The warning comes after a review of data from a five-year analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.
The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
Officials say information about this risk will be added to the label of the drug as well as the patient medication guide.
FDA officials say in light of this new information, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.
New Warning for Actos
The agency says it is also aware of a recent epidemiological study in France that also suggests an increased risk of bladder cancer associated with Actos. Based on this study, France has suspended use of the drug and advised not starting Actos in new patients.
The FDA says people currently taking Actos should continue taking it until advised otherwise by their health professional. Those who are concerned about the possible risk of bladder cancer should talk to their health care provider.