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FDA NOTE TO CORRESPONDENTS

For Immediate Release: Sept. 17, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reviewing preliminary safety information on Actos (pioglitazone)

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

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 Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos 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 Actos increases the risk of bladder cancer.

Actos is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone).  The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug. 

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

For more information

Ongoing Safety Review of Actos (pioglitazone) and Increased Risk of Bladder Cancer

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