Actos And The Risk Of Bladder Cancer – New Safety Warnings

As reported in IDDT’s July 2011 Newsletter, Actos [pioglitazone] has already been withdrawn in France prior to the conclusions of a review by the European Medicines Agency. This review was completed on July 2011.

In brief, the following applies to people already using Actos or Competact or where their use is being considered as treatment for Type 2 diabetes:

  • Actos should not be used if there is a history of bladder cancer or blood in the urine that has not been investigated with tests.
  • If you are already using or before starting treatment with Actos or Competact, your doctor should assess you for the risk factors stated below.
  • In elderly patients, the use of Actos or Competact should be carefully considered because the risk of bladder cancer increases with age.
  • Treatment with Actos or Competact should only be continued after 3 to 6 months if there is a benefit. Treatment should be stopped in patients who do not respond adequately to treatment with either of these drugs.
  • Similar monitoring should also take place in people already taking Actos.

Here is the actual safety warning has issued by the MHRA.

Safety warnings and messages for medicines
22 July 2011

Pioglitazone (Actos) is used to treat type 2 diabetes, either on its own or in combination with other anti-diabetic medicines. Pioglitazone is also available as a combination tablet with metformin (Competact). A review of pioglitazone and a possible increased risk of bladder cancer conducted by the European Medicines Agency (EMA) concluded on 21 July 2011.

Risk of bladder cancer

The review found that there is a small increased risk of bladder cancer associated with pioglitazone use. It is not clear if the risk increases early in treatment or only after prolonged administration. However, with careful patient selection, the benefits of pioglitazone continue to outweigh the risks.

New recommendations

It is advised that 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.

Before starting pioglitazone treatment the following known risk factors for bladder cancer should be assessed in individual patients: age; current or past history of smoking; exposure to some occupational or chemotherapy agents such as cyclophosphamide; or previous radiation therapy to the pelvic region. Such risk factors should also be considered in those already receiving treatment as part of an overall evaluation of the safety and effectiveness of pioglitazone treatment in individual patients. Use in elderly patients should be considered carefully before and during treatment because the risk of bladder cancer increases with age.

Advice for healthcare professionals

Prescribers should review the safety and efficacy of pioglitazone in individuals after 3–6 months of treatment to ensure that only patients who are deriving benefit continue to be treated. Patients who are already receiving pioglitazone should also commence a similar programme of monitoring. Pioglitazone should be stopped in patients who do not respond adequately to treatment (eg, reduction in glycosylated haemoglobin, HbA1c).

A Direct Healthcare Professional Communication on the risk of bladder cancer with pioglitazone will be circulated shortly to healthcare professionals in the UK.

Advice for patients

Patients should not stop taking pioglitazone without consulting 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 evaluated by their doctor at their next scheduled appointment.

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