FDA Significantly Restricts Access To The Diabetes Drug Avandia
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Make Sure You Stop Using This Drug!
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[09-23-2010] The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
Related Information
- Decision on continued marketing of rosiglitazone (Avandia, Avandamet, Avandaryl) (PDF – 167KB)
Janet Woodcock, MD , Director, Center for Drug Evaluation and Research - Recommendations for Regulatory Action for Rosiglitazone and Rosiglitazonecontaining Products (NDA 21-071, supplement 035, incoming submission dated August 25, 2009) – 9/12/2010 (PDF – 148KB)
Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology - Comments on the study by Wertz et al. published in Circulation 2010 (PDF – 46KB)
David J. Graham, MD, MPH, Associate Director for Science and Medicine, Office of Surveillance and Epidemiology - Analysis of Medicare thiazolidinedione study data by date of birth – 9/1/2010 (PDF – 47KB)
David J. Graham, MD, MPH, Associate Director for Science and Medicine, Office of Surveillance and Epidemiology - Recommendations for regulatory actions – rosiglitazone – 9/2/2010 (PDF – 152KB)
John K. Jenkins, M.D., Director Office of New Drugs - Recommendations on marketing status of Avandia® (rosiglitazonemaleate) and the required post-marketing trial, Thiazolidinedione Intervention and Vitamin D Evaluation (TIDE) following the July 13 and 14, 2010 public advisory committee meeting – 8/19/2010 (PDF – 185KB)
Mary H. Parks, M.D., Director, Division of Metabolism and Endocrinology Products - Pioglitazone Secondary Statistical Review (PDF – 37KB)
Mark Levenson, Ph.D., Acting Deputy Division Director, Division of Biometrics 7 - Pioglitazone Statistical Review – 9/10/2010 (PDF – 441KB)
Qian H. Li, Sc.D. - Avandia (rosiglitazone) AC Memo – 8/23/2010 (PDF – 100KB)
Curtis J. Rosebraugh, M.D., M.P.H., Director, Office of Drug Evaluation II - Avandia (rosiglitazone) Memo – 8/8/2010 (PDF – 178KB)
Robert Temple, M.D., Deputy Center Director for Clinical Science - Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
- Q&A: Avandia (rosiglitazone)
- FDA significantly restricts access to the diabetes drug Avandia
FDA News Release – 9/23/2010 - Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration
New England Journal of Medicine – 9/23/2010 - FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia
- HHS FDA: Briefing on Avandia
FDA Avandia announcement audio – 9/23/2010 - Avandia (NDA 021071) – Safety Labeling Change, REMS, and PMR Notification (PDF – 75KB)
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