Actos and Congestive Heart Failure Risk

In addition to bladder cancer, Actos and other pioglitazone-containing medications have been linked to causing and worsening congestive heart failure (CHF) in patients taking the drug. Research suggests that approximately 3% of patients taking Actos may develop the disease. Because of the risk, the FDA in June 2007 ordered that a black box warning—the strongest warning available—be placed on Actos packaging to caution patients about the increased risk of congestive heart failure.

Congestive heart failure is a medical condition in which the heart is unable to pump sufficient blood to the rest of the body. Symptoms of congestive heart failure can include a large weight gain in a short amount of time; swelling of the arms, legs, hands or feet; shortness of breath; abdominal swelling or pain; fatigue; and a dry cough. If you take Actos or any pioglitazone-containing drug and have any of these symptoms, or if you have ever been diagnosed with congestive heart failure, heart disease, or a heart defect, it is important to tell your doctor as soon as possible.