Approval has been issued by the FDA for updated label information on pioglitazone (Actos) and medications that contain it. This follows its warning in June 2011 regarding a risk of bladder cancer with use of pioglitazone, a warning that came just days after France and Germany banned use of the drug.
According to the new label warnings, use of pioglitazone for more than a year may increase the possibility of bladder cancer, a finding based on an interim analysis of an epidemiological study of almost 200,000 diabetic patients in which a 1.4-fold increased risk of bladder cancer with 2 years of pioglitazone treatment was found.
Pioglitazone/metformin (Actoplus Met), pioglitazone/metformin extended release (Actoplus Met XR), and pioglitazone/glimepiride (Duetact) will also carry the new warning.
The updated label advises against the use of pioglitazone in patients with active bladder cancer and recommends cautious use in those with a history of bladder cancer. Also, for patients experiencing any potential symptoms of bladder cancer, including blood in their urine, urinary urgency, or pain on urination, the warning urges them to contact their healthcare provider.
Pioglitazone is the second medication in the thiazolidinedione (TZD) class to be linked with serious side effects. In the fall of 2010, due to concerns over heart attack risk, the use of rosiglitazone (Avandia) was severely restricted in the United States.