FDA reviews potential bladder cancer risk with Actos

The FDA has notified healthcare professionals and patients that it is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone, from Takeda) is associated with an increased risk of bladder cancer. At this time, the FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.

Takeda had conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

When prescribing Actos, healthcare professionals should follow the recommendations in the drug label. Patients should continue taking Actos unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.

Actos is a thiazolidinedione indicated as an adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226257.htm.