Pioglitazone and bladder cancer - Diabetes UK



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|Title |Date |

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|Pioglitazone and Bladder cancer |December 2011 |

|Key points |

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|Reports have linked pioglitazone and bladder cancer. |

|The European Medicines Agency (EMA) has made a decision after reviewing the evidence that pioglitazone is safe to use with |

|prescribing restrictions. |

|Introduction |

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|Following reports of a link between pioglitazone and bladder cancer, the European Medicines Agency (EMA) carried out a safety |

|review of the drug using all the available data from preclinical studies, the PROactive study (1) and population-based |

|studies. |

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|Pioglitazone is a second generation in the group of drugs known as thiazolidinediones. Pioglitazone is an oral treatment for |

|diabetes which improves insulin sensitivity and may help the patient avoid or delay the need for insulin injections. As well |

|as improving diabetes control, it has been shown to reduce the number of heart attacks in people living with diabetes. |

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|Current situation |

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|In July 2011 the EMA’s Committee for Medicinal Products for Human Use (CHMP) found that |

|‘there was a small increased risk of bladder cancer. However, because the Committee considered that there are a number of |

|patients who cannot be adequately treated by other treatments, the Committee concluded that pioglitazone should remain as a |

|treatment option, but that prescribers should carefully select patients and monitor their response to treatment.’ (2) |

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|Diabetes UK calls to action |

|To assist both patients and prescribers the following advice is suggested |

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|Advice to patients |

|Immediately report to your doctor any blood in your urine or any bladder condition such as pain when passing urine or urinary |

|urgency (needing to pass urine without delay) |

|Make sure that your doctor looks at your treatment options at your next appointment. |

|If you smoke, consider stopping. Smoking cigarettes is the principal preventable risk factor for bladder cancer in both men |

|and women. In Europe it is estimated that two-thirds of bladder cancer cases in men and a third in women are caused by |

|cigarette smoking (3) |

|Certain workplace and environmental chemicals have been linked to bladder cancer, for example, substances used in the rubber |

|and dye industries, so tell your doctor if you work or have worked in that type of industry. |

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|Advice to prescribers |

|Discontinue treatment with pioglitazone in those patients who have, or have had, bladder cancer, include those who are |

|awaiting investigation of haematuria. |

|Patients treated with pioglitazone for three to six months should have their treatment reviewed, with treatment discontinued |

|in those not deriving sufficient benefit. |

|Patients’ risk factors for bladder cancer should be considered before commencing treatment; these include age (most common in |

|those older than 50), smoking, exposure to certain chemicals and treatment. such as those used in rubber and dye industries. |

|(4) |

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|Conclusion |

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|The CHMP noted that there are some patients who cannot be adequately treated by other treatments and who will benefit from |

|pioglitazone. Considering the risks associated with pioglitazone and its benefits to some patients, the CHMP concluded that |

|the benefits outweigh the risks in those patients responding well to pioglitazone. Prescribers are advised to carefully select|

|patients and monitor how they respond to treatment. (3) |

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|Further information |

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|Other position statements relating to the conclusion of the EMA |

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|The Association of British Clinical Diabetologists (ABCD) |

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|Primary Care Diabetes Society (PCDS) |

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|References |

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|Last reviewed |December 2011 |

|Due for review |December 2012 |

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