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)

• Testimony to FDA Drug Safety and Risk Management and Endocrine and Metabolic Drugs Advisory Committees Regarding Rosiglitazone Safety, June 6, 2013
• Position Statement: FDA’s Rejection of Public Citizen’s Petition to Ban Rosiglitazone (Avandia) Translates to More Harm to Patients, November 22, 2011
• Position Statement: FDA’s Decision Not to Take Rosiglitazone (Avandia) Off the Market Jeopardizes Public Health, September 23, 2010
• Testimony on Rosiglitazone (Avandia) Safety, July 14, 2010
• Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial, May 11, 2010
• Testimony on Rosiglitazone (Avandia), April 28, 2010
• Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness, March 8, 2010
• Life-Threatening Liver Toxicity of Rosiglitazone (Avandia) Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal, July 22, 2009
• Petition to Ban Diabetes Drug Rosiglitazone (Avandia), October 30, 2008
• Testimony on Rosiglitazone (Avandia), July 30, 2007
• Letter Demonstrating that FDA Knew About Rosiglitazone (Avandia) Dangers, May 22, 2007
• Statement: New Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Rosiglitazone (Avandia), May 21, 2007
• Letter in the Lancet on the Availability of Information on Thiazolidinediones, July 15, 2000
• Petition Requesting Updated Labeling for Diabetes drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos), March 7, 2000