» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


More information on rosuvastatin (Crestor)

Statement Regarding the FDA's Decision to Leave Rosuvastatin (Crestor) on the Market

In Refusing to Ban Crestor, FDA Chooses Drug Company Over Safety

March 14, 2005

Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen

The U.S. Food and Drug Administration’s (FDA's) denial today of our petition to ban Crestor has a familiar ring in its similarity to the agency’s initial response to the dangers of many other drugs that were eventually banned. This response should give no comfort to either physicians or patients who are using or considering using Crestor. More than a year before Baycol was banned because of its uniquely high rate of rhabdomyolysis compared to other statins, the FDA was aware of this difference, as was the agency more than two years before the diabetes drug Rezulin was banned because of liver toxicity. Four years before Vioxx was banned, the FDA refused to even require a black box warning about known increased risk of heart attacks.

We are aware that because of its concerns about the increased rate of rhabdomyolysis and unique kidney toxicity of Crestor, the agency at least considered warning that the drug should be a last-choice drug for lowering cholesterol. Although this would not have been preferable to banning the drug, it would have been a much less reckless choice than merely allowing cosmetic labeling changes to be made.

  • On page 16 of its response  to Public Citizen’s petition to ban Crestor, the agency admits that although “estimates of the reporting rate [for rhabdomyolysis] are higher than those of other marketed statins, the time period [post-Baycol] conceivably contributed to the enhanced reporting … because of publicity.” This is absurd since our recent analysis of the most recent year of rhabdomyolysis data on all of the statins, showing the rate for Crestor to be 6.2 times higher than other statins combined, covered a period from 10/03 through 9/04, during which the reporting of all statins would have been affected by the “Baycol effect.”
  • While acknowledging (page 27) that as many as 15 cases of kidney failure with Crestor had a “history supporting possible direct causation by Crestor,” a similar analysis was not done for cases of renal failure reported with other statins. The agency also states (p. 30) that “neither does a review of the cases fully dispel concerns of possible renal effects of Crestor that might, in some instances, result in renal insufficiency or failure.” Thus, our earlier statement that the rate of such reports is much higher with Crestor compared to other statins is not rebutted.

Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency’s badly tarnished reputation.

Copyright © 2016 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.