Actos has been Linked to Bladder Cancer

The federal Food and Drug Administration has issued a warning to all diabetics who take Actos (generically known as pioglitazone), a popular drug for treatment of type 2 diabetes mellitus, that continued use of the medication for more than 12 months increases the risk of bladder cancer. 

Cancer Risk Jumps 40%

A ten-year evaluation of diabetic patients’ treatment and outcomes was conducted on approximately 200,000 individuals participating in the Kaiser Permanente Northern California health plan.  The FDA analyzed interim data from that study and found that diabetics who took Actos for more than 12 months had a 40% greater chance of developing bladder cancer – a significant increase in risk.

European Study Finds Significant Increase in Risk

Similar results were obtained in a French study involving 1.5 million patients with diabetes between the years 2006 and 2009.  The results of that analysis lead France to ban completely the sale of Actos, while Germany chose to prohibit new prescriptions of the medication.

Actos and Metformin Combination Drugs Increase Risk of Bladder Cancer

The manufacturer of Actos, Takeda Pharmaceuticals America, Inc., is required to issue warnings about its drug’s risks.  These warnings extend beyond Actos, to include these metformin combination drugs:

  • Actoplus Met,
  • Actoplus Met XR, and
  • Duetact (glimepiride)

Patients and physicians must be warned that diabetics who currently have bladder cancer should not be prescribed Actos or any Actos/metformin combination drugs.  Patients who previously have had bladder cancer should be cautious about using the medications given the increased finding of bladder cancer after long-term use.

Know the Symptoms of Bladder Cancer

In 2010 alone, more than 2.3 million patients filled a prescription for Actos or an Actos/metformin combination drug.  All of these individuals should be aware of the symptoms of bladder cancer, including the following:

  • Blood or red color in urine;
  • Urgent need to urinate or pain while urinating; and
  • Pain in back or lower abdomen.

Final analysis of the data obtained from the diabetic study group has not been completed; however, the data to date is clear that use of Actos for more than one year is associated with a significant increase in risk for bladder cancer.  All diabetic patients should discuss this risk with their physician and be diligent in monitoring their health for signs of bladder cancer.  Anyone who develops bladder cancer while taking Actos or a combination drug that includes Actos should act promptly to secure their rights.

Fibich Hampton lawfirm can be reached at 713-751-0025 or 888-751-7050


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