Physicians are advised to consider using lower starting doses of the Crestor in some individuals as a means of reducing the risk of serious muscle damage, says the FDA.

The Crestor advisory is intended to notify the public of "potentially significant emerging safety data," says Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER).

Risk of Serious Muscle Damage

The FDA is updating 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, the agency notes. 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.

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, according to the FDA.

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 Risk

Kidney failure of various types also has 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 FDA's 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, FDA says it 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's Public Health Advisory is available online. FDA's Patient Information Sheet and Alert for Healthcare Professionals also can be accessed on the Internet.