- Prescribing Advice for GPs - https://www.prescriber.org.uk -

FDA link pioglitazone and fractures

The American Food and Drugs Administration has issued a warning to healthcare professionals after an increased risk of fracture was also seen in the clinical trial database of pioglitazone (Actos®).

The risk appears to be very similar to rosiglitazone. The risk appears to only affect women and the fractures are mainly located in the distal portion of the limbs, e.g. hand, foot, wrist, ankle, forearm, tibia and fibula.

The manufacturer recommends that, "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".

This analysis strongly suggests that the increased risk of fracture is a class effect of the glitazones. Further investigation is required before the nature and mechanism of this excess risk is understood. Metformin remains the first-line hypoglycaemic and sulphonylureas provide a suitable second-line option as an alternative to the glitazones.

Action: Fracture risk should be considered during medication reviews for female patients already on glitazones. In patients whose type 2 diabetes is poorly controlled the pros and cons of each of the available hypoglycaemic agents should be considered and discussed with the patient before any treatment is started.