HEALTH AND SAFETY

» 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

 

Rosiglitazone

Brand name: Avandia

The American Diabetes Association estimates that 23.6 million Americans currently have diabetes. Although some patients with Type-2 diabetes can control their blood sugar levels adequately with diet and exercise, many patients also require treatment with diabetes drugs that help to keep glucose levels stable.

Among these drugs is rosiglitazone (Avandia), for which 3.1 million prescriptions were filled in 2008. But Avandia is associated with heart failure, heart attacks, liver toxicity, bone fractures, anemia and macular (retinal) edema with vision loss.

Public Citizen petitioned the FDA to revise the labeling for Avandia due to multiple safety issues in 2000. In 2007 a study published in the New England Journal of Medicine associated the drug with a 43 percent increase in the risks of heart attacks. At an FDA hearing in 2007, we advocated removing the drug from the market. In 2008, we petitioned the FDA to remove drug from the market. In 2009, Public Citizen published new research showing that Avandia and a closely related drug pioglitazone (Actos) can cause liver toxicity. In 2010, we urged the FDA to stop an unethical clinical trial of Avandia, and Dr. Wolfe testified before an FDA advisory committee about Avandia's risks. In September of 2010, the FDA restricted sales of Avandia.

More Information on rosiglitazone (Avandia)

Copyright © 2014 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

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.