Question: I’ve been on pioglitazone for 3 years and heard it might be link to bladder cancer. Should I stop taking it?

Last June 15, 2011, The U.S. Food and Drug Administration (FDA) informed the public that use of the diabetes medication Pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

This safety information was based on FDA’s review of data from a planned five-year analysis of an ongoing, ten-year study. The five-year results showed that although there was no overall increased risk of bladder cancer with Pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to Pioglitazone, and in those exposed to the highest cumulative dose of Pioglitazone.

The FDA is also aware of an epidemiological study conducted in France which suggested an increased risk of bladder cancer with Pioglitazone. Based on the results of this study, France has suspended the use of Pioglitazone, and Germany has recommended not to start Pioglitazone in new patients.

FDA recommended that healthcare professionals should:

• Not use Pioglitazone in patients with active bladder cancer.
• Use Pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with Pioglitazone should be weighed against the unknown risks for cancer recurrence.

FDA gave additional information for patients, as follows:

• There may be an increased chance of having bladder cancer when you take Pioglitazone.
• You should not take Pioglitazone if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with your Pioglitazone medicine. It explains the risks associated with the use of Pioglitazone.
• Talk to your healthcare professional if you have questions or concerns about Pioglitazone medicines.

On July 21, 2011, there was an Update from the European Medicines Agency (EMA):

Finalizing its review on Pioglitazone-containing medicines and the occurrence of bladder cancer, the EMA’s Committee for Medicinal Products for Human Use (CHMP) confirmed that Pioglitazone remains a valid treatment option for certain patients taking these medicines. However, CHMP also concluded that the small increased risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient’s treatment.

Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic hematuria (visibly bloody urine). Risk factors for bladder cancer should be assessed before initiating Pioglitazone treatment.

The CHMP further concluded that there are some patients who cannot be adequately treated by other anti-diabetic treatments and who will benefit from treatment with Pioglitazone. The committee agreed that it was not possible to further restrict the current indications of Pioglitazone. Instead, prescribers are advised to carefully select patients and monitor response to treatment. In patients responding to treatment, the CHMP concluded that the benefits outweigh the risks.

In summary, you and your doctor will have to weigh the risks and the benefits of stopping or continuing your Pioglitazone. It is difficult to remove the stigma from the word “cancer.” However, it will need to be considered that the dreaded complications of uncontrolled diabetes are far more common than the incidence of bladder cancer. Please discuss this with your doctor thoroughly.

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