Thiazolidinediones [Actos (pioglitazone HCl), Avandia (rosiglitazone)]
April 26, 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 Revised, highlighted label: Actos - Takeda]
[February 2001 Revised, highlighted label: Avandia - GSK]
[January 2002 Letter: Actos - Takeda]
[September 2001 Letter: Avandia - GSK]
[March 2001 Letter: Avandia - GSK]
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