Healthy Skepticism Library item: 14541

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Publication type: report

Public Citizen
Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)
: Public Citizen 2008 Oct 30
http://www.citizen.org/publications/release.cfm?ID=7614

Abstract:

October 30, 2008

Andrew Von Eschenbach, M.D., Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Von Eschenbach:

Public Citizen, representing more than 80,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately ban the diabetes drug, Avandia (rosiglitazone; GlaxoSmithKline). Our petition is based on rosiglitazone’s multiple, serious risks, including one just documented by our new analysis of 14 cases of liver failure, of which 12 resulted in death. In addition there is clear previous evidence of increased risk of heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema with vision loss. The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes, such as metformin, insulin and sulfonylureas. Because of a lack of evidence that benefits are outweighed by risks, both the American Diabetes Association and the European Association for the Study of Diabetes, in a statement submerged in a pre-publication consensus article on treatment of diabetes released last week, concluded that for the treatment of diabetes, “given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone.”¹

As evidence of the multiple serious side effects of rosiglitazone has mounted, there has been a sharp decrease in prescriptions for the drug, as shown on page 2 of this document. The peak number of prescriptions was in 2006, with 13.2 million prescriptions filled in the U.S. In the past full year (July 2007-June 2008), there were still 4.6 million prescriptions filled, thus exposing hundreds of thousands of people with diabetes to a drug that is clearly doing more harm than good. This means that each day, approximately 10,000 prescriptions for rosiglitazone are still being filled. Thus, it is urgent for the FDA to immediately ban rosiglitazone.