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Pioglitazone (Actos)

The Drug

Type 2 Diabetes affects approximately 18-20 million Americans, and is characterized by high blood glucose levels caused by the body’s inability to correctly respond to insulin.  Left untreated, it can lead to blindness, kidney problems, and cardiovascular disease.

Actos, like Avandia, is an anti-diabetic drug classified as a thiazolidinedione (TZD).  Pharmacologically, TZD’s produce a hypoglycemic effect by stimulating the transcription of insulin sensitive genes, ultimately lowering insulin resistance in patients with type 2 diabetes.

Actos was submitted to the FDA by Takeda Pharmaceuticals, and approved in 1999.  It is marketed either alone as Actos, or combined with other active ingredients such as metformin (as Actoplus Met), or glimepiride (as Duatect).  Sales of Actos skyrocketed in 2007 after a report in The New England Journal of Medicine suggested Avandia, its main rival, increased the risk of heart attacks and death[1].  In 2008, Actos was the tenth best selling pharmaceutical, with sales over $2.4 billion.  In 2009, sales reached $3.4 billion.

The Controversy

In 2010, the FDA announced they had found a potential link between exposure to Actos and the development of bladder cancer.  Specifically, when researchers took into account the duration of Actos administration, the risk of developing bladder cancer was significantly increased after 24 months exposure.  In addition, they also reported an increased risk in patients with a high cumulative exposure to Actos [2].


Adverse side-effects associated with the use of Actos include:

  • Bladder cancer

  • Fluid retention (edema)

If you or a loved one has been diagnosed with any cardiac problems, bladder cancer, or bone fractures and have used Actos in the past, please contact Freese & Goss today. Attorneys are available by phone, e-mail, or by clicking here.

[1] Nissen S, Wolski K.  Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.  The New England Journal of Medicine, 2007, 356(24):2457-2471.

[2] FDA.  FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer after Two Years Exposure.  September 17, 2010.

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