Women Taking Rosiglitazone at Increased Risk of Fracture

GlaxoSmithKline has recently sent a letter to physicians notifying them about a significant increased risk for fractures of the upper arm, hand, or foot among women taking rosiglitazone (Avandia).

N Engl J Med

The risk for fracture in women taking rosiglitazone was 9.3% compared with 5.1% in women taking metformin (Glucophage) and 3.5% with glyburide (DiaBeta). These results were reported in the trial known as ADOPT (A Diabetes Outcome Progression Trial), which was published at the end of 2006 (. 2006; 355:2427-2443).

No difference was observed in the number of fractures reported in men in the treatment groups. A preliminary review of an interim analysis of fractures in another large, ongoing, placebo-controlled clinical trial was reportedly consistent with the findings from ADOPT. The full letter is available at www.fda.gov/medwatch/safety/2007/Avandia_GSK_Ltr.pdf