The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data is taken from a planned 5 year analysis of an ongoing 10-year epidemiological study designed to examine the association of the drug with bladder cancer, following earlier studies suggesting a possible risk. Although the current analysis found no overall association between pioglitazone and bladder cancer, a further analysis found an increase in bladder cancer in those taking the highest cumulative doses of the drug and in those with the longer exposure to the drug.
The FDA said it has not yet concluded that piolglitazone increases the risk of bladder cancer and advised healthcare professionals to continue to follow the recommendation in the drug label.
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Click here for the FDA communication.
Here is the FDA press release:
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 (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.
For more information
Ongoing Safety Review of Actos (pioglitazone) and Increased Risk of Bladder Cancer