In a letter to physicians posted to the FDA website, GlaxoSmithKline stated that a review of clinical data for Avandia (rosiglitazone) showed an increased risk of fractures in female patients with type 2 diabetes who received long-term treatment with the drug.
A review of safety data from the 4360-patient ADOPT trial demonstrated that significantly more female patients who received Avandia during a median of four years experienced fractures, compared with those who received either metformin or glyburide. Glaxo indicated that most of the fractures were observed in the upper arm, hand or foot, which is different from the hip and spine fractures generally associated with postmenopausal osteoporosis. In a separate review of interim data from an ongoing study of rosiglitazone, the results were consistent with the ADOPT findings, the company noted in its letter.
"In the interest of transparency, we are sharing this information with health professionals,'' remarked Glaxo spokesperson Mary Anne Rhyne, Bloomberg reports. Rhyne added that "this will not change our marketing activities around Avandia.'' Glaxo also indicated it is in discussions with European regulators regarding issuing a similar letter to physicians in EU countries.
The Avandia family of products, which also includes rosiglitazone-containing diabetes drugs Avandamet and Avandaryl, had sales of about $1.6 billion pounds in 2006.
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