A recent study funded by the Ontario Ministry of Health and Long Term Care and published on August 19, 2009, in the
British Medical Journal has found that patients taking Actos have a lesser risk of developing heart failure or dying than patients taking rival drug
Avandia. Researchers studied prescription data for nearly 40,000 patients age 66 and older who took Avandia or Actos between April 2002 and March 2008. However, despite the lessened risk, experts said patients with heart failure should avoid taking Actos. Actos has been linked to a risk of congestive heart failure.

While the study found Actos to present a lower potential risk of heart failure than Avandia, the study found no significant difference between Actos and Avandia when it came to a risk of heart attacks.
Meanwhile, a 24-week post-marketing safety study was performed to compare Actos to glyburide (a drug that is also used to treat type 2 diabetes and is in a class called sulfonylureas) in uncontrolled diabetic patients. Over the course of the study, overnight hospitalization for congestive heart failure was reported in 9.9% of patients on Actos compared to 4.7% of patients on glyburide.
A 2005 study found that patients in the high risk group who were taking Actos had an increased risk of weight gain, edema, non-serious hypoglycemia and heart failure. The study, called the PROactive Study, was published in 2005 in the medical journal
The Lancet.
According to a "Dear Colleague" letter, found online at fda.gov and sent by Takea and Eli Lilly and Company, Actos has been found to cause fluid retention, which can lead to heart failure.
In 2002, the package label included the following warning regarding the risk of Actos side effects: "In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin." In July, 2004, the label was changed to add "Carcinogenesis, Mutagenesis, Impairment of Fertility" to the precautions.
Actos is used to treat type 2 diabetes, sometimes in conjunction with insulin. It was initially approved for use in 1999.