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Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use

Note: This press release was updated on Dec. 11, 2008

Oct. 30, 2008  

Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use

Risks Outweigh Benefits of the Diabetes Drug; Safer Alternatives Are Available

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits, Public Citizen said in a petition filed today with the agency.

New research released by Public Citizen about the drug, used to treat Type 2 diabetes, comes as a working group with representatives from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes, unanimously advised against using Avandia, whose generic name is rosiglitazone, because of their concerns about the drug’s risks. This statement appears in the newly published issue of Diabetes Care, the ADA’s peer-reviewed medical journal. Despite a significant decrease in its use since publication of a study linking it to increased risk of heart attacks, approximately 10,000 prescriptions a day are still filled for this unacceptably dangerous drug, which is sold by Glaxo-SmithKline.

Public Citizen has identified 14 cases of Avandia-induced liver failure, including 12 deaths. These cases were derived from the FDA Adverse Event Reporting System after careful review of the agency’s MedWatch forms, which are submitted to the agency when adverse drug reactions are suspected.

Liver toxicity is only the most recently noted danger of Avandia; Public Citizen has encouraged diabetes sufferers to avoid taking the drug because it increases the risk of heart attack approximately 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million prescriptions filled for Avandia than for an older diabetes drug, glipizide.

Avandia prescriptions fell sharply following a May 2007 study published in The New England Journal of Medicine connecting the drug with increased heart attack risk. In 2006, the number of prescriptions for the drug peaked at 13.2 million. Since then, that number has dropped to 4.6 million for the last full year. This means that about 10,000 prescriptions a day are still being filled for this dangerous drug.  

“The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug.”

Safer, more effective drugs for Type 2 diabetes include metformin (brand name Glucophage) and glipizide (brand name Glucotrol). Pioglitazone (sold as Actos), a drug in the same family as Avandia, is not recommended, as it shares most of Avandia’s toxicities – except for the risk of heart attack – and   the ADA does not number it among the preferred therapies for most diabetics.

The full petition is available at https://www.citizen.org/our-work/health-and-safety/articles/petition-ban-diabetes-drug-rosiglitazone-avandia.