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


FDA’s Rejection of Public Citizen’s Petition to Ban Avandia Translates to More Harm to Patients

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

Late yesterday, the Food and Drug Administration (FDA) faxed Public Citizen its letter rejecting our Oct. 30, 2008, petition in which we asked the FDA to ban the diabetes drug Avandia (rosiglitazone) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems. In September 2010, the European Medicines Agency (EMA) announced a ban of the drug because of its decision that Avandia’s benefits were clearly outweighed by its risks and that additional restrictions to reduce risk could not be identified.* Subsequently, it also has been banned in New Zealand, India and other countries.

In the year since the EMA announcement, according to health-care analytics experts IMS, there have been approximately 1.1 million prescriptions for Avandia-containing drugs filled in the U.S., thereby ensuring the occurrence of hundreds or more patients suffering heart attacks and cases of severe heart failure – including many deaths and hospitalizations. All of this from a drug deemed too dangerous to stay on the market in all of Europe and in an increasing number of other countries.

The FDA’s decision not to ban the drug but to limit prescriptions for the drug, so that patients will have allegedly tried other treatments first, is a dangerous and reckless refutation of the precautionary principle that is supposed to guide decisions involving public health. The evidence shows the drug has no unique clinical benefits but unique risks. Unless the FDA can provide evidence that Americans are more resistant to the life-threatening adverse effects of Avandia than people in Europe and the other countries that have banned the drug, this decision, unlike the wise decision last week concerning Avastin, cannot be described as science-based or rational.

The FDA’s rejection of our petition closely follows the announcement by the manufacturer of rosiglitazone, GSK, that it has agreed to pay $3 billion in civil and criminal penalties including the illegal marketing of this drug.

*From the EMA press release announcing the ban:

“The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk.  The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.” 


Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.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.