GSK WARNS OF FRACTURES IN WOMEN TAKING DIABETES DRUG

GlaxoSmithKline (GSK) has alerted healthcare providers about the increased risk of fractures related to Avandia, Avandamet and Avandaryl tablets, which are used to treat Type 2 diabetes mellitus.

A review of the safety data from the recent ADOPT trial showed that significantly more female patients receiving rosiglitazone, the active ingredient in the tablets, experienced fractures than those taking either metformin or glyburide. The rates of fractures observed in male patients were similar across the three treatment groups, GSK said.

Most of the fractures seen in female patients were in the upper arm, hand or foot, which are sites not commonly associated with postmenopausal osteoporosis (e.g., hip or spine). In the trial, the number of female patients with hip or spine fractures was low and similar across the three treatment groups.

GSK had also requested that an independent safety committee review an interim data analysis of fractures in another large, ongoing, long-term, controlled clinical trial of rosiglitazone. The results from the preliminary analysis matched the observations from the ADOPT trial, and the safety committee recommended that the study continue without changes. Final results of this study are expected in 2009, GSK said.