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EMA issues new recommendations for use of pioglitazone

The European Medicines Agency (EMA) has announced new guidelines for the use of pioglitazone, which can be found in the medicines Actos, Glustin, Competact, Glubrava and Tandemact. Actos is used along with diet and exercise to control blood glucose levels in adults with Type 2 diabetes. The announcement follows recent studies which indicate a small increased risk of developing bladder cancer.

Valid treatment option

The EMA’s Committee for Medicinal Products for Human Use (CHMP) carefully reviewed these studies and confirmed that pioglitazone remains a valid treatment option for patients with Type 2 diabetes. However, the CHMP concluded that pioglitazone should not be used for patients with active bladder cancer or who have a history of bladder cancer.

Healthcare professionals are being advised to review the treatment of patients on pioglitazone regularly to ensure that only patients that are benefiting from this drug continue using it.

The CHMP concluded that the benefits outweigh the risks in patients that are responding well to pioglitazone and who have no other viable treatment options. However, the CHMP advises healthcare professionals to undertake careful selection of patients and closely monitor treatment response.

The benefits outweigh the risks

Simon O'Neill, Director of Care, Information & Advocacy Services at Diabetes UK, said, "Diabetes UK believes patient safety is of paramount importance and has welcomed the review of the increased bladder cancer risk of taking pioglitazone (Actos).

"Research trials show Actos reduces the incidence of heart attacks and stroke. People with diabetes are at increased risk of cardiovascular complications if their condition is poorly managed. Evidence shows that the benefits outweigh the risks of taking Actos for people with diabetes.

"The EMA has decided that Actos remains a valid treatment for Type 2 diabetes. However, doctors should not prescribe the drug to anyone who has or has had bladder cancer. In addition, older people should be carefully assessed before starting treatment and then regularly reviewed due to age-related risks.

"If anyone taking Actos has concerns, we recommend they should not stop taking it without talking to their healthcare team first. People should be given information about the risks and benefits of all the relevant and available treatment options to them so that they can reach an informed decision about their best option with their healthcare team."

If you are affected by this issue, you can contact the Diabetes UK Careline on 0845 120 2960*

The full announcement can be read on the EMA’s website.

*The cost of calling 0845 numbers can vary according to your provider, your tariff and when you are calling. Check with your own provider for details. From BT domestic landlines the call may be free or may cost up to 7.6p per minute with a set up charge of up to 11.5p. From landlines on a standard BT business tariff with no special call package, calls cost 3.36p+VAT. Calls to 0845 numbers from mobiles cost considerably more. Alternatively, you may wish to call 020 7424 1000 and ask Reception to transfer your call to the Careline.

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