FDA issues information on the risks and benefits of Crestor

Mar 2 2005

The U.S. Food and Drug Administration (FDA), today issued public health advice, patient information, and professional healthcare information on the risks and benefits of Crestor (Rosuvastatin calcium), a cholesterol-lowering drug.

Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER) said the advice is in line with the FDA's committment to providing Americans with the latest and most comprehensive information on the medicines they use; it 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's up-to-date information about the risk of rhabdomyolysis (serious muscle damage) in patients taking Crestor and other statin drugs is welcome. The rare adverse effect of statins is well-known and has been extensively documented and reviewed.

As a result of discussions with the FDA., Crestor's manufacturer Astra-Zeneca Pharmaceuticals revised the package insert for Crestor; recommendations made originally about the need for physicians to consider using lower starting doses of the drug in some individuals to reduce the risk of rhabdomyolysis have been re-emphasised.

This is particularly important in treating Asian American patients, since trial data suggests that they may be at greater risk of muscle injury due to Crestor (along with patients on cyclosporine or patients with severe renal insufficiency) as they may have higher drug levels.

Kidney failure has also been reported in patients treated with Crestor, as well as other statins. But patients who are likely to benefit from statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may be at higher risk for kidney failure before taking these drugs. FDA cannot confirm that recommended doses of statins, including Crestor, can cause or worsen kidney failure.

The agency believes the 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.

The FDA will continue to carefully evaluate the scientific data on Crestor and the other statin drugs and, when appropriate, modify the drug label(s) when appropriate

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