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TUESDAY, March 13 (HealthDay News) -- Long-term use of type 2 diabetes drugs containing pioglitazone may cause an increased risk of upper and lower limb fractures, according to Takeda Pharmaceuticals North America, Inc. of Deerfield, Ill., and the U.S. Food and Drug Administration. Takeda is the manufacturer of ACTOS (pioglitazone HCI), ACTOplus met; (pioglitazone HCI and metformin hydrochloride) and duetact (pioglitazone HCI and glimepiride) tablets.
The warning stems from safety evaluation data from Takeda's clinical trial database, which includes 8,100 patients taking pioglitazone and 7,400 patients taking placebo or a comparator drug, who were followed-up for up to 3.5 years.
The drug did not alter fracture risk in men. However, in women, there were 1.9 fractures per 100 patient-years in the pioglitazone group compared with 1.1 fractures per 100 patient-years in the control and comparator group.
"The explanation for this finding is currently not known," according to a statement from Takeda. "Due to the limitations of the existing data set, multiple known risk factors for fractures cannot be excluded as confounding variables. Further evaluation of these findings is ongoing. The risk of fracture should be considered in the care of female patients with type 2 diabetes mellitus who are currently being treated with pioglitazone, or when initiation of pioglitazone treatment is being considered."
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