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  • Diabetes drugs Actos, Actoplus Met, Actoplus Met XR and Duetact linked to bladder cancer
  • More than 12 months of use causes 40% increase in bladder cancer risk
  • FDA ordered warnings for all pioglitazone-containing drugs in June 2011
  • Germany and France pulled the pioglitazone drugs from the market in June 2011

Attorney Kim Truongle on the dangers of Actos and Bladder Cancer


Pioglitazone is one of the best-selling diabetes drugs in the United States. In 2010, the pioglitazone-containing drugs Actos, Actoplus Met, Actoplus Met XR, and Duetact were prescribed to over 2.3 million people. In spite of its widespread use and popularity, these drugs have recently been associated with life-threatening side effects. Both France and Germany have withdrawn pioglitazone products from the market because of safety concerns associated with bladder cancer. This action was based on a clinical study conducted by the French National Health Insurance Plan using 1.5 million diabetic patients treated with pioglitazone. The study showed that pioglitazone treatment for over 12 months carried a 40% increased risk of bladder cancer. Further, the risk of shorter-term treatment causing bladder cancer cannot yet be excluded.

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In the United States, these findings coupled with its own investigation led the FDA to issue a Safety Alert and order that warnings be added to the labels of all pioglitazone medications. The mandatory warnings acknowledge the increased risk of bladder cancer – a risk which increases with longer duration and higher doses. The FDA advised doctors to avoid using pioglitazone in patients with active bladder cancer and to weigh the risks and benefits when there is a history of bladder cancer.


Takeda Pharmaceuticals, the manufacturer of Actos, Actoplus Met, Actoplus Met XR and Duetact, owes a duty to its consumers to provide a safe and effective drug and to warn of the potential dangers associated with its use. By placing Actos and the other drugs on the market without adequate warnings of the potential dangers, including bladder cancer, Takeda has ignored this responsibility. Takeda must now compensate those patients who by merely seeking treatment for their diabetes are now suffering from bladder cancer.

Message from Howard Nations

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