Healthcare providers are being notified by the Takeda Pharmaceuticals, the manufacturer of Actos, of a possible increased risk of fractures in women taking this medication.

Actos has been used to treat women with PCOS – polycystic ovary syndrome, insulin resistance, and diabetes. Takeda recently performed an analysis of its clinical trial database of Actos with a special focus on fractures, comparing patients treated with Actos or a comparator (either placebo or a different medication). It is unclear from their letter as to why they undertook this particular analysis at this time.

The clinical trial database was collected when Takeda was conducting studies to gain FDA-approval for Actos. These studies were not designed to look specifically at fracture risk but data on fractures was collected as part of the routine adverse events reporting.

The maximum duration of Actos treatment was up to 3.5 years. There were more than 81 00 patients in the Actos-treated groups and over 7400 patients in the comparator-treated groups.

The majority of fractures observed in female patients who received Actos were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). Based on their calculations, if 1000 women took Actos for one year, 19 fractures would be expected compared to 11 expected fractures in the comparison group. There was no increased risk of fracture identified in men.

Due to the limitations of the data, other known risk factors for fractures cannot be excluded.