GlaxoSmithKline Advises Health Officials on Avandia
ROCKVILLE, Md., Feb. 21, 2007-Glaxo SmithKline (GSK) notified
healthcare professionals of the results of a randomized,
double-blind parallel group study [ADOPT] 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.
Read the complete MedWatch 2007 Safety attached.
Posted: February 2007