The FDA published the notice on its website, urging physicians to consider the risk of fracture when treating female patients with type 2 diabetes with pioglitazone-containing products. Three of Takeda’s diabetes products, Actoplus met, Actos and Duetact, contain the ingredient.
The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8,100 patients in the pioglitazone-treated groups and over 7,400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. There was no increased risk of fracture in men.
“The explanation for this finding is currently not known. It should also be noted that none of the pioglitazone studies in the database addressed, or were designed to study, the effect on bone, but fractures were collected as adverse events,” Takeda said, in its letter to physicians. The company added that investigations are ongoing.