British MHRA issues ACTOS bladder cancer warning

British MHRA issues ACTOS bladder cancer warning

A warning has been issued over the diabetes medication pioglitazone (Actos) after it was linked with a small increased risk of developing bladder cancer.

The UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) says patients should not stop taking pioglitazone without seeing their doctor. Patients receiving pioglitazone should immediately report any visible blood in their urine or bladder problems such as pain while urinating or urgency to urinate, to their doctor. Patients receiving pioglitazone will have their treatments assessed by their doctor at their next routine appointment.

The review found that there is a small increased risk of bladder cancer associated with taking pioglitazone, but it is not clear if the risk increases early in treatment or only after prolonged use.

However, it says if patients are selected carefully for this treatment, the benefits continue to outweigh the risks. Pioglitazone should not be used in patients with a history of bladder cancer or in patients with uninvestigated visible blood in the urine. This applies to those being considered for pioglitazone treatment and those already receiving it.

Doctors will be told to review the safety and efficacy of pioglitazone for patients after three to six months of treatment to ensure that only patients who are getting a benefit continue to be treated. Patients who are already receiving pioglitazone will also be monitored. Pioglitazone should be stopped in patients who do not respond adequately to treatment.