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Actos (Pioglitazone): Bladder Cancer Risk

Bladder Cancer Risk from Actos (pioglitazone).  On June 15, 2011 the U.S. Food and Drug Administration (FDA) announced that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. 

Actos is manufactured by Takeda Pharmaceuticals and was first approved for Diabetes Type II in 1999. The FDA announced in 2010 that although Takeda Pharmaceuticals had conducted their own planned data review which indicated no statistically significant association between Actos and bladder cancer, the FDA’s own analysis of that data indicated that a correlation between the length of time patients were taking Actos and the development of bladder cancer was significant.   

An increased risk of bladder cancer was observed among patients with longer exposure and higher cumulative doses of Actos.  This same drug is also in Actoplus Met, and Actoplus Met XR, as well as Duetact. In August 2011, the FDA required updated drug labels for Actos which included that use of this drug for over one year may be associated with an increased risk of bladder cancer.  The FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.

Our firm is concerned that the data review by Takeda Pharmaceuticals demonstrated a statistical correlation between the length of time of Actos usage and the development of bladder cancer.  Takeda Pharmaceuticals appears aware of this correlation and has not taken the necessary steps to advise patients. If you have taken Actos or any pioglitazone derivative medication for over a year and have developed bladder cancer our firm is reviewing these cases.  Please contact our office for a free review.



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