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Increased Risk of Bone Fractures in Women Treated with Diabetes Drugs

Posted on April 29, 2008

Two manufacturers of thiazolidinedione drugs, which are used to treat type 2 diabetes, have notified healthcare professionals that women taking these drugs have an increased risk of bone fractures. The first company, GlaxoSmithKline, makes Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride), which all contain rosiglitazone.

In a recent clinical trial, women who took drugs containing rosiglitazone experienced a higher incidence of fractures than those treated with metformin or glyburide therapy. The majority of these fractures were in the upper arm, hand and foot.

The second company, Takeda, makes Actos (pioglitazone), ACTOplus met (pioglitazone and metformin hydrochloride), and Duetact (pioglitazone and glimepiride) which all contain pioglitazone. An analysis of the company's clinical trial database showed that drugs that contain pioglitazone may also increase fracture risk in women.

The clinical significance of these findings is uncertain at present. Still, both companies recommend that the possibility of fracture be taken into account when rosiglitazone or pioglitazone are considered for treating female patients with type 2 diabetes.

Additional Information:

FDA MedWatch Safety Alert. Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), Avandaryl (rosiglitazone maleate and glimepiride). February 21, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone

FDA MedWatch Safety Alert. Actos (pioglitazone) Tablets
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actos

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