The U.S. Food and Drug Administration today announced it has begun a safety review [1] of the diabetes drug pioglitazone (Actos), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.[2]

The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between pioglitazone exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to pioglitazone and in those with the highest cumulative dose of the drug.

At this time, the FDA’s review is ongoing. The agency has not concluded that pioglitazone increases the risk of bladder cancer. Pioglitazone is used to control blood sugar in patients with T2DM. It is in the class of drugs known as peroxisome proliferator-activated receptor or PPAR agonists. The only other drug in this class is rosiglitazone (Avandia, GlaxoSmithKline). The FDA has no clinical information associating rosiglitazone with bladder cancer in patients receiving that drug.

Patients should talk to their health care professional if they have concerns about pioglitazone. They should not stop taking the drug unless told to do so by their health care professional.

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For more information
[1] Ongoing Safety Review of Pioglitazone and Increased Risk of Bladder Cancer
[2] Seer Stat Fact Sheets: Urinary Bladder. National Cancer Institute Web site. Bethesda, MD. Accessed September 16, 2010.

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