FDA Looking at Possible Actos Bladder Cancer LinkSep 20, 2010 | Parker Waichman LLP
The diabetes drug Actos (pioglitazone) is the subject of a Food & Drug Administration (FDA) safety review, after preliminary results of a study indicated that it may be associated with an increased risk of bladder cancer.
Actos was approved in 1999 to improve glycemic control in adults with Type 2 Diabetes. The drug, which is in a class of medications known as thiazolidinediones (TZD), works by reducing insulin resistance.
According to the FDA, Takeda, the maker of Actos, has been conducting a 10-year observational study designed to evaluate the risk of bladder cancer associated with Actos. Early (5-year) results showed no overall association between Actos exposure and risk of bladder cancer. However, according to the FDA, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.
At this time, the FDA’s review is ongoing, and the agency has not concluded that Actos increases the risk of bladder cancer. The FDA is reviewing the data from this observational cohort study and a case control study that is nested within it, and will update the public in several months when the review is complete or earlier should additional data become available.
For the time being, the agency is advising that:
• Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Actos.
• Patients should continue taking Actos unless told otherwise by their healthcare professional.
• Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.