Pioglitazone and bladder cancer - Diabetes
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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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