Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Luis Castilla, Press Officer, Public Citizen’s Texas office
w. (512) 637-9467

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter



Oct. 29, 2004

Rate of Kidney Damage in Crestor Patients Is 75 Times Higher Than in Patients Taking Other Cholesterol Drugs

Public Citizen Renews Call for Crestor to Be Removed From Market

WASHINGTON, D.C. – The rate of reports of kidney failure or damage among patients taking the cholesterol drug Crestor is 75 times higher than in all patients taking all other statins, according to a Public Citizen analysis of government data. Public Citizen sent the information today to the U.S. Food and Drug Administration and renewed its call for the drug to be taken off the market.

“It becomes clearer by the day that this drug is uniquely toxic but offers no unique benefit, and must be removed from the market,” wrote Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, to FDA Acting Commissioner Lester Crawford.

According to the analysis, the rate of reports to the FDA of acute renal failure or renal insufficiency per million prescriptions in patients using rosuvastatin (Crestor) – 29 U.S. reports in less than one year since the drug was first marketed in this country – is approximately 75 times higher than the rate for all other statin drugs combined.

The FDA had evidence before approving the cholesterol drug Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration), yet the agency approved it anyway, erroneously believing that this toxicity was limited to an 80 milligram dose that was not ultimately approved. The drug went on the market in September 2003. In March 2004, Public Citizen petitioned the FDA to remove the drug from the market because it had been linked to muscle damage and kidney failure.

There have been 29 reported U.S. cases of acute renal failure or renal insufficiency out of 4.5 million Crestor prescriptions filled between September 2003 and the end of August 2004. For all other statins (including Lipitor, Zocor, Lescol, Pravachol and Mevacor), there have been 27 cases of acute renal failure or renal insufficiency reported from Jan. 1, 2001, through Sept. 30, 2003, out of 316 million prescriptions filled. This is a rate of .085 cases reported per million prescriptions filled.

Thus, the rate of reports of acute renal failure or renal insufficiency for Crestor is 6.4/.085, or 75 times higher than that of all of the other statins.  In addition, as of August 26, 2004, there had been 65 reports of rhabdomyolysis among U.S. patients taking Crestor, a rate of reports approaching that of Baycol, a cholesterol drug that was taken off the market because of rhabdomyolysis. To read Wolfe’s letter, go to http://www.worstpills.org.


Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.