Actos and Bladder Cancer

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Actos (pioglitazone hydrochloride) is a Type II diabetes drug manufactured by Takeda Pharmaceuticals. The drug was originally approved by the FDA to treat Type II diabetes in July of 1999. Actos is a very popular drug in the treatment of Type II diabetes and its popularity was recently elevated due to cardiovascular problems associated with Actos’ main competitor, Avandia. In 2010, Actos grossed $4.3 billion in sales.

Medications including Actos:

Actos™

Actoplus Met™

Actoplus Met ® XR

Duetact™

Actos Warnings and Recall:

After a recent study determined an increased risk of developing bladder cancer, French and German regulators suspended the drug in their respective countries. France pulled the drug from shelves on June 9th of 2011. In the United States, the FDA recently approved a new warning for Actos about the risk of bladder cancer with use of the drug.

The new “Warnings and Precautions” section of Actos’ labeling states that health care providers not use Actos in patients who actively have bladder cancer and with those who have a prior history of bladder cancer. The new labeling also indicates that the risk of bladder cancer is increased with the duration of use.

FDA Investigates Actos:

After a 10 year study determined that users of Actos may face an elevated risk of bladder cancer, the FDA launched a review of the drug in September of 2010. The study found that after the use of a drug containing Actos, the risk of bladder cancer reached a point of statistical significance.

In June of 2011, the FDA concluded that the risk of bladder cancer after using Actos for a year was substantially higher than those who were not taking Actos.

Hardison & Cochran is currently reviewing Actos claims in North Carolina and nationwide.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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