Australia, 18 July: The TGA is advising health professionals and consumers that use of the diabetes medicine, pioglitazone, for more than a year may be associated with an increased risk of bladder cancer.
This advice is partly based on the results of a study in the United States indicating a possible increase in bladder cancer risk among patients taking pioglitazone for more than two years, compared with diabetes patients who are not taking the medicine1. The study found an increased risk of bladder cancer in patients with the longest exposure to pioglitazone. The chance of developing bladder cancer in patients on pioglitazone for greater than 24 months was 1.4 times the chance in diabetic patients not on pioglitazone.
This advice is also based on a preliminary assessment of a recent study in France which suggests a similarly increased potential risk of bladder cancer with pioglitazone treatment for more than one year.
To put these results into context, one thing to consider is the 'normal' incidence of bladder cancer. Incidence of bladder cancer varies from group to group, depending on risk factors such as age, gender, cigarette smoking and occupational exposure to certain chemicals. The Australian Institute of Health and Welfare estimated there would be around 2500 new cases of bladder cancer in Australia for 2010, about three-quarters of these in males2.
The Product Information (PI) and Consumer Medicine Information (CMI) for the Actos brand of pioglitazone have been updated and the sponsor of the Actos brand has also written to health professionals advising them of the changes to the Product Information. The TGA is working with the other sponsors of pioglitazone medicines to update the PI and CMI to include the results of the United States study.
Pioglitazone is under review by a number of international regulators. Pending the outcome of their reviews, regulatory agencies in France, Germany and Mauritius have suspended the use of pioglitazone. Other regulators in Europe (EMA) and the US (FDA) have issued safety statements.
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