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Clearwater Florida Actos LawyerIn September of 2010, the FDA began a formal safety review of the Type-2 diabetes drug Actos (pioglitazone) after receiving disturbing preliminary data mid-way through a 10-year clinical trial which showed a significant increase in bladder cancer among patients taking the drug.  The data did not indicate an across-the-board risk of bladder cancer among all patients; rather, the risk of bladder cancer rose with increasing dose and duration of pioglitazone use.  The study data showed a 40% increased risk of bladder cancer in patients taking the drug for more than one year.

New Warning of Bladder Cancer With Use of Diabetes Drug Actos

Recently, on June 16, 2011, the FDA officially announced that patients who use Actos for more than one year have an increased risk of developing bladder cancer. The risk for bladder cancer will be added to the labels of Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended release), and Duetact (pioglitazone/glimepiride). The ten-year study on which the new warnings are based will be completed in 2012. The FDA says people currently taking Actos should continue taking it until advised otherwise by their health professional. Those who are concerned about the possible risk of bladder cancer should talk to their health care provider. 

Facts About Actos (pioglitazone)

  • Actos had sales of $4.8 billion in the last fiscal year making it Japan-based Takeda Pharmaceuticals’s best selling drug.

  • Pioglitazone is sole as a single-ingredient product under the brand name Actos.  Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).

  • Actos is used along with diet and exercise to improve control of blood sugar in adults with Type-2 diabetes.

  • From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing drug.

Tampa Actos Attorneys

If you are currently taking Actos, you should continue taking the medication until you discuss your concerns with your health professional.  If you or a loved one has taken Actos, Actoplus Met, Actoplus Met XR, or Duetact and have been diagnosed with bladder cancer, please contact Tampa Actos attorneys with the law firm of Alley, Clark & Greiwe for important information regarding your legal rights.

Helpful Consumer Links on Actos

Click here to read the FDA Press Announcement from June 2011

Click here to read the FDA Press Announcement from September 2010

Click here to read the text or listen to an FDA Podcast from September 2010

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