The federal Food & Drug Administration has approved updated label information for pioglitazone (Actos), following its warning in June about bladder cancer risk with the drug.
The updated label recommends against use of Actos in patients with active bladder cancer and urges cautious use by physicians in those with a history of bladder cancer.
The new labeling, released by the FDA this past Friday, warns that use of Actos for more than a year may increase the risk of bladder cancer. The findings are based upon scientific studies.
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.
Jones Ward PLC's pharmaceutical injury team is actively evaluating the Actos bladder cancer risk cases. It is simply unconscionable that Takeda continues to sell this drug in the United States after France and Germany banned the drug. It is time to pull this highly profitable drug from the market.
