FDA Reviewing Preliminary Safety Information on Actos (pioglitazone)

FDA notified healthcare professionals and patients that the agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer….

At this time, the FDA’s review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.

The drug manufacturer, Takeda, conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. These early results showed no overall association between Actos exposure and risk of bladder cancer. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

Actos (pioglitazone) 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.

U.S. Food and Drug Administration