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Actos (Pioglitazone) is Being Reviewed by the FDA for Risk of Bladder Cancer
by admin on: June 24th, 2011

Actos is a brand name formulation of a drug known as pioglitazone (or pioglitazone hydrochloride). This pharmaceutical agent may be prescribed as a ???monotherapy,??? although many physicians prescribe Actos as part of an adjunct therapy for managing a patient???s glycemic index.

In most cases, the patients that require Actos are diagnosed with the most common form of diabetes: type 2 diabetes mellitus. In the United States, it is estimated that millions of Americans have been diagnosed with this form of diabetes.

People diagnosed with type 2 diabetes fall into one of two condition categories:

  • the body of the patient does not produce a sufficient amount of insulin, or
  • the insulin produced by the body is not recognized by the body and, therefore, is not used.

Through the pharmacological actions of Actos, a person???s body may be better able to control the level of blood sugar. In fact, the actions of Actos assist a patient’s ability to not only handle glucose metabolism, but also better manage lipid metabolism.

While Actos has been effective in managing diabetes, there is preliminary data that Actos poses a risk for developing bladder cancer. The U.S. Food and Drug Administration (FDA) announced September 17, 2010 that it is reviewing data on the subject. The data comes from two sources:

  • a five-year study
  • an ongoing study (a 10-year observational study)

Both studies are being conducted by the drug manufacturer, Takeda Pharmaceuticals (North America, Inc.). The early results from these studies indicate that there is no overall association between patients taking Actos and risk for developing bladder cancer; however, patients that have the longest history of taking Actos (therefore, have the highest cumulative dose of Actos) show an increased risk for bladder cancer.

Actos is classified as a peroxisome proliferator-activated receptor agonist. Avandia (rosiglitazone) is also in this class of drugs, although there is no current data demonstrating any association with Avandia and bladder cancer.

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