Thursday, June 16, 2011 (Last Updated: 06/17/2011)
THURSDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration has warned consumers and health care professionals that pioglitazone (Actos) may increase the risk of bladder cancer when used for more than one year.
Pioglitazone is a thiazolidinedione, a drug class which also includes the diabetes drug rosiglitazone (Avandia). Rosiglitazone was pulled off the market in May because it was linked to an increased risk of myocardial infarction. Pioglitazone is used to control blood sugar levels and is sold alone or in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).
The new bladder cancer warning will appear on the label of pioglitazone and is based on the FDA's review of data from an ongoing study that involves more than 193,000 patients with diabetes. The data revealed a 40 percent increased risk of bladder cancer in patients taking the drug longer than 12 months as compared to those never exposed to pioglitazone. Both France and Germany recently pulled pioglitazone from the market based on similar findings. The FDA recommends that patients should talk to their health care provider regarding any concerns about the drug and should contact their physician if they are experiencing any symptoms of bladder cancer.
According to the FDA, "the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence."
Hematology & Oncology
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