Pioglitazone linked to fracture risk in women

Yael Waknine

March 09, 2007

Rockville, MD - Pioglitazone (Actos, Takeda Pharmaceuticals North America, Inc) therapy may be linked to an increased risk for fracture in women, warns the US Food and Drug Administration (FDA) and the manufacturer [1].

The warning is based on data from the company's clinical trial database, showing that pioglitazone-treated women were more likely to have sustained a fracture than those receiving a comparator drug or placebo during a maximum period of 3.5 years, according to an alert sent today from MedWatch, the FDA's safety information and adverse-event reporting program. No increased risk for fracture was identified in men.

In the study, fracture incidence (per 100 patient-years) was found to be 1.9 in the pioglitazone group vs 1.1 for those receiving a comparator drug (excess risk 0.8). The majority of cases involved fractures of the distal upper limb (eg, forearm, hand, wrist) or lower limb (eg, foot, ankle, tibia, fibula), which differ from those commonly associated with postmenopausal osteoporosis (eg, hip or spine).

Pioglitazone HCl is currently marketed as a single drug and in combination with metformin HCl (Actoplus Met) or glimepiride (Duetact).

According to a Takeda news release, the mechanism for the observed increase in fractures remains unclear. Because the database was not designed to study the effect of pioglitazone on bone (the fractures were reported as adverse events), multiple known risk factors for fractures cannot be excluded, and further evaluations are ongoing.

In the interim, the risk for fracture should be considered when physicians are initiating or continuing pioglitazone therapy, particularly in women. As with all type 2 diabetic patients, assessment and maintenance of bone health according to current standards of care is advised.

Healthcare professionals are encouraged to report pioglitazone-related adverse events to the company at 1-877-TAKEDA7 (825-3327). This information may also be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 

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