The FDA has approved updated label information for pioglitazone (Actos) and medications that contain it, following its warning in June about bladder cancer risk with the drug.
The new labeling, released Friday, warns that use of pioglitazone for more than a year may increase the risk of bladder cancer, a finding based on an interim analysis of an epidemiological study.
Other medications that will carry the warning include pioglitazone/metformin (Actoplus Met), pioglitazone/metformin extended release (Actoplus Met XR), and pioglitazone/glimepiride (Duetact).
The updated label recommends against use of pioglitazone in patients with active bladder cancer and urges cautious use in those with a history of bladder cancer.
It also urges patients to contact their healthcare provider if they experience any potential symptoms of bladder cancer, including blood in their urine, urinary urgency, or pain on urination.
The original warning on pioglitazone was based on an interim review of an ongoing epidemiological study of almost 200,000 diabetic patients by drugmaker Takeda, and came just days after France and Germany banned use of the drug.
The analysis found a 1.4-fold increased risk of bladder cancer with two years of treatment, although the agency said the finding was of "nominal" significance.
At that time, Takeda said it was "committed to supporting [the 10-year study] through its conclusion at the end of 2012."
Pioglitazone is the second medication in the thiazolidinedione (TZD) class to be associated with serious side effects. Last fall, use of rosiglitazone (Avandia) was severely restricted in the U.S. because of concerns over heart attack risk.