EMA: "small increased risk of bladder cancer" with pioglitazone

A review into the possible increased risk of bladder cancer with pioglitazone has been completed by the MHRA. The results indicated that there is a small increase in risk associated with pioglitazone use.

As a result, pioglitazone is contraindicated in patients with active or historical bladder cancer, or uninvestigated haematuria and all patients should be assessed for risk factors. These include:

• age
• current or history of smoking
• previous pelvic irradiation
• exposure to certain occupational or chemotherapy agents, for example cyclophosphamide.

Additionally, treatment in the elderly should be carefully considered due to their increased risk of bladder cancer.

In patients who are prescribed pioglitazone, the risk-benefit should be considered after 3–6 months and patients swapped to other treatment (if appropriate).

Two pioglitazone-containing products are available in the UK: pioglitazone alone (Actos) and pioglitazone plus metformin (Competact).