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

This information is not current. The issues described in this communication have been addressed in product labeling, please see Drugs@FDA.

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 [PDF] 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.

 

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.