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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. In 2008, Actos was the tenth best selling pharmaceutical, with sales over $2.4 billion. In 2009, sales reached $3.4 billion.

The Controversy

While research initially suggested Actos may be safer than Avandia, subsequent studies have cast doubt on this assertion. In 2007, a report in the Journal of the American Medical Association revealed that while Actos did show beneficial effects amongst diabetic patients, it also significantly increased the risk of serious heart failure. In another study, Actos and Avandia exhibited no significant differences with regards to their propensity to increase the risk of acute myocardial infarction, acute heart failure, or death.

Actos has also been associated with an increased risk for bone fractures, particularly in females. For example, one study found that both postmenopausal women taking Actos, and men taking Actos and a diuretic, were at an increased risk for fractures. Another study reached similar conclusions for both men and women, but also found that fracture risk was increased even in younger women. Finally, a collaboration between Medco Research and the University of Texas Health Sciences Center presented data to the American Diabetes Association which suggested that while both men and women were at risk of fractures, men took a longer period of time before experiencing a fracture. In all of the aforementioned studies, no differences between Actos or Avandia were observed.

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.


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

  • Bone fractures, especially around the hands, arms, feet, ankles, and lower legs
  • Bladder cancer
  • Heart attack
  • Congestive heart failure
  • Hepatitis
  • Liver failure
  • Inflammation of the liver
  • Unusually rapid increases or decreases in weight
  • Fluid retention (edema)
  • Shortness of breath
  • Unexplainable confusion, fatigue, and weakness
  • Chest pains

Contact Us

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 Kondos & Kondos today. Attorneys are available by phone, e-mail, or by clicking here.