SECOND WARNING FOR WOMEN TAKING DIABETES DRUG

Takeda Pharmaceuticals has alerted healthcare providers about the increased risk of fractures related to Actos, Actosplus met and Duetact tablets, used to treat Type 2 diabetes mellitus.

An analysis of the manufacturer's clinical trial data on pioglitazone, the active ingredient in the tablets, showed an increase in reports of fractures in female patients taking pioglitazone than in those taking a comparator, either placebo or active. Most of the fractures observed in female patients were in the forearm, hand, wrist, foot, ankle or lower leg.

Healthcare providers should consider the risk of fractures when treating female patients with Type 2 diabetes mellitus with products that contain pioglitazone.

The notice marks the second adverse event report issued concerning Type 2 diabetes treatments in female patients. GlaxoSmithKline recently alerted providers about similar fractures discovered among patients taking its tablets containing rosiglitazone.