Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information

FDA ALERT [5/21/2007, updated 11/19/2007]: This update highlights changes to the prescribing information for rosiglitizone including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the label about the potential increased risk of myocardial ischemia. FDA also has requested that the manufacturer, GlaxoSmithKline, develop a Medication Guide for patients that provides information about the safe use of rosiglitazone. Healthcare professionals should factor this new information into their individual treatment decisions for their patients.

FDA ALERT [8/14/2007]: This Alert highlights important revisions to the full prescribing information for rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl).  The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS and CONTRAINDICATIONS to emphasize that rosiglitazone may cause or exacerbate heart failure, particularly in certain patient populations.  The implications of this new labeling for healthcare professionals who prescribe Avandia, Avandamet, and Avandaryl are summarized below.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

Healthcare Professional Information

• Information for Healthcare Professionals (updated 11/19/2007)
• Prescribing Information (Avandia labeling with boxed warning approved 8/14/2007)

Patient Information

• Patient Information Sheet (last updated 8/2006)
• Consumer Update: New Safety Information on Diabetes Drug Rosiglitazone

Other Information

• FDA News: FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia (11/14/2007)
  • Transcript of 11/14/2007 FDA Press Conference on the Update to the Existing Box Warning on Avandia
• FDA News: FDA Issues Safety Alert on Avandia (5/21/2007)
• Regulatory History of Rosiglitazone from Drugs@FDA 
• Endocrinologic and Metabolic Drugs Advisory Committee, July 30, 2007; briefing information, presentations, transcripts, and more.

Historical Information

• Information for Healthcare Professionals (updated 8/14/2007)

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Date created: May 21, 2007, updated February 19, 2008

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