefits of Crestor and other statin
drugs when used as recommended outweigh their potential risks.
Statins provide an important treatment option for millions of Americans at
risk of heart disease, it says.