The FDA Safety Announcement says "Actos is used along with diet and exercise to control blood sugar or improve control of blood sugar in adults with type 2 diabetes mellitus. Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.1 The drug manufacturer, Takeda, has 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. 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. "
In June 2011,
Suspension of use of these medicines in France while Europe-wide review continues.
In August 2011, The FDA has issued a warning of elevated risk to patients who have been taking Actos®.
The updated drug labels recommend that healthcare professionals should:
• Not use pioglitazone in patients with active bladder cancer.
• Use pioglitazone with caution in patients with a prior history of bladder cancer.
The updated drug labels recommend that patients should:
Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.
The active ingredient in Actos® is also contained in other drugs, named Actoplus Met®, Actoplus Met XR®, and Duetact®. Although Actos® continues to cause bladder cancer, it is still sold in the United States.
Actos® is under a long-term investigational study by the FDA.
