The FDA has issued a public health advisory to further explain the risks and benefits of the cholesterol-lowering drug Crestor (search). 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 similar drugs, called statins. This is a well-known, rare side effect of all statins, it says.

Rhabdomyolysis (search) 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 careful about how they prescribe Crestor. And in January 2005, Crestor’s manufacturer, AstraZeneca Pharmaceuticals, reported that a patient died while taking Crestor.

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.

Three 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:

—Asian-Americans

—People taking the immune suppressing drug cyclosporine, such as organ transplant patients

—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.

By Michael W. Smith, MD, reviewed by Brunilda Nazario, MD

SOURCE: News release, FDA.