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U.S. Department of Health and Human Services

Safety

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Avandia (rosiglitazone) April 2002

Audience: Primary care providers, endocrinologists, cardiologists and other healthcare professionals treating patients with type 2 diabetes mellitus

FDA approved changes to strengthen the labeling for Actos and Avandia. The WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections have been modified to more clearly describe the cardiovascular risks associated with the use of thiazolidinediones as monotherapy and in combination with other antidiabetic agents, particularly insulin.

[April 26, 2002 - Summary - FDA]
[January 2002 - Letter: Actos - Takeda]
[September 2001 - Letter: Avandia - GSK]
[March 2001 - Letter: Avandia - GSK]