The FDA released last Friday newly updated label information for pioglitazone (Actos) and medications that contain Actos. The new labeling warns that use of Actos 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 the use of the drug.