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Diabetes Drug Actos Linked to Bladder Cancer
Actos (generically known as pioglitazone), ACTOplus met (pioglitazone HCI and metformin HCI), Actoplus met xr (pioglitazone HCI and metformin HCI extended-release) and Duetact (pioglitazone HCI and glimepiride) are used to treat type 2 diabetes. The manufacturers of Actos (pioglitazone) warned doctors that the drug may cause or worsen congestive heart failure and that Actoplus met and Actoplus met xr can cause lactic acidosis, but did not warn that the drug may cause bladder cancer.
On July 15, 2011, the FDA announced (FDA 6.15.11 Safety Announcement) that the use of the diabetes medication Actos for more than a year may be associated with an increased risk of bladder cancer. The agency’s information was based on its review of data from an ongoing ten-year study. That study showed that an increased risk of bladder cancer was noted among patients with the longest exposure to Actos and the highest cumulative dose of Actos.
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” (FDA 6/15/11 Announcement.) This finding prompted the FDA to add a warning to the medication label.