Inpharma 1663 - 8 Nov 2008 Public Citizen wants Avandia ban The consumer advocacy group Public Citizen has filed a petition with the US FDA calling for an immediate ban on the antihyperglycaemic drug Avandia [rosiglitazone; GlaxoSmithKline] "because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits". 1 "The scientific consensus against Avandia is overwhelming," said Dr Sidney Wolfe, director of Public Citizen’s Health Research Group, which identified 14 cases of rosiglitazone-induced liver failure, including 12 deaths, after reviewing reports to the FDA’s Adverse Event Reporting System. 1 At the same time, a working group with representatives from the American Diabetes Association and the European Association for the Study of Diabetes has unanimously advised against using Avandia, due to concerns about the drug’s risks. The working group’s statement appears in the latest issue of Diabetes Care. * Responding to the petition, GSK points out that data from long-term clinical trials provide substantial evidence to enable assessment of the risk-benefit profile of Avandia. 2 The company notes that an external Hepatic Safety Board, which continuously reviews any adverse event reports received by GSK of liver failure, liver- related deaths and liver transplants, continues to endorse a favourable hepatic safety profile for Avandia. In addition, outcomes from five long-term studies did not show an increased risk of total mortality for Avandia, compared with other commonly used antihyperglycaemics. * Diabetes Care 2009; 32 (1): 1-11 1. Public Citizen. Public Citizen Petitions FDA to Ban Avandia, Cites Life- Threatening Toxicity as Top Diabetes Associations Advise Against Use. Media Release : 30 Oct 2008. Available from: URL: http://www.citizen.org. 2. GlaxoSmithKline. GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition. Media Release : 30 Oct 2008. Available from: URL: http://www.gsk.com. 801075417 1 Inpharma 8 Nov 2008 No. 1663 1173-8324/10/1663-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Public Citizen wants Avandia ban

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Inpharma 1663 - 8 Nov 2008

Public Citizen wants Avandia banThe consumer advocacy group Public Citizen has filed

a petition with the US FDA calling for an immediate banon the antihyperglycaemic drug Avandia [rosiglitazone;GlaxoSmithKline] "because it can cause death from liverfailure and has many other life-threatening risks that faroutweigh its benefits".1

"The scientific consensus against Avandia isoverwhelming," said Dr Sidney Wolfe, director of PublicCitizen’s Health Research Group, which identified14 cases of rosiglitazone-induced liver failure, including12 deaths, after reviewing reports to the FDA’s AdverseEvent Reporting System.1 At the same time, a workinggroup with representatives from the American DiabetesAssociation and the European Association for the Studyof Diabetes has unanimously advised against usingAvandia, due to concerns about the drug’s risks. Theworking group’s statement appears in the latest issue ofDiabetes Care.*

Responding to the petition, GSK points out that datafrom long-term clinical trials provide substantialevidence to enable assessment of the risk-benefit profileof Avandia.2 The company notes that an external HepaticSafety Board, which continuously reviews any adverseevent reports received by GSK of liver failure, liver-related deaths and liver transplants, continues toendorse a favourable hepatic safety profile for Avandia.In addition, outcomes from five long-term studies didnot show an increased risk of total mortality for Avandia,compared with other commonly usedantihyperglycaemics.* Diabetes Care 2009; 32 (1): 1-11

1. Public Citizen. Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use. MediaRelease : 30 Oct 2008. Available from: URL: http://www.citizen.org.

2. GlaxoSmithKline. GSK Believes There Is No Liver Safety Issue WithAVANDIA; Responds to Public Citizen Petition. Media Release : 30 Oct 2008.Available from: URL: http://www.gsk.com.

801075417