Healthy Skepticism Library item: 8628

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Rapaport L.
Glaxo Warns of Fractures in Women on Diabetes Drugs
Bloomberg.com 2007 Feb 20
http://www.bloomberg.com/apps/news?pid=20601202&sid=agaVAbSVt_xY&refer=healthcare

Full text:

Feb. 20 (Bloomberg) — GlaxoSmithKline Plc warned doctors that studies found increased risk of broken bones in women who used three of its drugs for diabetes.

A letter from the U.K.-based drugmaker, citing the results of long-term studies, was posted today on the U.S. Food and Drug Administration’s Web site.

Three of Glaxo’s diabetes medicines containing a drug called rosiglitazone — Avandia, Avandamet and Avandaryl — had higher instances of fractures in female patients than two older diabetes medicines, metformin and glyburide, the company said.

Most of the fractures observed in female patients taking the Glaxo drugs for type-2 diabetes were in the upper arm, hand or foot. Those are different locations from fractures commonly associated with post-menopausal loss in bone density, such as breaks in the hip or spine, the company said.

``In the interest of transparency, we are sharing this information with health professionals,’‘ Mary Anne Rhyne, a U.S. spokeswoman for Glaxo, said in a telephone interview. ``This will not change our marketing activities around Avandia.’‘

Rhyne declined to comment on whether the company expected prescriptions or revenue for Avandia to decline as a result of the study findings.

Sales of Avandia, which has been taken by more than 9 million patients worldwide, rose 25 percent to 324 million pounds ($634 million U.S.) in the fourth quarter, after research released in December showed the drug was effective in 85 percent of patients with type-2 diabetes after five years.

Avandia had 1.4 billion pounds in sales last year, compared with Avandament’s 204 million pounds and Avandaryl’s 42 million.

To contact the reporter on this story: Lisa Rapaport in New York at Lrapaport1@bloomberg.net