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Avandia resource centre

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Avandia (rosiglitazone) for the treatment of type 2 diabetes, is the most widely studied oral anti-diabetic medicine, with experience in over 52,000 patients worldwide.

Press releases and statements

• 7 Feb 2011: GSK revises US Avandia label to include new restrictions on use
• 23 Sep 2010: Stock Exchange Announcement: GSK regulatory update on Avandia following EMA and FDA reviews
• 6 Sep 2010: BBC Panorama – 6 September 2010: “A Risk Worth Taking?” Programme. GlaxoSmithKline Right of Reply Statement
• 6 Sep 2010 - Audio recording of meeting between GSK and Dr Nissen to discuss Avandia
• 6 Sep 2010: GlaxoSmithKline pre-broadcast statement: BBC Panorama, 6 September 2010
• 6 Sep 2010: GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)
• 21 July 2010: GlaxoSmithKline statement in response to FDA announcement on TIDE trial
• 14 July 2010: GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)
• 13 Jul 2010: GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA
• 9 Jul 2010: Data support Avandia (rosiglitazone maleate) cardiovascular safety profile
• 9 Jul 2010: GSK EU regulatory update on Avandia (rosiglitazone)
• 28 June 2010: GlaxoSmithKline statement in response to JAMA publications on rosiglitazone (PDF 76KB)
• 23 March 2010: GSK responds to JAMA editorial and comment (PDF 200KB)
• 24 Feb 2010: GlaxoSmithKline LLC’s white paper response to Senate Finance Committee's “Staff Report on GlaxoSmithKline and The Diabetes Drug Avandia”
• 24 Feb 2010: GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia
• 20 Feb 2010 - GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
• 20 Feb 2010 - GSK rejects conclusions reported in The New York Times story on Avandia
• 5 Jun 2009 - Large, long-term study, RECORD, shows Avandia has no increased overall cardiovascular risk compared to other commonly used diabetes medicines

 

Audio recording of meeting between GSK and Dr Nissen to discuss Avandia

• 6 Sep 2010 - Audio recording of meeting between GSK and Dr Nissen to discuss Avandia

FDA Advisory Committee - 13-14 July 2010

• 21 July 2010: GlaxoSmithKline statement in response to FDA announcement on TIDE trial
• 14 July 2010: GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)
• 13 Jul 2010: GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA
• 9 Jul 2010: Data support Avandia (rosiglitazone maleate) cardiovascular safety profile
• 9 Jul 2010: GSK EU regulatory update on Avandia (rosiglitazone)
• FDA: Advisory Committee page

 

Avandia background information

The following information is for US residents only.

• 13 July 2010 - Avandia fact sheet (PDF 41KB)
• 13 July 2010 - Avandamet fact sheet (PDF 43KB)
• 13 July 2010 - Avandaryl fact sheet (PDF 43KB)
• 5 June 2009 - RECORD fact sheet (PDF 42KB)

Information for healthcare professionals

• May 2010 - Avandia Summary of Product Characteristics - EU version (PDF 301KB)
• Feb 2011 - Avandia US prescribing information (PDF 568KB)
• Feb 2011 - Avandamet US prescribing information (PDF 408KB)
• Feb 2011 - Avandaryl US prescribing information (PDF 512KB)

For regulatory updates since 2007, click on the "Information by category" tab at the top of this page.

Consistent with the approved product labelling in the US and Europe the scientific evidence does not establish that rosiglitazone  increases cardiovascular ischemic risk or causes myocardial ischemic events. 

Patient safety is a priority at GSK and our efforts to understand the cardiovascular safety profile of rosiglitazone  began before submission of the initial marketing application forrosiglitazone and continue to this day.  GSK has consistently shared this data with regulators around the world, and worked with them to ensure that therosiglitazone product labelling is updated to add cardiovascular and other safety information as new data become available so that physicians can make the best treatment choices for their patients

In addition, GSK has posted the results of all its clinical trials as well as meta-analyses and observational studies on its Clinical Study Register for all to see. 

For further information and data related to Avandia, click on the "Information by category" tab at the top of this page.

Since the original New England Journal publication on rosiglitazone and the subsequent FDA joint Advisory Committee Meeting to address questions about the cardiovascular safety of rosiglitazone, seven large prospective, randomized, clinical trials have reported results.  None of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, shows a statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events. 

External information

• FDA: Advisory Committee page
• MHRA: Thiazolidinediones, rosiglitazone and pioglitazone
• MHRA: Statement on cardiac safety of rosiglitazone (brand name Avandia)
• MHRA: Press statement: Europe wide review confirms positive benefit-risk balance for rosiglitazone and pioglitazone
• European Association for the Study of Diabetes
• Primary Care Diabetes Europe
• World Heart Federation
• International Diabetes Federation
• American Diabetes Association
• The Endocrine Society

Clinical data

To review clinical data on Avandia, visit the GSK Clinical Study Register.