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FDA Issues Public Health Advisory, Patient Information Sheet for Rosuvastatin

March 2, 2005 -- Rockville, MD -- 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 AstraZeneca 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: https://www.fda.gov/cder/drug/advisory/crestor_3_2005.htm.

FDA's Patient Information Sheet and Alert for Healthcare Professionals can be accessed at: https://www.fda.gov/cder/drug/infopage/rosuvastatin/default.htm

Source: The Food and Drug Administration

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