Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate and metformin hydrochloride) Avandaryl (rosiglitazone maleate and glimepiride)

Published: Tue Feb 20 00:00:00 -0500 2007

Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.