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FDA MedWatch -- Rosiglitazone and Risk of Fractures

Healthcare professionals should consider the risk of fracture when initiating or treating female patients with rosiglitazone for type 2 diabetes mellitus.

Glaxo SmithKline (GSK) recently 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. The patients were followed for four to six years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies.

In the study, 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. Preliminary analysis was reported as being consistent with the observations from ADOPT.