New Actos Study Confirms Bladder Cancer Risk

Published on April 8, 2016 by Sandy Liebhard

Yet another study has tied  Actos to the development of bladder cancer. This time, Canadian researches found that use of the Type 2 diabetes drug might increase a patient’s risk for the disease by as much as 63%.

Actos (pioglitazone)  was approved by the U.S. Food & Drug Administration in 1999,  and belongs to a class of medications called thiazolidinediones. These medications help lower blood sugar levels by increasing the body’s resistance to insulin.  In 2011, the Actos label was updated to included information about bladder cancer, after a clinical trial indicated that long-term use of the drug was associated with a higher risk of the disease. But other studies have produced conflicting findings.

In an attempt to obtain clarification, researchers at Canada’s McGill University analyzed data from the UK Clinical Practice Research Database (CPRD), which followed 145,806 patients newly treated with diabetes drugs between 2000 and 2013.  Patients were followed for a mean of 4.7 years.

After taking account of  age, sex, duration of diabetes, smoking status, alcohol-related disorders and other issues that could influence outcomes, the study team determined that use of Actos was associated with an overall 63% increased risk of bladder cancer. The risk increased with higher doses and length of time on the drug.

When compared with another thiazolidinedione called Avandia (rosiglitazone), Actos was associated with  48 percent increased risk of bladder.

“The results of this large population based study indicate that pioglitazone is associated with an increased risk of bladder cancer,” the study authors concluded. “The absence of an association with rosiglitazone suggests that the increased risk is drug specific and not a class effect.”

Actos Bladder Cancer Settlement

In 2015, Takeda Pharmaceuticals, the manufacturer of Actos, agreed to pay at least $2.37 billion to settle bladder cancer claims involving the medication. The accord resolved more than 9,000 lawsuits filed on behalf of patients who allegedly developed the disease due to their use of Actos. Takeda did not admit to any liability in agreeing to the Actos settlement