The FDA and GlaxoSmithKline, Avandia’s manufacturer, have advised doctors to carefully consider fracture risk before beginning Avandia therapy for women with type 2 diabetes.
Compared to women who received metformin or glyburide, a large study found that significantly more women who received Avandia suffered fractures of the arm, hand, and foot. There was no increase in hip or spine fractures. Recently, GlaxoSmithKline reviewed fracture data from a currently ongoing study designed to evaluate cardiovascular safety of Avandia. The fracture data thus far corroborated the earlier results, leading to the current warning.