THURSDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration reported this week that rosiglitazone increases the risk of fractures in women with type 2 diabetes. The tablets, made by GlaxoSmithKline, include Avandia (rosiglitazone maleate), Avandaryl (rosiglitazone maleate and glimepiride), and Avandamet (rosiglitazone maleate and metformin hydrochloride).
In a letter to health care providers, GlaxoSmithKline reports that an analysis of data from a randomized clinical trial of 4,360 type 2 diabetics found that significantly more women treated with rosiglitazone (60) had fractures than those taking metformin (30) or glyburide (21). An independent review of data from another ongoing trial had similar results, and found that most fractures involved the upper arm, hand or foot.
"GlaxoSmithKline believes the risk of fracture should be considered in the care of patients, especially female patients, with type 2 diabetes mellitus who are currently being treated with rosiglitazone, or when initiation of rosiglitazone treatment is being considered," the company said in a statement.
"Health care professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes with rosiglitazone," according to the FDA.
More Information - FDA
More Information - Letter to Health Care Professionals
