Increased Incidence of Fractures in Female Patients Who Received Long-Term Treatment with Avandia® (rosiglitazone maleate)

In agreement with European Regulatory Authorities, GlaxoSmithKline (GSK) is informing you of recent safety data concerning rosiglitazone-containing products, i.e., Avandia® (rosiglitazone maleate) Tablets, Avandamet® (rosiglitazone maleate and metformin hydrochloride) Tablets, and Avaglim® (rosiglitazone maleate and glimepiride) Tablets. The information could be summarized as follows:

• Clinical trial data (ADOPT) show that female patients treated with rosiglitazone experienced significantly more fractures in feet, hands and upper arms (humerus) than female patients who received either metformin or glyburide.

• The mechanism for the observed increase in fractures is uncertain. Further evaluation of these findings is ongoing.

• The risk of fracture should be considered in the care of patients, in particular female patients treated with rosiglitazone.


Source: Medicines and Health Care Products Regulatory Agency