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On June 15, 2011, the US Food and Drug Administration (FDA) issued a Safety Announcement to inform the public about the link between the Type 2 diabetes drug Actos (pioglitazone) and bladder cancer. The FDA issued the Actos bladder cancer Safety Announcement after an interim review of an ongoing 10-year epidemiological study conducted by Actos manufacturer Takeda Pharmaceuticals, Inc. The study found exposure to Actos for longer than 12 months is associated with a 40 percent increased risk of developing bladder cancer.

Actos became the third medication in the thiazolidinediones (TZD’s) class of diabetes drugs to be associated with dangerous side effects. Previously, the FDA issued a Safety Announcement concerning Avandia, another diabetes medication. Avandia, which had been associated with an increased risk of heart attack, was severely restricted by the FDA in 2010. 

The first TZD to be withdrawn from the market was Rezulin. The manufacture of Rezulin agreed to withdraw the drug from the market in 2000 after a review of safety data on Rezulin, Avandia and Actos showed that Rezulin is more toxic to the liver than the other two drugs.

The Safety Announcement concerning the deadly Actos side effect was also influenced by a retrospective cohort study with data from the French National Health Insurance Plan. The study, which followed 1.5 million people with diabetes for up to four years (2006-2009), showed that there was a “statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents.” The study indicated that both increased dosage and duration of pioglitazone use was associated with an increased risk of bladder cancer.

Based on the results of the French study, both France and Germany took swift action in suspending the use of pioglitazone-containing drugs (Actos, Competact). In the United States, however, the FDA only mandated that information about the risk of bladder cancer be added to the Warnings and Precautions section of the label for Actos.

Additionally, the FDA issued recommendations to healthcare professionals regarding the use of pioglitazone, stating that patients should not be given the drug if they have active bladder cancer.

The FDA also recommended that healthcare practitioners “use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”

Read the FDA’s Safety Announcement regarding the Actos bladder cancer risk.