Drugs
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Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program
11/4/2011FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
5/18/2011FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
5/2011FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
2/3/2011- FDA Drug Safety Podcast: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
2/3/2011 HHS FDA: Briefing on Avandia
9/23/2010FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia FDA significantly restricts access to the diabetes drug Avandia
9/23/2010FDA Statement on Avandia TIDE Trial
7/21/20102010 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee
July 13-14, 2010 MeetingBriefing Information for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
7/9/2010FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety
2/22/2010- April 30, 2009 Updated Analysis of Acute Liver Failure Reports (PDF - 1.9MB)
4/30/2009 Information for Healthcare Professionals Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl)
Updated 11/19/2007FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia [ARCHIVED]
11/14/2007November 14, 2007 Transcript of FDA Press Conference on the Update to the Existing Box Warning on Avandia (PDF - 89KB) [ARCHIVED]Avandia label 8/2007 (PDF - 360KB)
Avandia labeling with boxed warning approved 8/14/2007Information for Healthcare Professionals Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) 5/21/2007
5/21/2007FDA Issues Safety Alert on Avandia
5/21/2007New Safety Information on Diabetes Drug Rosiglitazone 2009 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee
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