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FDA Issues Crestor Advisory

March 3, 2005
The Food and Drug Administration (FDA) has issued a public health advisory outlining the identified risks and benefits of Crestor, a cholesterol-lowering drug. But critics say the agency didn't go far enough.

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The Astra-Zeneca product has been plagued by claims that it can cause rhabdomyolysis, a breakdown of muscle fibers that can lead to kidney damage. This is a well-known, rare adverse effect of all statins.

The FDA's advisory says an extensive review of the data indicates that patients taking recommended doses of Crestor have a risk similar to patients on other statin cholesterol treatments.

David Graham, a safety researcher at the FDA, had singled out the drug as deserving closer safety scrutiny during congressional hearings last fall. The advocacy group Public Citizen has also targeted Crestor and issued a blistering denunciation of the FDA's action, calling "another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

"Like statements from AstraZeneca, the FDA’s statement is replete with false and misleading information," said Sidney M. Wolfe, MD, Director, Public Citizen’s Health Research Group.

"Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review." Wolfe said.

Besides the FDA advisory, Crestor's manufacturer Astra-Zeneca Pharmaceuticals has 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 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).

Galson says the advisory "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."

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.

But Public Citizen said that since October 2004, when it petitioned FDA to clamp down on Crestor, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year.

Overall, FDA said 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.

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