The FDA has issued a warning that there may be an increased risk of bladder cancer for patients who use the drug Actos for prolonged periods of time. Patients exposed to higher cumulative doses of the drug also appear to be at an increased risk of bladder cancer. The warning comes after a 5 year study of Actos by the manufacturer. Notice about this risk will be added to the Warning and Precautions section of the prescription label.
The FDA warns that Actos should not be prescribed to patients who either have bladder cancer or have a family history of bladder cancer. Recent studies in France support these findings and use of the drug Actos has been suspended in France.
The complete Safety Announcement can be found on the FDA website.