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Pioglitazone Linked with Increased Fracture Risk in Women

The FDA warned physicians of an increased fracture risk in women taking medications containing pioglitazone for type 2 diabetes.

In a letter to healthcare providers, Takeda Pharmaceuticals reports that an analysis of their clinical trials database found that patients on pioglitazone had a fracture incidence of 1.9 fractures per 100 patient-years, compared with an incidence of 1.1 for those on placebo or a different drug. There was no increased risk in men. Most fractures occurred in the patients' distal limbs.

The FDA advised clinicians to consider fracture risk when treating women with pioglitazone. The warning applies to Actos (pioglitazone), Actoplus met (pioglitazone and metformin), and Duetact (pioglitazone and glimepiride).

Last month, the agency issued a similar warning on rosiglitazone.

Link: FDA notice on pioglitazone (Free)

Link: Manufacturer's letter (Free PDF)

Link: Physician's First Watch coverage of rosiglitazone warning. (Free)

Published in Physician's First Watch March 12, 2007