National regulators in Australia and the United Kingdom (UK) have issued safety advisories on the association between pioglitazone use and bladder cancer. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age.
In an updated review in 2016, the U.S. Food and Drug Administration (FDA) concluded that use of pioglitazone may be linked to an increased risk of bladder cancer. The FDA advised that pioglitazone should not be used in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.
Contra-indicated in patients with established NYHA Class III or IV heart failure.
