Increased Risk of Fractures in Women Who Take Rosiglitazone

According to MedWatch, The FDA Safety Information and Adverse Event Reporting Program, GlaxoSmithKline has issued a letter of notification to healthcare professionals advising that during the ADOPT trial (A Diabetes Outcome Progression Trial) a 4-6 year study involving rosiglitazone (Avandia), it was noticed that a significant number of female participants who took rosiglitazone suffered fractures of the upper arm, hand or foot. GlaxoSmithKline confirmed the evidence with the results of another large study that was in progress at the same time, and the findings were similar.

The ADOPT study originally was initiated to measure the effectiveness of three medications, rosiglitazone, metformin and glyburide on glycemic control, b-cell funtion in the pancreas and cardiovascular risk over a period of 4 to 6 years. 4,360 people, both men and women, with recently diagnosed Type 2 diabetes participated in the study.

Rosiglitazone is a thiazolidinedione which improves insulin receptivity in Type 2 diabetes. Another recent study that took place in September of 2006, known as the DREAM study showed that combining Avandia (rosigliatazone) with a healthier lifestyle, helped people who are at high risk for getting diabetes, by lowering their chances of ever getting the disease. The results were presented Sept. 15, 2006 in Copenhagen, Denmark, at the 42nd Annual Meeting of the European Association for the Study of Diabetes.

But, combined with this new information about increased fracture risk, caution should be exercised when prescribing rosiglitazone to female patients. Healthcare professionals are advised by the FDA and GlaxoSmithKline, to consider the risk of fracture when prescribing rosiglitazone to women with type 2 diabetes.

Patients who have questions about their medications should ask their doctors and discuss the possibilities of these and other side effects.